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Monday, June 12
 

9:30am CDT

11A: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use
Component Type: Tutorial

Pre-registration required and is an additional fee.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, but the approaches described here are useful for health technology assessments for payers. Following the major points from recently released guidance documents from around the world, 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 when real-world studies will be sufficient to meet regulatory evidence requirements.

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


Monday June 12, 2023 9:30am - 12:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09 - Regulatory, Tutorial |   20 - Short Courses, Tutorial

1:00pm CDT

12P: Understanding the Bayesian Approach in Decision Making for Anyone Involved in Clinical Trial Design or Interpretation
Component Type: Tutorial

Pre-registration required and is an additional fee. This short course will introduce common basic concepts in Bayesian approaches through graphical illustrations and examples in non-statistical language for anyone involved in clinical trials or research studies. Group activities and polls will be designed for interactive learning throughout the course.

Who should attend?

Professionals involved in or interested in clinical trial design, conduct, data collections and analysis, or results interpretation, who is interested in Bayesian approaches. There is no prior knowledge of statistics required. Basic knowledge of clinical trial and clinical development will be helpful but not necessary.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Compare the differences between frequentist and Bayesian methods along with their roles in clinical trial designs and analyses
  • Identify the appropriate methods for the trial objectives
  • Evaluate the strengths and limitations of the study results
  • Interpret Bayesian results in plain language


Monday June 12, 2023 1:00pm - 4:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11 - Statistics, Tutorial |   20 - Short Courses, Tutorial
 
Tuesday, June 13
 

9:30am CDT

21A: Signal Management in Pharmacovigilance
Component Type: Tutorial

Pre-registration required and is an additional fee.This short course covers all aspects of the Signal Management process. The course is sub-divided into three modules:
  1. The first module discusses the Importance of robust and efficient Signal Management, and the Signal Detection step: we discuss definitions, applicable regulations, methodologies, quantitative v. qualitative techniques, and common datasets reviewed.
  2. The second module covers Signal Validation where the validation process, relevance, and possible conclusions shall be elaborated.
  3. Next, we discuss the Signal Assessment process in detail, in the third and final module. We start with the various data-sources that can be evaluated and their relative importance, explain the formulation of the search strategy, and finally outline the key aspects of case assessment and literature summarization. We cover the basic structure of the Signal Assessment Report and discuss the importance of using multiple data sources for a comprehensive signal assessment. We end by touching upon various possible outcomes of the Signal Management process.
We do not aim to have an entirely theoretical discussion on this complex topic: illustrative examples will be described to illustrate how the principles discussed are put into practice. At the end of the course, participants can expect to have a good understanding of Signal management from a theoretical and practical standpoint.

Who should attend?

Drug Safety and Clinical Trial professionals with at least a basic understanding of safety signals and who want to better understand the details of the various processes involved, as well as how signal management fits into the bigger picture of Patient Safety. This course would be helpful to individuals who have recently started, or are looking to start, in a Signal Management/Brand Safety role.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Evaluate the importance and relevance of Signal Management in the current Regulatory environment and Patient Centricity
  • Discuss the challenges associated with Management of Safety Signals and provide strategies to overcome these challenges
  • Identify recent advances with AI for Signal Management and future possibilities


Tuesday June 13, 2023 9:30am - 12:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01 - Clinical Safety and Pharmacovigilance, Tutorial |   20 - Short Courses, Tutorial

1:00pm CDT

22P: Global Labeling: The Basics of Core Datasheet
Component Type: Tutorial

Pre-registration required and is an additional fee.This short course will present the basic labeling requirements for global labeling documents. It will cover the concept of the Company Core Data Sheet (CCDS), the impact inside and outside of the company, and how local labeling changes and regulatory requirements may have an impact on CCDS. In addition, we will discuss the consequence for a company of having a CCDS and how that will impact local labeling and labeling departments.

Who should attend?

