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Monday, June 13
 

10:00am CDT

11A: “Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save You
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-22-500-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

The intent of this short course is to provide a quick overview and practical insight into locating, analyzing and applying precedent as an aid to making better strategic regulatory decisions. In a rapidly evolving regulatory environment of drugs and biologics, it is critical for regulatory professionals to employ research skills in locating precedent, determining those that are deemed meaningful and discarding those that are misleading, and developing an understanding of the bigger picture as a critical deliverable in a time of data-driven decision-making.


Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Registration Info Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of full meeting registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides
  • Return to DIA 2022 

    Who should attend?

    This short course is designed for members involved in: Regulatory affairs, regulatory intelligence and policy professionals, professionals engaged in regulatory research and precedent analysis to support regulatory decision-making.

    Learning Objectives

    At the conclusion of this short course, participants should be able to:
    • Recognize the importance and context of precedent in drug and biologics regulatory strategy
    • Identify and analyze precedent from EU and US health authority databases
    • Discuss knowledge of core labeling implementation and deviations
    • Assess the impact of precedent for regulatory decision-making



Moderators
avatar for Linda Bowen

Linda Bowen

Head of Global Regulatory Policy and Intelligence, Seagen Inc., United States
Linda joined the BioPharma industry in 1983 and has spent the last 29 years in regulatory strategy, intelligence and policy roles. She is Global Head of Regulatory Policy and Intelligence at Seagen Inc. and Assistant Professor in the Temple University RAQA graduate program. She attained... Read More →

Speakers
avatar for João Duarte

João Duarte

Director, Business Planning & Operations, Global Regulatory Affairs, R&D and Com, Alexion, Astrazeneca Rare Disease, France
João Duarte is currently Director, Business Planning & Operations at Alexion, AstraZenenca Rare Disease. João serves as Chief of Staff to the Head of Regulatory & Quality Affairs and leads regulatory policy activities within the team. He held several roles since 2012 in Regulatory... Read More →
CW

Chris Whalley

Associate Director, Regulatory Policy and Intelligence, Seagen Inc., United States
Chris Whalley brings 20 years of experience in biotechnology & healthcare operations and is currently Associate Director of Regulatory Policy & Intelligence at Seagen Inc., a biopharmaceutical company focused on oncology therapies. Prior to joining Seattle Genetics, Chris established... Read More →


Monday June 13, 2022 10:00am - 1:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

2:00pm CDT

12P: Defining the Clinical Questions of Interest: Why Everyone Developing a Protocol Should Understand Estimands!
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-501-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

People familiar with the design, conduct and analysis of clinical trials understand efficacy endpoints and their analyses, however the term estimand is not familiar to most non-statisticians. While many groups and large companies are moving forward and implementing ICH E9 R1 as well as incorporating estimands into their protocols, some companies have yet to understand or incorporate the components of an estimand in their trial design.

The final definition of an estimand in ECH E9 R1 is “A precise description of the treatment effect reflecting the clinical question posed by the trial objective. It summarizes at a population-level what the outcomes would be in the same patients under different treatment conditions being compared.“ and “An estimand is a parameter which is to be estimated in a statistical analysis. The term is used to more clearly distinguish the target of inference from the function to obtain this parameter (i.e., the estimator) and the specific value obtained from a given data set (i.e., the estimate).”

Regulatory agencies have not consistently asked for estimands in late-stage trials making it harder for industry to follow. What is needed is a way to simplify and effectively communicate the key concepts around the use of estimands and sensitivity analyses to non-statisticians.

This presentation will share the current status of industry’s understanding and adoption of estimands. Example estimands pertaining to diseases will be reviewed. The presentation will also suggest ways to improve understanding of estimands as statisticians communicate the concepts of ICH E9-R1 to non-statisticians.

Registration info: Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.

Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides

Download Registration Form
Registration Questions? Send Email
1.888.257.6457

Return to DIA 2021 

Who should attend?

Statisticians, non-statisticians, and physicians involved in clinical protocol review or development.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Discuss why the estimand framework and sensitivity analyses as described in ICH E9 are important for non-statisticians to understand
  • Review example estimands and how one can apply the estimand framework to most Phase 2 and 3 studies
  • Apply the Estimand framework and concepts to develop better protocols



Speakers
RJ

Rekha Jhamnani

Medical Officer, DPACC, OND, CDER, FDA, United States
Rekha Jhamnani is a medical officer in the Division of Pulmonology, Allergy, and Critical Care at the FDA. She completed medical school at the George Washington University School of Medicine and internal medicine residency at Georgetown University Hospital. She then completed a fellowship... Read More →
KP

Khalid Puthawala

Medical Officer, DPACC, OND, CDER, FDA, United States
EG

Elisa Gomez-Valderas

Senior Advisor, Eli Lilly and Company, United States
avatar for Munish Mehra

Munish Mehra

Managing Director, Tigermed India, Tigermed, United States
Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across... Read More →


Monday June 13, 2022 2:00pm - 5:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   11: Statistics, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Tuesday, June 14
 

10:00am CDT

21A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved in Clinical Trials
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-502-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

Statistical methods are a powerful tool used in clinical trials to assess whether the data support evidence of a treatment effect. It is therefore key that the results of any statistical analysis are interpreted correctly. However, understanding and interpreting statistical results can be challenging for non-statisticians. In this workshop, participants will be introduced to common statistical methods applied to specific outcomes and their results. Some examples of potential statistical concepts to be covered can include commonly seen hypothesis test, survival analyses, regression modelling, MMRM, and adjusting for multiplicity. Important concepts such as p-values will be explained fully. Idealized examples as well as examples from publicly posted FDA reviews and results on clinicaltrials.gov will be used.

Group discussions using example outputs (including examples from FDA reviews) will give participants the opportunity to apply their learning by critically evaluating statistical analysis approaches and interpreting statistical results, thus giving participants the tools necessary to effectively communicate with their colleagues involved in drug development.


Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Registration info: Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides


Return to DIA 2022

Who should attend?

This course would be of interest to those working in clinical trials with a non-statistical background who would like to gain a high-level understanding of statistical analyses and interpretation so they can communicate with their statistical colleagues more effectively.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Discuss why certain statistical analyses are applied to specific outcomes
  • Assess statistical summaries and extract the important information
  • Evaluate the statistical results using easily understandable language



Moderators
avatar for Stephen Corson

Stephen Corson

Principal Statistician, PHASTAR, United Kingdom
I am a Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of Mathematics... Read More →

Tuesday June 14, 2022 10:00am - 1:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

2:00pm CDT

22P: Machine Learning in Pharmacovigilance
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-503-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

This short course will explore machine learning (ML) within the Regulatory/ Pharmacovigilance (PV) landscape. The instructors will provide a high-level introduction to machine learning, including common tools and project tips. We will then evaluate example applications, such evaluation of Single Case Drug-Event-Pair (DEP) causality using the Modified Naranjo Causality Score for ICSRs (MONARCSi). The course will also focus on important non-technical aspects of using ML in PV, including potential approaches to performance evaluation, monitoring over time, maintaining human oversight, reporting, and legal considerations. Since machine learning requires resources from across the organization, this course is designed for anyone interested in sponsoring or joining a machine learning project within their organization.

Registration Info Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides


Return to DIA 2022 

Who should attend?

This course is designed for anyone with broad interest in PV, Statistics, or Quality that is interested in sponsoring/participating in machine learning projects applied to Pharmacovigilance (PV).

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Discuss key recent advances making Machine Learning in pharmacovigilance practical
  • Identify potential use cases in pharmacovigilance
  • Assess the potential benefits, limitations, and risks of Machine Learning applied to pharmacovigilance



Speakers
avatar for Shaun Comfort

Shaun Comfort

Principal Science Enablement Director, Genentech, A Member of the Roche Group, United States
Dr. Comfort is a Principle Scientific Enablement Director for Roche in Science Enablement and Processes, leading innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 20 years combined biopharma industry/regulatory experience. Dr. Comfort’s current... Read More →
avatar for Bruce Donzanti

Bruce Donzanti

PV Consultant, Self, United States
Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while... Read More →
avatar for Robert Ball

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World... Read More →
avatar for Sunita Dhar

Sunita Dhar

Executive Medical Group Director, Genentech, United States
Sunita Dhar is an Executive Medical Group Director in Clinical Safety and the Franchise head for the I2O portfolio at Genentech. Sunita joined the industry after 12 years of clinical practice and has over seventeen years of experience in drug development, safety science, and pharmacovigilance... Read More →
avatar for Phil Tregunno

Phil Tregunno

Head of Vigilance Operations, Safety & Surveillance, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Head of Vigilance Operations within the MHRA's Safety & Surveillance function and has over eighteen years of experience working in pharmacovigilance. Prior to his current role Phil spent nine years leading and developing the Signal Management function, including systems... Read More →


Tuesday June 14, 2022 2:00pm - 5:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   01: ClinSafety-PV, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

2:00pm CDT

23P: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-22-504-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

This short course will provide an overview of how real-world evidence is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December 2019, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements, including highlights from the recent draft guidance documents in 2021. Although much of the focus will be on FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data.


Download Registration Form
Registration Questions? Send Email
1.888.257.6457

Registration Info Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of full meeting registrationregistration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides


  • Return to DIA 2022 

    Who should attend?

    Professionals involved in or interested in learning about real-world evidence, real-world data, epidemiology, clinical research, regulatory and technology development.

    Learning Objectives

    At the conclusion of this short course, participants should be able to:
    • Discuss how regulators are using RWE for regulatory decision support
    • Describe the concept of RWE being “fit for purpose” including the importance of relevant data and methodologic rigor
    • Identify how RWE can be assembled and integrated to generate a compelling message



Speakers
avatar for Jaclyn Bosco

Jaclyn Bosco

Senior Director, Global Head, Epidemiology, IQVIA, Real World Solutions, United States
Dr. Jaclyn Bosco is the Global Head of Epidemiology in Real World Solutions at IQVIA. With her practical experience leading observational and low-intervention research studies in North America, Europe, and Asia-Pacific regions, she develops strategies for using real world study methods... Read More →
avatar for Matthew Reynolds

Matthew Reynolds

Vice President, Real World Evidence, IQVIA, United States
Dr. Reynolds is a member of the Center for Advanced Evidence Generation, Real World Solutions at IQVIA. He designs innovative solutions for real world evidence on effectiveness and safety. Dr. Reynolds brings more than 20 years of diverse experience in non-interventional research... Read More →
avatar for Robert Reynolds

Robert Reynolds

Vice President, Epidemiology & Patient-Centered Outcomes, GSK, United States
Dr. Reynolds is Vice President, Epidemiology & Patient-Centered Outcomes in Value Evidence and Outcomes, part of Research and Development at GSK. He heads a group responsible for leading the epidemiologic and patient components of integrated evidence plans. He is also an Adjunct Associate... Read More →
avatar for Rachel Sobel

Rachel Sobel

Executive Director, Head of Pharmacoepidemiology, Global Patient Safety, Regeneron, United States
Dr. Sobel has over 24 years of experience in epidemiology, risk management, and registries. She is currently Head of the Pharmacoepidemiology department at Regeneron in Global Patient Safety and has held roles of increasing responsibility at Pfizer Inc and UBC, a CRO. She has extensive... Read More →


Tuesday June 14, 2022 2:00pm - 5:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Wednesday, June 15
 

10:00am CDT

32A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-506-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

The short course will provide an overview of the development of a cross functional quality strategy framework in an R&D QA organization which, when implemented will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle. Business and operations risks are not addressed in this course. Examples will be workshopped to demonstrate how this methodology can help assure confidence in the quality oversight in preparation for submission to regulatory agencies and for inspections. The value of this approach will be shown, revealing the positive impact on drug development and the potential for enhanced relationships with regulatory agencies.




Download Registration Form


Registration Questions? Send Email
1.888.257.6457 Registration Info Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.

Upon completion of full meeting registration participants will gain access to the following:
  • Live Event Access
  • Presentation Slides

    Return to DIA 2022 

    Who should attend?

    This short course is designed for members involved in Clinical Quality Assurance, R&D Quality Assurance, Clinical operations, Clinical Auditees, and Inspection Management.

    Learning Objectives

    At the conclusion of this short course, participants should be able to:
    • Describe the risk process
    • Design a strategy to manage risk throughout the drug development lifecycle including establishing Quality Tolerance limits
    • Discuss approaches to implementation of a cross functional quality strategy framework that will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle



Speakers
avatar for Matt Burtt

Matt Burtt

Director Clinical QA, AbbVie, United States
After completing a Biomedical Engineering undergraduate degree, I built upon my internship with Abbott (eventually AbbVie) in a 2 year rotational program with different assignments every six months across the business landscape. Since then I've been in the R&D Quality Assurance world... Read More →
avatar for Arun Mathew

Arun Mathew

Associate Director, Abbvie, United States
Business process owner for quality risk management in R&D(2.6yrs) Risk Management experience(19 yrs.) Medical devices experience (16yrs). Contributed and reviewed the book Foundations of Quality Risk Management.


Wednesday June 15, 2022 10:00am - 1:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   08: RD Quality-Compliance, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

10:00am CDT

31A: Global AdPromo: Considerations for Compliance and Success
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-22-505-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

Navigating a global advertising and promotion function can be challenging. Creating a compliant and flexible process while bearing in mind regional and country differences along with ensuring processes are not “US-centric” is a common challenge faced by sponsors. Focusing on the EU and Canada, this session will address the foundational regulatory and legal requirements, provide insights into best practices for a global adpromo process, and using case studies and examples, highlight key pitfalls and how to overcome them. The presenters will address the biggest questions faced by sponsors today (eg, direct to consumer messaging, press releases, social media, advertising and promotion v. information, corporate websites) to ensure the development of globally compliant materials while reducing burden on the company.


Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Registration Info Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides


Return to DIA 2022 

Who should attend?

Professionals with intermediate to advanced knowledge of, and experience in, advertising and promotion and who are involved in: Benefit-risk assessment and communication, Medical product safety assessment, Post-market studies and Real-world evidence generation, Regulatory affairs, Medical information, Medical Communications, Medical Affairs, Corporate and Commercial Communications, Customer Engagement Programs, including Patient Support Programs.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Identify various country and regional approaches in the review committee organization and representation
  • Discuss common advertising and promotion pitfalls
  • Describe key regulatory and legal advertising and promotion requirements for EU and Canada



Moderators
avatar for Kimberly Belsky

Kimberly Belsky

Executive Director Reg Policy & Intelligence, AdPromo, RegOps, Regulatory Affair, Mallinckrodt Pharmaceuticals, United States
Kimberly (Kim) Belsky is the Executive Director of Regulatory Policy & Intelligence, AdPromo and RegOps at Mallinckrodt Pharmaceuticals. With over 30 years of global experience in the medical product industry, including 20+ years in regulatory affairs, Kim's diverse experience including... Read More →

Speakers
KT

Karen Timmins

Senior Director, Head of Regulatory International Advertising and Promotion, GRA, Takeda, Switzerland
Karen joined the pharmaceutical industry in 2002, following a successful career in teaching and worked in various sales and marketing roles at Eli Lilly Ireland, BMS, Lilly UK and Shire. Following a successful launch of Elvanse in the UK in 2013 Karen and her family relocated to Zug... Read More →
avatar for Erik Vollebregt

Erik Vollebregt

Partner, AXON Lawyers, Netherlands
Erik's practice focuses on (medical) technology, pharmaceuticals, healthcare and life sciences in regulatory matters and he is active in litigation, commercial and transactional work in all of these fields.
avatar for John Wong

John Wong

Director, Scientific Affairs and Medical Information, TPIreg/ Innomar Strategies, an AmerisourceBergen Company, Canada
John Wong is a pharmacist graduate from Université Laval, Quebec, Canada. He started his career at the Toronto General as an Oncology Pharmacist. In 1998, he joined the Pharmaceutical Advertising Advisory Board (PAAB), a national regulatory body for the review of drug advertising... Read More →


Wednesday June 15, 2022 10:00am - 1:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

2:00pm CDT

33P: Presentation of Safety Risks Throughout the Product Lifecycle Framework: Key Findings and Practical Uses
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-507-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.

The TransCelerate “Interpretation of Pharmacovigilance Guidances and Regulations” (IGR PV) Initiative designed a framework (entitled “A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle”) outlining regulatory requirements and considerations for presenting risks in key required safety-related regulatory documents throughout the lifecycle.

This framework was developed based on specific health authority (HA) guidance documents applicable throughout the product lifecycle to support safety documents such as:
  • Investigator’s Brochure (IB)
  • Development Safety Update Report (DSUR)
  • Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER)
  • Risk Management Plan (RMP)


The information was synthesized into a framework to review the key definitions of risk, provide clarity, and assist with how to handle presenting risks across the lifecycle to meet health authority requirements. Considerations are also offered to help pharmaceutical companies develop approaches for presenting risk through the lifecycle and across relevant safety documents, given differing regulatory requirements over a product’s lifecycle. This framework supports a transparent approach to presenting risks and provides a starting point for collaboration between industry and health authorities to protect and improve the health of trial subjects, patients, and the public.

This session will share key findings that the framework synthesized and discuss practical use cases, such as how it can be used to upskill and educate safety professionals within biopharma organizations. By leveraging this framework, participants will be able to incorporate these key findings and considerations into their organizations and better operationalize the presentation of safety information in key documents.

Registration Info Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.

Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides



Download Registration Form
Registration Questions? Send Email
1.888.257.6457

Return to DIA 2022 

Who should attend?

Professionals in the fields of Pharmacovigilance and drug safety including risk management, periodic reports, therapeutic area safety, signal management, QPPV, etc. as well as clinical development and regulatory.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Explain the framework’s key findings on presenting safety risks across different regulatory documents
  • Analyze concepts from the framework in order to apply these learnings and considerations within their organization
  • Describe real-life examples of how this framework has been used within companies to enhance their process for presenting safety risks



Speakers
avatar for Anju Garg

Anju Garg

Safety Analyses Innovation and Submission Readiness Lead, Sanofi, United States
Anju has been in the pharmaceutical Industry for over 15 years. After appointments at UCB and Schering Plough, Anju joined Sanofi in 2005. Her career has been predominantly in pharmacovigilance as a Safety Officer at the affiliate and global level. She has gained experience in all... Read More →
avatar for Michelle Geller

Michelle Geller

Executive Medical Director, Global Patient Safety, Amgen Inc., United States
Dr. Michelle Geller has spent the last 12 years of her career at Amgen, currently as an Executive Medical Director in Global Patient Safety and a Safety Therapeutic Area Head for the Immuno Oncology TA. She has also led various other product and process teams in the Amgen Global Patient... Read More →
avatar for Frances McNierney

Frances McNierney

Project Manager (Contractor), TransCelerate BioPharma Inc. , United States
Frances has 9 years of experience in strategic project and change management, product launch, and innovation in the life science industry. After being on the supplier side of the pharmaceutical industry, Frances began working with TransCelerate BioPharma Inc. in 2019. Having managed... Read More →


Wednesday June 15, 2022 2:00pm - 5:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   01: ClinSafety-PV, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Thursday, June 16
 

8:00am CDT

41A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-22-508-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review. Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/ My Events

Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides

Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2022 

Who should attend?

This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Explain the major elements of the Japanese regulatory system
  • Describe the regulatory procedures during development, registration, and post-approval
  • Discuss knowledge of core labeling implementation and deviations
  • Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies



Speakers
YA

Yoshitaka Ando

Senior Director, Reguratory & Access Consulting, Parexel International, Japan
Andy has 25 years of pharmaceutical and CRO industry experience. He has supported a numbers of small biotech start-up companies to global pharmaceutical companies to make their regulatory strategy in Japan and facilitated PMDA consultation meetings. He and his team also prepare eCTD... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for all epidemiological activities in PMDA including the projects of MIHARI(Medical Information for risk assessment... Read More →


Thursday June 16, 2022 8:00am - 11:00am CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

2:00pm CDT

42P: Become a DCT Master: Understanding the Lifecycle of Decentralized Clinical Trials
Component Type: Tutorial

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.

With a growing industry trend to incorporate decentralizing solutions in trial design, what does it really mean to run a Decentralized Clinical Trial and how is it any different than running traditional clinical trials? What new technologies are needed, and do these technological advancements require new processes and organizational structure changes? In this short course, you will learn some of the foundational elements of designing decentralized clinical trials/ hybrid trials, and how these advancements in trial design impact all of the stakeholders involved including the patient, sponsor, and site. At the end of the course, you will become Medidata certified in Mastering DCTs.

Registration info: Rate: $350
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides



Download Registration Form
Registration Questions? Send Email
1.888.257.6457

Return to DIA 2021 

Who should attend?

Head of ClinOps, Head of Innovation, Head of Patient Engagement and Recruitment

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Distinguish what defines decentralized clinical trials/hybrid trials and the foundational elements
  • Describe how decentralized clinical trials/hybrid trials operate at the patient and site levels and how to optimize the experience for patients, sponsors, and sites
  • Identify regulatory and privacy considerations when considering decentralizing solutions



Speakers
avatar for Brian Barnes

Brian Barnes

Senior Director, Product Development - RBQM, Medidata, A Dassault Systèmes company, United States
Brian Barnes is a Senior Director, Product Development – RBQM for Medidata Solutions. Brian has 16 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian... Read More →
AH

Aryana Hosseinkhani

Senior Director Product Marketing, Patient Cloud, Medidata, a Dassault Systèmes company, United States
Aryana Hosseinkhani is the Senior Director of Product Marketing in Patient Cloud at Medidata, a Dassault Systemes Company. She completed her education at the University of California, Davis in Genetics and shortly after began working as a bench scientist in stem cell research. Aryana... Read More →
HR

Holly Robertson

Senior Director, Advisory & Enablement Services, Medidata, a Dassault Systèmes company, United States
Holly Robertson is the Sr. Director of Advisory & Enablement Services within the Patient Cloud team at Medidata Solutions, with over 20 years of experience in pre-clinical and clinical research. Dr. Robertson obtained her PhD in Pharmacology from the University of Colorado Health... Read More →
avatar for Michael Tucker

Michael Tucker

Medidata, a Dassault Systèmes Company, United States
Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last six years, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world... Read More →


Thursday June 16, 2022 2:00pm - 5:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
 
Monday, June 20
 

8:00am CDT

Coffee Service
Component Type: Social Event




Monday June 20, 2022 8:00am - 10:00am CDT
Skyline Ballroom Foyer McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

9:00am CDT

Annual Meeting Orientation
Component Type: Forum

First time at the DIA Annual Meeting? We encourage you to attend the Annual Meeting Orientation to learn how to make the most of your time at the meeting and meet fellow first-timers.

Chair

Jeanne Cure


Speakers
avatar for Jeanne Cure

Jeanne Cure

Senior Project Manager, Annual Meeting, DIA, United States
Jeanne Cure serves as the Senior Project Manager, Annual Meeting at DIA. She has been developing and executing content for professional development programs, including workshops, meetings, and web-based trainings for several non-profit associations for over 20 years.
avatar for Chris Matheus

Chris Matheus

Chief Commercial and Networking Officer, Global Life Sciences Alliance (GLSA), United States
Chris has over 25 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and select eclinical companies. Chris establishes strong working relationships with customers and co-workers and has built a significant... Read More →


Monday June 20, 2022 9:00am - 9:45am CDT
Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

10:00am CDT

#100: Opening Plenary: The Future of Healthcare
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-660-L04-P; CME 1.00; RN 1.00

As we emerge from the SARS-CoV-2 pandemic, the importance of inspiration and seeing a future where all people have access to lifesaving interventions has never been greater, and DIA aims to highlight some of the most forward-looking and positive views of what the future of healthcare will be. This year’s format will be presented as a series of perspectives representing diversity of thinking, topic, and geography, to include:

The Future of Healthcare is Inclusive
The COVID-19 pandemic has brought increased awareness to the importance of including the intended population for use of products in their development. Specifically, assuring gender, racial and ethnic, and age-related diversity and inclusion are actively sought and included in the design, testing and implementation of approaches for the treatment and prevention of disease. This presentation will focus on the use of data and analytics, including artificial intelligence to recruit a representative population for a trial.

The Future of Healthcare is Global
Overcoming barriers to access globally requires information sharing, trusted communication, and increased awareness of regulatory science challenges. Collaboration and coordination, as demonstrated by medicines regulatory authorities in times of crisis, can enhance global reliance and cooperation to increase efficiency and bring solutions to the patients that need them.

The Future of Healthcare is Centered on the Individual Patient
Patients have always been at the center of their care but there is growing need and acceptance in clinical R&D that patients are stakeholders in clinical decision making, health IT user experience, and medical product development. Focusing on what matters to patients and gathering feedback through the clinical development pipeline is an important element of improving study quality and ultimately impacting accessibility, perceptions, and market penetration. Patient preferences and satisfaction also serve as indicators for continuous improvement that can drive retention and operational efficiency.

The Future of Healthcare is Digital
Digital technologies such as wearables and video-enabled exchanges now allow for the remote collection of data and interactions with patients. In this talk a patient will share first-hand accounts of the impact of digital access to their health journey and participation in clinical trials.

Learning Objectives

Recognize the diverse sources of data that need to be collected and analyzed to provide customized and improved care; Identify collaborations that can enhance global cooperation to increase efficiency and bring solutions to the patients that need them; Discuss forward-looking and positive perspectives regarding the future of healthcare.

Chair

Barbara Lopez Kunz, MBA, MS, MSc

Speaker

Introduction of Global Awards and Fellows
Judith Ng-Cashin, MD

Honorary Co-Chair
Robert M. Califf, MD

Honorary Co-Chair
Stephanie Y. Crawford, PhD, MPH, MS

Plenary Moderator
Cynthia L. Verst, PharmD, MS

The Future of Healthcare is Centered on the Individual Patient
Kenneth Getz, MBA

The Future of Healthcare is Inclusive
Miruna Sasu, PhD, MBA

The Future of Healthcare is Global
Emer Cooke, MBA, MSc

The Future of Healthcare is Digital: A Patient Perspective
Andre Asbury



Speakers
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

Global Chief Executive, DIA, United States
Barbara Lopez Kunz serves as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s... Read More →
avatar for Judith Ng-Cashin

Judith Ng-Cashin

United States
Judith Ng-Cashin, MD, former Chief Medical Officer at Eagle Pharmaceuticals, leading R&D across the development pipeline and marketed products. Prior to this role, she served as CMO for AOBiome Therapeutics, leading end-to-end asset development strategy, medical governance, and manufacturing... Read More →
avatar for Robert Califf

Robert Califf

Commissioner, FDA, United States
As Commissioner, Dr. Califf oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological... Read More →
avatar for Stephanie Crawford

Stephanie Crawford

Professor, Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago, United States
Stephanie Crawford, PhD, MPH, is Executive Associate Dean for Faculty Affairs & Strategic Initiatives and Professor in the Department of Pharmacy Systems, Outcomes and Policy at the University of Illinois at Chicago College of Pharmacy. Her research focuses on access, disparities... Read More →
avatar for Cynthia Verst

Cynthia Verst

President, Design and Delivery Innovation, Research & Development Solutions, IQVIA, United States
Dr. Cynthia Verst is President, Design and Delivery Innovation, Research & Development Solutions at IQVIA. Having previously served as president of both Clinical Operations and Real World and Late Phase Research for IQVIA, Dr. Verst brings a holistic view of clinical research, and... Read More →
avatar for Kenneth Getz

Kenneth Getz

Executive Director/Professor, Tufts CSDD; Founder/Board Chair, CISCRP, Tufts University School of Medicine, United States
Ken Getz is a Professor and the Executive Director of the Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded studies on pharmaceutical R&D management and execution; protocol design optimization; CRO and investigative site... Read More →
avatar for Miruna Sasu

Miruna Sasu

President and Chief Executive Officer, COTA, United States
With over 20 years of experience leading digital health teams at large pharmaceutical companies, Miruna brings great insight and expertise to her new role at COTA. Since joining the company last year, she has made a significant impact driven by her commitment to better cancer care... Read More →
avatar for Emer Cooke

Emer Cooke

Executive Director, Chair, ICMRA, European Medicines Agency, Netherlands
Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →
avatar for Andre Asbury

Andre Asbury

Patient Representative, The Chicago Lighthouse, United States
Andre Asbury is a Retail Sales Lead at The Chicago Lighthouse’s Tools for Living Store. In his role he meets with blind and visually impaired customers to answer questions about the newest innovations in assistive technology and independent living aids. In addition, Andre is an... Read More →


Monday June 20, 2022 10:00am - 11:30am CDT
Room Skyline 375 CDE McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  00: Plenary, Forum |   14: DIAmond, Forum
  • Level Basic
  • Level Basic
  • Credit Type ACPE, CME, RN
  • Tags Forum

11:30am CDT

Luncheon Service
Component Type: Social Event




Monday June 20, 2022 11:30am - 1:00pm CDT
Exhibit Hall McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

11:50am CDT

#101 IT: Advanced Clinical Innovation Theater: Implementing Innovative Patient and Site Engagement Strategies for More Predictable Outcomes
Component Type: Session

Innovative patient and site engagement strategies have provided significant value for pharma and biotech companies through the design, predictability and success of their clinical programs. You will learn about real cases that have positively impacted site-sponsor relationships and successfully incorporated the patient voice, including:

  • Study-specific strategies
  • Novel patient and site engagement methods
  • Decentralized clinical trial (DCT) components


Chair

Advanced Clinical

Speaker

Speaker
Donna Hanson

Speaker
Caroline Redeker

Speaker
Stacey Arrambide, MS

Speaker
Cheryle S. Evans, RN



Speakers
avatar for Advanced Clinical

Advanced Clinical

United States
avatar for Stacey Arrambide

Stacey Arrambide

Senior Vice President, Functional Service Solutions, Advanced Clinical, United States
Stacey Arrambide, M.S., has over 21 years of global statistical and data management experience across a broad range of therapeutic areas. Stacey oversees strategic growth and operational delivery of biometrics services for Advanced Clinical. He has held numerous leadership positions... Read More →
avatar for Donna Hanson

Donna Hanson

Senior Director, Strategy and Optimization, Advanced Clinical , United States
Donna Hanson has been in the clinical trial industry for nearly 20 years. Donna has a comprehensive background, including leading teams in patient recruitment and engagement, feasibility and site engagement, bids and proposals and vendor management/outsourcing. Her passion is to enhance... Read More →
avatar for Caroline Redeker

Caroline Redeker

Senior Vice President, Corporate Development, Advanced Clinical, United States
Caroline Redeker is a results-oriented professional with 30 years of experience in planning and managing pharmaceutical, biotech and medical device clinical research, creating successful partnerships with sponsor companies to add value to their programs. Areas of specialty include... Read More →
avatar for Cheryle Evans

Cheryle Evans

Senior Vice President, Global Clinical & Biometric Operations, Advanced Clinical, United States
Cheryle Evans is a senior-level executive with extensive, progressive experience in operational execution of clinical trials including a track record of accomplishments in healthcare/pharmaceutical research. She is the head of Operations in North America for Advanced Clinical. Cheryle... Read More →


Monday June 20, 2022 11:50am - 12:20pm CDT
Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

11:50am CDT

#102 IT: Syneos Health Innovation Theater: Leveraging the Power of Medical Affairs - Overcoming Obstacles to Optimize Product Development
Component Type: Session

Medical Affairs (MA) has become one of the most critical success factors for realizing the full promise of biopharma innovation – but there are hurdles yet to cross. To get a clear snapshot of the landscape, Syneos Health surveyed MA executives on key challenges, opportunities for growth and how the function is positioning itself for the future. This session will discuss the results of this survey to understand the pain points MA faces and potential solutions to optimize product development.

Chair

Syneos Health

Speaker

Speaker
Suma Ramadas, PhD

Speaker
Colin Oliver, PhD, MBA



Speakers
avatar for Syneos Health

Syneos Health

United States
avatar for Colin Oliver

Colin Oliver

Managing Director, Medical Affairs Consulting, Syneos Health, United States
Colin Oliver is a managing director in the medical affairs consulting practice at Syneos Health with over 10 years of pharmaceutical/biotechnology experience at small, medium and large companies. Colin has broad Medical Affairs experience, from working in the field as a Medical Science... Read More →
avatar for Suma Ramadas

Suma Ramadas

Executive Vice President, Head of Global Medical Affairs, Syneos Health, United States
Suma Ramadas, Ph.D. has over 17 years of experience as a thought leader in industry, consulting and integrated commercialization solutions specializing in the Medical Affairs space. She leads the Medical Affairs and Value, Access, and HEOR Advisory at Syneos Health, where she has... Read More →


Monday June 20, 2022 11:50am - 12:20pm CDT
Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

11:50am CDT

#103 IT: Microsoft Innovation Theater: Accelerating Clinical Research - How a New Collaboration is Driving Digital Data Flow Solutions from Protocol Design to Electronic Data Capture
Component Type: Session

TransCelerate, in collaboration with Accenture, CDISC and Microsoft, have developed and released a vendor agnostic, open-source approach Study Definitions Repository that utilizes technology and data standards to manage the information flow across systems. A new protocol study definition standard developed by CDISC compliments these efforts. Join this session to discover how these efforts are paving the way for new innovations in the R&D landscape and more seamless, open collaboration.

Chair

Microsoft Corporation

Speaker

Speaker
David Meyers

Speaker
Robert DiCicco, PharmD

Speaker
William Illis, MPH



Speakers
avatar for Microsoft Corporation

Microsoft Corporation

Microsoft Corporation, United States
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma, United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also... Read More →
avatar for William Illis

William Illis

Global Head, Collaboration/Technology Strategy, Clinical Development & Analytics, Novartis Pharmaceuticals Corporation, United States
Bill is Global Head of Technology Strategy and Collaboration in Clinical Development and Analytics responsible for developing and implementing the analytics technology strategy and managing collaborations with internal and external partners. He has been responsible for leading large-scale... Read More →
avatar for David Meyers

David Meyers

National Director Life Sciences, US Health and Life Sciences, Microsoft, United States
Dave Meyers is the National Director for the Life Sciences Industry in the U.S. Health and Life Sciences group at Microsoft. He is focused on strategy, business development, and managing the portfolio of solutions in pharmaceuticals, genomics and precision medicine – collaborating... Read More →


Monday June 20, 2022 11:50am - 12:20pm CDT
Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

12:00pm CDT

#01 POS : Poster Session I
Component Type: Poster Presentation

Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.