Professionals working in Labeling, Pharmacovogilance, Regulatory and other departments who want to learn the basics of company labeling specifically the CCDS process to understand the use and impact of a CCDS inside and outside a company.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Demonstrate a basic understanding of concept core labeling
  • Describe the use and impact of core labeling during development
  • Identify the impact of core labeling on local labeling such as US, EU, and Japan Labeling
  • Apply basic knowledge of core labeling implementation and deviations


Tuesday June 13, 2023 1:00pm - 4:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  20 - Short Courses, Tutorial |   09 - Regulatory, Tutorial |   01 - Clinical Safety and Pharmacovigilance, Tutorial
 
Wednesday, June 14
 

9:00am CDT

31A: Introduction to Cell and Gene Therapies: Specific Regulatory, CMC, Non-clinical and Clinical Requirements and Considerations
Component Type: Tutorial

Pre-registration required and is an additional fee.Cell and Gene Therapies (CGTs) are a rapidly expanding area in the pharmaceutical sector, offering the potential to address serious unmet medical needs in many indications. Yet some of the conceptual frameworks in this field differ dramatically from those of traditional pharmaceutical medicines, specifically with regard to CMC, Non-clinical and Clinical requirements and Health Authority expectations. This short course will help those who have pharmaceutical sector experience but are newcomers to the CGT field ‘get into the right frame of mind’ to think about CGT development. The course will outline some of the global regulatory frameworks that have been put in place to specifically address the needs of CGTs. It will then introduce CGT-specific requirements for each of the major disciplines for regulatory submissions: CMC, Non-clinical and Clinical. The course will also explain the rationale behind the CMC approach to CGT manufacture and basic CMC regulatory expectations for CGT products, including process and product characterization, comparability and process validation. Biological mechanisms for CGTs will also be discussed, with a focus on how mechanistic understanding can inform the design of in vitro and animal studies to provide Non-clinical evidence of safety and efficacy. Key principles for clinical development of CGTs will be presented, with an emphasis on clinical study design elements that are critical for Health Authority evaluation of benefit-risk. Expedited development programs and early engagement opportunities for CGTs will also be covered. The presenters include ex-Health Authority Regulators who have a combined 30 years of experience in FDA, EMA, NMPA/CDE.

Who should attend?

Anyone who wants to gain an understanding of the basics of cell and gene therapy development, including Regulatory personnel, Clinical Operations personnel, Researchers and Investigators, Medical Writers, and Commercial Specialists.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Demonstrate why Cell & Gene Therapies (CGT) require a different and very specialized regulatory approach compared to small molecules and biologics
  • Develop knowledge of CGT-specific considerations and requirements for CMC, Non-Clinical, and Clinical development
  • Recognize important Regulatory considerations for domestic and global CGT development programs


Wednesday June 14, 2023 9:00am - 12:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09 - Regulatory, Tutorial |   06 - Translational Sciences and Precision Medicine, Tutorial |   20 - Short Courses, Tutorial

1:00pm CDT

32P: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials
Component Type: Tutorial

Preregistration required and is an additional fee.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 short course, 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. Group activities and slide-based learning will be used to introduce commonly used statistical concepts that are used in the analysis of clinical trials in a simple, easy to understand manner for anyone involved in clinical trials.

Who should attend?

Professionals involved in or interested in clinical trials who wants to understand how to interpret the results of common statistical analyses and have more effective communications with their statistical team members.

Learning Objectives

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


Wednesday June 14, 2023 1:00pm - 4:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11 - Statistics, Tutorial |   20 - Short Courses, Tutorial
 
Monday, June 26
 

10:45am CDT

Artificial Intelligence: Delivering on the Promise
Component Type: Session
Level: Intermediate

Three real-world examples will illustrate the benefits of artificial intelligence in pharmacovigilance data handling. The examples will include triage of COVID-19 vaccine adverse events, automated analysis of case narratives, and results of work from the TransCelerate initiative.

Learning Objectives

to be updated

Chair

Greg Ball, PhD

Speaker

Employing AI to Automate Omni-Channel Triage of Safety and Quality Events Leveraging an AI “Funnel”
Jane Carroll, BSN, MS, RN

Evaluating Safety Compliance in Clinical Trials Leveraging Patient Narratives and Deep Learning
Sherrine Eid, MPH

Using Benchmark Data to Identify Intelligent Automation Implementation and Opportunity Trends Within the ICSR Process
Neal Grabowski, MBA, MS


Speakers
avatar for Greg Ball

Greg Ball

Owner and Consultant, ASAP Process Consulting, 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 Jane Carroll

Jane Carroll

Vice President, Medical Operations, Moderna, United States
Jane Carroll is the interim Head of Global Patient Safety Regions since February 25, 2019 and Head of Global Patient Safety Region Americas for the Biopharma business of Merck KGaA Darmstadt, Germany since 2015. Jane is responsible to ensure a robust system to collect and report adverse... Read More →
avatar for Sherrine Eid

Sherrine Eid

Global Head, RWE, Epidemiology and Observational Research, SAS Institute, 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 →
NG

Neal Grabowski

TransCelerate Lead; Head, Signal Management, Sanofi, United States
Prior to joining AbbVie, Neal held multiple roles in Patient Safety and Clinical Operations at Amgen, Genzyme and Sanofi. He holds a MS in biomedical engineering and MBA from Pepperdine University.

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

10:45am CDT

Risk-Based Monitoring in Clinical Trials: A Four Year Analysis
Component Type: Forum
Level: Intermediate

The popular panel is back this year to report out on a 4-year analysis conducted on over 5,000 clinical trials. We looked at the study-level and surveyed how risk-based and quality-by-design approaches are being adopted across the industry. The panel will report out on our landscape data findings, discuss the implications for clinical trial operations, and lay out the trends that indicate how industry is adopting risk-based strategies. We will take questions from the audience and engage in a discussion about how to implement these risk-based and quality-by-design strategies, and why you should.

Learning Objectives

Describe how risk-based approaches are being used in the industry, and how adoption shifted during the COVID pandemic and afterwards; 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

Anina Adelfio

Speaker

An Industry Clinical Trialist Executive Becomes the Diagnosed Patient Volunteer: What has been Learned Thus Far?
Peter A. DiBiaso, MHA


Speakers
AA

Anina Adelfio

Vice President, Industry Relations, Association of Clinical Research Organizations (ACRO), United States
avatar for Peter DiBiaso

Peter DiBiaso

Senior Vice President, Clinical Solutions and Strategic Partnerships, WCG, United States
Peter us a clinical development professional with a strategic focus in leading global operations that support the optimization of bio-pharmaceutical research and investigator relationships. In a series of progressive roles for Quintiles, he currently serve as the Global Vice President... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

10:45am CDT

Sponsor-CRO Collaborations and the Impact of Decentralized Clinical Trials
Component Type: Forum
Level: Intermediate

The session will examine how approaches to decentralized trials disrupt sponsor-CRO collaborations including evaluating oversight and performance. Organizations are re-assessing their relationships in terms of costs, structure, and effectiveness.

Learning Objectives

Identify the decentralized clinical trial technologies and solutions that are most effectively implemented by biopharmaceutical companies and contract research organizations; Describe the key performance indicators used to evaluate sponsor-CRO relationship effectiveness in implementing decentralized and hybrid clinical trials.

Chair

Mary Jo Lamberti, PhD, MA

Speakers
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She is a global expert on benchmarking drug development operating practices. Her research focuses on a variety of areas including... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

10:45am CDT

Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation
Component Type: Forum
Level: Intermediate

This session explores the challenges and lessons-learned from multi-year aspirational clinical trial digital transformation initiative.

Learning Objectives

Discuss considerations prior to embarking on a major digital transformation initiative in clinical development; Describe the significance of effective change management practices and the follow-through; Assess the pros and cons of the Agile development framework with complex initiatives.