Speakers
avatar for Emmanuel Amponsah

Emmanuel Amponsah

Pharmacy Student- Class of 2023, Chicago State University College of Pharmacy, United States
Emmanuel Amponsah is a fourth year Doctor of Pharmacy Student at Chicago State University College of Pharmacy. He holds bachelors and masters in biochemistry from the University of Cape Coast and the University of Ghana. His research interest include retro-synthesis of novel opioid... Read More →
AB

Amy Barton

Science Lead, Nanomedicine, Vifor Pharma, United States
Dr. Amy Barton is a nephrology-trained clinical pharmacist. Prior to joining Vifor Pharma as the Science Lead for Nanomedicine, Dr. Barton had a 20+ year career as an academic researcher focused on translational investigations of intravenous iron-carbohydrate nanomedicines. She was... Read More →
avatar for Walker Bradham

Walker Bradham

Lead Product Manager, IBM Watson Health, United States
Walker Bradham is the Product Leader for IBM Clinical Development, IBM Watson Health's flagship CDMS solution. He brings 20 years of experience defining, designing and deploying web applications to the marketplace, and leads the product roadmap for all EDC/CDMS and eCOA offerings... Read More →
IB

Isabel Brown

Patient Inclusion and Health Equity Intern, Genentech, A Member of the Roche Group, United States
My name is Isabel Brown and my pronouns are she/her/hers. I currently sit on the Patient Inclusion and Health Equity team within Genentech's Chief Diversity Office, where I work to further our goal of improving and increasing representation in our clinical trials. I am focused on... Read More →
avatar for Julia Donnelly

Julia Donnelly

Regulatory Affairs Director, Westat, United States
Julia Solarczyk Donnelly is a regulatory affairs expert with nearly two decades of experience managing the creation, review, compilation, and submission of dossiers to regulatory authorities. She has provided regulatory guidance and strategy for numerous clinical research efforts... Read More →
avatar for Kurt Douglass

Kurt Douglass

Director, GPV Compliance & Business Management (CBM), Otsuka Pharmaceutical Development & Commercialization, Inc., United States
Seasoned professional with strong leadership skills and clinical research experience in the management of drug, device and diagnostic trials. In-depth knowledge of Good Clinical Practices (GCP), project management, clinical operations, research design, regulatory compliance, data... Read More →
SE

Samuel Ewusie

Senior Manager, Global Risk Management, Bristol-Myers Squibb Company, United States
A registered pharmacist with a PharmD and an MS in Global Clinical and Pharmacovigilance Regulations, experienced in Clinical Drug Safety and Pharmacovigilance, Risk Management including Risk Evaluation and Mitigation Strategy (REMS), Pharmacoepidemiology and Research Data analys... Read More →
RH

Rezzan Hekmat

Biomedical Research Program Manager, IBM Watson Health, United States
avatar for Ruth Indelicato

Ruth Indelicato

Executive Director, Global Quality, Bristol-Myers Squibb Company, United States
Executive Director of Compliance and Monitoring, Regulatory Compliance and External Engagement in Global Quality at BMS, with over 30 years in the Pharmaceutical Industry. Currently leading team responsible for driving quality and compliance excellence across BMS through external... Read More →
avatar for Koji Ishizuka

Koji Ishizuka

Senior Director, Oncology Alliance Management, Daiichi Sankyo, Inc, United States
For over 16 years, Koji Ishizuka has been working in Clinical Development, Clinical Operations, and Alliance Management spaces. He has worked for various oncologic and antibiotic drugs in Daiichi Sankyo Japan and moved to US in 2014. Since then, he has been based in NJ, USA. As an... Read More →
avatar for Becky Johnson

Becky Johnson

Director, Clinical Trial Recruitment, Sun Pharma Advanced Research Company (SPARC), United States
Becky’s experience in the biopharmaceutical industry is in healthcare communications and clinical trial recruitment with a focus on diversity, equity and inclusion. In her current role, Becky leads the clinical trial recruitment function at Sun Pharma Advanced Research Company (SPARC... Read More →
HJ

Honey Joseph

PGY2 Drug Information Pharmacy Resident, University of Illinois at Chicago, United States
I am currently a second-year pharmacy resident specializing in Drug Information at the University of Illinois at Chicago. I obtained my Doctor of Pharmacy degree from Midwestern University Chicago College of Pharmacy, and completed my first year of residency at NorthShore University... Read More →
avatar for Hayley Karpick

Hayley Karpick

Postdoctoral Fellow, University of North Carolina/Glaxosmithkline, United States
Hayley Karpick, PharmD, RPh, is currently a Global Regulatory Affairs post-doctoral fellow through The University of North Carolina Eshelman School of Pharmacy and GlaxoSmithKline. She graduated with her PharmD from Purdue University in May of 2021 and started the fellowship in July... Read More →
QL

Qian Li

Biostatistics, Statistics & Data Corporation, United States
avatar for Ralph McKibbin

Ralph McKibbin

Chairman, Alliance for Safe Biologic Medicines, United States
Dr. McKibbin is a practicing gastroenterologist at Blair Gastroenterology Associates in Altoona, PA. He is past president of both the Pennsylvania Society of Gastroenterology and of the Digestive Disease National Coalition (DDNC). He sits on the Member Advisory Panel of the Pennsylvania... Read More →
avatar for Timothe Menard

Timothe Menard

Head of Quality Data Science, F. Hoffmann-La Roche, Switzerland
Dr. Timothé Ménard, PharmD has been leading the PD Quality Data Science Team at Roche since January 2018. From simple analytics methods to machine learning, his team is creating and implementing data-driven solutions that help understand, early detect or predict clinical quality... Read More →
avatar for Tim Mikhelashvili

Tim Mikhelashvili

CEO & Co-Founder, Amedea Pharma, Inc., United States
Tim Mikhelashvili, PharmD is a senior thought leader in the pharmaceutical industry, post-doctoral fellowship in Medical Education and Scientific Publications, and an MIT certification in Leading Organizational Change with 18 years of experience in his field. He is dedicating his... Read More →
avatar for Heena Murarji

Heena Murarji

Associate Director – Global PVAs and PV CAPAs/Deviations Lead, Otsuka Pharmaceutical Europe Limited, United Kingdom
Heena Murarji is an Associate Director in Global Pharmacovigilance Compliance & Business Management at Otsuka Pharmaceuticals, responsible for the strategic management and oversight of global PV processes such as pharmacovigilance agreements, safety management plans, compliance monitoring... Read More →
avatar for Eva Oakkar

Eva Oakkar

Associate Principal, Emerging Methods and Solutions, IQVIA, United States
Dr. Eva Oakkar is an epidemiologist with more than 10 years of real world research experience, both in academia and industry. She is responsible for developing novel study methodologies to build comprehensive patient records for research, linking primary and secondary real world data... Read More →
avatar for Benjamin Ogorek

Benjamin Ogorek

Chief Data Scientist, Spencer Health Solutions, United States
Ben Ogorek leads Data at Spencer Health Solutions. Ben’s 15 years of experience in Data Science spans Marketing Analytics at Nationwide Insurance, HR Analytics at Google, and metric forecasting at Facebook, among others. While in insurance, he focused on bridging the gap between... Read More →
avatar for Yash Patel

Yash Patel

Student, Ernest Mario School of Pharmacy, Rutgers University, United States
I am a fifth year pharmacy student in the Ernest Mario School of Pharmacy at Rutgers University with aspirations to join the pharmaceutical industry and make innovative advancements in drug development. My passion grew from a Clinical Science internship at BMS a few years ago. This... Read More →
avatar for Valerie Powell

Valerie Powell

Chief Patient Officer, CorEvitas and Vice President, Patient Experience, Healthivibe, The Patient Experience Team of Corevitas, LLC, United States
Valerie Powell has over 35 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She is the Chief Patient Officer of CorEvitas, ensuring the organization's services center on and address the needs of patients worldwide... Read More →
AP

Angie Price

Director, Site Network, Quality Improvement, The Institute For Advanced Clinical Trials For Children., United States
Angie Price has 25 years of experience in the clinical trials industry. She currently serves as the QI Director at the Institute for Advanced Clinical Trials (I-ACT) for Children. Currently, Mrs. Price oversees the Pediatric Improvement Collaborative for Clinical Trials & Research... Read More →
RP

Ranjini Prithviraj

Senior Manager, Medical Communications, Emergent Biosolutions, United States
PR

Phillip Reveal

Consultant, Reveal Regulatory LLC, United States
Phillip Reveal has worked in the pharmaceutical and device industry in various capacities for almost 25 years, with the bulk of his career focused on both the Global and US Ad Promo spaces (Medical and Regulatory). Phil's main areas of interest in the ad promo space are 1) helping... Read More →
JH

John Hertig

Associate Professor, College of Pharmacy and Health Sciences, Butler University, United States
avatar for Liam Paschall

Liam Paschall

Senior Consultant of Management Development, Parexel, United States
Liam is a transgender man who has found immense courage, strength, and pride in being his authentic self. He is a Senior Consultant of Management Development at Parexel, and is a dynamic public speaker, DEI consultant, and experienced learning & development professional. Liam, who... Read More →
avatar for Magda Bujar

Magda Bujar

Senior Manager, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Dr Magda Bujar is Senior Manager, Regulatory Programme and Strategic Partnerships and has over 8 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those of... Read More →
EG

Eric Gemmen

Senior Director, Scientific Services, IQVIA, United States
AH

Adam Hamm

Senior Vice President, Biostatistics and Strategic Consulting, Statistics & Data Corporation (SDC), United States
avatar for Stephanie Terrey

Stephanie Terrey

Patient Experience: Sr. Director, CorEvitas, United States
Stephanie has 14 years’ experience conducting research in pharmaceutical and non-profit settings. Stephanie is the Senior Director of Patient Engagement Research Delivery at Healthivibe, leading a team in executing qualitative research projects that cultivate accurate and meaningful... Read More →
avatar for Ngoctran Tran

Ngoctran Tran

Graduate Student, University of Southern California School of Pharmacy, United States
Ngoctran Tran, PharmD/MS ‘23 is a PharmD/MS Regulatory Science dual degree candidate at the University of Southern California. She received her bachelor’s degree in Biochemistry and Molecular Biology at the University of California, Irvine. Her current research examines medical... Read More →


Monday June 20, 2022 12:00pm - 1:15pm CDT
Level 3 F2 Entrance McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

12:15pm CDT

#104 CH: What Do Patients Want From Digital Solutions? Considerations for Access, Self Determination of Their Data and Portability
Component Type: Workshop
Level: Intermediate

This content hub will share feedback from Patient Advocates on the clinical research experience and what technologies can address their needs. The unique role that digital solutions can play in facilitating clinical research will also be explored.

Learning Objectives

Reassess the perspective of the patient as we advance our use of digital solutions in clinical research; Compare the experience gained in the clinical research community over the last 2 years on digital solutions with patient needs; Describe the adoption of digital solutions and trends in patient behavior and explore impact on clinical research strategy.

Chair

Michelle Hoiseth

Speaker

Facilitator
Joy Bhosai, MD, MPH



Speakers
avatar for Michelle Hoiseth

Michelle Hoiseth

Chief Data Officer, Parexel, United States
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently serves Parexel... Read More →
avatar for Michelle Hoiseth

Michelle Hoiseth

Chief Data Officer, Parexel, United States
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently serves Parexel... Read More →


Monday June 20, 2022 12:15pm - 12:45pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

12:35pm CDT

#105 IT: CRIO Innovation Theater: Creating an EMR to EDC Pipeline Through eSource
Component Type: Session

EMR-to-EDC integration is challenging to scale due to the fragmentation of health care providers. With EMR interoperability, patients have the power to collect their own medical records and direct them into e-clinical platforms. CRIO and Pluto Health will demonstrate a groundbreaking innovation whereby Pluto Health aggregates medical records on behalf of patients and sends them to CRIO’s integrated eSource-to-EDC platform, thus creating the industry’s first truly scaleable EMR-to-EDC pipeline.

Chair

Clinical Research IO

Speaker

Speaker
Raymond Nomizu, JD

Speaker
Seung Park

Speaker
Elena Christofides



Speakers
avatar for Clinical Research IO

Clinical Research IO

United States
avatar for Elena Christofides

Elena Christofides

Chief Executive Officer, Endocrinology Associates Inc., United States
Elena Christofides, MD, FACE, is a physician and CEO at Endocrinology Associates, Inc, an adult-only specialty practice in Columbus, Ohio. She is also the founder and director of Endocrinology Research Associates, Inc, an independent research facility. Dr. Christofides earned her... Read More →
avatar for Raymond Nomizu

Raymond Nomizu

CEO & Co-founder, Clinical Research IO (CRIO), United States
Raymond Nomizu is the co-founder and CEO of CRIO, an e-clinical provider for sponsors, CROs and sites. CRIO's system allows research sites to collect data accurately and contemporaneously, and sponsors to view the data in real-time, without costly source data verification. Prior to... Read More →
avatar for Seung Park

Seung Park

Chief of Informatics, Pluto Health, United States
Seung Park MD is the Head of Medical Informatics at Pluto Health. He was the first 2-year trained subspecialty Medical Informaticist in the country, a board-certified Clinical Pathologist, a formally-trained computer scientist, and has been CIO, CHIO, and CMIO at some of the largest... Read More →
avatar for Seung Park

Seung Park

Head of Medical Informatics, Pluto Health, United States
Seung Park MD is the Head of Medical Informatics at Pluto Health. He was the first 2-year trained subspecialty Medical Informaticist in the country, a board-certified Clinical Pathologist, a formally-trained computer scientist, and has been CIO, CHIO, and CMIO at some of the largest... Read More →


Monday June 20, 2022 12:35pm - 1:05pm CDT
Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

12:35pm CDT

#106 IT: IQVIA Innovation Theater: Redefining Patient Centricity in a Post-Pandemic Era
Component Type: Session

The pandemic forced our industry to challenge the status quo. We found innovative ways to reach patients, accelerate processes and leverage technology. These advances have one commonality: each puts the patient at the center of the clinical trial. How do we take the best of those innovations, turn them into best practices and not fall back into the way “we have always done it?” This session explores the next best for the future of patient-centric drug development.

Chair

IQVIA

Speaker

Speaker
Cynthia L. Verst, PharmD, MS



Speakers
avatar for IQVIA

IQVIA

IQVIA, United States
avatar for Cynthia Verst

Cynthia Verst

President, Design and Delivery Innovation, Research & Development Solutions, IQVIA, United States
Dr. Cynthia Verst is President, Design and Delivery Innovation, Research & Development Solutions at IQVIA. Having previously served as president of both Clinical Operations and Real World and Late Phase Research for IQVIA, Dr. Verst brings a holistic view of clinical research, and... Read More →


Monday June 20, 2022 12:35pm - 1:05pm CDT
Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

12:35pm CDT

#107 IT: SAS Innovation Theater: Level Up! Advancing Clinical Trial Operations with Novel Methods and Richer Data
Component Type: Session

Join SAS for a lightning-round presentation on next-generation approaches for driving excellence in clinical trial operations including:
  • Integrating multiomics data to identify druggable targets and the best patients for trials
  • Leveraging observational data to generate synthetic control arms
  • Rescuing trial enrollment with simulation


  • These methods can help you design and execute better clinical trials, improve diversity and more. Don’t miss this chance to level up!

    Chair

    SAS Institute Inc.

    Speaker

    Speaker
    Matt Becker

    Speaker
    Jim Box, MBA, MS

    Speaker
    Sherrine Eid, MPH

    Speaker
    Scott McClain



    Speakers
    avatar for SAS Institute Inc.

    SAS Institute Inc.

    SAS Institute Inc, United States
    avatar for Matt Becker

    Matt Becker

    Advisory Consultant and Life Science Team Lead, SAS, United States
    Becker has been a Principal Industry Consultant at SAS since 2013. Prior to joining SAS, he had been using SAS in the life sciences industry since 1988. He focused on clinical programming, data management and visualizations. Becker presented numerous papers and won best paper awards... Read More →
    avatar for Jim Box

    Jim Box

    Principal Data Scientist for Life Sciences, SAS, United States
    Box provides strategic insights across the life sciences industry, with a focus on optimizing the execution of clinical trials. He spent 18 years in the CRO industry, holding leadership roles in statistics, statistical programming, data management and information technology. Throughout... Read More →
    avatar for Sherrine Eid

    Sherrine Eid

    Health and Life Sciences Industry Consultant, SAS, SAS, United States
    Eid has more than 20 years of experience in real-world evidence, epidemiology and biostatistics. Her passion for better public health led her to work for USAID, CDC and other donors in global health development with a focus on reproductive health and family planning and infectious... Read More →
    avatar for Scott McClain

    Scott McClain

    Principal Consultant, SAS Health Care and Life Sciences, SAS, United States
    Dr. McClain brings 30 years of experience in toxicology, biotechnology, and product safety risk assessment. His academic background is environmental and molecular toxicology with a focus in quantitative risk assessment. He received his advanced degrees from Miami University in Oxford... Read More →


    Monday June 20, 2022 12:35pm - 1:05pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:15pm CDT

    #108: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP)
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-511-L04-P ; CME 1.00; RN 1.00

    A 2021 FDA guidance discusses a sponsor’s responsibility for IND reporting of anticipated adverse events in studies. This session will discuss how the Aggregate Safety Assessment Plan can assist sponsors in meeting IND reporting responsibilities. Join the DIA Clinical Safety & Pharmacovigilance Community for a follow up round table discussion (session #124 RT) on Monday, June 20, 2:30pm - 3:30pm.

    Learning Objectives

    Identify the contents of the new FDA Draft guidance on IND safety reporting; Recognize the importance of proactive multidisciplinary aggregate safety assessment planning; Discuss how the Aggregate Safety Assessment Plan (ASAP) supports IND safety reporting decisions; Describe considerations in developing a safety surveillance plan.

    Chair

    Barbara Hendrickson, MD

    Speaker

    FDA Update
    Jacqueline A. Corrigan-Curay, JD, MD

    Industry Update
    Greg Ball, PhD

    Industry Update
    Mengchun Li, MD, MPA



    Speakers
    avatar for Greg Ball

    Greg Ball

    Head of Safety Statistics, Global Vaccine Safety, Novavax, Inc., United States
    Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists... Read More →
    avatar for Jacqueline Corrigan-Curay

    Jacqueline Corrigan-Curay

    Principal Deputy Director, Office of the Center Director, CDER, FDA, United States
    Jacqueline Corrigan-Curay, J.D., M.D., serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality... Read More →
    avatar for Barbara Hendrickson

    Barbara Hendrickson

    Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety, AbbVie, Inc., United States
    Dr. Barbara Hendrickson is the Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety. She is a physician with subspecialty training in pediatrics and infectious diseases and has 18 years of pharmaceutical industry experience. Dr. Hendrickson has been involved in... Read More →
    avatar for Mengchun Li

    Mengchun Li

    Director, Phamacovigilance, Global Alliance For TB Drug Development, United States
    Dr. Mengchun Li is the Director of Pharmacovigilance at TB Alliance. In this position, Dr. Li chairs the multidisciplinary safety management team for all compounds and is responsible for clinical safety and pharmacovigilance. Prior to this, Dr. Li worked at Janssen Pharmaceutical... Read More →


    Monday June 20, 2022 1:15pm - 2:15pm CDT
    Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Session |   09: Regulatory, Session

    1:15pm CDT

    #109: Risk-Based Monitoring in Clinical Trials: An Evolution of Practices During the COVID Pandemic
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-512-L04-P ; CME 1.00; RN 1.00

    The industry embraced an enormous shift during the global pandemic. This panel will report out on a two-year analysis conducted on over 6,000 clinical trials. We looked at the study-level and surveyed how risk-based and approaches are being adopted

    Learning Objectives

    Describe how risk-based approaches are being used in the industry, and how adoption shifted during the pandemic; Identify components that are being underutilized (e.g., centralized monitoring) and discuss potential benefits of adopting them; Explain how your organization can benefit from taking a risk-based quality management approach to every study

    Chair

    Brian Barnes, MA

    Speaker

    Panelist
    Nicole Stansbury

    Panelist
    Paula Jo Butler, MA

    Panelist
    Lauren Garson

    Panelist
    Jennifer Glonke Stewart, MBA



    Speakers
    avatar for Brian Barnes

    Brian Barnes

    Senior Director, Product Development - RBQM, Medidata, A Dassault Systèmes company, United States
    Brian Barnes is a Senior Director, Product Development – RBQM for Medidata Solutions. Brian has 16 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian... Read More →
    avatar for Paula Butler

    Paula Butler

    Senior Director, Operational Transformation and Performance (OTP), IQVIA, United States
    Paula Jo Butler has over 35 years of experience in the Clinical Research Industry serving roles within Biostatistics and Project Management. She is currently IQVIA’s Senior Director of Operational Transformation and Performance (OTP). Her leadership experiences include oversight... Read More →
    avatar for Lauren Garson

    Lauren Garson

    Senior Director, Clinical Strategy, Veeva Systems, United States
    Lauren joined Veeva in 2018 and is a Sr Director in the Vault Clinical Operations Strategy team. She is responsible for Vault eTMF, SSU, CTMS and Payments for Enterprise level customers and is the lead strategist for Vault Risk Based Study Management. She is passionate about ensuring... Read More →
    avatar for Nicole Stansbury

    Nicole Stansbury

    VP, Global Clinical Trial Management, Syneos Health, United States
    Nicole Stansbury, Vice President, Clinical Trial Management, joined Syneos Health in February 2019 and is responsible for global clinical trial management and monitoring strategy. Prior to leading the global CTMs at Syneos, Nicole led the Global Central Monitoring team and risk -based... Read More →
    avatar for Jennifer Stewart

    Jennifer Stewart

    Executive Director, Clinical Data Sciences, Premier Research, United States
    As Executive Director, Jennifer Stewart coordinates the efforts of Premier Research’s global Clinical Data Sciences department, offering expertise in clinical data management and data surveillance. She plays an active role in corporate initiatives for improving quality, efficiency... Read More →


    Monday June 20, 2022 1:15pm - 2:15pm CDT
    Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Forum |   08: RD Quality-Compliance, Forum
    • Level Intermediate
    • Featured Topics COVID-19
    • Level Intermediate
    • Feature Topics COVID-19
    • Credit Type ACPE, CME, RN
    • Tags Forum

    1:15pm CDT

    #110: Adaptive Designs Save Time and Money: Regulatory Agencies Accept Them - Why Aren’t They Used More?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-513-L04-P ; CME 1.00; RN 1.00

    Adaptive designs are accepted by regulatory agencies so why aren't more sponsors using them? These trials enable sponsors to fail faster and focus effort on where they succeed. We will cover the process from protocol design to interim analysis and communication to key stakeholders for adaptations. There are too many reasons why adaptive designs should be used on more clinical trials. This session will explore those reasons and benefits.

    Learning Objectives

    Identify the types of adaptive trials; Describe best practices and recommendations for the protocol design phase as well as pre-study planning; Identify what communication is needed to conduct the interim analysis; Assess which stakeholders should be part of this process; Discuss how success should be defined.

    Chair

    Marc Kaufman

    Speaker

    Using Trial Simulations to Provide Tailored Adaptive Design in Early Stage Clinical Trials
    Song Wang, PhD, MS

    Impact of Adaptive Trials to Global Clinical Supply Plans
    Haneen S Mazahreh, MS

    Adaptive Designs: CRO Perspective
    Russell Reeve



    Speakers
    avatar for Marc Kaufman

    Marc Kaufman

    Director, Product Management, RTSM Customer Adoption and Value Realization, Medidata, a Dassault Systèmes company, United States
    Marc Kaufman has been in the Life Sciences Industry for close to 20 years, specializing in IRT/RTSM technology for the past 15 years. Marc is a Director - RTSM Customer Adoption and Value Realization at Medidata Solutions. Marc has been at Medidata Solutions for 5 years. Marc is a... Read More →
    HM

    Haneen Mazahreh

    Chief Executive Officer, Pivot Consulting and Services, United States
    Haneen Mazahreh-Boivert is a global clinical supply expert and end to end supply chain advocate. Throughout her 15+ year career, she has worked and consulted for numerous companies of varying footprints including British Petroleum, Schering-Plough, Merck, Celgene, KMPG, and OptiNose... Read More →
    RR

    Russell Reeve

    Vice President, Biostatistics, IQVIA, United States
    SW

    Song Wang

    Senior Statistical Science Director, PPD, Part of Thermo Fisher Scientific, United States
    Song Wang got his Master and PhD degree from University of Utah. He worked as a statistician in PPD for 18 years. He has comprehensive experience in study design and data analysis in clinical trials across phases and indications. His passion is to use innovative study design and analysis... Read More →


    Monday June 20, 2022 1:15pm - 2:15pm CDT
    Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Session |   11: Statistics, Session

    1:15pm CDT

    #111: The Role of Sensors in Clinical Research: Integrating Sensor Generated Data into Data Platforms to Power Clinical Research and Patient Care
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-514-L04-P ; CME 1.00; RN 1.00

    To advance the effective and efficient use of remote patient monitoring and digital endpoints in clinical trials at scale, this session will describe best practices for meeting stakeholder needs when integrating sensor data to cloud platforms.

    Learning Objectives

    Describe the role of data integration to successfully scale sensor technologies to power clinical trials; Define the needs of end users, from participants and investigators to biostatisticians and regulators, of sensor data generated during clinical trials; Apply a best practice framework to optimize sensor data integration into electronic data capture (EDC) systems and other cloud storage solutions.

    Chair

    Jennifer Goldsack, MA, MBA, MS

    Speaker

    Industry Update
    Ariel Dowling, PhD

    Industry Update
    Shruti Iyer, MS

    Industry Update
    Gillian Livock, MBA

    Results from a Survey of Biopharmaceuticals on Attitudes Towards the Use of Wearables and Sensors in Clinical Research
    Alison Ritchie



    Speakers
    avatar for Ariel Dowling

    Ariel Dowling

    Director of Digital Strategy, Takeda Pharmaceuticals, United States
    Ariel V. Dowling, PhD is a Director of Digital Strategy within the Data Sciences Institute at Takeda Pharmaceuticals. In this role, Ariel oversees the strategy, assessment, and deployment of digital devices in clinical trials across the organization. She was previously a Senior Clinical... Read More →
    avatar for Jennifer Goldsack

    Jennifer Goldsack

    Chief Executive Officer, Digital Medicine Society (DiMe), United States
    Jennifer Goldsack is the Chief Executive Officer of the Digital Medicine Society (DiMe). Founded in 2019, DiMe is the first professional organization for experts from all disciplines comprising the diverse field of digital medicine. Together, we drive scientific progress and broad... Read More →
    avatar for Shruti Iyer

    Shruti Iyer

    Principal Innovation Architect, Clinical Innovation, Oracle Health Sciences, United States
    Shruti Iyer is a Principal Innovation Architect supporting Clinical Innovation in the Health Sciences Global Business Unit at Oracle. Shruti has had over seven years of experience at Medtronic as a subject matter expert in end-to-end medical device product development focusing on... Read More →
    avatar for Gillian Livock

    Gillian Livock

    SVP & GM, Connected Devices, Medable, United States
    avatar for Alison Ritchie

    Alison Ritchie

    Sensor Solutions Director, Parexel, United Kingdom
    Alison is the Global Head of Sensor solutions at Parexel. Alison has over 23 years’ experience within the clinical trial industry, 19 at Parexel. Alison plays a key role by selecting and implementing real world data and connected sensor device solutions for clinical trial use. Alison... Read More →


    Monday June 20, 2022 1:15pm - 2:15pm CDT
    Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Forum |   02: ClinTrials -ClinOps, Forum

    1:15pm CDT

    #112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Based Approvals of Analytical Procedures and Changes?
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-521-L04-P ; CME 1.00; RN 1.00

    ICH Q2 (R2) and Q14 - Is the juice worth the squeeze? In this session, subject matter experts will demonstrate how ICH 02 (R2) and Q14 can lead to stronger methods and enhanced flexibility.

    Learning Objectives

    Discuss what kinds of method development studies can help to support established conditions for the method and apply principles of current analytical procedure development; Describe how a risk assessment can be used to evaluate impact of a method change, and aid identification of reporting category; Identify science and risk-based approaches to analytical procedure lifecycle management.

    Chair

    Celeste Frankenfeld Lamm, PhD

    Speaker

    Managing the Analytical Procedure Lifecycle in the Future: Perspectives from ICH Q2(R2)/Q14
    Nina S. Cauchon, PhD, RAC

    ICH Q14: Analytical Procedure Development : Towards Risk-Based Lifecycle Management of Analytical Procedures – An EU Regulatory Perspective
    Robert Bream, PhD, MA, MS

    Lifecycle Management and Post-Approval Changes to Analytical Procedures: A Case Study
    Christof Finkler, DrSc



    Speakers
    avatar for Robert Bream

    Robert Bream

    Pharmaceutical Quality Senior Specialist, European Medicines Agency, Netherlands
    Rob is a pharmaceutical quality senior specialist in the EMA Quality Office, responsible for quality aspects of new and generic medicinal products from development phase via initial authorisation (MAA) to post-authorisation lifecycle management. He also coordinates the development... Read More →
    avatar for Nina Cauchon

    Nina Cauchon

    Director Regulatory Affairs CMC, Amgen, United States
    Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
    avatar for Christof Finkler

    Christof Finkler

    Senior Technical Advisor Biotech Development, F. Hoffmann-La Roche AG, Switzerland
    Christof joined Roche, working in as a team leader in biotechnology analytics in Switzerland and worked in several positions with increasing responsibilities. As Site Head Analytical Development Biochemistry he was responsible for the establishment of new analytical technologies... Read More →
    avatar for Celeste Frankenfeld Lamm

    Celeste Frankenfeld Lamm

    Director, Global Regulatory Affairs – CMC, Merck Sharp & Dohme LLC , United States
    Celeste Frankenfeld Lamm, Ph.D., is currently a Director of Global Regulatory Affairs – CMC at Merck & Co, Inc. with 15 years of industry experience. In this capacity she is responsible for regulatory strategy, engagement with regulatory authorities, and preparation of clinical... Read More →


    Monday June 20, 2022 1:15pm - 2:15pm CDT
    Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      10: RegCMC-Product Quality, Session |   11: Statistics, Session

    1:15pm CDT

    #113: Fostering Innovation and Psychological Safety
    Component Type: Workshop
    Level: Basic

    If you want to foster innovation on your teams, discover how to embrace and encourage diverse points of view. Learn about research on psychological safety and how psychological safety explains team success and team failure. Leave with tips to make your team culture safe to disagree.

    Learning Objectives

    Describe what psychological safety means; Apply psychological safety to blameless project post - mortem; Identify psychological safety tips to foster innovation.

    Chair

    Susan Morris, MEd

    Speaker

    When the Dead Speak: Tips on Hosting a Project Post Mortem
    Robin Whitsell

    The Benefits of Psychological Safety in Teams
    Denise McNerney



    Speakers
    avatar for Denise McNerney

    Denise McNerney

    Chief Strategy and Operations Officer / Partner, Global Life Sciences Alliance (GLSA), United States
    Denise has over 25 years of experience in Business, Marketing, and Technology in the life sciences industry. Her entrepreneurial spirit coupled with her knowledge and resources has led her to build several businesses, processes, and teams. During that time, she has launched new products... Read More →
    avatar for Susan Morris

    Susan Morris

    Professional Coach and Personal Growth Speaker, Susan Morris Coaching, United States
    Susan Morris has over 30 years of experience as a professional coach and international personal growth speaker specializing in the professional development needs of pharmaceutical R&D scientists, technical experts and functions who partner with R&D. Susan believes that scientists... Read More →
    avatar for Robin Whitsell

    Robin Whitsell

    President, Whitsell Innovations, Inc., United States
    Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years’ experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →


    Monday June 20, 2022 1:15pm - 2:15pm CDT
    Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      13: ProfDevelopment, Workshop

    1:30pm CDT

    #114: Data Integrity Across the Product Lifecycle
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-22-515-L04-P ; CME 1.00; RN 1.00

    This session will provide an educational lesson on the latest guidance documents (e.g., EMA) and their impact to data integrity and trends observed in regulatory actions. A case study on Data Integrity will be presented and how it impacted product approval through accelerators, and finally lessons on preparing for data integrity for supply chain and manufacturing through master data management

    Learning Objectives

    Describe the latest regulatory trends and how they translate to data integrity operations; Discuss how to manage and assess data operations with third parties effectively and compliantly; Define critical aspects of compliant data governance management systems; Apply data integrity strategies to the product approval process

    Chair

    Brooke Casselberry, MS, RAC

    Speaker

    Data Integrity in GCP: Trends in 2021 and Beyond
    Ulrich Koellisch, DrSc, PhD

    Data Integrity Across the Preclinical and Development Life Cycle and it’s Impact on Product Development and Commercialization
    Patrick Dentinger

    Impact of Data Integrity on Supply Chain
    Christoph Krahenbuhl



    Speakers
    avatar for Brooke Casselberry

    Brooke Casselberry

    Associate Vice President, US Life Sciences Advisory and Consulting, NNIT, Inc., United States
    Brooke Casselberry is Associate Vice President of NNIT Inc, leading the US Life Sciences Advisory and Consulting team consisting of Clinical, Regulatory, Digital Technology, Training/OCM, and Program Management. Brooke is programming chair for DIA US Annual Meeting with the Data and... Read More →
    avatar for Patrick Dentinger

    Patrick Dentinger

    Chief Executive Officer, CellPort Software, LLC, United States
    Patrick Dentinger is CEO of CellPort Software. Prior to CellPort Mr. Dentinger Co-Founded Absorption Systems, an analytical CRO in 1996, and was CEO until its sale in November 2020 to Pharmaron. At Absorption Systems, a need was identified to do away with paper lab notebooks and digitalize... Read More →
    avatar for Ulrich Koellisch

    Ulrich Koellisch

    Manager Data Integrity Operations, GxP-CC, Germany
    Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous six years. He has supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has experience in consulting for audit preparation... Read More →
    avatar for Christoph Krahenbuhl

    Christoph Krahenbuhl

    Senior Director, Excellis Health, United Kingdom
    Christoph Krähenbühl’s background in the pharma industry includes Supply Chain, Master Data, Serialisation / Traceability and Product Security. Working for Swiss and then UK-based global leaders, he then founded 3C Integrity Consulting that became part of Excellis Health Solutions... Read More →


    Monday June 20, 2022 1:30pm - 2:30pm CDT
    Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Session |   08: RD Quality-Compliance, Session

    1:30pm CDT

    #115: Scientific Communication During a Pandemic: The Ethics of Ensuring Accuracy and Combatting Misinformation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-516-L04-P ; CME 1.00; RN 1.00

    During the COVID pandemic, rapid coverage of non-peer-reviewed information– some of which was later retracted - created confusion and mistrust. This session will discuss the ethical issues in rapid, yet accurate, scientific communications. The last two years have brought increased attention to the difficulty of ensuring accurate and effective scientific communications. During the COVID pandemic, the rapid media coverage of non-peer-reviewed information posted on pre-print servers and disseminated through other routes – some of which was later retracted as inaccurate or fraudulent - created confusion and mistrust in both care providers and the public. Some of these communications resulted in significant resources being invested in research on potential therapies, and the incorporation of unproven therapies into treatment paradigms, even though they really had no scientific evidence to support their use. Retraction of these therapies, when they were found ineffective, has caused significant public controversy. In this session, presenters will discuss the challenges and ethical implications of ineffective scientific communication, and the personal and public health harms that may result. Presenters will also a journalistic perspective on how the layperson can ask basic questions to assess the validity of scientific reports conveyed by the media. We will also discuss what the drug development community can do to combat the problem of scientific misinformation and disinformation.

    Learning Objectives

    Discuss the moral and ethical underpinnings of the importance of accurate scientific communication; Develop awareness of tactics for evaluating scientific communications for quality, rigor, and scientific validity; Recognize and combat misinformation in scientific communications and media communications.

    Chair

    Lindsay McNair, MD, MPH, MS

    Speaker

    Overview of the Moral and Ethical Underpinnings of the Need for Accurate Scientific Communication
    Karla Childers, MS

    Lessons from a Journalist: Practical Tools for Identifying Reliable and Accurate Information
    Sydney Lupkin



    Speakers
    avatar for Karla Childers

    Karla Childers

    Bioethics & Strategic Projects Leader, Office of the Chief Medical Officer, Johnson & Johnson, United States
    Karla Childers is the Bioethics and Strategic Projects Leader in the Johnson & Johnson Office of the Chief Medical Officer where her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has... Read More →
    SL

    Sydney Lupkin

    NPR Pharmaceutical Correspondent, National Public Radio (NPR), United States
    Sydney Lupkin is the pharmaceuticals correspondent for NPR. Prior to NPR, she was a correspondent at Kaiser Health News, where she covered drug prices and specialized in data reporting for its enterprise team. She's reported on how tainted drugs can reach consumers, how companies... Read More →
    avatar for Lindsay McNair

    Lindsay McNair

    Chief Medical Officer, WCG, United States
    Lindsay McNair, MD, MPH, MS in Bioethics is the Chief Medical Officer for the WIRB-Copernicus Group (WCG). She oversees the physician team within the WCG IRB, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design... Read More →


    Monday June 20, 2022 1:30pm - 2:30pm CDT
    Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      04: MedAffairs-SciComm, Forum

    1:30pm CDT

    #116: Incorporating Patient Experience Data in Global R&D
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-517-L04-P ; CME 1.00; RN 1.00

    This session will bring together experiences and lessons learned from sponsors, regulators, payors, and patients on realizing the potential of patient experience data through the R&D, regulatory, and market access lifecycle.

    Learning Objectives

    Describe new and upcoming regulatory guidance and programs enabling incorporation of patient experience data in medical product development, regulatory, and market access decision-making; Compare, contrast, and integrate lessons learned from sponsor, regulator, payor, and patient perspectives on leveraging patient experience data across the development, regulatory, and market access life cycle.