Chair

Nareen Katta, MBA, MS

Speakers
avatar for Nareen Katta

Nareen Katta

Head of Data Science & Analytics, AbbVie, United States
Nareen Katta works as the Head of Data Science and Analytics at AbbVie. Nareen has over 20 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the advanced analytics strategy, that covers both Scientific and Business... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum

10:45am CDT

What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development?
Component Type: Forum
Level: Intermediate

The forum will present a multi-stakeholder discussion on the future of patient-focused medical product development. Experts will discuss existing barriers, upcoming efforts, and where they see the field going in the next five to 10 years.

Learning Objectives

Discuss how patient-focused medical product development should advance in the coming years; Identify existing barriers to advancing patient engagement and patient-focused medical product development; Describe upcoming patient-focused efforts.

Chair

Pujita Vaidya, MPH

Speakers
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 (e.g., Patient Centricity, Pediatrics, and Innovative Trials). Her work includes partnering with cross-functional colleagues... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Forum

10:45am CDT

New Alternative Methods-Only IND Application: Distant Dream or Immediate Possibility?
Component Type: Session
Level: Intermediate

This session will discuss practical experiences developing IND applications with new alternative methods (NAMs). Panelists will share a potential framework identifying different categories of modalities and indications where NAMs could be leveraged.

Learning Objectives

Discuss potential framework and strategies to leverage new alternative methods (NAMs) in IND applications; Share successful case studies; Identify gaps and opportunities to advance the use of NAMs for drug development.

Chair

Imein Bousnina, PharmD, MSc

Speakers
avatar for Imein Bousnina

Imein Bousnina

Program Director, US Regulatory Policy, Product Development Regulatory, Genentech, A Member of the Roche Group, United States
Imein Bousnina, Pharm.D, is a Program Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Imein trained as a pharmacist and holds an MSc in International Regulatory Affairs. Over her seven years at Roche-Genentech, she has specialized in FDA's regulation... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: TranslationalScience-PrecisionMedicine, Session

10:45am CDT

ICH E6 R3 Forum: Highlights of What's new and What Changed Regarding Sponsor Responsibilities
Component Type: Forum
Level: Intermediate

This is a placeholder for discussing ICH E6 R3 that we assume will be released before June 2023.

Speakers
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA, United States
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Forum

10:45am CDT

Cell and Gene Therapies Pulse Check
Component Type: Session
Level: Intermediate

In this session we will review the cell and gene therapy landscape and priorities of major countries/regions and consider the possibility of global regulatory convergence and its potential impact.

Learning Objectives

Discuss convergence efforts that will help bring efficiencies to help bring therapies sooner to patients around the world

Chair

Chin Koerner, MS

Speakers
CK

Chin Koerner

Executive Director, Development and Regulatory Policy, Novartis Pharmaceuticals Corporation, United States
Chin Koerner is Executive Director of Regulatory Policy for Novartis Pharmaceuticals. Chin's has over 20 years of experience in Drug Development spanning from basic research to post approval. Prior to joining Novartis, Chin spent a number of years at the FDA and other small and large... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

10:45am CDT

Diversity and Inclusion Implications for Global Regulatory
Component Type: Session
Level: Intermediate

Adequate enrollment of underrepresented groups continues to be a challenge in a complex drug regulatory ecosystem, compounded by varying expectations for framing these in regulatory filings. Discuss best practices and opportunities for convergence.

Learning Objectives

Describe FDA guidance and proposed law, including diversity plans; Compare US to other regions/ international on how to define and drive adequate diversity in clinical research (e.g., FDA guidance vs ICH E17); Highlight existing methods to describe outcomes, and limitations (e.g. DT Snapshots); Describe complexities in collecting, assessing, and reporting diversity and inclusion (e.g. terms/ practices used).