    Chair

    K. Kimberly McCleary
    Samantha Roberts, PhD

    Speaker

    Patient Input: Lessons Learned and Future Plans
    Yolanda Barbachano, PhD

    FDA Update
    Robyn Bent, MS, RN

    EMA Update
    Francesco Pignatti, MD



    Speakers
    avatar for Yolanda Barbachano

    Yolanda Barbachano

    Leading Senior Statistical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    Yolanda is a lead statistical assessor at the MHRA where she has been working for the last 10 years. In her role she advises pharmaceutical companies on the design of their clinical trials and assesses the data supporting licensing applications to make a decision on the benefit/risk... Read More →
    avatar for Robyn Bent

    Robyn Bent

    Director, Patient Focused Drug Development Program, OCD, CDER, FDA, United States
    Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn was... Read More →
    avatar for K. Kimberly McCleary

    K. Kimberly McCleary

    Founder and Chief Executive Officer, The Kith Collective, LLC, United States
    Kim McCleary has been at the forefront of patient engagement for more than 30 years. She is a nationally regarded subject matter expert on patient-focused medical product development, patient-centered benefit-risk assessment, and organizational change. Kim has authored scores of publications... Read More →
    avatar for Francesco Pignatti

    Francesco Pignatti

    Head of Oncology and Hematology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    SR

    Samantha Roberts

    Group Director, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
    Samantha Roberts is a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize and improve the efficiency of drug development and review. Her portfolio includes patient-focused drug development... Read More →


    Monday June 20, 2022 1:30pm - 2:30pm CDT
    Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum |   12: Value-Access, Forum

    1:30pm CDT

    #117: The Translational Value of Animal Models in Rare Diseases
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-22-518-L04-P ; CME 1.00; RN 1.00

    Many disease-specific animal models have been used to test emergent medicines for rare diseases. Appropriate animal models, based on the knowledge of the molecular pathology of the human disease, are a significant element to support the medical plausibility of an orphan designation during the development of orphan medicines for these rare diseases. There is a body of evidence, however, that there is a substantial difficulty in choosing/accessing an optimal model or choosing measurements which would be truly informative of the product’s efficacy. We intend to present a critical revision of preclinical models that may be used to support orphan drug designations in rare infectious and neurologic diseases, which are validated for each disease and to evaluate assays pertinent to the core features of selected diseases or otherwise relevant from the clinical standpoint. The analysis will help identify models with best predictive value as well as those acceptable based on their face value, highlighting the areas of most unmet need where development of better preclinical tools is necessary. We will present also results from a study that has investigated the nature of data submitted to the Committee Orphan Medicines to support medical plausibility of orphan designations for a group of rare and paediatric neurological diseases, where the use of in vivo nonclinical data was significantly higher than clinical data. We will explore the data for several case studies and discuss the importance of the availability and publication of this information in encouraging sponsors to develop innovative medicines in rare infectious and neurologic conditions. Nonclinical appropriate models, assessing disease relevant endpoints, may contribute to increase the translational value of animal models in rare diseases, to accelerate research and the effective development of treatment options.

    Learning Objectives

    Discuss the importance and value of nonclinical efficacy animal models in rare diseases (neurological and infectious); Apply real-world experience from available historical data to the development strategy using animal models of disease towards an increase into the translational value of these models in drug development for rare diseases.

    Chair

    Martine Zimmermann, PharmD

    Speaker

    The Translational Value of Animal Models in Rare Disease: Regulator View
    Dinah Duarte, MSc

    Perspectives on Evaluating New Tools for Regulatory Use: Organ on a Chip Technology
    Donna L. Mendrick, PhD

    The Translational Value of Animal Models in Rare Diseases: Sponsor's Perspective
    Melissa Haskell, DVM



    Speakers
    avatar for Martine Zimmermann

    Martine Zimmermann

    Senior Vice President, Head of Global Regulatory Affairs, R&D and Commercial Qua, Alexion, Astrazeneca Rare Disease, Switzerland
    Martine Zimmermann is Senior Vice President and Head of Regulatory Affairs, R&D & Commercial Quality at Alexion, AstraZeneca Rare Disease. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion in 2009 and has since then been... Read More →
    avatar for Dinah Duarte

    Dinah Duarte

    Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED, Portugal
    Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
    MH

    Melissa Haskell

    Executive Director, Non-Clinical Toxicology, Alexion, AstraZeneca Rare Disease, United States
    Dr. Melissa Haskell is the Head of Non-Clinical Toxicology and Attending Veterinarian at Alexion Pharmaceuticals in Boston, MA. She has been at Alexion since 2012, where she leads a team working to develop both large and small molecules. She has extensive experience in animal model... Read More →
    avatar for Donna Mendrick

    Donna Mendrick

    Associate Director for Regulatory Affairs, NCTR, FDA, United States
    Dr. Donna L. Mendrick is the Associate Director of Regulatory Activities at the National Center for Toxicological Research (NCTR) and serves as the liaison between NCTR and the regulatory centers at the FDA. Her FDA wide committee assignments include Chairing the Emerging Sciences... Read More →


    Monday June 20, 2022 1:30pm - 2:30pm CDT
    Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      06: PreClinical Dev-EarlyPhaseCR, Session |   11: Statistics, Session

    1:30pm CDT

    #118: Real-World Evidence Frameworks Across the World: Three International Perspectives
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-519-L04-P ; CME 1.00; RN 1.00

    In this session, three global regulatory agencies will present their frameworks for the use of Real World Evidence. The focus will be on the types of questions that can be answered now, as well as a view of the opportunities in the future.

    Learning Objectives

    Describe the similarities and differences between global regulatory frameworks for real-world evidence (RWE); Discuss how regulators are using RWE and how they will use it in the future, including the types of regulatory procedures it can support.

    Chair

    Andrew Thomson, PhD, MA, MS

    Speaker

    Moderator
    Rachele Hendricks-Sturrup, DrSc, MA, MSc

    FDA Perspective
    John Concato, MD, MPH, MS

    Health Canada Perspective
    Melissa Kampman, PhD, MS



    Speakers
    avatar for Rachele Hendricks-Sturrup

    Rachele Hendricks-Sturrup

    Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States
    Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →
    avatar for John Concato

    John Concato

    Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
    Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator... Read More →
    avatar for Melissa Kampman

    Melissa Kampman

    Manager and Senior Epidemiologist, Marketed Health Products Directorate, Health Canada, Canada
    Melissa Kampman is a manager and senior epidemiologist at Health Canada. She holds an MSc in Chemical and Environmental Toxicology and a PhD in Population Health. Her training is in pharmacoepidemiology and pharmacovigilance. Her main areas of interest are population health, study... Read More →
    avatar for Andrew Thomson

    Andrew Thomson

    Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
    Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics... Read More →


    Monday June 20, 2022 1:30pm - 2:30pm CDT
    Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Forum
    • Level Intermediate
    • Featured Topics RWD-RWE
    • Level Intermediate
    • Feature Topics RWD-RWE
    • Credit Type ACPE, CME, RN
    • Tags Forum

    1:30pm CDT

    #119: Is it Time to Change the Accelerated Approval Pathway?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-520-L04-P ; CME 1.00; RN 1.00

    A discussion on potential changes to accelerated approval pathways to streamline processes while continuing to maintain the gold standard of approval.

    Learning Objectives

    Explain advantages of the accelerated approval pathway; Discuss future potential changes to accelerated approval pathways.

    Chair

    Khyati Roberts, RPh

    Speaker

    Industry Perspective
    Kristin Van Goor, PhD

    Patient Perspective
    Jeff Allen, PhD



    Speakers
    avatar for Jeff Allen

    Jeff Allen

    President and Chief Executive Officer, Friends of Cancer Research, United States
    Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →
    avatar for Kristin Van Goor

    Kristin Van Goor

    Regulatory Policy and Intelligence, Global Regulatory Affairs, Vertex Pharmaceuticals, Inc., United States
    Kristin Van Goor received her Ph.D. in Genetics from Yale University and continued her research as a post-doctoral fellow in the Cancer Genetics Branch of the National Human Genome Research Institute at the NIH. She then spent a number of years at PhRMA as the Assistant Vice President... Read More →
    avatar for Khyati Roberts

    Khyati Roberts

    Head US/Canada, Regulatory Policy and Intelligence, AbbVie, United States
    Khyati Roberts leads regulatory policy advocacy efforts for U.S. and Canada and co-leads the day-to-day operations of the global regulatory policy and intelligence team at AbbVie. She has over 30 years of regulatory experience including nearly 14 years at the U.S. FDA/Center for Drug... Read More →


    Monday June 20, 2022 1:30pm - 2:30pm CDT
    Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Forum

    1:30pm CDT

    #120: Practical Applications of the Estimand Framework in Novel, Complex Settings
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-22-522-L04-P ; CME 1.00; RN 1.00

    Since the release of the ICH E9(R1) document in 2019, the estimand framework is becoming a fundamental part of clinical trial protocols. In addition, as missing data may occur due to various reasons, it is important to consider the different sources of missing data and appropriately account for these distinct sources in the statistical inference. In this session, we present the application of the estimand framework to three distinct and representative clinical trial settings: • The application to binary outcomes observed longitudinally, • The application to complex innovative designs (e.g. basket and platform trials); and • The application to outcomes measured by digital health technologies.

    Learning Objectives

    Discuss how different statistical methods perform in handling intercurrent events and missing data for binary outcome data observed longitudinally; Apply the estimand components in different types of complex innovative designs; Identify unique missing data challenges incurred from digital health technologies and strategies for minimizing missing data generated from them.

    Chair

    Mat Soukup, PhD

    Speaker

    Moderator
    Munish Mehra, PhD, MS, MSc

    Considerations to Address Missing Data When Deriving Clinical Trial Endpoints from Digital Health Technologies
    Junrui Di, PhD

    Estimands and Complex Innovative Designs
    Olivier Collignon, PhD

    Handling Intercurrent Events and Missing Data for Longitudinal Binary Data Under the Estimand Framework
    Yunxia Sui, PhD



    Speakers
    avatar for Olivier Collignon

    Olivier Collignon

    Statistics Leader, GlaxoSmithKline, United Kingdom
    Dr Olivier Collignon works as Associate Director at GSK in the United Kingdom where he contributes to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in basket, umbrella and platform trials, use... Read More →
    JD

    Junrui Di

    Digital Medicine Statistician, Pfizer Inc, United States
    Dr. Junrui Di is a statistican who supports the digital medicine team Pfizer Inc. His research centers around high dimensional and high frequency data collected by wearable devices and digital health technologies which have been widely used in multiple therapeutic areas at Pfizer... Read More →
    avatar for Munish Mehra

    Munish Mehra

    Managing Director, Tigermed India, Tigermed, United States
    Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across... Read More →
    avatar for Mat Soukup

    Mat Soukup

    Deputy Director, Division of Biometrics VII, OB, OTS CDER, FDA, United States
    Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team... Read More →
    YS

    Yunxia Sui

    Data and Statistical Sciences, Global Pharmaceutical R&D, AbbVie, Inc., United States
    Dr. Sui is an Associate Director of statistics in AbbVie Inc.. She received her PhD in Biostatistics from Brown University. She joined AbbVie in 2017 and has been working on clinical trials in immunology and oncology supporting phase 3 program development and regulatory submissio... Read More →


    Monday June 20, 2022 1:30pm - 2:30pm CDT
    Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      11: Statistics, Session

    1:30pm CDT

    #121: Identifying Value and Driving Access to Drug-Based Products Evaluated Using Digital Endpoints
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-22-523-L04-P ; CME 1.00; RN 1.00

    This forum will discuss case studies from the US, Europe, and Asia to present a framework developed as part of a multi-stakeholder effort that supports a transparent, consistent, and patient-centered decision process for digital endpoints as value-evidence for reimbursing drug-based products.

    Learning Objectives

    Identify roadblocks/misaligned incentives across stakeholders evaluating information derived from digital endpoints used in drug development; Define shared terminology surrounding value of evidence of drug-based product efficacy derived from digital endpoints; Demonstrate value of evidence of drug-based product efficacy derived from digital endpoints across stakeholders/global regions.

    Chair

    Smit Patel, PharmD

    Speaker

    Patient Perspective
    Mariah Leach, JD, MS

    Industry Perspective
    Jiat Ling Poon, PhD

    Payer Perspective
    Siavash Sarlati, MD



    Speakers
    avatar for Mariah Leach

    Mariah Leach

    Founder, Patient Advocate, Mamas Facing Forward, United States
    Mariah is a writer, patient advocate, and mom of three living with rheumatoid arthritis. After learning firsthand the challenges of facing pregnancy and motherhood with a chronic illness, Mariah has become passionate about supporting women with chronic illnesses who are or want to... Read More →
    avatar for Smit Patel

    Smit Patel

    Clinical Innovation Lead, Digital Medicine Society (DiMe), United States
    Dr. Smit J. Patel, PharmD serves as the Clinical Innovation Lead at the Digital Medicine Society (DiMe), a 501(c)(3) global non-profit organization dedicated to better health powered by digital medicine. Smit’s work focuses on applied approaches to the safe, effective, ethical... Read More →
    avatar for Jiat Ling Poon

    Jiat Ling Poon

    Director, Value, Evidence, and Outcomes, Eli Lilly and Company, United States
    Jiat Ling (Jiat) Poon is a Director in Value, Evidence, and Outcomes at Eli Lilly and Company, responsible for the development of innovative and efficient patient-focused endpoints and measurement strategies to support drug development across Lilly’s portfolio. Jiat has over 8 years... Read More →
    SS

    Siavash Sarlati

    Medical Director, Digital Technology, Anthem, Inc., United States
    Siavash Sarlati is a practicing Emergency Physician who serves as medical director for Anthems Digital Platforms Devision. He provides clinical expertise for Anthem's digital health solutions development and manages the clinical evaluation of both first and third-party digital health... Read More →


    Monday June 20, 2022 1:30pm - 2:30pm CDT
    Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      12: Value-Access, Forum

    2:15pm CDT

    Refreshment Break
    Component Type: Social Event




    Monday June 20, 2022 2:15pm - 4:00pm CDT
    Exhibit Hall McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:30pm CDT

    #122 CH: Transgender and Non-Binary Patients’ Inclusivity in Clinical Research: How Far Have We Come and Where Are We Going Next?
    Component Type: Workshop
    Level: Basic

    Sharing patient feedback and literature review results to highlight barriers to transgender and non-binary patient involvement in research, ways to overcome them, and areas that need addressing to enable equity in healthcare access.

    Learning Objectives

    Describe clinical research barriers to transgender and non-binary patient inclusivity; Discuss approaches to enhance the clinic environment to promote inclusivity; Explore strategies that could be implemented by healthcare providers and pharmaceutical companies to promote inclusivity.

    Chair

    Liam Paschall


    Speakers
    avatar for Liam Paschall

    Liam Paschall

    Senior Consultant of Management Development, Parexel, United States
    Liam is a transgender man who has found immense courage, strength, and pride in being his authentic self. He is a Senior Consultant of Management Development at Parexel, and is a dynamic public speaker, DEI consultant, and experienced learning & development professional. Liam, who... Read More →


    Monday June 20, 2022 2:30pm - 3:00pm CDT
    Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:30pm CDT

    #123 CH: Mastering the Science of Medical Writing Communications
    Component Type: Workshop
    Level: Intermediate

    Medical writers don't just write documents, we are also strategic planners, mediators and conflict resolvers and need to be effective communicators. This session aims to give MWs hands on tools for better communication with their team members.

    Learning Objectives

    Identify key communication errors; Share examples of best practices for good planning and communication; Discuss how to train reviewers.

    Chair

    Mitali Purohit, PhD, MS


    Speakers
    avatar for Mitali Purohit

    Mitali Purohit

    Associate Director, Immunology TA Lead, CSL Behring, United States


    Monday June 20, 2022 2:30pm - 3:00pm CDT
    Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:30pm CDT

    Annual Meeting of Members
    Component Type: Forum

    Join us for the Annual Meeting of Members on Monday, June 20 at 2:30-3:15 PM in Booth #1719 in the Exhibit Hall


    Monday June 20, 2022 2:30pm - 3:15pm CDT
    Exhibit Hall Booth #1719 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:30pm CDT

    #124 RT: Round Table Discussion: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP)
    Component Type: Session
    Level: Basic

    Join the DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #108: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP) (Monday, June 20, 1:15-2:15pm.) Space is limited.

    Chair

    Greg Ball, PhD


    Speakers
    avatar for Greg Ball

    Greg Ball

    Head of Safety Statistics, Global Vaccine Safety, Novavax, Inc., United States
    Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists... Read More →


    Monday June 20, 2022 2:30pm - 3:30pm CDT
    Room 375 A Zone 1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:40pm CDT

    #125 IT: PPD, part of Thermo Fisher Scientific Innovation Theater: Patients as Influencers - How Today’s Patients are Shaping Tomorrow’s Clinical Trial Designs
    Component Type: Session

    Today’s data increasingly supports the notion that patients prefer to engage in clinical research when and where more digitally flexible options are made available to them and their loved ones. Study participants are actively shaping the design and functionality of clinical research – sharing their outcomes and data through multiple modern channels and platforms. As life science leaders, we must help drive momentum for these changes and enhance access for underrepresented patient groups.

    Chair

    PPD, Inc.

    Speaker

    Speaker
    Rose Blackburne, MD, MBA



    Speakers
    avatar for PPD, Inc.

    PPD, Inc.

    United States
    avatar for Rose Blackburne

    Rose Blackburne

    Vice President, Clinical Research, PPD, part of Thermo Fisher Scientific, United States
    Rose Blackburne, MD, MBA is Vice President and Global Head of Women’s Health/General Medicine. Dr. Blackburne is board certified in Obstetrics/Gynecology with over 25 years of experience in Health Care, including 17 years in clinical research. Dr. Blackburne is a globally recognized... Read More →


    Monday June 20, 2022 2:40pm - 3:10pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:40pm CDT

    #126 IT: Medable Innovation Theater: The Real R&D Accelerator
    Component Type: Session

    Innovation in medicine no longer resides in research labs.Indeed the key to solving R&D stagnation is deploying technology that can slash clinical trial timelines & accelerate needed therapies to market.Recent evidence shows that DCT solutions save 1-3 mths for a typical phase 2/3 trial generating a net benefit of up to 14x the initial investment.These savings could cover substantial portions of top pharma companies’ total yearly R&D spend & open possibilities of bringing more drugs to patients.

    Chair

    Medable

    Speaker

    Speaker
    Pamela Tenaerts, MD, MBA

    Speaker
    Kenneth Getz, MBA



    Speakers
    avatar for Medable

    Medable

    United States
    avatar for Pamela Tenaerts

    Pamela Tenaerts

    Chief Scientific Officer, Medable, United States
    As Chief Scientific Officer, Dr. Pamela Tenaerts oversees Medable’s clinical research department to help identify, develop and implement responsible decentralized trial strategies for sponsors, sites and patients. Dr. Tenaerts brings more than 30 years of experience in clinical... Read More →
    avatar for Kenneth Getz

    Kenneth Getz

    Executive Director/Professor, Tufts CSDD; Founder/Board Chair, CISCRP, Tufts University School of Medicine, United States
    Ken Getz is a Professor and the Executive Director of the Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded studies on pharmaceutical R&D management and execution; protocol design optimization; CRO and investigative site... Read More →


    Monday June 20, 2022 2:40pm - 3:10pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    2:40pm CDT

    #127 IT: RWS Innovation Theater: Advancement Through Adversity - How COVID-Driven Innovations are Becoming Best Practices for Pharmacovigilance
    Component Type: Session

    The global Covid-19 vaccine rollout created an explosion in pharmacovigilance (PV) and related multilingual data requirements. This created an opportunity for language providers to adapt processes and technologies. In this session, we’ll discuss how:

  • Human and machine translation can help address 24x7 requests and unpredictable volumes
  • Hybrid AI/human options provide scale and flexibility to transform PV
  • Investment in PV-specific innovations can be transferred across the ecosystem


  • Chair

    RWS

    Speaker

    Speaker
    David Paré

    Speaker
    Silvio Scozzari



    Speakers
    avatar for RWS

    RWS

    United States
    DP

    David Paré

    RWS, United States
    Dave Paré, Executive Director RI/CRO at RWS, is a specialized translation solutions expert who has been helping life science companies unlock global understanding for over 20 years. Driven and passionate about language he said - “I believe that language is a bridge between people... Read More →
    avatar for Silvio Scozzari

    Silvio Scozzari

    Senior Account Director, RWS, United States
    Silvio Scozzari, Senior Account Director RI/CRO at RWS, is a localization expert with over 20 years’ experience in the practice, process and complexity of localization and internationalization. Silvio has held roles in Project, Program and Operations Management as well as having... Read More →
    avatar for Silvio Scozzari

    Silvio Scozzari

    RWS, United States
    Silvio Scozzari, Senior Account Director RI/CRO at RWS, is a localization expert with over 20 years’ experience in the practice, process and complexity of localization and internationalization. Silvio has held roles in Project, Program and Operations Management as well as having... Read More →


    Monday June 20, 2022 2:40pm - 3:10pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:00pm CDT

    #002 STU: Collective Connections: Networking with Leaders
    Component Type: Forum
    Level: Basic

    There's no denying the power a strong professional network can have over your career success. Expanding your contacts can open doors to new opportunities and career development. Come network with DIA members and form connections to help you grow and learn in your professional journey.


    Speakers
    avatar for David Fryrear

    David Fryrear

    Executive Vice President and Head of Quality Assurance, Astellas, United States
    David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization... Read More →
    avatar for Jeremy Jokinen

    Jeremy Jokinen

    Vice President and Head, Global Risk Management & International Patient Safety, Bristol-Myers Squibb Company, United States
    Jeremy is the Vice President and Head, Global Risk Management and International Patient Safety at Bristol Myers Squibb. In this role, he leads a global team of risk management and safety science leaders responsible for insights, evidence generation, and risk minimization efforts ensuring... Read More →
    avatar for David Olaleye

    David Olaleye

    Senior Manager and Principal Research Statistician, SAS Institute Inc., United States
    David Olaleye is a Senior Manager/Principal Research Statistician at SAS Institute, Cary, NC. He received his postgraduate training in demography and statistics, and clinical epidemiology from the University of Pennsylvania School of Arts and Sciences, and School of Medicine, Philadelphia... Read More →
    avatar for Keith Wenzel

    Keith Wenzel

    Senior Director, Scientific Data Organization, Parexel International, United States
    Mr. Wenzel has worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working... Read More →
    avatar for Robin Whitsell

    Robin Whitsell

    President, Whitsell Innovations, Inc., United States
    Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years’ experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →


    Monday June 20, 2022 3:00pm - 3:45pm CDT
    Room 471 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      13: ProfDevelopment, Forum

    3:20pm CDT

    #128 IT: Castor Innovation Theater: A New Paradigm in CDMS
    Component Type: Session

    The key to revolutionizing antiquated clinical trial models into more patient-centric, decentralized trials is leveraging the power of simplicity. Simple, reusable, and self-service tools within a single platform allow researchers the flexibility to create trials that focus on serving patients and their communities.

    In this session, CEO Derk Arts and Solutions Consultant Kristen Harnack showcase how to apply flexible, digital tools to support the stages of transformation for trials shifting from traditional clinical trials models to the next generation of CDMS.

    Chair

    Castor

    Speaker

    Speaker
    Kristen Harnack

    Speaker
    Derk Arts, MD, PhD



    Speakers
    avatar for Castor

    Castor

    Netherlands
    avatar for Derk Arts

    Derk Arts

    Founder and CEO, Castor, Netherlands
    Derk Arts MD, PhD has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials... Read More →
    avatar for Kristen Harnack

    Kristen Harnack

    Solutions Consultant, Castor, United States


    Monday June 20, 2022 3:20pm - 3:50pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:20pm CDT

    #129 IT: Precision for Medicine Innovation Theater: Solving the Unique Central Lab Services Challenges of Precision, Biomarker-Driven Trials
    Component Type: Session

    In today's drug development landscape, the collection, management, and reporting on patient samples has never been more relevant; being able to physically and virtually follow a sample over its lifecycle is a key component of most clinical trials. Join us as we discuss how a precision approach to central lab services leveraging smart, integrated technologies can generate impactful operational insights and help ensure clinical trial success.

    Chair

    Precision for Medicine

    Speaker

    Speaker
    Joseph Neal



    Speakers
    avatar for Joseph Neal

    Joseph Neal

    Vice President, Central Lab Services, Precision for Medicine , United States
    Mr. Neal is the Vice President of Central Lab Services at Precision for Medicine. He serves as the Global Head for the Global Shipping & Logistics, Biorepository, Clinical Trial Kitting, and sample processing within Precision’s labs. He is responsible for all aspects of the design... Read More →


    Monday June 20, 2022 3:20pm - 3:50pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:20pm CDT

    #130 IT: Deloitte Innovation Theater: Sanofi’s Approach to Automating Adverse Event Case Processing Through Machine Learning and Innovation
    Component Type: Session

    With the mission of protecting and improving human health and safety of medicines, life sciences organizations primarily drive to three objectives: Scientific innovation to discover & develop medicinal therapies; Deliver and sell therapies to healthcare professionals and patients; Continuously monitor safety and efficacy of therapies to protect patients. To ensure patient safety, life science organizations conduct continuous monitoring of the safety of their products by collecting, assessing and reporting Adverse Events (AE) from various sources a time-sensitive manner. Pharmacovigilance Organizations considers this a core/foundational activity to protect patients safety with over hundreds of thousands of AE cases annually. Processing of AE cases is an intensive, manual, expensive, and time-consuming activity and the entire process is highly regulated by global health authorities. In this presentation, learn how PV Organizations have demonstrated success and realized significant operational and scientific benefits through combining business and technology transformation leveraging natural language processing, machine learning and artificial intelligence with Deloitte’s ConvergeHEALTH Safety Cognitive Case Processing Platform.

    In this presentation you will hear:
  • Strategies for bringing AI to reality in a highly regulated environment
  • Actual benefits and improvements in quality and efficiency that were achieved by real clients
  • Methodologies for measuring benefits and costs in the automation journey
  • Mitigation strategies for potential roadblocks, such as GxP validation expectations, quality management system adjustments, and vendor/outsourcing cooperation
  • Lessons learned from our clients’ journey from proof-of-concept to production roll out
  • Change management, communication and negotiation strategies required to achieve benefits both with internal and external stakeholders


  • Chair

    Deloitte

    Speaker

    Speaker
    Sapna Elzer

    Speaker
    Amanda Bowles, MS

    Speaker
    Glenn Carroll, MBA



    Speakers
    avatar for Amanda Kirby Bowles

    Amanda Kirby Bowles

    Managing Director, Deloitte, United States
    Amanda has over 13 years of life sciences experience including over 10 years specializing as a pharmacovigilance and drug safety systems subject matter advisor. Amanda has in depth experience in drug safety, pharmacovigilance and regulatory affairs, including extensive experience... Read More →
    avatar for Glenn Carroll

    Glenn Carroll

    Principal, Deloitte, United States
    Glenn Carroll is a principal in our life science strategy practice with over 15 years pharmaceutical and biotech experience. Glenn leads Deloitte's US Safety and Medical practices. He has a strong track record in delivering strategic and operational excellence, specifically in the... Read More →
    avatar for Deloitte

    Deloitte

    United States
    SE

    Sapna Elzer

    PV Data Strategy Lead, Sanofi, United States


    Monday June 20, 2022 3:20pm - 3:50pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    4:00pm CDT

    #131: Innovations for Implementing REMS
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-524-L04-P ; CME 1.00; RN 1.00

    This session will focus on recent approaches to integrate REMS requirements into the normal workflow of healthcare providers and health care systems.

    Learning Objectives

    Identify the challenges in integrating REMS requirements into the health care system; Describe the potential REMS implementation benefits derived from innovative use of health information technology; Examine the future potential of REMS ETASU integration and implementation throughout the health care delivery system via the use of the health information technology.

    Chair

    Cynthia LaCivita, PharmD

    Speaker

    Industry Update
    James Aaron Curtis

    Industry Update
    James Shamp

    FDA Update
    George Neyarapally, JD, PharmD, MPH

    FDA Update
    Edward D. Millikan, PharmD, RPh



    Speakers
    JC

    James Curtis

    Director, Software Development Engineering, United Biosource Corporation, United States
    James Curtis is a Director, Software Development and Engineering at UBC, with over 13 years of experience in the biopharmaceutical industry. James has hand-on experience building several custom software platforms across UBC’s service lines and is currently responsible for UBC’s... Read More →
    avatar for Cynthia LaCivita

    Cynthia LaCivita

    Director, Division of Risk Management, OMEPRM, OSE, CDER, FDA, United States
    Cynthia LaCivita earned her undergraduate degree in microbiology and Doctor of Pharmacy from the University of Maryland (U of MD) and completed an oncology residency at the University of Maryland Cancer Center (UMCC). She was an assistant professor in the Department of Pharmacy Practice... Read More →
    avatar for Edward Millikan

    Edward Millikan

    Senior Informatics Pharmacist, OMEPRM, OSE, CDER, FDA, United States
    Ed Millikan, PharmD, is the Senior Informatics Pharmacist in the Division of Mitigation Assessment and Medication Error Surveillance, Office of Surveillance and Epidemiology (OSE), in FDA’s Center for Drug Evaluation and Research. With over 20 years of experience as an Informatics... Read More →
    avatar for George Neyarapally

    George Neyarapally

    Regulatory Science Research Policy Lead, Regulatory Science Staff, OSE, CDER, FDA, United States
    George Neyarapally, PharmD, JD, MPH, RPh works as a subject matter expert at the FDA in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER) on regulatory science and policy initiatives and research. George previously worked at MITRE/the... Read More →
    avatar for James Shamp

    James Shamp

    Managing Partner, Examoto, LLC, United States
    Jim Shamp has been working in the pharmaceutical industry for over 22 years. The last 18 years have been dedicated specifically to REMS with a focus on the design, implementation, operation, and assessment of REMS. Jim is a Managing Partner at Examoto, a company passionate in the... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Session |   09: Regulatory, Session

    4:00pm CDT

    #132: ICH E2D Update: Innovations in Collecting Safety Data from Disparate Sources
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-525-L04-P ; CME 1.00; RN 1.00

    This session will discuss how this document aims to establish an internationally standardized procedure to improve the quality of post-approval safety information and to harmonise the way of gathering and reporting information. It provides guidance on definitions and standards for post-approval expedited reporting, as well as good case management practices.

    Learning Objectives

    Describe an international standardized procedure to improve the quality of post-approval safety information; Discuss guidance on definitions and standards for post-approval expedited reporting.

    Chair

    Vicki Edwards, RPh

    Speaker

    Industry Update
    Michelle Grimes, MSc

    Industry Update
    David John Lewis, PhD

    FDA Update
    Robert Ball, MD, MPH, MSc

    FDA Update
    Craig Zinderman, MD, MPH



    Speakers
    avatar for Robert Ball

    Robert Ball

    Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
    Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World... Read More →
    avatar for Vicki Edwards

    Vicki Edwards

    Vice President, Pharmacovigilance Excellence and International QPPV, AbbVie, Inc., United Kingdom
    Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community... Read More →
    avatar for Michelle Grimes

    Michelle Grimes

    Head, International Pharmacovigilance. GCS&PV, Merck and Co., Inc., Denmark
    Michelle is leading the International Pharmacovigilance organization at Merck. She has 25+ years of experience in the pharma industry and worked in clinical research and consulting prior to moving into pharmacovigilance (PV). Since joining Merck in 2002 she has performed various roles... Read More →
    avatar for David Lewis

    David Lewis

    Head QPPV PRRC Office, Chief Medical Office & Patient Safety, Novartis Pharma AG, Switzerland
    Dr Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire. He has worked in country affiliates and in a variety of global safety & risk management functions with both investigational & marketed products, as well as in roles involving systems... Read More →
    CZ

    Craig Zinderman

    Associate Director for Medical Policy, Office of Biostatistics and Pharmacovigil, FDA, United States
    Dr. Zinderman has worked in the Division of Epidemiology in the Office of Biostatistics and Pharmacovigilance (OBPV) since 2004. He initially served as a Medical Officer and Epidemiologist in the Therapeutics and Blood Safety Branch for 4 years, before becoming the Acting Branch Chief... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Session |   09: Regulatory, Session

    4:00pm CDT

    #133: New Tools for Creating Flexible and Sustainable Master Protocols
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-526-L04-P ; CME 1.00; RN 1.00

    Master protocols enable innovative complex trials but can be highly detailed and challenging to review, which can impede their successful implementation. The TransCelerate Common Protocol Template can be a framework for developing master protocols.

    Learning Objectives

    Identify key considerations for preparing master protocols; Apply the Common Protocol Template to master protocols; Recognize opportunities to utilize the IMI EU-PEARL integrated research platform framework, including a master protocol template, to set up a platform trial.

    Chair

    Nancy Tam, MS

    Speaker

    Industry Update
    Madhavi Gidh-Jain, PhD

    Industry Update
    Mary Lynn Mercado, PhD



    Speakers
    avatar for Nancy Tam

    Nancy Tam

    Head of Medical Writing, Pfizer Inc, United States
    Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy has a longstanding interest in clinical trial design and serves as a business process owner for the interventional... Read More →
    avatar for Madhavi Gidh-Jain

    Madhavi Gidh-Jain

    Medical Writing Head, Sanofi, United States
    Madhavi Gidh-Jain has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. Currently, Madhavi is the Head of Medical Writing for multiple therapeutic areas... Read More →
    avatar for Mary Lynn Mercado

    Mary Lynn Mercado

    Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States
    Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Session |   04: MedAffairs-SciComm, Session

    4:00pm CDT

    #134: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-527-L04-P ; CME 1.00; RN 1.00

    PDUFA VII continues and strengthens prior commitments, accelerates CBER’s IT modernization to keep pace with complex scientific advancements, supports the increasing use of digital health technologies in clinical trials, and explores innovation through the use of cloud-based technologies. This session will review the commitments and their value to stakeholders. Join the DIA Regulatory Affairs Community for a follow up round table discussion (session #236 RT) on Tuesday, June 21, 12:30pm - 1:30pm.

    Learning Objectives

    Describe the data and technology-focused commitments in PDUFA VII.

    Chair

    Ethan Chen, MBA

    Speaker

    Moderator
    Brooke Casselberry, MS, RAC

    IT/Informatics: What's Coming in PDUFA VII
    Mary Ann Slack

    FDA Update
    Michael Foecking



    Speakers
    avatar for Brooke Casselberry

    Brooke Casselberry

    Associate Vice President, US Life Sciences Advisory and Consulting, NNIT, Inc., United States
    Brooke Casselberry is Associate Vice President of NNIT Inc, leading the US Life Sciences Advisory and Consulting team consisting of Clinical, Regulatory, Digital Technology, Training/OCM, and Program Management. Brooke is programming chair for DIA US Annual Meeting with the Data and... Read More →
    avatar for Ethan Chen

    Ethan Chen

    Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States
    Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →
    MF

    Michael Foecking

    IT Branch Chief and ADCIO, CBER, FDA, United States
    Michael has been in the IT industry for over 38 years. He worked for a variety of software, hardware and services companies before joining the U.S. Federal government 20 years ago. Michael led multiple agency-wide programs across the Department of Health and Human Services. He is... Read More →
    avatar for Mary Ann Slack

    Mary Ann Slack

    Director, Office of Strategic Programs, CDER, FDA, United States
    Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Session |   09: Regulatory, Session

    4:00pm CDT

    #135: Demystifying the Delivery of Healthcare Economic Information (HCEI) by Medical Affairs and Market Access Personnel
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-528-L04-P ; CME 1.00; RN 1.00

    Focus is on the exchange of healthcare economic information to the payor audiences. Since FDAMA 114 was instituted, many changes have occurred in the pharmaceutical industry regarding the what, the when, and the who around this information exchange.

    Learning Objectives

    Describe health economic and outcomes research and potential consumers of this research; Examine how healthcare economic information (HCEI) is communicated and how the customer segments in this area are expanding; Discuss a case study on the benefits and challenges of communicating health economics and outcomes research to a variety of customer segments.

    Chair

    J. Lynn Bass, PharmD, RPh

    Speaker

    Panelist
    Iris Tam, PharmD

    Panelist
    Jeff Lee, PharmD

    Panelist
    Dara S. Katcher Levy, JD



    Speakers
    avatar for J. Lynn Bass

    J. Lynn Bass

    Senior Director, Medical Sciences, Medexus Pharma, United States
    With 20+ years of experience in Medical Science Liaison and Medical Affairs roles across the pharmaceutical industry, Lynn is currently the Senior Director, Medical Sciences at Medexus Pharma. Her industry career has spanned many therapeutic areas and she has authored/ co-authored... Read More →
    avatar for Jeff Lee

    Jeff Lee

    Vice President, US Value Strategy and Services, Lumanity, United States
    Jeff is a senior HEOR leader, with a focus on generating and communicating value evidence for payor audiences. Jeff led the Global Health Outcomes and Payer MSL teams at Allergan after several years as International Director of Pharmacoeconomics at Glaxo. Jeff is an ACCP Fellow, led... Read More →
    avatar for Iris Tam

    Iris Tam

    Vice President and Head, Medical Affairs and HEOR, Coeus Consulting Group, United States
    Iris Tam, PharmD, FAMCP, has over 28 years of experience in health care, including hospital pharmacy administration, managed care pharmacy, and 17 years in the biopharmaceutical industry. She is Senior Director & Head of HEOR, Patient Access and Value at Coeus Consulting Group, a... Read More →
    avatar for Dara Katcher Levy

    Dara Katcher Levy

    Director, Hyman Phelps & McNamara P.C., United States
    Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements. In the... Read More →
    avatar for Iris Tam

    Iris Tam

    Vice President and Head, Medical Affairs and HEOR, Coeus Consulting Group, United States
    Iris Tam, PharmD, FAMCP, is Vice President & Head of Medical Affairs and HEOR at Coeus Consulting Group with over 30 years of experience in health care, including hospital pharmacy, managed care pharmacy, and the biopharmaceutical industry. In previous industry roles, she led Medical... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      04: MedAffairs-SciComm, Forum

    4:00pm CDT

    #136: Developing and Implementing a Strategic Framework to Guide Patient Engagement
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-529-L04-P ; CME 1.00; RN 1.00

    Strategic patient engagement helps ensure clinical development addresses a community’s most important needs. Presenters will describe examples of development and implementation of a strategic, flexible, and iterative framework for patient engagement.

    Learning Objectives

    Discuss an approach to establish a company-wide culture of patient inclusion in drug development; Identify ways to build recognition of patient engagement, patient-centered activities, and patient-focused drug development; Explore strategies to engage key stakeholders' Describe a process to establish a systematic and strategic approach to patient involvement across a compound’s life cycle.

    Chair

    Kristin Voorhees, MA

    Speaker

    Panelist
    K. Kimberly McCleary

    Panelist
    Adam Diamond

    Panelist
    Jessica Riviere, MHS



    Speakers
    avatar for Adam Diamond

    Adam Diamond

    Patient Advocate, United States
    Having been diagnosed with Glycogen Storage Disease Type Ia in 1979, I have learned and overcome various medical treatments to live a normal adult livelyhood at the young vibrant age of 43. Over the past few years, I have served as an Advisory Board member for Ultragenyx in hopes... Read More →
    avatar for K. Kimberly McCleary

    K. Kimberly McCleary

    Founder and Chief Executive Officer, The Kith Collective, LLC, United States
    Kim McCleary has been at the forefront of patient engagement for more than 30 years. She is a nationally regarded subject matter expert on patient-focused medical product development, patient-centered benefit-risk assessment, and organizational change. Kim has authored scores of publications... Read More →
    avatar for Jessica Riviere

    Jessica Riviere

    Vice President of Global Patient Advocacy and Patient Engagement, Ultragenyx, United States
    Jessica leads Global Patient Advocacy and Patient Engagement at Ultragenyx, where she and her passionate team forge strategic alliances with diverse patient advocacy groups to understand patient and caregiver perspectives across the drug discovery continuum. Her passion is building... Read More →
    avatar for Kristin Voorhees

    Kristin Voorhees

    Director, Patient Advocacy, Ultragenyx, United States
    As Director of Patient Advocacy at Ultragenyx, Kristin partners with the rare disease community and strives to make a positive and meaningful difference in the lives of patients, caregivers and families. She partners closely with internal functions such as clinical development, discovery... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      05: Patient Engagement, Forum

    4:00pm CDT

    #137: Successful Virtual Partnering
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-530-L04-P ; CME 1.00; PDU 1.00 PMI 2166OXQND7; RN 1.00

    This session will discuss virtual partnering and how teams can get the most from these new types of collaborations. Virtual outsourcing, effective communications, and building effective virtual processes will be discussed in this session.

    Learning Objectives

    Describe optional strategies, tactics, and tools being used among virtual partners to help teams meet their project goals.

    Chair

    Shannon Heacock

    Speaker

    Successful Virtual Partnering
    Abdu Nessralla, MPH

    Successful Virtual Partnering
    Michelle McGuinness, MSc



    Speakers
    avatar for Shannon Heacock

    Shannon Heacock

    Head of Regulatory Submissions, WAYS Pharmaceutical Services, LLC, United States
    Shannon Heacock has 16 years of experience in regulatory operations and specializes in eCTD. Her expertise is focused on global submission management, eCTD technical requirements and data standards requirements. She has led teams responsible for compiling, managing, and submitting... Read More →
    avatar for Michelle McGuinness

    Michelle McGuinness

    President and Principal, Pharmaceutical Compliance Partners, LLC, United States
    Leveraging her broad experience across QA, regulatory and commercial compliance, Ms. Mc Guinness has earned a reputation for crafting successful regulatory strategies, driving principles-based compliance initiatives, & providing advice that empowers the business to make informed... Read More →
    AN

    Abdu Nessralla

    Associate Director, Global Regulatory Affairs and Strategy, Morphic Therapeutics, United States


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      07: ProjectManagement-StrategicPlanning, Session

    4:00pm CDT

    #138: ICH E8(R1): Regulators' Perspectives on Quality-by-Design of Clinical Studies
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-531-L04-P ; CME 1.00; RN 1.00

    Global regulators will discuss their perspectives on ICH E8(R1) and the importance of implementing quality-by-design principles and practices in the planning, conduct, and reporting of clinical trials.

    Learning Objectives

    Discuss quality-by-design principles;Describe how effective proactive implementation of quality-by-design principles impacts clinical development; Discuss regulator’s perspectives on the role of quality-by-design to ensure a clinical study results in data that is fit for purpose.

    Chair

    Jean M. Mulinde, MD

    Speaker

    FDA Update
    Ann Meeker-o`Connell, MS

    MHRA Update
    Mandy Budwal-Jagait, MSc



    Speakers
    avatar for Ann Meeker-o`Connell

    Ann Meeker-o`Connell

    Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC, FDA, United States
    Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner. In this role, she leads an organization that coordinates the development of human subject protection and good clinical practice policy across the agency. Ms. Meeker-O’Connell... Read More →
    avatar for Jean Mulinde

    Jean Mulinde

    Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI, FDA, United States
    Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
    avatar for Mandy Budwal-Jagait

    Mandy Budwal-Jagait

    Head of GCP and Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      08: RD Quality-Compliance, Forum

    4:00pm CDT

    #140: ICMRA: COVID-19 Response and International Collaboration
    Component Type: Forum
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-534-L04-P ; CME 1.00; RN 1.00

    The first part of this session will provide an overview of initiatives and channels of collaboration established/intensified during the pandemic, applying regulatory flexibilities and agile approaches in this public health emergency setting. The second part will discuss lessons learned and will look at which of the introduced flexibilities could be sustained, both for emergency and non-emergency contexts.

    Learning Objectives

    Discuss initiatives of international collaboration and cooperation during the Covid-19 pandemic; Describe key achievements; Identify lessons learned.

    Chair

    Emer Cooke, MBA, MSc

    Speaker

    EMA Update
    Marco Cavaleri, PhD

    Update on Clinical Trial Design Issues
    Yasuhiro Fujiwara, MD, PhD

    Update on Pharmacovigilance and Vaccine Confidence
    John Skerritt, PhD



    Speakers
    avatar for Marco Cavaleri

    Marco Cavaleri

    Head of Health Threats and Vaccines Strategy, European Medicines Agency, Netherlands
    Head of Anti-infectives and Vaccines, European Medicines Agency (2009-present) Therapeutic Group Leader for Anti-infectives, European Medicines Agency (2008-2009) Associate Scientific Director, Cosmo Pharmaceuticals S.p.A., Lainate, Italy (2008) Scientific Administrator, European... Read More →
    avatar for Emer Cooke

    Emer Cooke

    Executive Director, Chair, ICMRA, European Medicines Agency, Netherlands
    Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →
    avatar for Yasuhiro Fujiwara

    Yasuhiro Fujiwara

    Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
    avatar for Peter Marks

    Peter Marks

    Director, Center for Biologics Evaluation and Research, FDA, United States
    Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
    avatar for John Skerritt

    John Skerritt

    Deputy Secretary for Health Products Regulation, Australian Department of Health, Australia
    Dr John Skerritt joined the Australian Department of Health in 2012 and is currently a Deputy Secretary and member of the executive team of the Department of Health. He was formerly the National Manager of the Therapeutic Goods Administration (TGA), until his role was expanded and... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Forum

    4:00pm CDT

    #139: FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-532-L04-P ; CME 1.00; RN 1.00

    An expert panel will review the EMA and FDA benefit-risk frameworks and how to optimize these processes, including the addition of sponsor input to highlight critical considerations in the submission; and offer suggestions for effective public communications.

    Learning Objectives

    Compare and contrast FDA and EMA benefit-risk (BR) assessments and how they drive or factor into regulatory decisions for marketing authorizations; Discuss how these decisions are communicated to the public; Explore how sponsors may provide input on benefit-risk to EMA and FDA to better inform regulatory review and decision making and contribute to review modernization.

    Chair

    Julie Anne Zawisza, MA, MT

    Speaker

    FDA Guidance on Benefit-Risk Assessment for New Drug and Biological Products
    Graham Thompson

    EMA Update
    Francesco Pignatti, MD

    Industry Update
    Pujita Vaidya, MPH

    Industry Update
    Ellis Unger, MD



    Speakers
    avatar for Francesco Pignatti

    Francesco Pignatti

    Head of Oncology and Hematology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    GT

    Graham Thompson

    Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA, United States
    Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Staff (DSAS) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and... Read More →
    avatar for Ellis Unger

    Ellis Unger

    Principal Drug Regulatory Expert, Hyman, Phelps & McNamara, P.C., United States
    Dr. Ellis Unger is a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara. A cardiologist with 24 years of FDA experience in drug regulation, safety, clinical trial design, and analysis, he started as a Medical Officer in CBER, ultimately serving 8 years as the Director, Office... Read More →
    avatar for Pujita Vaidya

    Pujita Vaidya

    Director, Global Regulatory and R&D Policy, Patient Centricity, Pediatrics, ROD, Amgen, United States
    Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies, specifically Patient Centricity, Pediatrics, and Rare Diseases. Her work includes partnering with cross-functional... Read More →
    avatar for Julie Anne Zawisza

    Julie Anne Zawisza

    Senior Director, Global Regulatory Policy, MRL GRACS, Merck & Co., Inc., United States
    Ms. Zawisza leads regulatory policy for Merck’s oncology business. She is active on PhRMA and BIO committees for biosimilars, new drug clinical development, CDx, adaptive trial design, and other key FDA policy initiatives. She is a Board member of The Alliance for a Stronger FDA... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Forum |   01: ClinSafety-PV, Forum

    4:00pm CDT

    #142: The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-536-L04-P ; CME 1.00; RN 1.00

    Modernizing regulatory activities will facilitate simultaneous global submissions and concurrent collaborative reviews, significantly reducing global licensing timelines. This session will describe industry and regulator efforts in this space.

    Learning Objectives

    Discuss modernization efforts from industry and regulatory perspectives; Identify how to solve challenges related to management of module 3 (CMC) data in regulatory submissions; Discuss and link CMC risks to patient risk/benefit; Describe the potential benefit of summarizing the overall control strategy, established condition and patient benefit in the Quality Overall Summary.

    Chair

    Nina S. Cauchon, PhD, RAC

    Speaker

    Integrated Summary of Quality: The Importance of a Patient Focused Risk-Based Submission
    Gregory Rullo, MS

    Industry Update
    Sheetal Gaiki, MPharm

    FDA Update
    Geoffrey Wu, PhD



    Speakers
    avatar for Nina Cauchon

    Nina Cauchon

    Director Regulatory Affairs CMC, Amgen, United States
    Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
    SG

    Sheetal Gaiki

    Senior Scientist, Regulatory Dossier Development, Janssen Research & Development, LLC, United States
    Sheetal Gaiki is Senior Scientist, at Janssen Research & Development, LLC; a division of Johnson & Johnson. Sheetal is responsible for developing dossier strategy and preparing CMC dossier sections to support global CTAs and marketing applications across a diverse portfolio of SM... Read More →
    GR

    Gregory Rullo

    Senior Director, Regulatory Affairs - CMC, AstraZeneca Pharmaceuticals LP, United States
    Greg Rullo has a wide range of experience in the strategic and tactical aspects of pharmaceutical drug development and global regulatory cmc knowledge. This regulatory knowledge/experience includes CMC specific knowledge of requirements in Latin American countries with a detailed... Read More →
    avatar for Geoffrey Wu

    Geoffrey Wu

    Deputy Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA, FDA, United States
    Commander Geoffrey Wu, Ph.D., PMP, CPH, Deputy Office Director, Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), joined the FDA’s Office of Testing and Research (OTR) in 2010, has served as research scientist, science staff, chemistry reviewer, special... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      10: RegCMC-Product Quality, Session

    4:00pm CDT

    #143: A Targeted Learning Framework for Causal Effect Estimation Using Real-World Data
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-537-L04-P ; CME 1.00; RN 1.00

    This session will discuss how to maximize potential for informing regulatory decision making from real-world data by following the Targeted Learning Roadmap. Compare findings using TMLE+Super Learning with propensity score-based estimators. Develop a TL-based SAP.

    Learning Objectives

    Describe how to follow steps in the Targeted Learning (TL) Estimation Roadmap to extract reliable evidence from real-world data (RWD); Assess level of support for substantive conclusion; Recognize challenges of analyzing RWD, and how they can be mitigated by using data adaptive machine learning and TMLE; Access resources for developing a TL-based, completely pre-specified, statistical analysis plan.

    Chair

    Susan Gruber, PhD, MPH, MS

    Speaker

    Targeted Learning for Real World Evidence
    Mark van der Laan, PhD

    Regulatory Perspective
    Hana Lee, PhD

    Industry Perspective
    Yixin Fang, PhD



    Speakers
    YF

    Yixin Fang

    Medical Affairs and Health Technology Assessment, AbbVie, United States
    Yixin Fang is a Director of Medical Affairs & Health Technology Assessment Statistics (MA&HTA Statistics) at AbbVie. He received his PhD degree in statistics from Columbia University and holds experiences combined in academia and pharmaceutical industry. His research interests include... Read More →
    avatar for Susan Gruber

    Susan Gruber

    Principal, Putnam Data Sciences, LLC, United States
    Dr. Susan Gruber is a biostatistician and computer scientist whose expertise is in the development and application of data adaptive methodologies to improve the quality of evidence generated by studies of observational health care data. She is a leading expert in Targeted Learning... Read More →
    avatar for Mark van der Laan

    Mark van der Laan

    Professor in Biostatistics and Statistics, University of California, Berkeley, United States
    Mark van der Laan is the Jiann-Ping Hsu/Karl E. Peace Professor of Biostatistics and Statistics at the University of California, Berkeley. He has made contributions to survival analysis, semiparametric statistics, multiple testing, and causal inference. He also developed the targeted... Read More →
    HL

    Hana Lee

    Senior Statistical Reviewer, OB/OTS/CDER, FDA, United States
    Hana Lee, PhD, is a Senior Statistical Reviewer of the Office of Biostatistics in the CDER, FDA. She leads and oversees various FDA-funded projects intended to support development of the agency’s RWE program including multiple Sentinel projects to develop causal inference framework... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      11: Statistics, Session
    • Level Basic
    • Featured Topics RWD-RWE
    • Level Basic
    • Feature Topics RWD-RWE
    • Credit Type ACPE, CME, RN
    • Tags Session

    4:00pm CDT

    #144: Value of Patient Experience Data in Healthcare Decision-Making
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-538-L04-P ; CME 1.00; RN 1.00

    This expert panel will focus on the topics related to the value of patient experience data in healthcare decision making from patient/ caregiver, manufacturer and payer perspectives. Join the DIA Patient Engagement Community for a follow up round table discussion (session #335 RT) on Wednesday, June 22, 12:30pm - 1:30pm.

    Learning Objectives

    Discuss the place of patient experience data in healthcare decision-making, including patient, provider and payer perspectives; Debate and outline potential opportunities and use cases for patient experience data coverage and reimbursement decision-making.

    Chair

    Ruslan Horblyuk, PhD, MA

    Speaker

    Patient Perspective
    Nell Meosky Luo

    Industry Perspective
    Robyn T. Carson, MPH



    Speakers
    avatar for Robyn Carson

    Robyn Carson

    Vice President, Patient-Centered Outcomes Research, AbbVie, United States
    Robyn T. Carson, MPH, is Vice President & Head, Patient-Centered Outcomes Research at AbbVie, where she leads a team focused on integrating the patient voice into medical product development and establishing best practices for clinical outcome assessment (COA) development, validation... Read More →
    RH

    Ruslan Horblyuk

    Chief Strategic Consulting Officer, AESARA, United States
    Ruslan Horblyuk started his career in international health policy consulting over 20 years ago working in the countries of former Soviet Union as part of the US Agency for International Development funded Health Policy Reform Initiative. He transferred to the industry in 2003 and... Read More →
    NM

    Nell Meosky Luo

    Chief Executive Officer, Folia Health, United States
    Nell Meosky Luo is the Founder & CEO of Folia Health, where she has led a team for the past 5 years to develop a novel method for enabling the collection and use of home-reported outcomes for precision care & research. She was the recipient of the Massachusetts Women in Digital Health... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      12: Value-Access, Forum

    4:00pm CDT

    #145: Design Thinking: The Empathy Map
    Component Type: Workshop
    Level: Basic

    This workshop will teach attendees how to develop and utilize an empathy map. Empathy maps can help you to understand your patient and their care circle from their view, giving you a valuable perspective when designing protocols and studies for a patient population.

    Learning Objectives

    Define an empathy-based mindset and an empathy map; Describe how an empathy-based interview approach can derive patient insights; Explain how to create an actionable empathy map based on an interview with the parent of a child that has participated in a clinical trial; Summarize how an empathy map can contribute to optimal design of a clinical study.

    Chair

    Jacqui Whiteway, PhD

    Speaker

    Introduction to Design Thinking Framework
    Nadia Bracken

    Design Thinking: The Empathy Map
    Aaron J Horowitz



    Speakers
    avatar for Jacqui Whiteway

    Jacqui Whiteway

    Senior Director, Center for Pediatric Clinical Development, ICON, Canada
    Dr. Jacqui Whiteway brings more than 18 years experience in clinical research to her current role as Senior Pediatric Strategy Liaison in the Center for Pediatric Clinical Development (CPCD) at PRA. She has a PhD in Molecular Biology, was a Postdoctoral Fellow in cancer genomics at... Read More →
    avatar for Nadia Bracken

    Nadia Bracken

    Operational Advisor (RBQM), Medidata, a Dassault Systèmes company, United States
    Founder and Chief Experience Officer (CXO) at GCP Cafe community and networking group for clinical researchers. Her top-ranked pharma-industry blog has been frequented by visitors from 150+ countries. Nadia, finalist in the 2010 inaugural Pharmatimes US Clinical Researcher of The... Read More →
    avatar for Aaron Horowitz

    Aaron Horowitz

    Chief Executive Officer, Co-Founder, Sproutel, United States
    Aaron is a maker; from sculptures to business, he is fascinated with the process of taking an idea from concept to reality. His experience growing up with human growth hormone deficiency inspired a desire to bring empathy, design, and a patient-centered mindset to healthcare. He is... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      13: ProfDevelopment, Workshop

    4:00pm CDT

    DIA Student Case Competition Presentation
    Component Type: Session

    Each year, DIA hosts a Student Case Competition at our Global Annual Meeting that provides students the opportunity to respond and propose viable solutions to current challenges faced throughout the drug development lifecycle. The competition will be judged by a committee of DIA Fellows, who include our most experienced and engaged members that encompass a broad range of expertise.

    Participating Universities
  • Northeastern University
  • Rutgers
  • UIC


  • Chair

    Tamei Elliott, MS


    Speakers
    avatar for Rebecca Vermeulen

    Rebecca Vermeulen

    Vice President, Chapter Lead Global Patient Networks | PD Medical Affairs, Hoffmann-La Roche Ltd., United States
    Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →
    avatar for E. Stewart Geary

    E. Stewart Geary

    Senior Vice President, Eisai Co., Ltd., Japan
    Stewart Geary, MD, is Global Safety Officer and a Senior Vice President at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Boards for Applied Clinical Trials and Pharmaceutical Medicine. A member of CIOMS... Read More →
    avatar for Tamei Elliott

    Tamei Elliott

    Senior Manager, Scientific Programs, DIA, United States
    Tamei Elliott is the Senior Manager of Scientific Programs for the Americas Region at DIA. She is responsible for identifying and prioritizing content areas and topics of importance to DIA constituents, assessing the implications of important regulatory and health policy changes... Read More →
    avatar for Joseph Scheeren

    Joseph Scheeren

    Founder, Scheeren Health Care LLC, United States
    Dr. Scheeren worked in R&D in the Pharmaceutical Industry for over 35 years in the USA, China and Europe. Former Chair of DIA. Currently , he is a Board Member of VacciTech plc. He recently founded a consultancy company ScheerenHeathCare LLC. Since January 2019, he is Adjunct Professor... Read More →


    Monday June 20, 2022 4:00pm - 5:00pm CDT
    Room 471 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      17: Networking Opportunities, Session

    5:00pm CDT

    DIA Welcome Reception supported by Change Healthcare
    Component Type: Session

    Network with thousands of attendees and more than 300 exhibiting companies at the DIA Opening Reception, held in the Exhibit Hall. Supported by Change Healthcare


    Monday June 20, 2022 5:00pm - 6:00pm CDT
    Exhibit Hall McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    5:15pm CDT

    #146 IT: Labcorp Innovation Theater: How AI Modeling of Diagnostic Data is Providing Actionable Insights for Difficult to Diagnose Conditions
    Component Type: Session

    NASH and CKD affect different organs but suffer from the same fundamental problems in clinical care and research: under-diagnosis and low awareness. We will discuss how world class diagnostic capabilities, medical expertise, and artificial intelligence combine to develop new ways of identifying individuals at risk of these diseases. Outcomes include development of registries, supporting diversity, research ready patient communities and accelerating trial enrollment.

    Chair

    Labcorp Drug Development

    Speaker

    Speaker
    Earl Seltzer, MBA



    Speakers
    avatar for Earl Seltzer

    Earl Seltzer

    Senior Director, Global Feasibility, Labcorp Drug Development, United States
    Earl Seltzer has over 17 years of industry experience shared across clinical investigator sites in the United States and working at CROs in the strategic planning and feasibility space. At Labcorp, Mr Seltzer leads the global feasibility team as part of the larger, feasibility recruitment... Read More →


    Monday June 20, 2022 5:15pm - 5:45pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    5:15pm CDT

    #147 IT: Care Access Innovation Theater: The DRO Model for Global Clinical Trials: A Demonstrated Transformation that Delivers Game-Changing Speed, Quality, and Access
    Component Type: Session

    Innovations that include transformation at both the sponsor- and site-side of clinical research hold much potential for impact. The Decentralized Research Organization (DRO) model breaks down the activities and responsibilities of sites and sponsors into their atomic units, re-thinks and re-organizes those units, and then reassembles them in new ways that unlock untapped potential. Through this approach, 18 months of enrollment can be shortened to 3-6 months; diverse and underserved populations can participate in previously inaccessible study opportunities; and higher-quality data can be produced to assess the efficacy and safety of new medication.

    Chair

    Care Access

    Speaker

    Speaker
    Ahmad Namvargolian, MPA



    Speakers
    avatar for Care Access

    Care Access

    United States
    avatar for Ahmad Namvargolian

    Ahmad Namvargolian

    Chief Executive Officer & Co-founder, Care Access, United States
    Ahmad Namvargolian co-founded Care Access in 2015 which quickly grew into one of the most trusted clinical research companies in the US. His one core mission for Care Access is to remove barriers in clinical research for sponsors, physicians, and patients; making clinical research... Read More →


    Monday June 20, 2022 5:15pm - 5:45pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    5:15pm CDT

    #148 IT: Parexel Innovation Theater: An Ethical Framework to Guide the Development of AI in Clinical Research
    Component Type: Session

    Scores of ethical concerns are rising with the increasing scale of AI applications, from the impact of unintended consequences to wealth inequality created by machines. In clinical research, how do we ensure trust and confidence when relying on AI-powered solutions to boost speed, accuracy and deeper insights across clinical trial design, planning, and execution? This session focuses on an ethical framework based on the philosophy of technology and science for the intended use of AI tools in research.

    Chair

    Parexel

    Speaker

    Speaker
    Mark Graves



    Speakers
    avatar for Parexel

    Parexel

    United States
    avatar for Mark Graves

    Mark Graves

    NLP Data Scientist, Director, Parexel, United States
    Mark Graves is NLP Data Scientist, Director, at Parexel AI Labs where he leads natural language processing (NLP) data science projects to extract information from electronic medical records for clinical trials and from scientific literature and regulatory documents for pharmacovigilance... Read More →


    Monday June 20, 2022 5:15pm - 5:45pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
     
    Tuesday, June 21
     

    8:00am CDT

    Coffee Service
    Component Type: Social Event




    Tuesday June 21, 2022 8:00am - 9:00am CDT
    Meeting Rm Lobby Level 1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    9:00am CDT

    #202: Innovations in Risk Minimization: Methods, Tools, and Design Approaches
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-540-L04-P ; CME 1.00; RN 1.00

    This session will discuss various methods of collecting information and conducting needs assessment in the safe use of medicines.

    Learning Objectives

    Describe ethnographic methods for engaging with key stakeholders to collect information and conduct needs assessment; Discuss ethnographic methods as a tool for risk minimization materials development from rapid prototyping through user testing; Identify how to incorporate human factors into the entire process of risk minimization tools development to ensure optimum human-centric design; Describe the roles of human factor studies in safe use of medicines.

    Chair

    Anthony Gbadebo Oladipo, PharmD, MPH

    Speaker

    Ethnographic Methods for Human-Centered Design of Risk-Minimization tools in the Era of COVID-19
    Anthony Gbadebo Oladipo, PharmD, MPH

    What is the Place of Human Factors Studies in Helping Ensure Safe Use of Pharmaceuticals?
    Brian Edwards, DrMed

    Ethnographic Methods for Human-Centered Design of Risk Minimization Materials in the Era of COVID-19
    Moira Kyweluk, PhD, MPH



    Speakers
    avatar for Brian Edwards

    Brian Edwards

    Managing Director, Husoteria Ltd, United Kingdom
    After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
    MK

    Moira Kyweluk

    Head of Healthcare and Life Sciences, Senior Research Director, idea couture, A Cognizant Company, United States
    Dr. Moira Kyweluk, PhD, MPH leads Healthcare & Life Sciences for Idea Couture, a Cognizant Digital Business specializing in patient-centered design. As a medical anthropologist and public health professional, she leverages innovative qualitative and mixed-methods research with patients... Read More →
    AO

    Anthony Oladipo

    Senior Scientific Director, Risk Management, Pharmacovigilance & Patient Safety, AbbVie, Inc., United States
    Dr. Oladipo began his Pharmacovigilance carrier over 20 years ago and worked as scientist and leader in PV and Risk Management at Medimmune, AstraZeneca, ProStrakan and Duramed/ Barr until recently as Senior Scientific Director in Benefit Risk Management at AbbVie. He his passionate... Read More →


    Tuesday June 21, 2022 9:00am - 10:00am CDT
    Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Session

    9:00am CDT

    #201: Transforming PV at the MHRA
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-539-L04-P ; CME 1.00; RN 1.00

    This session will discuss the MHRA concept proposal on Yellow Card Biobank, Post EU Exit Vigilance and developments with the introduction of a New Multi-vigilance system at MHRA including the use of AI for case management.

    Learning Objectives

    Describe new initiatives within the MHRA including case management using artificial intelligence.

    Chair

    Mick Foy

    Speaker

    Vigilance Transformation at MHRA
    Phil Tregunno

    Device Safety Vigilance
    Sarah Vaughan

    Industry Update
    Vicki Edwards, RPh



    Speakers
    avatar for Mick Foy

    Mick Foy

    Deputy Director of Patient Safety Monitoring, MHRA, United Kingdom
    Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team and has recently been appointed Deputy Director of Patient Safety Monitoring . Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries... Read More →
    avatar for Phil Tregunno

    Phil Tregunno

    Head of Vigilance Operations, Safety & Surveillance, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Phil is the Head of Vigilance Operations within the MHRA's Safety & Surveillance function and has over eighteen years of experience working in pharmacovigilance. Prior to his current role Phil spent nine years leading and developing the Signal Management function, including systems... Read More →
    avatar for Vicki Edwards

    Vicki Edwards

    Vice President, Pharmacovigilance Excellence and International QPPV, AbbVie, Inc., United Kingdom
    Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community... Read More →
    avatar for Sarah Vaughan

    Sarah Vaughan

    Head of Vigilance Development, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, with 6 years as the Pharmacovigilance Information Unit Manager. She has been MHRA representative on the MedDRA Points to Consider Group, and worked on implementation of the 2012 EU Pharmacovigilance legislation... Read More →


    Tuesday June 21, 2022 9:00am - 10:00am CDT
    Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Session |   09: Regulatory, Session

    9:00am CDT

    #203: The Site Landscape: Data and Discussion of the State of the Clinical Research Site
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-541-L04-P ; CME 1.00; RN 1.00

    Hear and learn from a panel of clinical research sites as they discuss data gathered from other sites all over the world. This data is critical to the continued success and sustainability of the clinical research sites and the panel will discuss what

    Learning Objectives

    Examine real-world data gathered from sites as it pertains to their operations; Discussdata points from a site prospective, guiding the industry on ways to deepen relationships; Explain how this data has changed and what its applications are to the industry.

    Chair

    Jimmy Bechtel, MBA

    Speaker

    Industry Update
    David Vulcano, MBA, RAC

    Industry Update
    Brooke Hanscom

    Industry Update
    Shannon Zelenka



    Speakers
    avatar for Jimmy Bechtel

    Jimmy Bechtel

    Vice President, Site Engagement, Society for Clinical Research Sites (SCRS), United States
    Jimmy brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum as a data specialist, patient recruiter and operations manager. On the pharma side where he worked... Read More →
    avatar for Brooke Hanscom

    Brooke Hanscom

    Director, Clinical Site Operations, USA, Global Product Development, Pfizer Inc, United States
    Brooke has worked in the pharmaceutical industry for 17 years focusing on clinical operations. With a range of experiences at big pharma, CRO and biotechs, Brooke works to bring the highlights of each type of industry to her current role of Director Clinical Site Operations at Pfizer... Read More →
    avatar for David Vulcano

    David Vulcano

    Honorary President, SCRS; VP, Clinical Research Compliance and Integrity, HCA Healthcare, United States
    David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA Healthcare, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical... Read More →
    avatar for Shannon Zelenka

    Shannon Zelenka

    Associate Director, Clinical Operations, PPD, Part of Thermo Fisher Scientific, United States
    Shannon Zelenka has been at PPD, part of Thermo Fisher Scientific for 14 years. She is currently an Associate Director in the North America region for Clinical Operations within the CDSD organization. This includes leadership of 6 Clinical Managers and their teams. She began her career... Read More →


    Tuesday June 21, 2022 9:00am - 10:00am CDT
    Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum
    • Level Intermediate
    • Featured Topics RWD-RWE
    • Level Intermediate
    • Feature Topics RWD-RWE
    • Credit Type ACPE, CME, RN
    • Tags Forum

    9:00am CDT

    #204: Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-542-L04-P ; CME 1.00; RN 1.00

    The session will focus on initiatives to enhance diversity and inclusion in clinical trials. Our panel of experts will discuss concrete strategies for achieving diversity and inclusion through community engagement, training, and educational campaigns

    Learning Objectives

    Discuss the importance of enhancing diversity and inclusion in clinical studies; Identify concrete strategies to achieve these goals through community partnerships, trialist training, and other proactive initiatives; Evaluate various strategies and initiatives for facilitating diverse participation in clinical trials.

    Chair

    James Lindsay Cobbs, RPh

    Speaker

    Panelist
    Susan C. Winckler, JD, RPh

    Panelist
    Lola Fashoyin-Aje, DrMed, MPH

    Panelist
    Sanjeeve Bala, MD

    Panelist
    Tesheia H. Johnson, MBA, MPH



    Speakers
    SB

    Sanjeeve Bala

    Vice President, NALA Regulatory Affairs, BeiGene, United States
    JL

    James Lindsay Cobbs

    NALA Regulatory Affairs Policy Head, BeiGene, Inc., United States
    Lindsay is currently the Regulatory Policy Head, NALA Regulatory Policy & Intelligence at BeiGene. BeiGene, founded in 2010, is a biotechnology company that specializes in the development of cancer treatments. As the NALA Policy Head, Lindsay leads a team responsible for analyzing... Read More →
    LF

    Lola Fashoyin-Aje

    Associate Director, Science and Policy to Address Disparities, OCE, FDA, United States
    Lola Fashoyin-Aje is a medical oncologist and Deputy Director in the Division of Oncology 3 in the Office of Oncologic Diseases at CDER/FDA. She provides scientific and policy guidance and oversight for the review of drugs under development for the treatment of solid tumor malignancies... Read More →
    TJ

    Tesheia Johnson

    Deputy Director and Chief Operating Officer YCCI; Director for Clinical Research, Yale University School of Medicine, United States
    avatar for Susan Winckler

    Susan Winckler

    Chief Executive Officer, Reagan-Udall Foundation, United States
    Prior to accepting the post at the FDA’s Foundation in May of 2020, she served as President of Leavitt Partners Solutions. She advised corporate executives on policy and business matters. As CEO of the Food & Drug Law Institute, she provided attorneys, regulators, industry leaders... Read More →
    avatar for Susan Winckler

    Susan Winckler

    Chief Executive Officer, Reagan-Udall Foundation, United States
    Prior to accepting the post at the FDA’s Foundation in May of 2020, she served as President of Leavitt Partners Solutions. She advised corporate executives on policy and business matters. As CEO of the Food & Drug Law Institute, she provided attorneys, regulators, industry leaders... Read More →


    Tuesday June 21, 2022 9:00am - 10:00am CDT
    Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Forum |   05: Patient Engagement, Forum |   12: Value-Access, Forum

    9:00am CDT

    #205: Optimizing Evidence Supporting Fit-for-Purpose Digital Clinical Measures Across the Drug Development Life Cycle
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-543-L04-P ; CME 1.00; RN 1.00

    Multi-stakeholder experts who participated in the Digital Medicine Society’s (DiMe) The Playbook will define and document evidentiary requirements for digital clinical measures used in a variety of different contexts of use in drug development.

    Learning Objectives

    Describe the evidentiary requirements for selecting, fit-for-purpose, meaningful digital clinical measures across the drug development lifecycle; Define the different levels of verification and validation needed to support the deployment of digital clinical measures across the drug development lifecycle, spanning pre-screening and exploratory through phase i, phase ii and phase iii to post-market.

    Chair

    Smit Patel, PharmD

    Speaker

    Panelist
    Ariel Aguilo, MD

    Panelist
    Betsy Tschosik, PhD

    Panelist
    Elizabeth Nicki Bush, MHS

    FDA Update
    Michelle Campbell, PhD



    Speakers
    avatar for Ariel Aguilo

    Ariel Aguilo

    Executive Medical Director, Head Americas Oncology, Global Clinical Development, Labcorp Drug Development, Argentina
    Ariel Aguiló, MD, is a board certified oncologist specialized in Gastrointestinal tumors. He is an Executive Medical Director and Head of the Americas Oncology Medical Team for Labcorp Drug Development. He provides subject matter expertise and support for the development and conduct... Read More →
    avatar for Elizabeth (Nicki)  Bush

    Elizabeth (Nicki) Bush

    Associate VP and Head, Patient-Focused Endpoints and Measurement, Eli Lilly and Company, United States
    Elizabeth (Nicki) Bush is Associate Vice President and Head of Patient-Focused Endpoints and Measurement at Eli Lilly and Company, responsible for the design and implementation of patient-centered measurement strategies to support drug development efforts across Lilly’s portfolio... Read More →
    avatar for Michelle Campbell

    Michelle Campbell

    Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
    Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer... Read More →
    avatar for Smit Patel

    Smit Patel

    Clinical Innovation Lead, Digital Medicine Society (DiMe), United States
    Dr. Smit J. Patel, PharmD serves as the Clinical Innovation Lead at the Digital Medicine Society (DiMe), a 501(c)(3) global non-profit organization dedicated to better health powered by digital medicine. Smit’s work focuses on applied approaches to the safe, effective, ethical... Read More →
    BT

    Betsy Tschosik

    Digital Innovation Chapter Head, Patient-Centered Outcomes Research, Genentech, a Member of the Roche Group, United States
    Betsy Tschosik is Head of Digital Innovation in Patient-Centered Outcomes Research (PCOR) at Genentech, bringing expertise in patient-centricity and measurement science to the validation and use of digital measures in drug development. Prior to her current role in digital innovation... Read More →


    Tuesday June 21, 2022 9:00am - 10:00am CDT
    Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Forum |   02: ClinTrials -ClinOps, Forum
    • Level Intermediate
    • Featured Topics Digital
    • Level Intermediate
    • Feature Topics Digital
    • Credit Type ACPE, CME, RN
    • Tags Forum

    9:00am CDT

    #206: The Future of Content Authoring and Web Portal Technology, Publishing Stability Calculators: Challenges for Pushing Automation
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-545-L04-P ; CME 1.00; RN 1.00

    This session will discuss the digitization and on-line medical information resources.

    Learning Objectives

    Describe the value and purpose around defining and architecting content for multi-channel use; Evaluate the capabilities of new technology for Self Service and MI Portals; Discuss questions around what is permissible within a regulatory framework; Identify artificial Intelligence capabilites in Medical Information Portals.

    Chair

    Joe Pierce

    Speaker

    The Future of Content Authoring and Web Portal Technology
    Joe Pierce

    Publishing Stability Calculators: Challenges for Pushing Automation
    Graham Harding, PharmD

    Content Formatting for Multi-Channel use
    John Jones, MBA



    Speakers
    avatar for Graham Harding

    Graham Harding

    Senior Operations Manager, PPD, Part of Thermo Fisher Scientific, United States
    Graham Harding, PharmD is a senior operations manager in Medical Information at PPD, part of Thermo Fisher Scientific. He has more than a decade of experience in health care including retail pharmacies and the biopharmaceutical industry. Within Medical Information, he has assisted... Read More →
    JJ

    John Jones

    Technology Director, PhactMI, United States
    John Jones is an experienced IT Strategist focused on developing innovative technology solutions for unmet business needs in Life Sciences. John is currently the Founder and CEO of Entitech Solutions, a Life Sciences focused IT Software and Consulting firm. Prior to starting his company... Read More →
    avatar for Joe Pierce

    Joe Pierce

    CEO, SciMax Global, United States
    Joe Pierce has worked with pharmaceutical and biotech companies since 1995, specifically in the area of medical information and medical affairs. He was VP of Sales and Marketing for Online Business Applications, leading that company’s core product IRMS, to become the most widely... Read More →


    Tuesday June 21, 2022 9:00am - 10:00am CDT
    Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      04: MedAffairs-SciComm, Session

    9:00am CDT

    #207: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-546-L04-P ; CME 1.00; RN 1.00

    This forum will present a landscape of current activities and tools and explore opportunities for further enhancement. Panel of experts will discuss examples of how the tools have shaped patient-focused product development and decision-making. Join the DIA Patient Engagement Community for a follow up round table discussion (session #257 RT) on Tuesday, June 21, 3:00pm - 4:00pm.

    Learning Objectives

    Explore the landscape of ongoing efforts; Describe how the different strategies and toolkits are being developed and implemented; Discuss how the various efforts complement each other to identify opportunities to further enhance or develop new frameworks and promote harmonization.

    Chair

    Pujita Vaidya, MPH

    Speaker

    Patient-Focused Medicines Development
    Nicholas Brooke, MBA

    IMI PREFER Recommendations: Why, When and How to Assess and use Patient Preferences in Medical Product Decision-Making
    Rebecca Noel Noel, DrPH, MPH

    Guide to Patient Involvement in Rare Disease Therapy Development
    Annie Kennedy

    Where Are We? Assessing Organizational Preparedness and Capabilities to Support Patient Engagement
    Kenneth Getz, MBA



    Speakers
    avatar for Nicholas Brooke

    Nicholas Brooke

    Executive Director, Patient Focused Medicines Development (PFMD), The Synergist.org, Belgium
    Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
    avatar for Kenneth Getz

    Kenneth Getz

    Executive Director/Professor, Tufts CSDD; Founder/Board Chair, CISCRP, Tufts University School of Medicine, United States
    Ken Getz is a Professor and the Executive Director of the Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded studies on pharmaceutical R&D management and execution; protocol design optimization; CRO and investigative site... Read More →
    avatar for Annie Kennedy

    Annie Kennedy

    Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, United States
    Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001... Read More →
    avatar for Rebecca Noel

    Rebecca Noel

    Executive Director, Benefit-Risk Assessment, Eli Lilly, United States
    Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly. Since joining Lilly, Becky has been extensively involved in leading the development of systematic approaches to benefit-risk assessment, both internally at Lilly and externally via the PhRMA... Read More →
    avatar for Pujita Vaidya

    Pujita Vaidya

    Director, Global Regulatory and R&D Policy, Patient Centricity, Pediatrics, ROD, Amgen, United States
    Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies, specifically Patient Centricity, Pediatrics, and Rare Diseases. Her work includes partnering with cross-functional... Read More →


    Tuesday June 21, 2022 9:00am - 10:00am CDT
    Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      05: Patient Engagement, Forum

    9:00am CDT

    #208: Keeping Passion for Project Management Alive
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-548-L04-P ; CME 1.00; PDU 1.00 PMI 2166ITBO85; RN 1.00

    This session will highlight growing and developing in project management,opportunities to expand in current role, Project Manager

    Learning Objectives

    Assess where you are in your current growth and development as a project manager; Determine areas of development and path forward; Create an action plan with next career goal in mind and designate a time frame.

    Chair

    Malini B Maysuria, PMP

    Speaker

    Development of the Project Manager
    Larissa Wilsie, MS, PMP

    Development of the Project Manager
    Malini B Maysuria, PMP



    Speakers
    avatar for Malini Maysuria

    Malini Maysuria

    Associate Director, Global Project and Alliance Management, Merck Sharp & Dohme LLC , United States
    Malini Maysuria is a Biologist and a Medical Labrotory Technician by training. She started her career in the clinical lab, then moved into microarray research working for a core facility at an academic insitution before stepping into the biotech industry. She worked for a small startup... Read More →
    avatar for Larissa Wilsie

    Larissa Wilsie

    Director, Strategic Alliance Project Management, Organon, United States
    A cell biologist by training, Larissa moved into project management in 2013 and has worked across therapeutic areas, supporting programs from early stage development through post-approval activities. She has been able to apply PM skills in a variety of settings within pharma, beyond... Read More →


    Tuesday June 21, 2022 9:00am - 10:00am CDT
    Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      13: ProfDevelopment, Session |   07: ProjectManagement-StrategicPlanning, Session

    9:15am CDT

    #209: New EU Clinical Trial Regulation: Experience So Far
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-544-L04-P ; CME 1.00; RN 1.00

    This session will discuss the EU Clinical Trials Regulation (Regulation (EU) No 536/2014; CTR) and Clinical Trial Information System (CTIS) promote research and innovation and improve transparency on clinical trials in the EU and providing for harmonised submission, assessment and supervision of clinical trials in the region. Clinical trial data become gradually available to scientists and the public through CTIS.

    Learning Objectives

    Describe the purpose and benefits of the EU Clinical Trials Regulation (CTR) for research, innovation, and public health; Discuss how the Clinical Trial Information System (CTIS) provides a single tool for clinical trial sponsors and authorities to facilitate and harmonize clinical trial application submission, assessment and supervision; Explain how CTR and CTIS improve transparency on clinical trials for healthcare professionals, patients and the public.

    Chair

    Fia Westerholm, DVM, MSc

    Speaker

    Moderator
    Sabine Haubenreisser, PhD, MSc

    The Clinical Trials Regulation: Transforming Clinical Trials in Europe
    Kristof Bonnarens, MPharm

    Potential of CTR to Advance Research and Innovation in EU, with CTIS as the Collaborative Tool
    Marianne Lunzer, DrMed

    First Experiences with CTR and the Use of CTIS as the Single Entry Point for Clinical Trial Application Submissions in EU
    Scott Feiner



    Speakers
    avatar for Kristof Bonnarens

    Kristof Bonnarens

    Policy Officer Pharmaceuticals, European Commission, Belgium
    Kristof is an industrial pharmacist. Being a Belgian national, he started working for the Belgian Federal Agency of Medicines and Health Products in 2005, and in 2009 he took up the responsibility for the Research and Development division, in charge of clinical trial applications... Read More →
    avatar for Scott Feiner

    Scott Feiner

    Senior Manager, Clinical Records Management, Strategic Clinical Operations, AbbVie, United States
    Scott has over a decade of experience with clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, to later operating in larger organizations, serving as an expert in summary results reporting and clinical document redaction/anonymization... Read More →
    avatar for Sabine Haubenreisser

    Sabine Haubenreisser

    Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
    Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →
    avatar for Marianne Lunzer

    Marianne Lunzer

    Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria
    avatar for Fia Westerholm

    Fia Westerholm

    Programme Assurance Manager, European Medicines Agency, Netherlands
    Programme Assurance Manager in the Clinical Trials Information System (CTIS) programme managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Educational background and degrees in veterinary medicine, toxicology and social sciences... Read More →


    Tuesday June 21, 2022 9:15am - 10:15am CDT
    Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Session |   09: Regulatory, Session |   04: MedAffairs-SciComm, Session |   02: ClinTrials -ClinOps, Session

    9:15am CDT

    #210: Challenges of Translational and Early-Phase ASO Development
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-547-L04-P ; CME 1.00; RN 1.00

    This session will discuss biomarker and/or model development considerations in ASO development.

    Learning Objectives

    Describe the opportunity non-linear imaging provides to track ASO distribution.

    Chair

    Yuri Zamostin

    Speaker

    Harnessing the Power of Multimodal Imaging to Explore ASO Distribution in Cells, Complex In Vitro Models, and Tissue
    Steve Hood, PhD



    Speakers
    SH

    Steve Hood

    Senior Director, Imaging Networks, GlaxoSmithKline, United Kingdom
    Steve Hood received a PhD in Molecular Toxicology from the University of Surrey in 1993 and joined Glaxo Group Research as an Industrial Post doc. Steve is now a senior Scientific Director in Bioimaging, responsible for external imaging collaborations in the Bioimaging Expertise Network... Read More →
    avatar for Anita Nelsen

    Anita Nelsen

    Executive Vice President, Translational Medicine, Parexel, United States
    Anita is a pharmaceutical industry leader who has applied pharmacogenetic, human and molecular genetics research in drug discovery and development. As Head of Translational Medicine, Anita leads a global team of scientists who are recognized thought leaders and influencers in early... Read More →
    avatar for Yuri Zamostin

    Yuri Zamostin

    Executive Vice President, Translational Medicine, Parexel, United States
    Anita is a pharmaceutical industry leader who has applied pharmacogenetic, human and molecular genetics research in drug discovery and development. As Head of Translational Medicine, Anita leads a global team of scientists who are recognized thought leaders and influencers in early... Read More →


    Tuesday June 21, 2022 9:15am - 10:15am CDT
    Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      06: PreClinical Dev-EarlyPhaseCR, Session

    9:15am CDT

    #211: Shifting the Audit Paradigm for a More Effective Outcome
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-549-L04-P ; CME 1.00; RN 1.00

    ICH E6(R2) and E8 (R1) require sponsors to focus on activities essential to the reliability and meaningfulness of study outcomes by identifying the critical to quality factors, associated risks and to review risk to determine effectiveness of QMS

    Learning Objectives

    Discuss how risk-based approach aligns with ICH; Describe key considerations for risk-based auditing; Identify the framework around the journey of moving from on-site audits to remote audits.

    Chair

    Stephanie Haley

    Speaker

    Industry Update
    Jonathan Rowe, PhD, MA, MS

    Quality Assurance and Auditing: The Regulatory Perspective
    Jason Wakelin-Smith



    Speakers
    avatar for Stephanie Haley

    Stephanie Haley

    Director, CQA, Astellas, United States
    Stephanie Haley has over 29 years of experience in pharmaceutical development which includes 21 years in Clinical Quality Assurance. Her professional experience also includes roles held in pre-clinical Histology, Data Management and Pharmacokinetics. Stephanie’s current role is... Read More →
    avatar for Jonathan Rowe

    Jonathan Rowe

    Principal, Head of R&D Quality and Operations Risk Management, ZS, United States
    Jonathan has >25 years in pharma developing medical therapies from clinical, operational, Quality and business perspectives. He is currently a Principal at ZS where he leads the Clinical Development Quality, Operations and Risk Management group. Previously, Jonathan held the position... Read More →
    avatar for Jason Wakelin-Smith

    Jason Wakelin-Smith

    Expert GCP Inspector, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the Inspectorate having previously... Read More →


    Tuesday June 21, 2022 9:15am - 10:15am CDT
    Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      08: RD Quality-Compliance, Session

    9:15am CDT

    #212: Where Are We with Antimicrobial Resistance (AMR) in the Regulatory Space?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-550-L04-P ; CME 1.00; RN 1.00

    Regulatory pathways have been streamlined but still benefit from further fine tuning. Business models that would guarantee return on investment for innovative products that may not be needed in the immediate but would improve our preparedness capacity need to be contemplated.

    Learning Objectives

    Describe current hurdles for R&D for new antibacterial agents; Discuss the mapping of initiatives that could enhance the rapid development of new products; Describe the need for rewards that would keep the availability of new products on the market.

    Chair

    Marco Cavaleri, PhD

    Speaker

    New Regulatory Pathways for AMR Products
    John Farley, MD, MPH

    How a Small Company is Navigating the Regulatory Pathway for New Antimicrobial Products
    Joseph C. Larsen, PhD

    ACTIV-3 Platform Trial
    David Vock, PhD, LLM



    Speakers
    avatar for Marco Cavaleri

    Marco Cavaleri

    Head of Health Threats and Vaccines Strategy, European Medicines Agency, Netherlands
    Head of Anti-infectives and Vaccines, European Medicines Agency (2009-present) Therapeutic Group Leader for Anti-infectives, European Medicines Agency (2008-2009) Associate Scientific Director, Cosmo Pharmaceuticals S.p.A., Lainate, Italy (2008) Scientific Administrator, European... Read More →
    JF

    John Farley

    Director, Office of Infectious Diseases, OND, CDER, FDA, United States
    Dr. John Farley is presently Director of the Office of Infectious Diseases in the Office of New Drugs at CDER, FDA. His office is responsible for the review of new antiviral and antibacterial drugs. In addition to new drug review work, Dr. Farley’s work at FDA has included implementation... Read More →
    JL

    Joseph Larsen

    Vice President, Strategic Portfolio Development, Venatorx Pharmaceuticals, United States
    Dr. Larsen is a globally recognized leader in the area of public health preparedness with more than 20 years’ experience. As Vice President, Strategic Portfolio Development at Venatorx Pharmaceuticals, Dr. Larsen is responsible for identifying new growth opportunities and translating... Read More →
    avatar for David Vock

    David Vock

    Associate Professor, Biostatistics, School of Public Health, University of Minnesota, United States
    My research focuses on two major areas. The first is statistical methods development for electronic health data with a particular focus on development of machine learning techniques to handle censored data. Second, I work on novel methods for causal inference and estimation of dynamic... Read More →


    Tuesday June 21, 2022 9:15am - 10:15am CDT
    Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session

    9:15am CDT

    #213: Reflections on PDUFA: A Look Back at PDUFA VI and A Preview of PDUFA VII
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-551-L04-P ; CME 1.00; RN 1.00

    With PDUFA VII reauthorization activities fully underway, it is important to understand the reauthorization process, the new performance goals and procedures, and what potential impact the new activities will have on future human drug review and deve

    Learning Objectives

    Explain the PDUFA VII reauthorization process and timeline; Identify the new performance goals and procedures in the PDUFA VII commitment letter and the strategic intent behind them; Summarize the potential impact the new PDUFA VII activities will have on future human drug review and development and what the landscape might look like in 2027.

    Chair

    Todd Paporello, PharmD, MBA

    Speaker

    FDA Updste
    Andrew Kish, MS

    Industry Update
    Khushboo Sharma, MBA

    Industry Update
    Lucy Vereshchagina, PhD



    Speakers
    avatar for Andrew Kish

    Andrew Kish

    Director, Office of Program and Strategic Analysis, OSP, CDER, FDA, United States
    Andrew is the Director of the Office of Strategic Programs and Analysis (OPSA) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA). Andrew oversees projects that span the application of economics, program evaluation, decision science... Read More →
    avatar for Todd Paporello

    Todd Paporello

    Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
    Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
    avatar for Khushboo Sharma

    Khushboo Sharma

    Chief of Staff/Senior Vice President, BIO, United States
    Khushboo Sharma is the Chief of Staff/Senior Vice President at Biotechnology Innovation Organization. Khushboo joined BIO after spending 11 years in various roles at the US FDA. Previously, Khushboo was the Deputy Director of Operations in the Office of New Drugs at the FDA. As Deputy... Read More →
    avatar for Lucy Vereshchagina

    Lucy Vereshchagina

    Vice President, Science and Regulatory Advocacy, PhRMA, United States
    Dr. Vereshchagina is the Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA represents the country’s leading innovative biopharmaceutical research companies, which are devoted to researching and developing medicines... Read More →


    Tuesday June 21, 2022 9:15am - 10:15am CDT
    Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session

    9:15am CDT

    #214: New Policy Developments in Combination Products
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-552-L04-P ; CME 1.00; RN 1.00

    This session will engage an expert panel in discussion on a number of timely regulatory policy topics for drug-device combination products. FDA is set to issue new draft guidance on human factors and EPRs, which will impact combination product reviews. In addition, there are still a number of outstanding regulatory questions around global approaches to combination products, especially with the implementation of the MDR in Europe. This session will also focus on digital health combination products as well as the impact of the Genus decision on certain products that have historically been regulated as drugs.

    Learning Objectives

    Discuss recent trends and changes in the regulation and development of combination products; Describe changes in digital health regulation and regulation of contrast agents that may impact combination products; Discuss new regulatory guidance and harmonization efforts, as applicable, or opportunities for new guidance to address current challenges.

    Chair

    Megan Doyle, JD, MPH

    Speaker

    Industry Update
    James Wabby, MHS

    Industry Update
    Susan Neadle, MS

    FDA Update
    John Barlow Weiner, JD

    Industry Update
    Chelsea O'Connell, MS, RAC

    EMA Update
    Christelle Bouygues



    Speakers
    avatar for Christelle Bouygues

    Christelle Bouygues

    Acting Head of Regulatory Affairs, Office Scientific and Regulatory Management, European Medicines Agency, Netherlands
    Degree in Pharmacy and Regulatory Affairs. Joined the EMA in 2004 as Regulatory Affairs Adviser. She is responsible for provision of regulatory and procedural advice in relation to centralised procedures and referrals.
    avatar for Megan Doyle

    Megan Doyle

    Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product, Amgen, United States
    Megan Doyle is an attorney and policy professional with more than 13 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public... Read More →
    avatar for Susan Neadle

    Susan Neadle

    Principal Consultant and President, Combination Products Consulting Services LLC, United States
    Susan Neadle is a recognized international Combination Products and Medical Device expert with over 30 years industry experience. Susan is well networked, published, and highly active in numerous industry groups with links to teaching institutions. Susan’s leadership, innovation... Read More →
    avatar for Chelsea O'Connell

    Chelsea O'Connell

    Director, Global Regulatory and R&D Policy, Amgen, United States
    Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various... Read More →
    avatar for James Wabby

    James Wabby

    Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, Inc., United States
    James Wabby is the Executive Director of Regulatory Affairs (Emerging Technologies and Combination Products) at AbbVie in Irvine, California. He has over 20 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
    avatar for John Weiner

    John Weiner

    Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
    John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of... Read More →


    Tuesday June 21, 2022 9:15am - 10:15am CDT
    Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session

    9:15am CDT

    #215: Efforts Toward Global Convergence of CMC and GMP Expectations
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-553-L04-P ; CME 1.00; RN 1.00

    This session will discuss differences in CMC regulatory requirements globally and impact on access to medicines.

    Learning Objectives

    Describe differences in CMC regulatory requirements globally and impact on access to medicines; Identify opportunities and pathways to accelerate and align guidelines.

    Chair

    Judith Maxwell Silverman, PhD

    Speaker

    How to Accelerate the Supply of Medicines to all Populations Worldwide: A Regulatory Perspective - Much Needed Convergence of Post Approval Change Guidelines Worldwide
    Diane Wilkinson, PhD, RPh

    Accelerating Regulatory Approvals Through Global Collaborative Registration Procedures
    Sharon Ayd, PhD, MBA

    Regulatory Strategies to Achieve a Coalition's 100 Day Mission
    Vincent Loh, PhD, RPh



    Speakers
    avatar for Max Silverman

    Max Silverman

    Program Officer, Vaccine Development and Surveillance, CMC, Bill & Melinda Gates Foundation, United States
    avatar for Sharon Ayd

    Sharon Ayd

    Vice President and Principal, Regulatory COE, Advarra Consulting, United States
    Sharon Ayd is a Life Sciences industry vertern with 35+ years of biopharma experience. She is currently VP & Principal, Regulatory Center of Excellence at Advarra Consulting. Sharon's experience has spanned from multi-national to spin-out & startup biotech companies. Her experience... Read More →
    VL

    Vincent Loh

    Head of Global Regulatory Affairs CMC, Coalition For Epidemic Preparedness Innovations (CEPI) , United Kingdom
    Vincent Loh obtained his B.Pharm and PhD in medicinal chemistry and molecular pharmacology at Nottingham University UK and is co-inventor of Lynparza, a first in class PARP inhibitor. He was a Senior Pharmaceutical Assessor at the MHRA for 10 years and was also the UK nominated expert... Read More →
    avatar for Diane Wilkinson

    Diane Wilkinson

    Executive Director, Global CMC Regulatory Affairs, AstraZeneca, United Kingdom
    Diane Wilkinson was awarded her B.Pharm at Nottingham and PhD in Pharmaceutical biotechnology at Manchester UK Universities. A 35 year career in the Pharmaceutical Industry. A strong advocate for regulatory harmonisation, as well as the use of science, risk based CMC approaches and... Read More →
    avatar for Judith Silverman

    Judith Silverman

    Program Officer, Vaccine Development and Surveillance, CMC, Bill & Melinda Gates Foundation, United States


    Tuesday June 21, 2022 9:15am - 10:15am CDT
    Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      10: RegCMC-Product Quality, Session

    10:00am CDT

    Coffee Break
    Component Type: Social Event




    Tuesday June 21, 2022 10:00am - 11:15am CDT
    Exhibit Hall McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    10:20am CDT

    #216 IT: Clario Innovation Theater: Decentralized Clinical Trials - Real Solutions in Real-Time
    Component Type: Session

    During this Innovation Theater, we'll poll the audience and explore how you feel about pressing issues and timely DCT topics. Our expert panel includes Jen Horonjeff, Craig Lipset, Bryan McDowell, and moderator, Matt McCarty will provide technology, science, and patient perspectives throughout the discussion and offer you real DCT solutions in real-time.

    Chair

    Clario

    Speaker

    Speaker
    Jen Horonjeff, PhD

    Speaker
    Craig H Lipset, MPH

    Speaker
    Bryan McDowell, MBA, MSc

    Speaker
    Matthew McCarty



    Speakers
    avatar for Clario

    Clario

    United States
    avatar for Jen Horonjeff

    Jen Horonjeff

    Co-Founder and CEO, Savvy Cooperative, United States
    Jen Horonjeff, PhD, is a patient advocate and the founder & CEO of Savvy Cooperative, the first and only patient-owned co-op that helps innovators connect directly with diverse patients to get the insights they need to build better and more inclusive healthcare solutions. Jen was... Read More →
    avatar for Craig Lipset

    Craig Lipset

    Co-Chair, Decentralized Trials & Research Alliance (DTRA), United States
    Craig Lipset is Founder and Managing Partner of Clinical Innovation Partners, a growth advisory practice for clinical trial innovation. He is Co-Chair of the Decentralized Trials & Research Alliance, Assistant Professor of Health Informatics at Rutgers University, and adjunct faculty... Read More →
    avatar for Matthew McCarty

    Matthew McCarty

    Chief Strategy & Marketing Officer, Clario, United Kingdom
    As Chief Strategy and Marketing Officer at Clario, Matt leads the enterprise’s strategic direction and marketing capabilities. Matt has 15 years’ experience in executive leadership roles leading clinical research and commercial healthcare organizations. Most recently, Matt spearheaded... Read More →
    avatar for Bryan McDowell

    Bryan McDowell

    Vice President, eCOA Clinical Science & Consulting, Clario, Switzerland
    In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide... Read More →


    Tuesday June 21, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    10:20am CDT

    #217 IT: Flatiron Health Innovation Theater: Leveraging Access at the Point of Care and Next-Generation Electronic Source (eSource) Technology to Accelerate Clinical Research
    Component Type: Session

    Recent regulatory guidance and increased use of EHR in interventional clinical research and RWE have clarified the role that EHRs and eSource technologies may play in bridging the divide between clinical care and clinical research. In this session we will show how Flatiron Health is leveraging its unique access at the point of care and suite of e-source technologies (including the industry's first system-agnostic EHR-to-EDC connector application) to meaningfully accelerate clinical research.

    Chair

    Flatiron Health

    Speaker

    Speaker
    Hugh Levaux, PhD

    Speaker
    Lauren Sutton



    Speakers
    avatar for Flatiron Health

    Flatiron Health

    United States
    avatar for Hugh Levaux

    Hugh Levaux

    Vice President, Clinical Research, Flatiron Health, United States
    Dr. Hugh Levaux is Vice President, Clinical Research at Flatiron Health. He joined Flatiron from Protocol First where he was Founder CEO. Dr. Levaux has over 20 years of dedicated experience in clinical trial design and operations, as well as web-based technologies - notably, SVP... Read More →
    avatar for Lauren Sutton

    Lauren Sutton

    Director, Product Management, Flatiron Health, United States
    Lauren Sutton is the Director of Product Management for Clinical Research at Flatiron Health. She is focused on integrating research into everyday patient care and building technology to facilitate the acceleration of drug development. Prior to Flatiron, Lauren was a Clinical Research... Read More →


    Tuesday June 21, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    10:20am CDT

    #218 IT: Twilio for Life Sciences Innovation Theater: Delivering Personalized Experiences through Omnichannel Engagement
    Component Type: Session

    Today’s rapid acceleration of virtual channels requires an omnichannel engagement strategy that meets customer demands and helps health organizations move towards a digital-first vision. Organizations investing in building unified solutions are making it possible to deliver frictionless experiences for patients that enable better health outcomes. Learn key considerations on how to infuse omnichannel engagement across your operations to make health more connected, simpler, and more affordable.

    Chair

    Twilio

    Speaker

    Speaker
    Susan Collins

    Speaker
    Kimberly Howland, PhD



    Speakers
    avatar for Susan Collins

    Susan Collins

    Global Head of Healthcare, Twilio Inc., United States
    Susan Collins is a globally recognized expert on healthcare technology and go to market strategy, speaking regularly at conferences and contributing thought leadership to a variety of professional journals and media outlets. Currently Global Head of Healthcare for Twilio, Collins... Read More →
    avatar for Kimberly Howland

    Kimberly Howland

    Vice President, Product Management, EnlivenHealth (an Omnicell company), United States
    Kim leads the product management organization for EnlivenHealth®. She works closely with customers and partners to develop the roadmap for current and future products, and then collaborates closely with EnlivenHealth’s engineering teams to deliver the innovative new digital solutions... Read More →
    avatar for Twilio

    Twilio

    United States


    Tuesday June 21, 2022 10:20am - 10:50am CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    11:00am CDT

    #219: Post-Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-554-L04-P ; CME 1.00; RN 1.00

    Historically, regulators have required sponsors to collect pregnancy safety information in the post-marketing setting through prospective registries. However, pregnancy registries have practical barriers to enrolling subjects and often suffer from the lack of an adequate control group, inadequate power to achieve study objectives, high operational cost, a lack of generalizability, and long timelines before results are available to support clinical decisions. There is increasing opportunity and ability for real-world data and real-world evidence (RWD/E) from claims and electronic health record (EHR) databases to address some of the challenges seen with registries and more efficiently answer the question of drug safety during pregnancy. Retrospective database studies allow for observation of patients representing a broad population – not just those self-selected for registry enrollment or referred by providers, and the larger sample size enables faster accumulation of data and ultimately insight into patient safety. This session will discuss various fit-for-purpose pregnancy study options to inform a future framework that includes prospective registries, retrospective database studies, single-arm safety studies or enhanced pharmacovigilance with criteria dependent on the patient population in scope. In addition, the recent EMA guideline on good pharmacovigilance practices for pregnancy prevention programs will be discussed.

    Learning Objectives

    Discuss fit-for-purpose pregnancy safety study options including prospective registries, real-world data retrospective database studies, single-arm safety studies, enhanced pharmacovigilance or a combination of studies to inform a future framework for pregnancy safety studies; Describe industry, FDA, and EMA current thinking of various study types, criteria, and requirements for post-approval pregnancy safety studies.

    Chair

    Chelsea O'Connell, MS, RAC

    Speaker

    FDA Perspective: Postapproval Safety Studies in Pregnant Individuals
    Leyla Sahin, MD

    Assessing Need and Effectiveness of Pregnancy Prevention Programs: A Crucial Piece of the Jigsaw
    Priya Bahri, PhD, RPh

    Fit-for-Purpose Pregnancy Safety Study Designs: Considerations for Developing a Framework
    Rohini Hernandez, PhD, MPH

    Barriers and Future Considerations to Generating Meaningful Safety Data from Post-Approval Safety Studies in Pregnancy
    Lockwood Taylor, PhD, MPH



    Speakers
    avatar for Priya Bahri

    Priya Bahri

    Lead Pharmacovigilance and Risk Management Guidance and Policy, European Medicines Agency, Netherlands
    Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
    avatar for Rohini Hernandez

    Rohini Hernandez

    Director, Center for Observational Research, Amgen, United States
    Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior... Read More →
    avatar for Chelsea O'Connell

    Chelsea O'Connell

    Director, Global Regulatory and R&D Policy, Amgen, United States
    Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various... Read More →
    LS

    Leyla Sahin

    Acting Deputy Director for Safety, DPMH, OND, CDER, FDA, United States
    Dr. Sahin is an ob/gyn who is the Acting Deputy Director for Safety in the Division of Pediatrics and Maternal Health in the Office of New Drugs in CDER. She has led various maternal health related scientific and regulatory/policy initiatives. She was a working group member on the... Read More →
    avatar for Lockwood Taylor

    Lockwood Taylor

    Senior Principal, Real-World Strategy and Innovation, IQVIA, United States
    Dr. Lockwood Taylor is a Senior Principal on the Real World Strategy and Innovation team at IQVIA. An epidemiologist by training with specific expertise in RWE for regulatory submissions, signal detection and evaluation, and post-approval safety studies in pregnancy, Lock has 15... Read More →


    Tuesday June 21, 2022 11:00am - 12:00pm CDT
    Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Forum

    11:00am CDT

    #220: Collection of Quality Endpoint Data in a Decentralized Trial in Complex Indications: The Practical and Logistical Challenges
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-597-L04-P ; CME 1.00; RN 1.00

    When using sophisticated assessments, sponsors must capture both structured and unstructured data — on site and remotely. Using diseases specific decentralized clinical trials as examples, this session discusses how remotely deployed data capture technology manages logistically and therapeutically complex clinical trials.

    Learning Objectives

    Describe how to plan for studies using ideas from the case studies presented; Formulate internal strategies for managing complex therapeutic areas; Apply best practices learned to prospective studies.

    Chair

    Jonathan Andrus, MS

    Speaker

    Industry Update
    Jonathan Andrus, MS

    Panelist
    Megan Petrylak



    Speakers
    avatar for Jonathan Andrus

    Jonathan Andrus

    President and Chief Operating Officer, Clinical Research IO (CRIO), United States
    Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical... Read More →
    avatar for Megan Petrylak

    Megan Petrylak

    EVP, Customer Delivery, Clinical Ink, United States
    Megan Petrylak brings 14+ years of pharma industry project management leadership and operational experience to her role as EVP of customer delivery at Clinical Ink. She leads our global project management team for emerging & growth accounts, PMO, Outcomes Science Solutions teams and... Read More →


    Tuesday June 21, 2022 11:00am - 12:00pm CDT
    Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Session |   02: ClinTrials -ClinOps, Session

    11:00am CDT

    #221: Complying with the EU-CTR Disclosure Standards in the Era of GDPR
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-557-L04-P ; CME 1.00; RN 1.00

    Hear from disclosure experts about their organizations’ approaches to EU-CTR disclosure requirements while complying with GDPR and how EU-CTR disclosure compares with EMA CDP (EMA Policy 0070) disclosure.

    Learning Objectives

    Identify the disclosure requirements and standards as written in the European Union (EU) – Clinical Trial Regulation (CTR); Evaluate how the disclosure standards for EU-CTR align with the requirements of the EU General Data Publication (GDPR); Describe how the disclosure standards in the EU-CTR compare to the standards of the Clinical Data Publication (CDP; aka EMA Policy 0070).

    Chair

    Robin Whitsell

    Speaker

    Preparing for EUCTR
    Lora Killian, MBA

    Influences in Transparency Approach for EU CTIS
    Julie G. Holtzople

    Lessons Learned for EU CTIS Submissions
    Wendy M Wimmer, MS



    Speakers
    avatar for Julie Holtzople

    Julie Holtzople

    Senior Director Clinical Transparency and Data Sharing, AstraZeneca, United States
    Julie Holtzople is the Sr. Director of Clinical Transparency & Data Sharing for AstraZeneca and co-lead of the CREG CTT group. Julie received her Bachelors of Science in Business Administration at Virginia Polytechnic Institute. Julie has been with AstraZeneca for 14 years. Prior... Read More →
    avatar for Lora Killian

    Lora Killian

    Clinical Trial Transparency and Disclosure Lead, Pfizer Inc, United States
    Lora has 20+ years of business experience, including more than a decade of pharmaceutical industry experience. She started her career in the military serving four years of active duty in the Medical Service Corp for the U.S. Army. In her first pharmaceutical industry position, Lora... Read More →
    avatar for Robin Whitsell

    Robin Whitsell

    President, Whitsell Innovations, Inc., United States
    Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years’ experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
    avatar for Wendy Wimmer

    Wendy Wimmer

    Director, Clinical Data Disclosure and Transparency, Merck & Co., Inc., United States
    Wendy Wimmer is a Director in the Clinical Data Disclosure & Transparency department at Merck Sharp & Dohme. She has over 25 years of clinical research experience and over the last 6 years has created and currently manages a centralized document transparency functional area for her... Read More →


    Tuesday June 21, 2022 11:00am - 12:00pm CDT
    Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    11:00am CDT

    #222: Patient-Focused Drug Development: Reflecting on a Decade of Insights
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-22-558-L04-P ; CME 1.00; RN 1.00

    This session will explain how to apply principles of patient-focused drug development to cross-disciplinary functions within research and development and in regulatory strategy and reflect on best practices both in eliciting patient input and in translating it.

    Learning Objectives

    Identify and apply best practices in employing methods to capture patient experience data; Identify the importance of applying patient insights throughout the drug development and regulatory decision-making approaches through examples.

    Chair

    Kristina Bowyer

    Speaker

    Patient-Focused Drug Development Meetings and Beyond: Lessons Learned and Future Opportunities for Engaging FDA
    James Valentine, JD, MHS

    Obtaining Input From People With Kidney Diseases to Design and Evaluate New Drugs and Devices
    Mark David Lim, PhD

    Patient Perspective
    Isabelle Lousada, MA



    Speakers
    avatar for Kristina Bowyer

    Kristina Bowyer

    Vice President, Patient Advocacy & Engagement, Ionis Pharmaceuticals, Inc., United States
    Kristina Bowyer joined Ionis in 1992 and currently serves as the Vice President of Patient Centric Drug Development. She founded Ionis’ Patient Advocacy program 2012 to ensure that the patient perspective is incorporated into every aspect of drug development. Kristina’s expertise... Read More →
    avatar for Isabelle Lousada

    Isabelle Lousada

    Chief Executive Officer and President, Amyloidosis Research Consortium, United States
    As a former patient, Lousada has spent 20 years dedicated to patient advocacy, accelerating drug development, and promoting awareness of rare diseases. Lousada founded the Amyloidosis Research Consortium (ARC) in 2015. ARC is a patient-focused nonprofit, harnessing the power of collaboration... Read More →
    avatar for Mark D Lim, PhD

    Mark D Lim, PhD

    Vice President for Research, Discovery, and Innovation, American Society of Nephrology , United States
    Mark D. Lim is Vice President of Research, Discovery, and Innovation at the American Society of Nephrology. The department aims to sustain the growth of innovations for people with kidney diseases, building on KidneyX, a partnership with US HHS that incentivizes entrepreneurs, and... Read More →
    avatar for James Valentine

    James Valentine

    Attorney, Hyman, Phelps & McNamara, PC, United States
    James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →


    Tuesday June 21, 2022 11:00am - 12:00pm CDT
    Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      05: Patient Engagement, Session

    11:00am CDT

    #224: ICMRA Update: Convergence and Collaboration on COVID-19 - Learning from the Present for the Future
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-661-L04-P; CME 1.00; RN 1.00

    This is the second of two sessions looking at the role and contribution of the ICMRA coalition. Following on from the first session on COVID-19 response and international collaboration, this session will focus on lessons learned and regulatory flexibilities and agilities used during the pandemic, and particularly their sustainability post-COVID-19.

    Learning Objectives

    Describe from a global regulators perspective how they introduced innovative approaches to fight the COVID-19 pandemic; Discuss how the International Coalition of Medicines Regulatory Authorities (ICMRA) provided strategic global leadership; Describe how regulators are discussing which of the agilities and flexibilities could be sustainably retained once the pandemic is over, either for business-as-usual or in future emergency situations.

    Chair

    Emer Cooke, MBA, MSc

    Speaker

    Remote and Hybrid Inspections
    Paula Walker, MA

    Pharmaceutical Quality Knowledge Management System (PQKMS)
    Theresa Mullin, PhD

    The Role of Regulators in Public Health Response
    Antonio Barra Torres, MD



    Speakers
    avatar for Emer Cooke

    Emer Cooke

    Executive Director, Chair, ICMRA, European Medicines Agency, Netherlands
    Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →
    avatar for Theresa Mullin

    Theresa Mullin

    Associate Director for Strategic Initiatives, CDER, FDA, United States
    Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
    avatar for Antonio Barra Torres

    Antonio Barra Torres

    President Director, ANVISA, Brazil
    Mr. Barra, President-Director of Anvisa, graduated in Medicine in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. He also concluded an MBA in Health Services Administration at the Federal University of... Read More →
    avatar for Paula Walker

    Paula Walker

    Head of Compliance (GCP, GPvP, GLP & GxP Expert Circle), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Head of Compliance (1) responsible for the GCP, GPvP, GLP inspections teams and GxP Expert Circle... Read More →


    Tuesday June 21, 2022 11:00am - 12:00pm CDT
    Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session

    11:00am CDT

    #223: Meeting Regulatory Expectations: What Needs to be Considered When Using Digital Technologies to Generate Clinical Evidence?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-533-L04-P ; CME 1.00; RN 1.00

    The digital transformation of clinical development poses challenges for regulators. These are being addressed but how far are we on the journey and what are the considerations to ensure that data generated by digital technologies is regulatory grade?

    Learning Objectives

    Describe opportunities and challenges in using digital health technologies during development for clinical evidence generation; Identify what needs to be considered to ensure that the data generated by these technologies is regulatory grade and supports regulatory decisions.

    Chair

    Max Wegner, PharmD, RPh

    Speaker

    Introduction and Closing Remarks
    Max Wegner, PharmD, RPh

    What Needs to be Considered to Ensure that Data Generated by Digital Health Technologies is Regulatory Grade?
    Leonard Sacks, MD

    Considerations for Using Digital Technologies in Clinical Development: A Multi-Stakeholder Perspective
    Jenny Sharpe, PhD

    Solutions for Using Digital Health Technology to Generate Clinical Evidence
    Alicia Staley, MBA, MS



    Speakers
    avatar for Jenny Sharpe

    Jenny Sharpe

    Senior Scientific Writer, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
    Jenny is currently Senior Scientific Writer at the Centre for Innovation in Regulatory Science (CIRS). CIRS is an independent, academic organisation that provides an international forum for industry, regulators, HTA bodies and other healthcare stakeholders to meet, debate and develop... Read More →
    avatar for Leonard Sacks

    Leonard Sacks

    Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
    Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →
    avatar for Alicia Staley

    Alicia Staley

    Vice President, Patient Engagement, Medidata, a Dassault Systèmes Company, United States
    Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →
    avatar for Max Wegner

    Max Wegner

    Head Regulatory Affairs, Bayer AG, Germany
    After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →


    Tuesday June 21, 2022 11:00am - 12:00pm CDT
    Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session |   03: Data-Tech in Clinical Trials, Session

    11:00am CDT

    #225: Solving for ‘Shared Value’ of Cell and Gene Therapy with Real-World Evidence in the Post-Pandemic Healthcare Ecosystem
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-22-563-L04-P ; CME 1.00; RN 1.00

    This forum will explain and explore the concept of 'shared value' in healthcare. We will work an interactive case study in cell & gene therapy focused on prioritizing elements of shared value and differentiating levels of real-world evidence.

    Learning Objectives

    Define health care system 'shared value'; Describe how to prioritize the element of shared value related to cell and gene therapy; Differentiate levels of real-world evidence to substantiate shared value.

    Chair

    John J. Doyle, DrPH, MPH

    Speaker

    Panelist
    Eric Faulkner

    Panelist
    Dorothy Hoffman, MA

    Panelist
    Clark Paramore, MPH



    Speakers
    avatar for John Doyle

    John Doyle

    Group Vice President and Principal Scientist, Exponent, United States
    Dr. Doyle is an epidemiologist and health services researcher who specializes in studying the risks, benefits, and value of healthcare interventions. He has over 25 years of experience in conducting research covering specialties such as pharmacoepidemiology, health economics and outcomes... Read More →
    avatar for Eric Faulkner

    Eric Faulkner

    Vice President, Global Real-World Evidence, Gene Therapies, Novartis Pharmaceutical Company, United States
    avatar for Dorothy Hoffman

    Dorothy Hoffman

    Senior Director, External Engagement Lead, Pfizer Inc, United States
    Dorothy Hoffman serves as External Engagement Lead in Pfizer’s Global Healthcare Innovation Center. Dorothy is responsible for leading Pfizer’s Enterprise strategy on access policy with a focus on value-based healthcare, digital health value and reimbursement, and equitable access... Read More →
    CP

    Clark Paramore

    Head of Value Demonstration, bluebird Bio, United States
    CLARK PARAMORE, MSPH Head of Value Demonstration, bluebird bio Clark Paramore is Vice President and Head of Value Demonstration at bluebird bio in Cambridge, MA. Mr. Paramore is responsible for creating and leading the value demonstration strategy for bluebird bio’s portfolio of... Read More →


    Tuesday June 21, 2022 11:00am - 12:00pm CDT
    Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      12: Value-Access, Forum
    • Level Intermediate
    • Featured Topics RWD-RWE
    • Level Intermediate
    • Feature Topics RWD-RWE
    • Credit Type ACPE, CME, RN
    • Tags Forum

    11:15am CDT

    #227: Approaching the Assessment of Clinical Protocol Complexity
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Application UAN: 0286-0000-22-556-L04-P ; CME 1.00; RN 1.00

    Data integrity is critical in addressing protocol complexity. Our analysis reveals that key data sources commonly used to support protocol complexity tools, analyses and scoring often lack data integrity, undermining claims to understand industry trends, create benchmarks of protocol complexity, and determine the features of trial design that negatively impact performance.

    We will also present a case study of 10 design variables collected from 187 protocols tested for correlations against 11 performance variables and cycle time durations. Among the significant correlations found, in several instances the design variable was found to be a stronger predictor of performance than phase or therapeutic area, highlighting where decisions made during protocol design can impact trial outcomes.

    There will be an “ask me anything” component to enable deeper discussion about challenges of protocol complexity and interactive polling to engage discussion.

    Learning Objectives

    Apply data source integrity required to construct a protocol complexity algorithm and industry benchmarking, improving identification and assessment of potential areas of excess complexity; Describe where complexity may affect clinical trial performance and how to revise protocols to reduce complexity, improving trial outcomes.

    Chair

    Denise Messer, MA

    Speaker

    Accuracy Matters: What it Takes to Scale a Meaningful Protocol Complexity Assessment
    Denise Messer, MA

    Protocol Design Variables Correlated with Clinical Trial Performance
    Zachary Smith, MA



    Speakers
    avatar for Denise Messer

    Denise Messer

    Director, Design Analytics, IQVIA, United States
    Denise Messer has over 25 years experience in research and clinical trials, including expertise in clinical trial planning and design. Areas of particular interest include assessing and scoring trial patient burden and protocol complexity; surfacing the voice of the patient, patient... Read More →
    avatar for Zachary Smith

    Zachary Smith

    Project Manager and Data Scientist, Tufts Center For the Study of Drug Development, United States
    Zachary Smith is a project manager and data scientist at the Tufts Center for the Study of Drug Development. He works on a variety of projects including studies focusing on drug development performance, efficiency, economics, and innovation adoption. He earned his BS at Florida Southern... Read More →


    Tuesday June 21, 2022 11:15am - 12:15pm CDT
    Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Session |   04: MedAffairs-SciComm, Session

    11:15am CDT

    #226: Simulating Trial Activities with Patients: Our Experiences
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-555-L04-P ; CME 1.00; RN 1.00

    Join us for an interactive panel discussion with industry leaders who have simulated in-person, hybrid, and decentralized trial activities with target patients to optimize trial design and ensure a successful implementation.

    Learning Objectives

    Outline the steps to simulating the clinical trial experience with patients; Identify the benefits of conducting clinical trial simulations; Describe how industry leaders have optimized hybrid and decentralized trials through simulation activities.

    Chair

    Abbe Steel, MSc

    Speaker

    Panelist
    Kimberley Kallsen, MPH

    Panelist
    Madeline Geday

    Panelist
    Sara Julian, MA, MLIS



    Speakers
    avatar for Valerie Powell

    Valerie Powell

    Chief Patient Officer, CorEvitas and Vice President, Patient Experience, Healthivibe, The Patient Experience Team of Corevitas, LLC, United States
    Valerie Powell has over 35 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She is the Chief Patient Officer of CorEvitas, ensuring the organization's services center on and address the needs of patients worldwide... Read More →
    KK

    Kimberley Kallsen

    Head of Global Clinical Development and Operations Patient & Site Engagement, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
    Kimberley Kallsen is a cell biologist by training and holds a PhD and a master in public health. She joined Boehringer Ingelheim in 2013, worked in different global strategic and operational roles including medical writing, scientific publications, patient engagement, and is currently... Read More →
    avatar for Madeline Geday

    Madeline Geday

    Senior Director, DCT Office/COE Patient Centriity, Astellas, United States
    Madeline provides subject matter expertise, thought leadership and analysis to product design, development, and commercial & marketing functions at ERT.
    SJ

    Sara Julian

    Patient, United States
    Sara was a participant in the Clinical Trial simulation as a patient.
    AS

    Abbe Steel

    Chief Growth Officer, CorEvitas, United States
    Ms. Steel has more than 25 years in the life sciences industry, leading clinical development and post-marketing programs. She is an advisor to pharma sponsors in the design and implementation of patient-directed programs. She previously worked as Vice President of Patient & Physician... Read More →


    Tuesday June 21, 2022 11:15am - 12:15pm CDT
    Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Forum |   12: Value-Access, Forum

    11:15am CDT

    #228: Individualized Therapeutics: Walking the Line Between Research and Treatment
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-559-L04-P ; CME 1.00; RN 1.00

    This multidisciplinary panel introduces the most pressing novel ethical considerations facing individualized therapeutics (antisense olgionucleotide) for those with ultra-rare genetic diseases, and suggests ways to address these challenges. Join the DIA Patient Engagement Community for a follow up round table discussion (session #237 RT) on Tuesday, June 21, 12:30pm - 1:30pm.

    Learning Objectives

    Describe the ethical challenges facing the emerging field of individualized anti-sense oglionucleotide (ASO) therapeutics; Discuss the overlapping roles of treatment and research in individualized therapeutics; Identify ways in which individualized therapies require unique regulatory and development considerations.

    Chair

    Alison Bateman-House, PhD, MA, MPH

    Speaker

    Panelist
    James P. Smith, MD, MS

    Panelist
    Sarah Glass, PhD

    Panelist
    Timothy W. Yu, MD, PhD

    Panelist
    Edward Neilan, MD, PhD



    Speakers
    avatar for Alison Bateman-House

    Alison Bateman-House

    Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Grossman School of Medicine, United States
    Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Grossman School of Medicine and a Professor of Practice in Law at University of Arizona James E. Rogers College of Law. She is co-chair of the Working Group on Compassionate Use... Read More →
    SG

    Sarah Glass

    Chief Development Officer, N-Lorem Foundation, United States
    Sarah Glass, PhD is the Chief Development Officer at n-Lorem Foundation. She has over twenty years of experience as a strategic leader in rare diseases across academic, pharmaceutical, and clinical research organizations. Sarah marries her professional experience with her passion... Read More →
    avatar for Edward Neilan

    Edward Neilan

    Chief Medical and Scientific Officer, National Organization for Rare Disorders (NORD), United States
    Dr. Neilan is a physician-scientist and rare disease expert with experience in both academic medicine and the pharmaceutical industry. His expertise spans laboratory research, medical practice, as well as clinical trial design and execution across all phases of development. After... Read More →
    avatar for James Smith

    James Smith

    Deputy Director, Office of New Drug Policy, OND, CDER, FDA, United States
    Dr. Smith is deputy director of the Office of New Drug Policy in the Office of New Drugs (OND), with his primary focus being clinical and scientific policy priorities. He was formerly deputy division director of the Division of Metabolism and Endocrinology Products, overseeing development... Read More →
    avatar for Timothy Yu

    Timothy Yu

    Associate Professor, Harvard Medical School; Division of Genetics and Genomics, Boston Children’s Hospital, United States
    Dr. Tim Yu, MD, PhD is a neurologist in the Division of Genetics and Genomics at Boston Children’s Hospital, Associate Professor at Harvard Medical School, and an Associate Member of the Broad Institute. His research group applies genetics, neurobiology, and bioinformatics to study... Read More →


    Tuesday June 21, 2022 11:15am - 12:15pm CDT
    Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      06: PreClinical Dev-EarlyPhaseCR, Forum

    11:15am CDT

    #230: Asia Town Hall
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-561-L04-P ; CME 1.00; RN 1.00

    “Regulatory convergence” has been advancing in Asia and expectation to this region as a field of drug development is also increasing. This session shares latest efforts for “regulatory convergence” in Asia and discuss future direction.

    Learning Objectives

    Describe activities to promote convergence in Asian country; Discuss activities based on convergence in Asian country; Discuss findings from each Asian countries' perspectives.

    Chair

    Nobumasa Nakashima, PhD

    Speaker

    Panelist
    Hiroyuki Arai, PhD

    Panelist
    Rubina Bose

    Panelist
    Jesusa Joyce N Cirunay



    Speakers
    avatar for Hiroyuki Arai

    Hiroyuki Arai

    Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Hiroyuki Arai has served as an Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA) since April 2020. Before joining PMDA, he was a professor of Department of Health Chemistry, Graduate School of Pharmaceutical Sciences at the University of Tokyo (2000-2019... Read More →
    avatar for Rubina Bose

    Rubina Bose

    Deputy Drugs Controller (India), CDSCO (West Zone), India
    Dr. Rubina has regulatory experience of more than 21 years, working in Central Drugs Standard Control Organisation (CDSCO), the National Regulatory Authority of India in various capacities as head of zones , head of division of import registration, new drug, quality assurance of vaccines... Read More →
    avatar for Jesusa Joyce  Cirunay

    Jesusa Joyce Cirunay

    Director IV , Center for Drug Regulation and Research (CDRR), Food and Drug Administration Philippines, Philippines
    JESUSA JOYCE N. CIRUNAY is a Registered Pharmacist (cum laude). She is currently the Director IV of the Center for Drug Regulation and Research at the Food and Drug Administration Philippines. Her government service began at the Product Services Division (PSD) covering Marketing Authorizations... Read More →
    avatar for Nobumasa Nakashima

    Nobumasa Nakashima

    Associate Executive Director for International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Nakashima joined Ministry of Health, Labour and Welfare (MHLW) in 1992. He spent his career in the international field such as WHO and OECD, not only in the domestic field. He worked as International Planning Director at MHLW since 2014, Director of Office of International Regulatory... Read More →


    Tuesday June 21, 2022 11:15am - 12:15pm CDT
    Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session

    11:15am CDT

    #229: Accelerating Cell and Gene Therapy Development Through International Regulator Collaboration
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-560-L04-P ; CME 1.00; RN 1.00

    Rapid progression of cell and gene therapy (CGT) development is leading regulators to build expertise and update regulatory frameworks. We will explore the role of collaboration and training to enable international regulatory convergence for CGT.

    Learning Objectives

    Assess why international collaboration is needed to support the rapid growth of the cell and gene therapy field; Describe how regulators are collaborating to work towards regulatory convergence, harmonization, work sharing, and knowledge sharing; Discuss where further collaboration is needed to facilitate the development of cell and gene therapies.

    Chair

    Nicholas Drago, MS, RAC

    Speaker

    FDA Perspective
    Judith A Arcidiacono, MS

    Industry Perspective
    Katherine Donigan, PhD

    Academia Perspective
    Jared Auclair, PhD



    Speakers
    JA

    Judith Arcidiacono

    International Regulatory Expert, Office of Tissues and Advanced Therapies, CBER, FDA, United States
    Judith received her B.S. in biology from West Virginia University in 1987, and M.S. in genetics from Clarion University. Her training in immunology includes course work at the National Institutes of Health Foundation for the Advancement of Education in the Sciences and the George... Read More →
    avatar for Jared Auclair

    Jared Auclair

    Director, CoE APEC; Associate Dean of Professional Programs and Graduate Affairs, Northeastern University, United States
    Jared R. Auclair is currently the Associate Dean of Professional Program and Graduate Affairs in the College of Science at Northeastern University and Associate Teaching Professor in the department of chemistry and chemical biology. In addition, Dr. Auclair is the Director of the... Read More →
    KD

    Katherine Donigan

    Senior Director, Science and Regulatory, Biotechnology Innovation Organization (BIO), United States
    Dr. Katherine Donigan is currently a Senior Director of Science and Regulatory at Biotechnology Innovation Organization (BIO). Prior to joining BIO, Dr. Donigan spent 7 years in regulatory policy at FDA as a Senior Scientific Advisor in CDER and as the Acting Director of Personalized... Read More →
    avatar for Nicholas Drago

    Nicholas Drago

    Associate Director, Global Regulatory Strategy, Bayer, United States
    Nicholas Drago is Associate Director of Global Regulatory Strategy at Bayer Pharmaceuticals. Previously, he led Bayer’s global regulatory policy efforts for cell & gene therapy and spearheaded the application of data science to support decision making in regulatory affairs. Nicholas... Read More →


    Tuesday June 21, 2022 11:15am - 12:15pm CDT
    Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session |   06: PreClinical Dev-EarlyPhaseCR, Session

    11:15am CDT

    #231: Leveraging Real-World Evidence for Regulatory Purposes
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-562-L04-P ; CME 1.00; RN 1.00

    This session discusses challenges and considerations in the design and implementation of real-world evidence studies including registry-based pragmatic trials and external control studies, based on real applications.

    Learning Objectives

    Demonstrate various designs of a real-world evidence study; Identify the challenges to plan and conduct a real-world evidence study; Discuss considerations for those challenges.

    Chair

    Yueqin Zhao, PhD

    Speaker

    Regulatory Considerations on Leveraging Real World Evidence
    Di Zhang, PhD

    DAPA-MI: World’s First Indication-Seeking Registry-Based Randomized Controlled Trial
    Jingyu (Julia) Luan, PhD

    The Use of a Real-World Data as a Hybrid Control in PAH
    Brian Hennessy, MSc



    Speakers
    BH

    Brian Hennessy

    Senior Director Statistician, Janssen, Switzerland
    Brian Hennessy is a Senior Director of Statistics and Decisions Sciences in Janssen. He has over 20 years experience in the pharmaceutical industry. He has significant experience in regulatory interactions, innovative clinical trial design and practical use of real-world data in clinical... Read More →
    avatar for Jingyu (Julia) Luan

    Jingyu (Julia) Luan

    Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D, AstraZeneca, United States
    Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →
    DZ

    Di Zhang

    Statistical Reviewer, OB, OTS, CDER, FDA, United States
    Di Zhang, Ph.D., is a Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. She holds a Ph.D. degree in Biostatistics from the University of Pittsburgh. Di specializes in causal inference using real-world data and leveraging real-world... Read More →
    YZ

    Yueqin Zhao

    Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
    Yueqin Zhao is a lead mathematical statistician in Office of Biostatistics, Center for Drug Evaluation and Research, FDA. Her research interests include benefit-risk assessment, signal detection, and statistical methods in observational studies.


    Tuesday June 21, 2022 11:15am - 12:15pm CDT
    Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      11: Statistics, Session

    11:15am CDT

    #232: Preparing for the Future of Research and Development:10-Years of Multistakeholder Innovation, Collaboration, and Transformation
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-659-L04-P

    Today’s environment for pharmaceutical product development is being shaped by major disruptive forces –two of which are public health emergencies and data availability, harmonization, use and sharing. These forces are driving unique and innovative approaches to solve the challenges they bring to efficiently create solutions for people living with or fighting disease.

    For example, response to emergent crisis has driven the rapid adoption of digital solutions and awareness that inclusion and health equity need to be core tenets in the future of R&D. Similarly, our ability to collect, harmonize and analyze data from multiple sources has evolved and is leading to new ways of thinking about risk/benefit, and about the type of evidence that can be used to make safety and efficacy decisions.

    Partnership and collaboration are the foundation to bringing new innovations to fruition and ultimately advancing the continued transformation of drug discovery and development. Through several initiatives since its founding 10 years ago, TransCelerate has brought a collaborative approach to identify, prioritize, design, and facilitate implementation of solution designed to foster efficiency in the delivery of new medicines.

    In this panel we will explore the impact of TransCelerate’s initiatives related to the demands of public health crises and the desire to integrate new data into evidence generation.

    Learning Objectives

    Explain factors influencing the future of clinical trials, including remote and digital approaches; Summarize the need for data standardization and approaches such as end-to-end data flow; Describe the critical role of cross-stakeholder collaboration in responding effectively in crisis situations.

    Chair

    Ania Mitan

    Speaker

    Panelist
    Dalvir Gill, PhD

    Panelist
    Adora Ndu, JD, PharmD

    Panelist
    Mick Foy

    Panelist
    Jackie Kent

    Panelist
    Ella Balasa



    Speakers
    avatar for Ella Balasa

    Ella Balasa

    Patient Advocate and Engagement Consultant, United States
    Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information... Read More →
    avatar for Mick Foy

    Mick Foy

    Deputy Director of Patient Safety Monitoring, MHRA, United Kingdom
    Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team and has recently been appointed Deputy Director of Patient Safety Monitoring . Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries... Read More →
    avatar for Dalvir Gill

    Dalvir Gill

    Chief Executive Officer, TransCelerate BioPharma Inc., United States
    Dalvir Gill has more than 30 years of drug development & leadership experience. Prior to his appointment as CEO of TransCelerate, he was the President of a major international CRO. Dr. Gill earned his BSc from the University of Hertfordshire and his PhD from the Royal Free Hospital... Read More →
    avatar for Jackie Kent

    Jackie Kent

    Chair, ACRO; Chief Customer Officer, Medidata, a Dassault Systèmes Company, United States
    Global Executive, board director and trusted advisor with a passion for clinical research working to ensure all patients have access to clinical trials. Jackie has over 30 years of experience in pharma and technology, currently serving as the Chief Customer Officer at Medidata Solutions... Read More →
    avatar for Ania  Mitan

    Ania Mitan

    SVP & Managing Director EMEAIS, DIA, Switzerland
    Ania Mitan serves as the Senior Vice President & Managing Director, DIA EMEA, India and Singapore. She is former Executive Director of the commercial organization at Celgene, where she built the oncology business in the EMEA region with healthcare partners to shape quality delivery... Read More →
    avatar for Adora Ndu

    Adora Ndu

    Chief Regulatory Affairs Officer, BridgeBio Pharma, United States
    Adora Ndu, PharmD, JD, is Chief Regulatory Affairs Officer at Bridgebio Pharma. Prior to joining Bridgebio, Adora spent several years at BioMarin Pharmaceutical in various roles including as Group Vice President, and Head of Worldwide Research and Development Strategy, Scientific... Read More →


    Tuesday June 21, 2022 11:15am - 12:15pm CDT
    Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      14: DIAmond, Forum
    • Level Basic
    • Featured Topics COVID-19
    • Level Basic
    • Feature Topics COVID-19
    • Credit Type ACPE
    • Tags Forum

    12:00pm CDT

    #02 POS: Poster Session II
    Component Type: Poster Presentation

    Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.


    Speakers
    avatar for Akira Fujie

    Akira Fujie

    SOUSEIKAI Global, Japan
    Receiving his B.S. from Kyusyu Sangyo University in Japan in 2017, Akira Fujie worked as a research scientist in the food development industry from 2018 to 2019. In 2020 he joined the Global Clinical Development Division of SOUSEIKAI Global Clinical Research Center, and over the last... Read More →
    avatar for Debu Baruah

    Debu Baruah

    Business Title Manager, Software Development, IQVIA
    Debu Moni Baruah's background spans the fields of clinical data management, research, marketing, and data analytics. He is lean six sigma black-belt certified and led many key innovation projects with a major focus on the areas of people, process, and technology in CROs and technology... Read More →
    CB

    Christine Barry

    Associate Director, Regulatory Operations, Otsuka Pharmaceuticals, United States
    Associate Director at Otsuka Pharmaceuticals with over 15 years of experience in Regulatory Operations, holding a B.S. in Biology. Christine has experience in managing a team responsible for original dossier and document level publishing activities supporting US, EU, Canada, and Switzerland... Read More →
    avatar for Nozomu Miyawaki

    Nozomu Miyawaki

    Senior Manager, SOUSEIKAI Global, Japan
    As a former study coordinator for 3 different SOUSEIKAI clinical research units (Kyushu Pharmacology Research Clinic, Sugioka Memorial Hospital, PS Clinic), this experience has grounded his overall view and understanding of the clinical trial process from early phase to post-marketing... Read More →
    avatar for Sheila Mahoney Jewels

    Sheila Mahoney Jewels

    Small Business Innovation and Aggregator Advocate, LifeSciHub , United States
    Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical... Read More →
    avatar for Katie Graham

    Katie Graham

    Assistant Professor, University of Southern California, United States
    Dr. Katie Graham is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California School of Pharmacy.  She received her PharmD from Drake University before completing a Pediatric Pharmacotherapy residency at Cincinnati Children’s... Read More →
    BF

    Beat Fluehmann

    Global Lead Non-Biological Complex Drugs, Vifor Pharma, Switzerland
    Dr. Flühmann is Pharmacist by training and holds a PhD in molecular biology. He was working in various position in the field of pharmaceuticals and functional nutrition. He was at Roche Deputy Department Head of a R&D department for 8 years. Dr. Flühmann was leading a global multidisciplinary... Read More →
    avatar for Dilhan Weeraratne

    Dilhan Weeraratne

    Deputy Chief Science Officer, Life Sciences, IBM Watson Health, United States
    Dr. Dilhan Weeraratne serves as the Deputy Chief Science Officer, Life Sciences at IBM Watson Health. Dilhan is invested in leveraging the explosion of genomics and other real-world data to transform disease treatment and improve patient outcome. He has over 15 years of post-PhD... Read More →
    avatar for Lindsay Hughes

    Lindsay Hughes

    Principal Scientific Advisor, Clario, United States
    Dr. Hughes is a scientist with over 15 years of experience in behavioral and life sciences, focusing particularly on the role of human behavior in optimizing health outcomes through prevention, care, and treatment. She is currently a Principal Scientific Advisor at ERT, a global data... Read More →
    avatar for Leonidas Drogaris

    Leonidas Drogaris

    Senior Medical Director, Abbvie, United States
    Leonidas Drogaris, MD is a Senior Medical Director in Immunology Pharmacovigilance and Patient Safety at AbbVie. Cumulative pharmacovigilance experience consisting of clinical/post-marketing safety and risk management responsibilities of 16 years as safety lead in therapeutic areas... Read More →
    SP

    Sabina Paglialunga

    Director, Scientific Affairs, Celerion, United States
    Sabina Paglialunga, PhD is a Director, Scientific Affairs at Celerion. In this key leadership position, she serves as both an internal and external subject matter expert for metabolic disease drug development programs including nonalcoholic steatohepatitis (NASH) and type 2 diabetes... Read More →
    RR

    Rosa Rodriguez

    PPD, part of Thermo Fisher Scientific, United States
    avatar for Stephanie Terrey

    Stephanie Terrey

    Senior Director, Patient Experience Delivery, Healthivibe, United States
    Stephanie has 14 years’ experience conducting research in pharmaceutical and non-profit settings. Stephanie is the Senior Director of Patient Engagement Research Delivery at Healthivibe, leading a team in executing qualitative research projects that cultivate accurate and meaningful... Read More →
    AM

    Ana Macarenco

    Risk Management Fellow, Pfizer, United States
    After receiving a bachelor’s degree in Biochemistry from the University of Sao Paulo, Ana Macarenco completed research at the University of California - Davis and subsequently received a PharmD/MPH dual degree at the University of North Carolina-Chapel Hill. She is currently a fellow... Read More →
    avatar for Irene Lin

    Irene Lin

    Regulatory Pharmaceutical Fellow in Medication Safety, FDA, United States
    Dr. Lin obtained her PharmD degree from University of Minnesota- Twin Cities campus with an emphasis separately on research and leadership and received her Master's in Public Health degree from Purdue University. She is currently a second-year Postdoctoral Fellow in Medication Safety... Read More →
    avatar for Vraj Patel

    Vraj Patel

    Pharmacovigilance and Risk Management Fellow, Butler University, United States
    Vraj Patel, PharmD, graduated from the UNC Eshelman School of Pharmacy in 2021. During his time in pharmacy school, he served as a pharmacovigilance intern at GSK and researched how a medication safety comic series can positively impact patient safety through education. His professional... Read More →
    avatar for Lauryn Congedo

    Lauryn Congedo

    Director, CQS, AbbVie, United States
    Lauryn Congedo is the Director of Comprehensive Quality Strategy (CQS) within the R&D Quality (RDQA) organization of AbbVie. CQS is a matrix program designed to anticipate and mitigate quality risks, leverage knowledge across the enterprise, and drive quality excellence across GxP’s... Read More →
    avatar for Walter Bender

    Walter Bender

    Chief Technology Officer, Sorcero, United States
    Walter Bender is a technologist, entrepreneur, and free software advocate. As CTO and Co-founder of Sorcero, Walter leverages technology to enhance the learning capabilities of humans and machines. Walter was a founding member of the MIT Media Lab where he held the Alexander W. Dreyfoos... Read More →
    EC

    Elisa Cascade

    Chief Product Officer, Science 37, United States
    Elisa Cascade, chief product officer at Science 37, has devoted more than 30 years to advancing clinical trial technology, direct-to-patient operations, and healthcare strategy. Throughout her career, she has been instrumental in using technology to transform clinical research to... Read More →
    ND

    Nicole Damour

    Director, Sarepta Therapeutics, United States
    Nicole currently works as a Director, Regulatory CMC, for Sarepta Therapeutics. In her career, she has contributed to drug product and process development, various approved NDA, sNDA and BLA programs, from a technical or regulatory role. Nicole's prior experience also includes working... Read More →
    NR

    Nina Ramdas

    Associate Director, Global Risk Management, Bristol Myers Squibb, United States
    avatar for Prachi Arora

    Prachi Arora

    Vice President and Head Medical Safety, APCER Life Sciences, India
    MD (Pharmacology) with more than 13.5 years of experience in PV in CRO space. Worked with Global Pharma Clients in leadership roles. Key responsibilities including; change management and set up of end to end PV services; strategic alliance with the clients to ensure successful delivery... Read More →
    RH

    Rezzan Hekmat

    Biomedical Research Program Manager, IBM Watson Health, United States
    SK

    Sanjay Kapoor

    Global Head of PV Compliance & Business Management, Otsuka Pharmaceuticals Europe Ltd., United Kingdom
    CR

    Cindy Ryan

    Associate Director, Global QMS Programs, Bristol-Myers Squibb, United States
    Quality-oriented team member with over twenty years’ experience in the pharmaceutical industry. I encourage Quality Management System end user adoption and intent of BMS’s electronic Quality Vault Platforms across GxPs. I lead the network of functional area experts across the... Read More →
    avatar for Stephanie Terrey

    Stephanie Terrey

    Patient Experience: Sr. Director, CorEvitas, United States
    Stephanie has 14 years’ experience conducting research in pharmaceutical and non-profit settings. Stephanie is the Senior Director of Patient Engagement Research Delivery at Healthivibe, leading a team in executing qualitative research projects that cultivate accurate and meaningful... Read More →
    NU

    Nobuo Uemura

    Adjunct Researcher, Institute For Medical Regulatory Science, WASEDA University, Japan
    Mr. Nobuo UEMURA is the International Liaison Officer of PMDA.From 1984 he was engaged in various positions in the Ministry(MHLW) , including Evaluation and Licensing Division, Office of Compliance, Blood and Blood Products Division, and National Institute of Health Sciences.


    Tuesday June 21, 2022 12:00pm - 1:15pm CDT
    Level 3 F2 Entrance McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:00pm CDT

    Luncheon Service
    Component Type: Social Event




    Tuesday June 21, 2022 12:00pm - 1:30pm CDT
    Exhibit Hall McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:00pm CDT

    Community Networking Lunch
    Component Type: Session

    Network with colleagues in your area of interest and learn about DIA Communities in the Community Networking area. Tuesday, 12:00 – 1:!5 PM CDT


    Tuesday June 21, 2022 12:00pm - 4:45pm CDT
    Exh Hall Community Area McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #233 IT: JMP Statistical Discovery Innovation Theater: Interactive Safety Assessment Reports to Aggregate, Filter, and Subgroup Clinical Trial Data
    Component Type: Session

    When conducting safety assessments, medical doctors and reviewers of clinical trials data have high expectations for the level of sophistication with which clinically relevant safety data is presented. Both tabulations and graphical visualizations should be interactive and customizable, bending to the will of the reviewer. Whether users are grouping, filtering, or performing subgroup analysis, clinical trials software should be intuitive and flexible.

    Chair

    JMP Statistical Discovery

    Speaker

    Speaker
    Rebecca Lyzinski, MS

    Speaker
    Geoff Mann, PhD



    Speakers
    avatar for JMP Statistical Discovery

    JMP Statistical Discovery

    JMP, A Business Unit of SAS, United States
    avatar for Rebecca Lyzinski

    Rebecca Lyzinski

    Clinical Research Developer, JMP Statistical Discovery, United States
    Rebecca Lyzinski is a Clinical Research Developer in the JMP Life Sciences group where she develops new reports and analyses for JMP Clinical software. Before joining JMP, Rebecca worked in statistical programming for the pharmaceutical industry. She was a Manager of statistical programming... Read More →
    avatar for Geoff Mann

    Geoff Mann

    Advanced Analytics Manager, JMP Statistical Discovery, United States
    Geoffrey Mann is Advanced Analytics Manager for the health and life sciences industry at JMP. In this role, he explores needs for visual and statistical discovery software in the clinical segment of the pharmaceutical and healthcare industries. After joining SAS in 2000, he helped... Read More →


    Tuesday June 21, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #234 IT: Labcorp Innovation Theater: The Labcorp Patient Recruitment Ecosystem - Designing a Better Clinical Trial Experience
    Component Type: Session

    What does “a better clinical trial experience” mean to patients, sites, clinicians and sponsors? And how can the industry deliver on this promise to drive participation that benefits all? We discuss (with examples) approaches that integrate diagnostic data, artificial intelligence and analytic techniques, patient and site informed design, site enablement techniques, direct-to-patient recruitment, and diversity & inclusion initiatives to bring “a better clinical trial experience” to benefit all.

    Chair

    Labcorp Drug Development

    Speaker

    Speaker
    Ben Quartley, PhD



    Speakers
    avatar for Ben Quartley

    Ben Quartley

    Labcorp Drug Development, United States
    Ben has spent 25 years in the Pharmaceutical Industry and has a broad range of experience, having worked in Pharma, CROs and at a Site Management Organization. During his time in Pharma he recognized the opportunities and challenges of clinical trial delivery from the site perspective... Read More →


    Tuesday June 21, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:25pm CDT

    #235 IT: Veeva Innovation Theater: Clinical Trials Prepare for a Digital, Connected Future
    Component Type: Session

    COVID-19 accelerated decentralized trial adoption, however, a decentralized model is only the beginning. We must continue the momentum toward patient- and site-centric trials with a digital trial model that is paperless and connected. Join Veeva as we explore the industrywide move toward end-to-end digital trials for seamless process execution and data flow across patients, sites, and sponsors to create a connected trial ecosystem.

    Chair

    Veeva Systems, Inc.

    Speaker

    Speaker
    Jim Reilly



    Speakers
    avatar for Veeva Systems, Inc.

    Veeva Systems, Inc.

    United States
    Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →
    avatar for Jim Reilly

    Jim Reilly

    VP, Vault R&D and Quality, Veeva Systems, United States
    As Vice President of R&D and Quality Strategy at Veeva, Jim is responsible for customer engagement, market adoption, and strategic alliances. For the last 20 years, Jim has held various senior positions in life sciences technology, where he has led software delivery and sales efforts... Read More →


    Tuesday June 21, 2022 12:25pm - 12:55pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:30pm CDT

    #237 RT : Round Table Discussion: Individualized Therapeutics: Walking the Line Between Research and Treatment
    Component Type: Session
    Level: Basic

    Join the DIA Patient Engagement Community for a round table discussion tied to session #228: Individualized Therapeutics: Walking the Line Between Research and Treatment (Tuesday, June 21, 11:00am - 12:00pm.) Space is limited.

    Chair

    Mary Murray, MBA, MS
    Karin McIntosh, MPharm


    Speakers
    KM

    Karin McIntosh

    Vice President, Regulatory Affairs, Neximmune, United States
    Vice President and Regulatory Affairs department head with a Master of Pharmacy, Regulatory Affairs Certification and 17 years of pharmaceutical industry experience whereof 14 years within Regulatory Affairs. Unique skillset with a combined Regulatory strategy expertise and an extensive... Read More →
    avatar for Mary Murray

    Mary Murray

    Vice President, Collaborative Action Networks, National Minority Quality Forum, United States
    Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →


    Tuesday June 21, 2022 12:30pm - 1:30pm CDT
    Room 375 A Zone 2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:30pm CDT

    #236 RT: Round Table Discussion: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment
    Component Type: Session
    Level: Basic

    Join the DIA Regulatory Affairs Community for a round table discussion tied to session #134: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment (Monday, June 20, 4:00pm - 5:00pm.) Space is limited.

    Chair

    Mamta Gautam-Basak


    Speakers
    MG

    Mamta Gautam-Basak

    Senior Director Regulatory Affairs, CMC, Celldex Therapeutics, United States


    Tuesday June 21, 2022 12:30pm - 1:30pm CDT
    Room 375 A Zone 1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:45pm CDT

    #237.2 CH: Location, Location, Location: Building the Next Generation of Community-Based Clinical Trial Site Networks
    Component Type: Workshop

    The industry is looking toward new site network models focused on community-based clinics. By being embedded in the community, new site networks have the opportunity to increase patient recruitment and convenience, improve retention, and enhance diversity in clinical trials. We will discuss strategies and ways non-traditional site networks could transform the clinical trial delivery model.

    The COVID-19 pandemic illustrated how non-traditional community-based retail pharmacies / clinics could quickly recruit and see patients for vaccine clinical trials. It raises the questions of if these community-based pharmacies / clinics can enhance:

  • Recruitment: With large retail client bases, extensive pharmacy and EHR records, and customer analytics and insights, can new site networks recruit patients faster?
  • Retention: With convenient locations and expanded hours, telemedicine and digital / decentralized trial capabilities, and patient engagement initiatives, can they improve patient retention throughout the study?
  • Diversity: Can they build on the trust of pharmacists to improve the rate of patients participating in clinical trials and can they recruit more diverse populations -- more representative of the communities where they are at scale across multiple states versus what we see at traditional academic medical centers?


  • Learning Objectives

    Recognize how retail pharmacies and other community-based clinics are transforming the clinical trial site delivery model; Describe how these retailers and community-based clinics can increase recruitment, enhance patient retention, and improve clinical trial diversity; Discover opportunities to build a new ecosystem of clinical trial site networks.

    Chair

    Dawn Anderson, BSN

    Speaker

    Panelist
    Marc R. Watkins



    Speakers
    avatar for Dawn Anderson

    Dawn Anderson

    Managing Director, Life Sciences, Deloitte, United States
    Dawn is a Managing Director in Deloitte’s Life Sciences practice, and a leader in Deloitte’s Clinical Transformation practice. She has more than 30 years of industry experience in Global Pharma and CROs across Clinical Development & Operations with an emphasis on enabling her... Read More →
    MW

    Marc Watkins

    Chief Medical Officer, Kroger, United States


    Tuesday June 21, 2022 12:45pm - 1:15pm CDT
    Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:45pm CDT

    #237.1 CH: Emerging Editorial Policies, Researcher, and Author Standards in Promoting Diversity, Inclusion, and Equity in Cancer Research
    Component Type: Workshop
    Level: Basic

    Medical journals are addressing systemic inequities in healthcare via new editorial policies requiring demographic reporting in published research. The workshop will explore stakeholder considerations, actions and metrics as these policies evolve.

    Learning Objectives

    Identify how to ensure transparent demographic, sexual orientation and gender identity (SOGI), and social determinants of health (SDoH) collection and reporting for inclusive research programs; Describe how to advocate for demographic collection and reporting in the research and clinical trial process with internal and external partner organizations, including Journal editors.

    Chair

    Jeanne Regnante


    Speakers
    JR

    Jeanne Regnante

    Chief Health Equity Advisor, Tiger Lily Foundation, United States
    Jeanne M. Regnante is Tigerlily Foundation’s Strategic Health Equity Advisor. Previous to this position, Jeanne was the Chief Health Equity and Diversity Officer at the LUNGevity Foundation, the Senior Vice President of Community Engagement for NMQF where she launched the Cancer... Read More →


    Tuesday June 21, 2022 12:45pm - 1:15pm CDT
    Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    12:45pm CDT

    #003 STU: Career Ladder or Career Lattice? Strategies for Career Development
    Component Type: Workshop




    Speakers
    avatar for Tywnia Brewton

    Tywnia Brewton

    Sr. Director, Human Resources, Astellas, United States
    Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
    avatar for David Fryrear

    David Fryrear

    Executive Vice President and Head of Quality Assurance, Astellas, United States
    David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization... Read More →
    GM

    Gerald Mosely

    President, CP&P Development Group, United States
    avatar for Anjali Shah

    Anjali Shah

    Executive Director, Business Capabilities and Innovation, Worldwide Patient Safe, Bristol-Myers Squibb Company, United States
    Anjali Shah, PharmD has 15+ years experience in the biopharmaceutical industry in a variety of therapeutic, operational and leadership roles across Medical Affairs and Patient Safety. Inspired by the opportunity to enable safe and informed use of medicines, Anjali is currently involved... Read More →


    Tuesday June 21, 2022 12:45pm - 1:30pm CDT
    Room 471 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      13: ProfDevelopment, Workshop

    1:05pm CDT

    #238 IT: Precision for Medicine Innovation Theater: Bridging Clinical Operations and Translational Science to Meet Critical Endpoints in Precision Medicine Trials
    Component Type: Session

    Precision, biomarker-driven clinical trials are becoming the norm yet carry complex challenges in clinical sample logistics and specialty lab assays. Join Precision as we discuss how primary, secondary, and exploratory objectives, and technologies like flow cytometry, IHC, and PBMC processing impact trial logistics. We’ll also share solutions to ensure a seamless handshake between sample logistics, specialty lab assays, and data analysis to help meet critical clinical milestones.

    Chair

    Precision for Medicine

    Speaker

    Speaker
    Deborah Phippard, PhD



    Speakers
    avatar for Deborah Phippard

    Deborah Phippard

    Chief Scientific Officer, Precision for Medicine , United States
    Dr. Deborah Phippard is a pharma industry veteran and expert at biomarker-driven clinical trial design and execution with more than 25 years of biotechnology and clinical translational research experience. She is a leader of biomarker and drug development programs for pharmaceutical... Read More →


    Tuesday June 21, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:05pm CDT

    #239 IT: IQVIA Innovation Theater: Delivering Better Outcomes with Connected Intelligence
    Component Type: Session

    Join Nagaraja (Sri) Srivatsan, SVP and Chief Digital Officer, Technology Solutions, IQVIA and Murray Aitken, SVP and Executive Director of The IQVIA Institute for Human Data Science and learn from recent research how the COVID pandemic is impacting clinical development, what it is doing to the adoption and use of technologies in clinical development, and how it is creating opportunities for faster development. This is a DIA discussion you don’t want to miss!

    Chair

    IQVIA

    Speaker

    Speaker
    Murray Aitken, MBA

    Speaker
    Wendy Morahan



    Speakers
    avatar for Murray Aitken

    Murray Aitken

    Executive Director, IQVIA Institute for Human Data Science, United States
    Murray Aitken is a senior vice president of IQVIA and Executive Director of the IQVIA Institute for Human Data Science. The Institute undertakes independent research for publication, drawing upon the resources of IQVIA, and focuses on improving understanding of critical healthcare... Read More →
    avatar for IQVIA

    IQVIA

    IQVIA, United States
    WM

    Wendy Morahan

    Sr Director, Clinical Data Analytics, IQVIA, United States


    Tuesday June 21, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:05pm CDT

    #240 IT: Microsoft Innovation Theater: The New Reality of Work in Pharma - How Mixed Reality is Modernizing Operations, Accelerating Research and Improving Patient Engagement
    Component Type: Session

    Mixed reality has become a key driver of digital transformation in Pharma. Discover how Microsoft and Altoura are helping organizations use mixed reality to train frontline workers, visualize operations data, and optimize manufacturing processes. Hear how companies like Thermo Fisher Scientific and Ecolab are using mixed reality to accelerate time to productivity, reduce errors, and improve customer engagement. Following, a HoloLens 2 demo will be available in Microsoft booth 2006.

    Chair

    Microsoft Corporation

    Speaker

    Speaker
    Daniel Carchedi

    Speaker
    Jamie Fleming

    Speaker
    Mark Reagan



    Speakers
    avatar for Microsoft Corporation

    Microsoft Corporation

    Microsoft Corporation, United States
    avatar for Daniel Carchedi

    Daniel Carchedi

    Director of Business Development and Strategy, US Health & Life Sciences, Microsoft, United States
    Daniel leads the development and implementation of strategic plans/partnerships associated with new product/partner offerings in Life Sciences (Pharma/Biotech/MD&D) at Microsoft. Previously, he was a founding member and the Director of Business Development and Strategy for Microsoft... Read More →
    avatar for Jamie Fleming

    Jamie Fleming

    CEO, Altoura, United States
    Jamie is the founder and CEO of Altoura. He is a recognized industry leader with a deep understanding of spatial computing and enterprise customers’ digital transformation priorities. Following his vision and leadership, Altoura has grown to a multinational corporation with over... Read More →
    avatar for Mark Reagan

    Mark Reagan

    Plant Manager, Ecolab, United States
    Mark is a plant manager at Ecolab and has a background working in manufacturing, both in operations and quality. He is passionate about creating simplified processes that are easy for users—and he’s excited about using mixed reality to help improve manufacturing processes. Mark... Read More →
    avatar for Jamie Fleming

    Jamie Fleming

    CEO, Altoura, United States
    Jamie is the founder and CEO of Altoura. He is a recognized industry leader with a deep understanding of spatial computing and enterprise customers’ digital transformation priorities. Following his vision and leadership, Altoura has grown to a multinational corporation with over... Read More →


    Tuesday June 21, 2022 1:05pm - 1:35pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    1:45pm CDT

    #241: Drug Safety in Africa: New PV Horizons
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-564-L04-P ; CME 1.00; RN 1.00

    MHRA will introduce colleagues from the Bill and Melinda Gates Foundation, the African Union Development Agency (AUDA Nepad) and the Nigerian regulator on a project to build capacity on pharmacovigilance in the region. Work so far has focussed on COVID-19 vaccines where data collection and signal detection and assessment to provide a platform for expansion to other products

    Learning Objectives

    Describe the progress in pharmacovigilance in the African Union and future plans

    Chair

    Mick Foy

    Speaker

    A Funder's Perspective on Building LMIC PV Systems: AU-3S Case Example
    Shyam Bhaskaran, PhD, MBA, MS

    Country Perspective from Nigeria
    Moji Christianah Adeyeye, MPharm, RPh

    Introducing the AU Smart Safety Surveillance (AU-3S)
    Aggrey Ambali



    Speakers
    avatar for Moji Adeyeye

    Moji Adeyeye

    Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria
    BIOGRAPHY Prof Mojisola Christianah Adeyeye, PhD, FAAPS, FAS Director General, NAFDAC Professor Adeyeye is the Director General (DG) of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) where she is leading regulatory and administrative reforms through... Read More →
    AA

    Aggrey Ambali

    Director, AUDA-NEPAD Agency, South Africa
    SB

    Shyam Bhaskaran

    Senior Program Officer, Bill & Melinda Gates Foundation
    Shyam Bhaskaran leads the Bill & Melinda Gates Foundation's Smart Safety Surveillance (3S) strategy - building functional pharmacovigilance systems in low- and middle-income countries (LMICs) to ensure patient safety as new global health products are launched. His recent focus has... Read More →
    avatar for Mick Foy

    Mick Foy

    Deputy Director of Patient Safety Monitoring, MHRA, United Kingdom
    Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team and has recently been appointed Deputy Director of Patient Safety Monitoring . Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries... Read More →


    Tuesday June 21, 2022 1:45pm - 2:45pm CDT
    Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Session

    1:45pm CDT

    #242: Risk Minimization for Health Products: What are we Learning for an Improved Path Forward
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-565-L04-P ; CME 1.00; RN 1.00

    Risk minimization measures are designed to promote patient safety. However, despite considerable advances made in this field, in some cases, the full potential of risk minimization measures has yet to be achieved.

    Learning Objectives

    Discuss different stakeholder perspectives with respect to key challenges encountered in risk minimization design and implementation; Describe good practices in designing and implementing risk minimization measures that allow for their optimal integration into the health care system; Identify lessons learned with the objective to minimize burden and barriers to patient access.

    Chair

    Rania Mouchantaf, PhD

    Speaker

    Identifying Undue Burden in Evaluation of REMS Both Pre and Post-Marketing
    Shelly Harris, DrSc, MPH

    MRisk Minimization Measures in Healthcare: The Way Forward in the EU with Qualitative and Participatory Approaches
    Priya Bahri, PhD, RPh

    Evaluating the Effectiveness of a Controlled Distribution Risk Minimization Program in: Designing a Mixed Methods Evaluation Study Protocol to Obtain Rich Insights on Program Implementation and Impact
    Meredith Smith, PhD, MPA, FISPE



    Speakers
    avatar for Priya Bahri

    Priya Bahri

    Lead Pharmacovigilance and Risk Management Guidance and Policy, European Medicines Agency, Netherlands
    Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
    SH

    Shelly Harris

    REMS Assessment Team Leader, OSE, CDER, FDA, United States
    Dr. Shelly Harris has over 25 years of experience in program evaluation, health policy, qualitative research, health communication, health outcomes, and health disparities. She has expertise in the evaluation of assessments and methodologies for risk evaluation and mitigation strategies... Read More →
    avatar for Rania Mouchantaf

    Rania Mouchantaf

    A/Executive Director, Health Canada, Canada
    Dr. Rania Mouchantaf has over 10 years of experience in the area of pharmacovigilance and drug safety. Her career at Health Canada has spanned a number of roles in assessment, management and strategic policy development from both a pre and post market perspective in the area of safety... Read More →
    avatar for Meredith Smith

    Meredith Smith

    Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
    Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →


    Tuesday June 21, 2022 1:45pm - 2:45pm CDT
    Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Session

    1:45pm CDT

    #244: Planning and Conducting Efficient, High-Quality Decentralized Trials: A Multi-Stakeholder Initiative
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-567-L04-P ; CME 1.00; RN 1.00

    Building on decentralized clinical trials work, this session offers multi-stakeholder insights, updated recommendations, and case examples for incorporating decentralized elements in trials, from tele-visits to mobile HCPs and D2P shipping.

    Learning Objectives

    Discuss new multi-stakeholder recommendations and best practices for effectively incorporating decentralized elements into clinical trials from the earliest stages of trial design; Identify current challenges to operationalizing decentralized elements, and opportunities to address these challenges in individual trials and programs, as well as through continued multi-stakeholder collaboration.

    Chair

    Megan Doyle, JD, MPH

    Speaker

    Planning and Conducting DCTs: An Industry Perspective
    Reem Yunis, PhD

    Patient Perspective
    Philip John Green

    FDA Perspective
    Susanne R. Goldstein, MD



    Speakers
    avatar for Megan Doyle

    Megan Doyle

    Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product, Amgen, United States
    Megan Doyle is an attorney and policy professional with more than 13 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public... Read More →
    SG

    Susanne Goldstein

    Medical Officer, ON, Office of New Drugs, CDER, FDA, United States
    Currently, I am a Medical Officer at FDA, CDER, Division of Neurology Products, involved in the scientific and regulatory review of of investigational new drug applications. I received my BA in Psychology from Brown University and my MD form Brown University School of Medicine. I... Read More →
    avatar for Philip Green

    Philip Green

    Steering Committee Patient Representative, CTTI, United States
    Phil was diagnosed with ALS in August of 2018 and immediately dedicated himself to making a difference in the fight against ALS. Phil is active with multiple ALS organizations and institutions (Team Gleason, I AM ALS, Augie’s Quest, ALS TDI, ALS Cure Project, UW Medicine, ALSA... Read More →
    avatar for Reem Yunis

    Reem Yunis

    Vice President, Digital Clinical Measures, Medable, United States
    Dr. Yunis is a scientist with multidisciplinary training and experience in mechanism of diseases. Reem enjoys working in startups bringing forward long term vision and strategies. At Medable, she works cross-functionally with engineers, product development, regulatory, and data science... Read More →


    Tuesday June 21, 2022 1:45pm - 2:45pm CDT
    Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Session

    1:45pm CDT

    #243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-566-L04-P ; CME 1.00; RN 1.00

    This session will focus on examining how technology can be leveraged to make clinical trials more widely accessible, inclusive and efficient and how “intentionally collected data” from EHRs can be used for prospective clinical research. Join the DIA Good Clinical Practices & QA Community for a follow up round table discussion (session #256 RT) on Tuesday, June 21, 3:00pm - 4:00pm.

    Learning Objectives

    Identify how technology can be useful in making clinical trials more inclusive; Recognize how EHR-derived data can contribute to the design and conduct of clinical trials; Discuss the potential for prospective data to be captured at the point of care through the EHR.

    Chair

    Neal Meropol, DrMed

    Speaker

    Regulatory Perspective
    Donna Rivera, PharmD, MSc

    Industry Perspective
    Kent Thoelke

    Investigator Perspective
    Stephanie L. Graff, MD, FACP



    Speakers
    avatar for Neal Meropol

    Neal Meropol

    Vice President of Research Oncology, Flatiron Health, United States
    Neal J. Meropol, MD is a medical oncologist, clinical investigator and outcomes researcher who serves as Vice President of Research Oncology at Flatiron Health. In this role, he provides scientific and clinical leadership in leveraging Flatiron’s technology platforms to close the... Read More →
    avatar for Stephanie Graff

    Stephanie Graff

    Assistant Professor, Brown University; Director of Breast Oncology Program, Lifespan Cancer Institute, United States
    Dr. Stephanie Graff, MD, FACP is Director of Breast Oncology at Lifespan Cancer Institute, Legorreta Cancer Center at Brown University in Providence, Rhode Island. She serves as co-lead of Breast Cancer Translational Research Disease Working Group and Assistant Professor of Medicine... Read More →
    avatar for Donna Rivera

    Donna Rivera

    Associate Director for Pharmacoepidemiology, OCE, FDA, United States
    Donna R. Rivera, PharmD., MSc., is the Associate Director of Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory... Read More →
    KT

    Kent Thoelke

    Former Chief Innovation Officer, ICON, Consultant, Ireland


    Tuesday June 21, 2022 1:45pm - 2:45pm CDT
    Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Session |   03: Data-Tech in Clinical Trials, Session

    1:45pm CDT

    #245: Understanding the Consumer's Journey for Information From Searching for Information to Using Information
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-570-L04-P ; CME 1.00; RN 1.00

    Consumers are active participants in the decision-making process for their own healthcare choices. The venues that they search for information; the format of that information; and the actions taken with that information are critical to understand. This session will discuss the results of three surveys conducted with US patients and caregivers to delineate where they search for medical information, their preferences on the format, and the how they use the information.

    Learning Objectives

    Identify where consumers search for medical information and the rationale for why and why not particular choices were made; Analyze the consumers' preferences and ease of understanding of information presented in different formats using different technology platforms/outputs; Describe how consumers use the medical information they have received.

    Chair

    Evelyn R. Hermes-DeSantis, PharmD

    Speaker

    The Finish Line: How Consumers' Use the Medical Information
    Anja Glaetzer, DrMed

    Moderator
    Jennifer Riggins, PharmD

    Starting the Journey: Where Consumers' are Looking for Medical Information
    Susan Wnorowski, PharmD



    Speakers
    AG

    Anja Glaetzer

    Head, Global Medical Information Content, Sanofi, United States
    Dr Anja Glaetzer is currently Head, Global Medical Information Content, Vaccines. Dr Glaetzer gained her Medical Degree and PhD in Immunology from Heinrich-Heine-University, Duesseldorf, Germany and a post-graduate Diploma in Health Economy for Healthcare Professionals from University... Read More →
    avatar for Evelyn Hermes-DeSantis

    Evelyn Hermes-DeSantis

    Director, Research and Publications, phactMI, United States
    Evelyn Hermes-DeSantis, PharmD, BCPS, the Director of Research and Publications for phactMI and Professor Emerita at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey. She received her undergraduate and graduate degrees from Rutgers University and... Read More →
    avatar for Jennifer Riggins

    Jennifer Riggins

    Technology and Partnership Strategist, phactMI, United States
    Jennifer Riggins, PharmD, has extensive experience in medical affairs, medical information, medical communications, and digital channels, and serves as President, JSR Medical Affairs Consulting, LLC. She is also Past-President of phactMI, a group dedicated to bringing medical information... Read More →
    avatar for Susan Wnorowski

    Susan Wnorowski

    Director, US Medical Information, Ipsen Biopharmaceuticals, Inc., United States
    avatar for Susan Wnorowski

    Susan Wnorowski

    Sr. Director, US Medical Information and Patient Safety, Ipsen Biopharmaceuticals, Inc., United States
    Susan Wnorowski, PharmD, BCMAS has been in the Pharmaceutical Industry for 22 years with extensive experience in both Medical Information and Drug Safety. She has expertise managing in-house Medical Information Teams as well providing Call Center vendor oversight for outsourced models... Read More →


    Tuesday June 21, 2022 1:45pm - 2:45pm CDT
    Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      04: MedAffairs-SciComm, Session

    1:45pm CDT

    #246: Project Management Across the Healthcare Continuum
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-572-L04-P ; CME 1.00; PDU 1.00 PMI 2166M0HPR0; RN 1.00

    This session will cover skills project management professionals need to develop and learn – regardless of which function you belong to deliver success delivery project outcomes.

    Learning Objectives

    Discuss what is it to be a project manager from three different functions across drug development life cycle in a pharma company; Assess if you are a practicing project manager or a new project manager and wondering – how does the project manager role look like to lead initiatives to deliver business results vary from Discovery to Pharmacovigilance to Commercial function.

    Chair

    Erin Mulrooney, MSc, PMP

    Speaker

    Project Management in Discovery
    Erin Mulrooney, MSc, PMP

    Project Management: New Market Development
    Nancy Watanabe, MS, PMP

    Project Management: Pharmacovigilance
    Jeffrey Mohr, PhD



    Speakers
    avatar for Hetal Doshi

    Hetal Doshi

    Director, Business Operations and Strategy, AbbVie, Inc., United States
    Hetal Doshi has over 15 years of experience in leading global business transformation initiatives in pharmaceutical and healthcare industry. Her experience span across leading strategic initiatives in Pharmacovigilance & Patient Safety, Regulatory, Technology and Digital Health initiatives... Read More →
    avatar for Jeffrey Mohr

    Jeffrey Mohr

    Director, Global Strategic Safety Initiatives and Portfolio Management, AbbVie, United States
    Jeffrey Mohr is a Director in the Pharmacovigilance and Patient Safety division of AbbVie R&D where he manages Strategic Initiatives and Global Portfolio Management, focused on driving business transformation. Prior to joining AbbVie, Jeffrey was the Senior Director, Portfolio Simplification... Read More →
    avatar for Erin Mulrooney

    Erin Mulrooney

    Director, Discovery Project and Portfolio Management, Merck Sharp & Dohme LLC , United States
    Erin Mulrooney is a Director in the Global Project and Alliance Management group at Merck where she manages the Discovery Portfolio. Prior to rejoining Merck at the end of 2020, Erin was the Director of Portfolio Management and Operations at BioCelerate, a subsidiary of TransCelerate... Read More →
    avatar for Nancy Watanabe

    Nancy Watanabe

    Executive Director, New Market Development Project Leadership, BeiGene, Inc., United States


    Tuesday June 21, 2022 1:45pm - 2:45pm CDT
    Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      07: ProjectManagement-StrategicPlanning, Forum |   13: ProfDevelopment, Forum

    1:45pm CDT

    #247: Paying for Digital Health: What Evidence is Needed?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-578-L04-P ; CME 1.00; RN 1.00

    This session will touch on two types of evidence for reimbursement decisions in the digital era of healthcare. First, the need to refine existing evidentiary frameworks to be fit-for-purpose for evaluating digital health products, including digital products with different risk profiles. Second, to consider how digitally generated evidence can be used to inform reimbursement decisions for traditional medical products using digitally measured nocturnal scratch for atopic dermatitis drugs and biologics.

    Learning Objectives

    Describe optimized criteria for evaluating digital health technologies for reimbursement; Define the evidence needed to use digital endpoint data to inform reimbursement and pricing decisions for traditional medical products.

    Chair

    Anita Burrell, MA, MBA

    Speaker

    Nocturnal Scratch: Value of a Digital Endpoint to Successful Commercialization of a New Medical Product
    Jennifer Goldsack, MA, MBA, MS

    Paying for Digital Health Interventions: What Evidence is Needed?
    Carl Asche, PhD, MSc



    Speakers
    CA

    Carl Asche

    Research Professor, University of Illinois College of Medicine, United States
    His research focuses on the use of comparative effectiveness research and cost-effectiveness analysis in health care decision making. His academic work has comprised authoring or co-authoring over 100 papers appearing in the medical and economic literature. He has presented his research... Read More →
    avatar for Anita Burrell

    Anita Burrell

    Founder, Anita Burrell Consulting LLC, United States
    Anita has over 23 years’ experience of leadership in the pharmaceutical industry in a wide variety of roles. She joined the industry as a pioneer in the field of Health Economics for Burroughs Wellcome and moved to New Jersey in 2001 to lead Global Health Economics and Outcomes... Read More →
    avatar for Jennifer Goldsack

    Jennifer Goldsack

    Chief Executive Officer, Digital Medicine Society (DiMe), United States
    Jennifer Goldsack is the Chief Executive Officer of the Digital Medicine Society (DiMe). Founded in 2019, DiMe is the first professional organization for experts from all disciplines comprising the diverse field of digital medicine. Together, we drive scientific progress and broad... Read More →


    Tuesday June 21, 2022 1:45pm - 2:45pm CDT
    Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      12: Value-Access, Session

    2:00pm CDT

    #248: Healthcare Datasets as Assets: Secure and Compliant Valuation and Transaction Methods
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-568-L04-P ; CME 1.00; RN 1.00

    This session will create awareness of the emerging marketplaces for real-world data exchanges and monetization while exploring several organizational hesitations. The presenters will also share data valuation strategies, and emerging technologies currently being used to facilitate data exchanges.

    Learning Objectives

    Recognize that health data sets are not only valuable for treatment and health-oriented research, but are intangible assets; Discuss how to construct data valuation and marketization strategies using generally accepted accounting principles and asset management approaches; Evaluate organizational constraints prior to data exchange and/or monetization, including ethical, legal, and accounting perceptions.

    Chair

    Wendy Charles, PhD

    Speaker

    Healthcare Datasets as Assets: Secure and Compliant Valuation and Transaction Methods
    Wendy Charles, PhD

    Healthcare Datasets as Assets: Real World Data
    Aaron Kamauu, MD, MPH, MS



    Speakers
    avatar for Wendy Charles

    Wendy Charles

    Chief Scientific Officer, BurstIQ, United States
    Dr. Wendy Charles has been involved in clinical trials from every perspective for nearly 30 years with a strong background in operations and compliance of digital health technologies. She currently serves as Chief Scientific Officer for BurstIQ, a health IT company specializing in... Read More →
    avatar for Aaron Kamauu

    Aaron Kamauu

    Managing Director, Ikaika Health LLC, United States
    Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical... Read More →


    Tuesday June 21, 2022 2:00pm - 3:00pm CDT
    Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Session

    2:00pm CDT

    #249: Regulatory-Grade Real-World Evidence: Distilling to Practice
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-569-L04-P ; CME 1.00; RN 1.00

    Real-world evidence (RWE) is increasingly used to complement randomized clinical trials (RCT), provide a better understanding of real-world effectiveness, and address information gaps. This session will explore various best practices, tools, and methods used.

    Learning Objectives

    Describe various levels of real-world evidence (RWE) validity and their relationship to current regulatory RWE guidance; Identify rigorous methodological approaches to maintain evidentiary standards and the impact of underlying data quality in RWE study results; Evaluate future study design using advanced RWE to support medical affairs, market access, and regulatory objectives.

    Chair

    Dan Riskin, MD, MBA

    Speaker

    Developing High-Validity Real-World Evidence to Meet Clinical, Regulatory, and Commercial Objectives
    Dan Riskin, MD, MBA

    FDA Update
    John Concato, MD, MPH, MS

    Practical Tools to Advance Fit-for-Purpose Use of Real-World Data in Regulatory Decision-Making
    Cathy W Critchlow, PhD, MSc

    Evaluating Machine Learning Derived Real-World Data to Support Regulatory Decision Making
    Irene Nunes, PhD



    Speakers
    avatar for Dan Riskin

    Dan Riskin

    Founder and Chief Executive Officer, Verantos, United States
    Dan Riskin is the founder and CEO of Verantos, the market leader in high-accuracy real-world evidence (RWE) generation. Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy... Read More →
    avatar for Cathy Critchlow

    Cathy Critchlow

    Vice President, R&D Data Strategy, Amgen, United States
    Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational... Read More →
    avatar for John Concato

    John Concato

    Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
    Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator... Read More →
    avatar for Irene Nunes

    Irene Nunes

    Vice President, Head of Regulatory Affairs, Flatiron Health, United States
    Irene Nunes is VP, Head of Regulatory Affairs at Flatiron Health, leading strategy and policy professionals focused on advancing RWD/RWE for regulatory decision-making and market access globally by working with pharmaceutical companies, regulatory agencies, HTAs, policy organizations... Read More →
    avatar for Dan Riskin

    Dan Riskin

    Founder and Chief Executive Officer, Verantos, United States
    Dan Riskin is the founder and CEO of Verantos, the market leader in high-accuracy real-world evidence (RWE) generation. Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy... Read More →


    Tuesday June 21, 2022 2:00pm - 3:00pm CDT
    Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Forum |   04: MedAffairs-SciComm, Forum |   09: Regulatory, Forum
    • Level Intermediate
    • Featured Topics RWD-RWE
    • Level Intermediate
    • Feature Topics RWD-RWE
    • Credit Type ACPE, CME, RN
    • Tags Forum

    2:00pm CDT

    #250: Patients as Central Partners in COA Design
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-571-L04-P ; CME 1.00; RN 1.00

    Co-designing with representative patient populations can enable the selection of COAs/PROs that are most relevant to patients and care givers. Participants will learn the background, reasoning, and technical process for bringing patients into drug development.Attendees will attend a panel discussion with FDA and Industry discussing where in the process patient engagement strategies assisted in shaping selection and implementation.

    Learning Objectives

    Discuss relevance of core COAs/PROSs to patient/caregivers of different ages, disease stages, demographics, and patient populations differentially impacted by social determinants of health ; Describe a process which enables adaptation of existing or creation of novel core COAs/PROs to align with disease state progression and innovation as well as potentially shifting patient perspectives.

    Chair

    Terrell Baptiste, MBA

    Speaker

    Conversations are Happening Whether you are There or Not: Using Social Media to Develop Meaningful Clinical Endpoints
    Bill Byrom, PhD

    FDA Update
    Michelle Campbell, PhD

    Patients as Central Partners in COA Design: Looking Beyond Semi-Structured Interviews
    Denise Globe, MHS, PhD

    Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
    Ji Li, MD, PhD



    Speakers
    TB

    Terrell Baptiste

    Associate Director, Regulatory Policy and Intelligence, Gilead Sciences, Inc., United States
    Terrell Baptiste, Regulatory Policy and Intelligence, Gilead Sciences represents the Regulatory Affairs and Development organization to support and advise regulatory strategies that leverage innovative regulatory programs. He has a track record of successfully forging collaborations... Read More →
    avatar for Bill Byrom

    Bill Byrom

    Principal, eCOA Science, Signant Health , United Kingdom
    Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
    avatar for Michelle Campbell

    Michelle Campbell

    Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
    Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer... Read More →
    avatar for Denise Globe

    Denise Globe

    Head, HEOR, Gilead Sciences, Inc., United States
    Denise Globe has 30 years of experience in health care with a focus on quantitative policy research and direct research experiences in disease management including the outcomes, process, financing and delivery of care. A particular focus has been on assessing the impact of disease... Read More →
    avatar for Ji Li

    Ji Li

    Reviewer, Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
    Dr. Ji Li is a primary reviewer at the Division of Clinical Outcome Assessment at the U.S. FDA. Dr. Li reviews the use of clinical outcome assessments in IND/NDA/BLA applications that are intended to support labeling claims of medical product development programs. Dr. Li also reviews... Read More →


    Tuesday June 21, 2022 2:00pm - 3:00pm CDT
    Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum

    2:00pm CDT

    #251: Data Science, Text Analytics, and Machine Learning to Derive Insights from Clinical Quality, Compliance, and Real-World Data
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-573-L04-P ; CME 1.00; RN 1.00

    This session will present examples of data science, NLP, and machine learning techniques used to unlock the value of Clinical Q&C and Real-World data and derive insights from them. No data science experience needed - come with an open mind ready to learn, contribute and apply!

    Learning Objectives

    Discuss how data science including text analytics/NLP and predictive modeling/machine learning can be applied to clinical quality and compliance (or real-world) data; Identify examples of use by speakers in the pharma industry, and summarize best practices and learnings from their experience; with the speakers and fellow attendees about meaningful collaboration to guide your own data science journey.

    Chair

    Deepak Bandyopadhyay, PhD

    Speaker

    Unlocking Free Text Quality and Compliance Data via Text Analytics and Machine Learning
    Deepak Bandyopadhyay, PhD

    Data Driven Quality Risk Management
    Haleh Valian, PhD

    Best Practices for Evaluating Machine Learning Derived Real-World Data: Proposals to Support Regulatory Decision Making
    Melissa Estevez, MS



    Speakers
    avatar for Deepak Bandyopadhyay

    Deepak Bandyopadhyay

    Interim Head, Quality Analytics Data Sciences, Janssen, United States
    Deepak Bandyopadhyay is a Computer Scientist by training who has spent his career developing methods and solving problems in the Life Sciences. He has worked as a Data Scientist and data science leader in many parts of the Pharma pipeline, including drug discovery, drug development... Read More →
    avatar for Melissa Estevez

    Melissa Estevez

    Senior Quantitative Scientist, Flatiron Health, United States
    Melissa is a Senior Quantitative Scientist at Flatiron Health where she focuses on the application of machine learning to real world data. Specifically, Melissa brings expertise in the underlying data and downstream analytic use cases to support development of machine learning based... Read More →
    HV

    Haleh Valian

    Associate Director, Quality Analytics, Biogen, United States
    Haleh is the Biogen's Head of R&D Data & Quality Analytics. She has more than 21 years of expertise utilizing advanced analytics to solve challenging business problems relating to process optimization in a variety of industries, including pharma, healthcare, and finance. She has depth... Read More →


    Tuesday June 21, 2022 2:00pm - 3:00pm CDT
    Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      08: RD Quality-Compliance, Session |   03: Data-Tech in Clinical Trials, Session

    2:00pm CDT

    #252: International Collaborations: What’s New in Oncology?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-574-L04-P ; CME 1.00; RN 1.00

    Oncology leaders from the European Medicines Agency and US Food and Drug Administration will share insights from their decades-long collaborations, practical aspects of global regulatory science in oncology.

    Learning Objectives

    Describe how EMA and FDA collaborate in the oncology space; Describe the areas of future collaboration between the two agencies.

    Chair

    Katherine Tyner, PhD

    Speaker

    FDA Update
    R. Angelo De Claro, MD

    EMA Update
    Francesco Pignatti, MD

    FDA Update
    Richard Pazdur, MD



    Speakers
    avatar for Katherine Tyner

    Katherine Tyner

    FDA Liaison to the EMA, Office of Global Policy and Strategy, OC, FDA, United States
    Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical... Read More →
    avatar for R. Angelo De Claro

    R. Angelo De Claro

    Associate Director, Global Clinical Sciences, OCE; Div Dir, DHM, OOD, CDER, FDA, United States
    Dr. de Claro is currently the Associate Director (Acting) for Global Clinical Sciences with US FDA Oncology Center of Excellence (OCE). In this role, he leads OCE efforts to advance cancer drug development and regulatory science across the globe, including direction of Project Orbis... Read More →
    avatar for Francesco Pignatti

    Francesco Pignatti

    Head of Oncology and Hematology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    avatar for Richard Pazdur

    Richard Pazdur

    Director, Oncology Center of Excellence, FDA, United States
    Richard Pazdur, M.D., is the director of the FDA’s Oncology Center of Excellence (OCE), which leverages the combined skills of FDA’s regulatory scientists and reviewers with expertise in drugs, biologics, and devices to expedite the development of novel cancer products. In this... Read More →


    Tuesday June 21, 2022 2:00pm - 3:00pm CDT
    Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session

    2:00pm CDT

    #254: Overcoming Challenges in Pediatric Product Development
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-576-L04-P ; CME 1.00; RN 1.00

    This session will discuss complexities in pediatric drug development including identification of appropriate endpoints and biomarker, challenges in extrapolation from adults and across age ranges, and best practices to overcome key development challenges.

    Learning Objectives

    Identify key challenges that may delay development of products for pediatric diseases; Discuss via case studies of historical development programs; Identify approaches to overcome challenges including the role of developers, regulators and patient groups.

    Chair

    Adora Ndu, JD, PharmD

    Speaker

    Industry Update
    Andrew Mulberg, MD

    FDA Update
    Lynne Yao, MD



    Speakers
    avatar for Lynne Yao

    Lynne Yao

    Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
    Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →
    avatar for Adora Ndu

    Adora Ndu

    Chief Regulatory Affairs Officer, BridgeBio Pharma, United States
    Adora Ndu, PharmD, JD, is Chief Regulatory Affairs Officer at Bridgebio Pharma. Prior to joining Bridgebio, Adora spent several years at BioMarin Pharmaceutical in various roles including as Group Vice President, and Head of Worldwide Research and Development Strategy, Scientific... Read More →
    avatar for Andrew Mulberg

    Andrew Mulberg

    Senior Vice President, Neurogene, United States
    Andrew is currently Senior Vice President, Regulatory Affairs at Neurogene Inc, a company devoted to gene therapy approaches to management of neurodegenerative disorders in children and adults. Formerly, he served Senior Vice President, Global Regulatory Affairs at Amicus Therapeutics... Read More →


    Tuesday June 21, 2022 2:00pm - 3:00pm CDT
    Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session

    2:00pm CDT

    #253: Efforts to Improve Diversity of Clinical Trial Participants
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-575-L04-P ; CME 1.00; RN 1.00

    This session will provide an overview of initiatives, collaborations, and partnerships from industry, regulators, and other stakeholders to enhance the diversity of clinical trial participants.

    Learning Objectives

    Describe efforts to promote diverse clinical trial participation and how they will be realized; Discuss how to develop cross functional collaborations within companies and engage with regulators to achieve diversity goals; Identify considerations to establish a robust reproducible framework for assessing trial diversity and planning for improvements.

    Chair

    Kim Ribeiro, MS, MT

    Speaker

    Improving Diversity of Health Disparities Clinical Trials with Community-Based Organization Engagement
    Barbara Goodman, MBA

    Industry Update
    Ramona Burress, PharmD

    FDA Update
    Jamie Renee Brewer, MD



    Speakers
    JB

    Jamie Brewer

    Acting Clinical Team Lead, DO3, OOD, CDER, FDA, United States
    Jamie Brewer, MD, is a medical oncologist and Acting Clinical Team Lead in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Food and Drug Administration (FDA). Dr. Brewer joined the FDA in 2018 and previously served as a clinical reviewer on the Genitourinary... Read More →
    avatar for Ramona Burress

    Ramona Burress

    Head of Patient Insights and Engagement, Takeda Pharmaceuticals, United States
    Ramona Burress, PharmD is Head of Patient Insights and Engagement – Center for Health Equity and Patient Affairs at Takeda. Prior to joining Takeda, Ramona Burress served as a Director, Diversity & Inclusion in Clinical Trials at Janssen. This in role, she led external stakeholder... Read More →
    avatar for Barbara Goodman

    Barbara Goodman

    President and Chief Executive Officer, Cures Within Reach, United States
    Barbara Goodman leads Cures Within Reach and its mission of testing of already approved therapies in new indications. She has 25 years of healthcare/life sciences experience, focused on strategic growth initiatives at both for-profit and nonprofit corporations. Prior to CWR, she led... Read More →
    avatar for Kim Ribeiro

    Kim Ribeiro

    Head, Diversity and Patient Inclusion, AbbVie, Inc., United States
    Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategy development for patient engagement, recruitment and retention planning as well as digital outreach and raising clinical... Read More →


    Tuesday June 21, 2022 2:00pm - 3:00pm CDT
    Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

    2:00pm CDT

    #255: Demystifying Statistical Concepts for Non-Statisticians Involved with Clinical Trials
    Component Type: Workshop
    Level: Basic
    CE: ACPE 1.00 Application UAN: 0286-0000-22-577-L04-P ; CME 1.00; RN 1.00

    Group activities and slide-based learning will be used to introduce common statistical concepts that are used in the analysis of clinical trials in a simple, easy to understand manner for non-statisticians involved in clinical trials.

    Learning Objectives

    Explain basic statistical concepts; Identify the appropriate statistical analysis for a given outcome; Describe the interpretation of data via tabulated and graphical summaries; Compare the difference between statistical significance and clinical meaningfulness.

    Chair

    Stephen Corson, PhD

    Speaker

    Visualizing Clinical Trial Design and Results in 20 Graphical Displays: Achieving 20-20 in CSRs
    Munish Mehra, PhD, MS, MSc



    Speakers
    avatar for Stephen Corson

    Stephen Corson

    Principal Statistician, PHASTAR, United Kingdom
    I am a Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of Mathematics... Read More →
    avatar for Munish Mehra

    Munish Mehra

    Managing Director, Tigermed India, Tigermed, United States
    Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across... Read More →


    Tuesday June 21, 2022 2:00pm - 3:00pm CDT
    Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      11: Statistics, Workshop
    • Level Basic
    • Level Basic
    • Credit Type ACPE, CME, RN
    • Tags Workshop

    2:45pm CDT

    Refreshment Break
    Component Type: Social Event




    Tuesday June 21, 2022 2:45pm - 4:30pm CDT
    Exhibit Hall McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:00pm CDT

    #256 RT: Round Table Discussion: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations
    Component Type: Session
    Level: Basic

    Join the DIA Good Clinical Practices & QA Community for a round table discussion tied to session #243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations (Tuesday, June 21, 1:45pm - 2:45pm.) Space is limited.

    Chair

    Terry Katz, MS


    Speakers
    avatar for Terry Katz

    Terry Katz

    Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
    Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →


    Tuesday June 21, 2022 3:00pm - 4:00pm CDT
    Room 375 A Zone 1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:00pm CDT

    #257 RT: Round Table Discussion: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities
    Component Type: Session
    Level: Basic

    Join the DIA Patient Engagement Community for a round table discussion tied to session #207: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities (Tuesday, June 21, 9:00am - 10:00am.) Space is limited.

    Chair

    Maria Paula Bautista Acelas


    Speakers
    avatar for Maria Paula Bautista Acelas

    Maria Paula Bautista Acelas

    Research Associate, DIA, United States


    Tuesday June 21, 2022 3:00pm - 4:00pm CDT
    Room 375 A Zone 2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #258 IT: IBM Watson Health Innovation Theater: User Centricity in Clinical Data Management - The Next Revolution for eClinical Solutions
    Component Type: Session

    While speed, cost, and efficiency are common industry metrics to grade effectiveness of EDC and CDMS solutions, user experience are often overlooked by many technology vendors. Join IBM Watson Health to learn how user-centric design is at the core of their solution development, and why this obsession over ease-of-use has revolutionized clinical data management for many of their clients.

    Chair

    IBM Watson Health

    Speaker

    Speaker
    Walker Bradham

    Speaker
    Sofia Puerto



    Speakers
    avatar for IBM Watson Health

    IBM Watson Health

    United States
    avatar for Walker Bradham

    Walker Bradham

    Lead Product Manager, IBM Watson Health, United States
    Walker Bradham is the Product Leader for IBM Clinical Development, IBM Watson Health's flagship CDMS solution. He brings 20 years of experience defining, designing and deploying web applications to the marketplace, and leads the product roadmap for all EDC/CDMS and eCOA offerings... Read More →
    avatar for Sofia Puerto

    Sofia Puerto

    Senior Client Program Specialist, Biorasi, United States
    As a Senior Client Program Specialist, Sofia Puerto is responsible for building relationships with our partners, understanding their development goals, and developing the budget and overall strategy to successfully execute their clinical studies. Sofia has been working in this role... Read More →


    Tuesday June 21, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #259 IT: UBC Innovation Theater: Modernizing Observational Research and Decentralized Studies with Patient Mediated Electronic Medical Record Release
    Component Type: Session

    Data acquisition in observational studies has traditionally relied on health care providers performing a review of the patient chart & manually entering data into a bespoke Electronic Data Capture system (EDC). This paradigm has been disrupted with the proliferation of interoperability solutions that enable the acquisition of secondary data for research purposes. One such solution that is fundamentally changing observational research is called Patient Mediated Electronic Medical Record Release.

    Chair

    UBC

    Speaker

    Speaker
    Aaron Berger, PMP

    Speaker
    Dana Hosseini



    Speakers
    avatar for Aaron Berger

    Aaron Berger

    UBC, United States
    Aaron Berger serves as the VP, Late Stage & RWE for UBC. In this role, he works towards the strategic design and execution of late stage clinical trials and observational research that will generate powerful, real world evidence of product effectiveness, safety, and value. Aaron joined... Read More →
    DH

    Dana Hosseini

    CBO & Co-Founder, Seqster, United States
    Dana Hosseini is the Chief Business Officer and Co-Founder of Seqster. Dana is a seasoned executive with decades of experience in the life sciences and CRO space and also as a serial entrepreneur having managed and co-founded a number of genomics-based companies including ProdermIQ... Read More →
    avatar for UBC

    UBC

    United BioSource Corporation, United States


    Tuesday June 21, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:10pm CDT

    #260 IT : Appian Innovation Theater: Shape the clinical trials journey by bringing people, process and data together on a unified platform
    Component Type: Session

    Learn how Appian partners with customers to streamline and reduce cycle time of the startup phase of clinical trials. Various factors are responsible for the delay of the startup phase of clinical trials, and understanding the impact of each element allows for optimization and faster execution.

    Join Appian to learn how users have leveraged new technologies and proven cloud-based solutions to manage successful trials with record-breaking cycle time.

    Chair

    Appian

    Speaker

    Speaker
    Paul Bidez



    Speakers
    avatar for Appian

    Appian

    United States
    PB

    Paul Bidez

    Industry Vice President, Life Sciences, Manufacturing & Automotive, Appian, United States


    Tuesday June 21, 2022 3:10pm - 3:40pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:30pm CDT

    #261 CH: How Drug Development Will Change Post-COVID
    Component Type: Workshop
    Level: Intermediate

    The COVID-19 pandemic forced everyone to think and work differently. The good news is that many changes, independent of COVID, should become new standards for the way drug development is planned and executed. This Content Hub will discuss some of the areas that will become future paradigms for drug development. New ‘normal’ trends include: • Study Design • Decentralized Trial Solutions • Patient Centricity • Risk Management • Remote Monitoring • Trial Timelines Examples under each of these trends will be discuss.

    Learning Objectives

    Describe how COVID-19 changed existing drug development practices; Identify areas of change within your environment; Apply these changes as new standards for drug development.

    Chair

    Mark Kryah, PMP

    Speaker

    Facilitator
    Teresa Lamantia, MSN, RN



    Speakers
    avatar for Mark Kryah

    Mark Kryah

    Executive Director/Program Team Leader, United States
    Mark Kryah is an Executive Director at Ultragenyx Pharmaceutical, leading rare disease development programs. He has been leading global development projects for 20+ years, with extensive international and partnership experience. Mark has been involved with DIA for over 15 years, contributing... Read More →
    avatar for Teresa Lamantia

    Teresa Lamantia

    Senior Vice President, Operational Transformation & Performance, IQVIA, United States
    Teresa Lamantia is Sr. Vice President, Operational Transformation and Performance at IQVIA, the world’s largest CRO and healthcare data science company. In this role she oversees the metrics and reporting team as well as the lifecycle transition management team for research and... Read More →


    Tuesday June 21, 2022 3:30pm - 4:00pm CDT
    Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:30pm CDT

    #262 CH: Mentoring 101
    Component Type: Workshop
    Level: Basic

    Mentoring experts will discuss key relationships that can influence the trajectory of your career. Your relationships with your network, coach, mentor and sponsor will be explored. A provided tool will be used to manage these relationships.

    Learning Objectives

    Differentiate a network, coach, mentor and sponsor; Discuss how using a provided tool, define their plan for managing their career relationships.

    Chair

    Leslie Sam

    Speaker

    Mentoring Update
    Tywnia Brewton



    Speakers
    avatar for Tywnia Brewton

    Tywnia Brewton

    Sr. Director, Human Resources, Astellas, United States
    Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
    avatar for Leslie Sam

    Leslie Sam

    President, Leslie Sam and Associates, United States
    With 25 years+ of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →


    Tuesday June 21, 2022 3:30pm - 4:00pm CDT
    Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #263 IT: Certara Innovation Theater: Optimizing Patient Narrative Technology - Automating the Complicated and Creating Efficiency
    Component Type: Session

    Narratives are a key component of clinical study reporting. To present a concise & medically relevant patient story, writers must analyze large volumes of data for patients. Implementing technology will ensure quality, consistency, and decreased turn-around times. We will discuss the automated approach to work through complex sources to produce streamlined narratives for submission. Greater efficiencies will empower writers to focus on critical thinking, a quality which remains unique to humans.

    Chair

    Certara

    Speaker

    Speaker
    Reema Selva Raju



    Speakers
    avatar for Certara

    Certara

    United States
    avatar for Reema Selva Raju

    Reema Selva Raju

    Safety Project Manager, Certara Synchrogenix, United States
    Reema SelvaRaju has more than 12 years of regulatory writing and project management experience in the pharmaceutical industry. Specialties include writing, auditing & project management. As the Safety Project Manager, Reema works closely with Sponsors to identify project requirements... Read More →


    Tuesday June 21, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #264 IT: Veeva Innovation Theater: Defining Digital Trials to Operationalize Decentralized Trials
    Component Type: Session

    Defining a clear strategy for digital trials requires clear and precise definitions, covering what, where, and how for digital trials. In this interactive “DTRA Clubhouse Live” session, our presenters will debate with each other and the audience three key questions:

  • What does DCT mean?
  • What does the implementation of DCT entail?
  • What are the expected outcomes of DCT?
  • The discussion includes what it means to “go digital” when managing clinical data in a decentralized trial.

    Chair

    Veeva Systems, Inc.

    Speaker

    Speaker
    Richard Young

    Speaker
    Craig H Lipset, MPH

    Speaker
    Saran Kukreja



    Speakers
    avatar for Veeva Systems, Inc.

    Veeva Systems, Inc.

    United States
    Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →
    avatar for Richard Young

    Richard Young

    Vice President, Vault CDMS Strategy, Veeva Systems, United Kingdom
    As a veteran of almost 25-years in life sciences, Richard has held multiple operational roles in Pharma and CRO organisations, such as GlaxoWellcome, Novo Nordisk, Chiltern and Parexel, before moving into eClinical Solutions, with Cmed and Medidata. Today, Richard brings Veeva customers... Read More →
    avatar for Saran Kukreja

    Saran Kukreja

    Senior Director, Business Engagement & Technology, Vertex Pharmaceuticals, United States
    Saran Kukreja has over 25 years of leadership and business strategy experience and has built a strong portfolio of success in strategic information management, data analytics, white-space management, smart sourcing, new product development, project management, and total quality management... Read More →
    avatar for Craig Lipset

    Craig Lipset

    Co-Chair, Decentralized Trials & Research Alliance (DTRA), United States
    Craig Lipset is Founder and Managing Partner of Clinical Innovation Partners, a growth advisory practice for clinical trial innovation. He is Co-Chair of the Decentralized Trials & Research Alliance, Assistant Professor of Health Informatics at Rutgers University, and adjunct faculty... Read More →


    Tuesday June 21, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #2 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    3:50pm CDT

    #265 IT: M-Files Innovation Theater: Does your Document Management System Support your Growth Trajectory? A Charles River Labs Story
    Component Type: Session

    Charles River was at a technology crossroads and needed an upgraded document management solution to support their growth trajectory. They were seeking a solution that would drive consistency and efficiency organization-wide and integrate seamlessly with current systems. Most importantly, it had to support faster delivery of client reports with minimal operational impact. M-Files outperformed the competition in CRL's calculations on time savings for priority tasks and overall cost savings.

    Chair

    M-Files

    Speaker

    Speaker
    Dennis Street

    Speaker
    Jenith Charpentier



    Speakers
    avatar for M-Files

    M-Files

    United States
    avatar for Dennis Street

    Dennis Street

    Principal Customer Success Manager, M-Files, United States
    Dennis Street has been working with M-Files for almost 8 years, always focused on growing relationships with clients to determine how they can get the most from their M-Files solution. Working with Charles River, Dennis has a solid understanding of the unique objectives and challenges... Read More →
    avatar for Jenith Charpentier

    Jenith Charpentier

    Senior Director of Data Enablement and Report Delivery Services, Charles River Laboratories, United States
    Jenith Charpentier, Senior Director of Data Enablement and Report Delivery Services at Charles River Laboratories, has made vast contributions to the success of the Report Services group. Her ability to take poorly organized and diverse documents and re-present them as clearly written... Read More →


    Tuesday June 21, 2022 3:50pm - 4:20pm CDT
    Exhibit Hall Theater #3 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    4:15pm CDT

    Poster Showcase Session
    Component Type: Session

    Hear our student travel award winners share their research in this engaging oral poster presentation session.


    Tuesday June 21, 2022 4:15pm - 4:45pm CDT
    Room 471 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      17: Networking Opportunities, Session

    4:15pm CDT

    #267: Improving Safety Data Through Innovative Use of Technology
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-22-580-L04-P ; CME 1.00; RN 1.00

    The speakers will aim to share their experience as a case study on how multitenant hosted solutions in PV: enable a standardized approach for Adverse Event and Signal Management processes for all products and compounds across all markets globally, leverage automation and other innovative capabilities that deliver efficiencies in case processing, and encourage a philosophy of using industry standard practices to align and improve overall process, based on input from multiple pharma companies and health authorities, ultimately influencing them rolling forward.

    Learning Objectives

    Discuss current-state applications of artificial intelligence (AI) and cloud applications in pharmacovigilance; Describe current and future opportunities and limitations of the use of AI and toxicogenomics in patient safety; Assess the changing regulatory environment.

    Chair

    Sameen Desai, MBA, MS

    Speaker

    Moderator
    Jeremy Jokinen, PhD, MS

    Safety Lessons for Pharmaceuticals from Other Industries
    Alan M Hochberg

    FDA Update
    Keith K. Burkhart, MD

    Industry Update
    Seth Krevat, MD, FACP

    Cloud-Based System for Pharmacovigilance: A Case Study
    Eileen Leonard, PharmD



    Speakers
    KB

    Keith Burkhart

    Senior Advisor for Medical Toxicology, DARS, OCP, OTS, FDA, United States
    Dr. Burkhart received his medical toxicology training at the Rocky Mountain Poison Center in Denver. He received his Emergency Medicine training at the University of Cincinnati. He is the former Medical Director of the Penn State Poison Center. Clinical care has been provided at the... Read More →
    avatar for Sameen Desai

    Sameen Desai

    Executive Director, IT Worldwide Patient Safety, Bristol-Myers Squibb Company, United States
    avatar for Alan Hochberg

    Alan Hochberg

    Principal Scientific Enablement Director, F. Hoffmann-La Roche, Switzerland
    Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engineering... Read More →
    avatar for Jeremy Jokinen

    Jeremy Jokinen

    Vice President and Head, Global Risk Management & International Patient Safety, Bristol-Myers Squibb Company, United States
    Jeremy is the Vice President and Head, Global Risk Management and International Patient Safety at Bristol Myers Squibb. In this role, he leads a global team of risk management and safety science leaders responsible for insights, evidence generation, and risk minimization efforts ensuring... Read More →
    SK

    Seth Krevat

    Senior Medical Director and Assistant Vice President, Medstar Health, United States
    Dr. Krevat practices palliative care at MedStar Georgetown University Hospital, is the senior medical director at MedStar Health National Center for Human Factors in Healthcare and is an assistant professor of clinical medicine at Georgetown University School of Medicine. Dr. Krevat... Read More →
    EL

    Eileen Leonard

    Vice President, Worldwide Patient Safety, Bristol-Myers Squibb Company, United States
    Eileen is Vice President of Global Safety Operations in Worldwide Patient Safety at Bristol-Myers Squibb. Prior to joining BMS in 2007, Eileen spent over nine years in the CRO industry managing outsourced safety services and over 12 years in clinical practice in both academic and... Read More →


    Tuesday June 21, 2022 4:15pm - 5:15pm CDT
    Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Forum

    4:15pm CDT

    #266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-579-L04-P ; CME 1.00; RN 1.00

    This forum will discuss how FDA, industry, and academia engage in generic drug safety evaluations; provides new options for REMS; and pilots use of emerging tools and technologies to monitor and ensure generic drug safety and substitutability.

    Learning Objectives

    Review how pharmacovigilance (through FDA, industry and academic perspectives) ensures the continued safety and therapeutic equivalence of generic drugs; Describe options for risk evaluation and mitigation strategies for generic drugs; Explore use of data analytic tools/technologies that ensure continued safety and therapeutic equivalence of generic drugs.

    Chair

    Howard Chazin, MD, MBA

    Speaker

    Moderator: Industry Perspective
    Jamie Wilkins, PharmD

    FDA's Perspective
    Howard Chazin, MD, MBA

    Academic Perspective
    Joseph Ross, MD, MHS



    Speakers
    avatar for Howard Chazin

    Howard Chazin

    Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER, FDA, United States
    Dr. Chazin joined FDA in 2002 and has held several leadership positions related to clinical policy and safety of new drugs, biologics and generics. He is the Director of the Division of Clinical Safety and Surveillance in the Office of Generic Drugs' Office of Safety and Clinical... Read More →
    avatar for Joseph Ross

    Joseph Ross

    Professor of Medicine and Public Health, Yale University School of Medicine, United States
    Joseph S. Ross, MD, MHS, is a Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management) at the Yale School of Medicine, an Associate Physician of the Center for Outcomes Research and Evaluation at Yale-New Haven Health System, and Co-Director of... Read More →
    avatar for Jamie Wilkins

    Jamie Wilkins

    Senior Director, Head - Risk Management Center of Excellence-Worldwide Safety, Pfizer Inc, United States
    Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →


    Tuesday June 21, 2022 4:15pm - 5:15pm CDT
    Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      01: ClinSafety-PV, Forum |   09: Regulatory, Forum

    4:15pm CDT

    #268: Life Science Research Innovation Powered by Real-World Data
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Application UAN: 0286-0000-22-581-L04-P ; CME 1.00; RN 1.00

    Real-world data (RWD) is increasingly easier to access, regulators are supportive of its use to improve drug development and success stories are being published at an ever expanding pace. This session will both provide an update as to where external control arms are in the respective life and hype cycles of adoption and provide a lens into the future of computer modeling leveraging RWD. This session includes case studies and learnings from ECA/In Silico implementations and will address if there is any future in classic randomized clinical trial (RCT) designs.

    Learning Objectives

    Describe how life science drug development is changing because of innovation powered by RWD; Apply novel biosimulation in the development new molecular entities and associated safety and risk mitigation strategies including expanded indications; Discuss the hype around ECAs/SCAs and where they best fit.

    Chair

    Keith Wenzel

    Speaker

    The Hype Cycle of Synthetic, External Control Arms and a Lens into the Future of Randomized Controlled Trials
    Manish Khatri

    Novel In Silico Clinical Trial for NME, SrLC, REMS, and Expanded Approval of Marketed Products
    Jeffrey Difrancesco, MBA, MSc



    Speakers
    JD

    Jeffrey Difrancesco

    Executive Vice President and Chief Life Science Officer, Tabula Rasa Healthcare Inc, United States
    Jeffrey DiFrancesco, M.Eng, M.Sci., SSMBB, is the Executive Vice President and Chief Life Science Officer at Tabula Rasa HealthCare in Moorestown, N.J. With over thirty-five years of technology, healthcare, and life science experience, Mr. DiFrancesco specializes in commercializing... Read More →
    avatar for Manish Khatri

    Manish Khatri

    Director, Scientific Lead - data42, Global Drug Development, Novartis, Switzerland
    Manish has focused his career with laser focus on making the science of medicines data driven. He has expertise in integrating data & technology with pharmaceutical R&D. His career spans CRO industry and R&D analytics consulting companies both in traditional clinical development and... Read More →
    avatar for Keith Wenzel

    Keith Wenzel

    Senior Director, Scientific Data Organization, Parexel International, United States
    Mr. Wenzel has worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working... Read More →


    Tuesday June 21, 2022 4:15pm - 5:15pm CDT
    Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      02: ClinTrials -ClinOps, Session |   03: Data-Tech in Clinical Trials, Session
    • Level Advanced
    • Featured Topics RWD-RWE
    • Level Advanced
    • Feature Topics RWD-RWE
    • Credit Type ACPE, CME, RN
    • Tags Session

    4:15pm CDT

    #269: Strategic Planning in Selecting the Right Countries and Sites for Clinical Trials
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-582-L04-P ; CME 1.00; RN 1.00

    Global clinical trials are a core pillar of many pharmaceutical product development strategies. But, selecting the right countries considering the various attributes of success and regulatory needs is essential. This session will discuss processes for making country inclusion recommendations along with the different factors to consider when deciding on country inclusion or exclusion.

    Learning Objectives

    Describe the critical attributes commonly included in strategic country selection for global trials; Discuss other elements (regulatory, marketing, diversity and inclusion) should be considered; Identify common data sources used to make country inclusion decisions; Discuss future areas for exploration, including use of real-world data.

    Chair

    Earl Seltzer, MBA

    Speaker

    Strategic Global Feasibility Considerations: Past, Present, Future
    Stathis Stathelos, MPharm, MSc, PMP

    Moving Data-Enabled Strategy to Execution: Innovative Pathways to Success
    Nicole Turner, MBA

    Integration of Real-World Claims Data to Inform Strategic Decisions for Trial Planning
    Jeff Fairbairn, MBA

    Aggregating Disparate Data Sources to Develop a Well Rounded Trial Strategy
    Jason Gagner, MBA, MS



    Speakers
    avatar for Jeff Fairbairn

    Jeff Fairbairn

    Vice President, Account Strategy, Komodo Health, United States
    Mr. Fairbairn is an AVP, Account Strategy at Komodo Health, where he helps sponsors and CROs optimize site selection and accelerate patient recruitment using Komodo's unrivaled data. Prior to Komodo, Jeff had operational roles at Decision Resources Group (2 years) and Parexel (10... Read More →
    JG

    Jason Gagner

    Director, Data Services, Parexel, United States
    As a Director in the Scientific Data Organization (SDO) at Parexel, Jason is responsible for the oversight and management of scientific data solution development, scientific data project start-up within the Americas, and global real world data strategies. Jason is the lead contact... Read More →
    avatar for Earl Seltzer

    Earl Seltzer

    Senior Director, Global Feasibility, Labcorp Drug Development, United States
    Earl Seltzer has over 17 years of industry experience shared across clinical investigator sites in the United States and working at CROs in the strategic planning and feasibility space. At Labcorp, Mr Seltzer leads the global feasibility team as part of the larger, feasibility recruitment... Read More →
    avatar for Stathis Stathelos

    Stathis Stathelos

    Director, Strategic Feasibility and Analytics - Oncology Team Lead, AstraZeneca, United Kingdom
    A highly motivated professional in Global Pharmaceutical Development with clinical Pharmacist background. I have more than 16 years of experience in the pharmaceutical industry across several roles in CROs, Biotech and Pharma. Having started my career in clinical trial operations... Read More →
    avatar for Nicole Turner

    Nicole Turner

    Director, Oncology Data Science Portfolio Management, Global Development, Janssen R&D, LLC, United States
    Nicole is responsible for leading and executing the Data Science strategy for clinical trial feasibility and analytical process optimization at Janssen. Prior to this role, Nicole served as the Immunology Global Therapeutic Area Head in the Feasibility Center of Excellence. Prior... Read More →


    Tuesday June 21, 2022 4:15pm - 5:15pm CDT
    Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

    4:15pm CDT

    #270: Recommendations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-583-L04-P ; CME 1.00; RN 1.00

    This session provides insight into key success factors for implementing BYOD studies that incorporate personal digital health technologies. We will discuss early identification and stakeholder engagement, study design including informed consent and recruitment strategies, outcomes, endpoints, and technology selection, data management and statistical considerations to meet regulatory requirements.

    Learning Objectives

    Describe key success factors for implementing BYOD studies that incorporate personal digital health technologies; Discuss early identification and stakeholder engagement, study design including informed consent and recruitment strategies, outcomes, endpoints, and technology selection, data management and statistical considerations to meet regulatory requirements.

    Chair

    Marie Mc Carthy, MBA, MSc

    Speaker

    Industry Update
    Elena Izmailova, PhD

    Considerations for Successful Deployment of Bring Your Own Device (BYOD) Approach in Clinical Studies
    Charmaine Demanuele, PhD



    Speakers
    MM

    Marie Mc Carthy

    Digital Endpoint Lead, Novartis, Ireland
    With over 12 years’ experience supporting the use of digital health technologies in drug development studies and clinical research. I have spent these years not only evangelizing the value and benefit of digital endpoints derived from digital health technologies but also supporting... Read More →
    avatar for Charmaine Demanuele

    Charmaine Demanuele

    Senior Director, Head of Digital Medicine & Translational Imaging Statistics, Pfizer Inc, United States
    Dr. Charmaine Demanuele is Senior Director, Head of Digital Medicine and Translational Imaging Statistics, Worldwide Research, Development and Medical at Pfizer. Charmaine received her first degree in Electrical Engineering from the University of Malta, and her Ph.D. in Neuroscience... Read More →
    avatar for Elena Izmailova

    Elena Izmailova

    Chief Scientific Officer, Koneksa, United States
    Elena Izmailova, PhD (Chief Scientific Officer) leads scientific strategy and partnerships at Koneksa Health Inc with over 25 years of experience in academic and industry research. Her academic appointments include Harvard Medical School and MIT. She is a co-founder of the Digital... Read More →


    Tuesday June 21, 2022 4:15pm - 5:15pm CDT
    Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Session |   02: ClinTrials -ClinOps, Session
    • Level Advanced
    • Featured Topics Digital
    • Level Advanced
    • Feature Topics Digital
    • Credit Type ACPE, CME, RN
    • Tags Session

    4:15pm CDT

    #271: Building the First Cloud-Based Submission Review Collaboration Platform
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-584-L04-P ; CME 1.00; RN 1.00

    This forum will discuss a highly secure cloud-based data exchange platform between biopharma companies and global health regulators enabling new ways of collaborations between HA’s (Orbis, ACCESS) by leveraging the most advanced cloud technologies.

    Learning Objectives

    Define how new and innovative cloud-based technology solutions can transform sponsor-HA data flow and HA to HA collaboration, introducing new ways of working to reduce regulatory review times; Discuss how this cloud platform performs in partnership with HA’s and industry will facilitate real-time, simultaneous, and global submissions, reviews, and assessments of therapies.

    Chair

    Dominique Lagrave, PharmD

    Speaker

    Development of a Cross-Industry Collaboration and Cross-Functional Integration of a Data Exchange Platform
    Dominique Lagrave, PharmD

    Agency Update
    Jesper Kjær, MS

    Industry Update
    Louise Gill, PhD



    Speakers
    avatar for Louise Gill

    Louise Gill

    Vice President, Regulatory Policy, Global Regulatory Affairs, GlaxoSmithKline Ltd, United Kingdom
    Louise Gill is VP, Regulatory Policy at GlaxoSmithKline. She leads the regulatory policy and intelligence organisation accountable for defining and driving the global regulatory policy topics. Louise also co-leads the Accumulus Synergy Europe team. Louise has worked in the pharmaceutical... Read More →
    avatar for Jesper Kjær

    Jesper Kjær

    Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre, Danish Medicines Agency (DKMA), Denmark
    Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past... Read More →
    avatar for Dominique Lagrave

    Dominique Lagrave

    Vice President of Regulatory Innovation, Accumulus Synergy, United States
    Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel, Dendreon and TCS. Dominique joined Amgen in 2015 as the... Read More →


    Tuesday June 21, 2022 4:15pm - 5:15pm CDT
    Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
      03: Data-Tech in Clinical Trials, Session |   09: Regulatory, Session |   01: ClinSafety-PV, Session

    4:15pm CDT

    #272: Fit-for-Purpose Patient Preference Studies: Emerging Recommendations from IMI PREFER
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-585-L04-P ; CME 1.00; RN 1.00

    This session provides a fit-for-purpose approach to developing preference studies, informed by emerging PREFER recommendations and select case studies. Examples from case studies highlight lessons learned by those involved in preference research, including how decision-makers and patient research partners were involved.

    Learning Objectives

    Identify content of emerging PREFER recommendations on patient preference studies; Demonstrate application of select emerging best practice for design and conduct of preference studies; Discuss importance of involving stakeholders in patient preference studies.

    Chair

    Kristin Bullok, PhD

    Speaker

    PREFER Recommendations on Patient Preference Studies
    Kristin Bullok, PhD

    Practical Applications of Preference Study Design and Conduct
    Carol Mansfield, PhD

    Regulatory Perspective
    Laura Lee Johnson, PhD



    Speakers
    avatar for Kristin Bullok

    Kristin Bullok

    Benefit-Risk Management Scientist, Global Patient Safety, Eli Lilly and Company, United States
    Kristin Bullok, PhD, is a research scientist in benefit-risk management at Eli Lilly and Company, Global Patient Safety. Since joining Lilly, she has years of combined experience in conducting structured benefit-risk assessments, consulting on patient preference trade-off studies... Read More →
    avatar for Laura Lee Johnson

    Laura Lee Johnson

    Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
    Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
    avatar for Carol Mansfield

    Carol Mansfield

    Senior Economist and Head, Health Preference Assessment, RTI Health Solutions, United States
    Carol Mansfield, PhD, is a Senior Economist and Head in the Health Preference Asse