Chair

Alexis Miller, JD

Speakers
avatar for Alexis Miller

Alexis Miller

US Lead, Global Regulatory Policy, Merck Sharp & Dohme LLC , United States
Alexis Reisin Miller leads the US Regulatory Policy group at Merck & Co., Inc., where she and her team help to shape the regulatory and policy environment on topics like expedited regulatory pathways, innovative approaches to trial design, embedding diversity and inclusion and patient... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

10:45am CDT

E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards in Clinical Trials and NDA/BLA Submissions to FDA
Component Type: Session
Level: Intermediate

This session will introduce the importance of addressing Estimands from Protocol to CSRs using the ICHE9R1 guidance and CDISC standards.

Chair

Munish Mehra, PhD, MS, MSc

Speakers
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 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session

10:45am CDT

Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned?
Component Type: Session
Level: Intermediate

Implementation science (IS) measures are increasingly being included in pragmatic trials to understand real world use and uptake of new therapeutics. This session will describe how IS data are being used for evidence generation via two case studies.

Learning Objectives

Describe what implementation science (IS) is, the types of data it provides, and how such data can support evidence-generation plans.

Chair

Meredith Smith, PhD, MPA, FISPE

Speakers
avatar for Meredith Smith

Meredith Smith

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States
Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Session |   01: ClinSafety-PV, Session

10:45am CDT

Negotiating your Next Offer
Component Type: Workshop
Level: Basic

It's important to negotiate a new job offer for you and the company to come to a mutually beneficial agreement. We’ll discuss the process for generating a holistic view of the offer to put you in a better position in order to be able to negotiate.

Learning Objectives

Identify your value in the marketplace and to the organization; Discuss what’s most important to you and your lifestyle; Describe how to assess the offer as a total compensation package; Explore tactical advice on negotiating.

Chair

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 →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  13: ProfDevelopment, Workshop

1:30pm CDT

Enhancing the Quality of Safety Data Collection
Component Type: Session
Level: Intermediate

A key cornerstone of pharmacovigilance is spontaneous reporting, which has largely relied upon traditional approached to data collection. Technology now gives the opportunity to significantly improve the data collected at source, and also how vigilance teams engage with stakeholders. In this session, colleagues from FDA will highlight opportunities arising from their active surveillance program while MHRA will present their vision for future data collection to enhance patient safety.

Chair

Phil Tregunno

Speakers
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over eighteen years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

1:30pm CDT

Can We Further Innovate Clinical Trial Designs? Lessons Learned and Future Opportunities
Component Type: Forum
Level: Intermediate

This forum will present current efforts and future opportunities to advance adoption and implementation of innovative trial designs. A panel of experts will discuss examples and highlight approaches for future exploration.

Learning Objectives

Discuss current progress by key stakeholders in adopting innovative approaches into medical product development; Discuss lessons learned in adopting innovative approaches, especially during the pandemic; Identify opportunities for further enhancing the use of innovative approaches in clinical trial design.

Chair

Pujita Vaidya, MPH

Speakers
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 (e.g., Patient Centricity, Pediatrics, and Innovative Trials). Her work includes partnering with cross-functional colleagues... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

1:30pm CDT

Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance
Component Type: Session
Level: Intermediate

In June '21, FDA issued draft guidance on core PROs in cancer trials. This provides insight into regulatory thinking, and may lead to more future PRO-based labeling. This session explores how the guidance might affect study design and PRO development.

Learning Objectives

Describe the limitations in current measurement strategy for patient-reported outomces in oncology trials; Discuss specificity of measures and its importance in PRO selection; Review how item banks can be used to ensure good measure selection and development.

Chair

Bill Byrom, PhD

Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Intelligence and Positioning, 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 30 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 →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session

1:30pm CDT

Building Trust: Data Privacy in Decentralized Clinical Trials
Component Type: Forum
Level: Intermediate

For the decentralized clinical trial modality to thrive, the data privacy concerns of multiple stakeholder groups must be addressed. This panel of industry luminaries will discuss how technology can continue to bring therapies to market faster while increasing diversity.

Learning Objectives

Identify data privacy concerns from multiple perspectives: patient/participant, sponsor, innovator, technology provider; Explore how to meet all stakeholders’ needs for the sake of diversity, equity and inclusion; Describe how to increase stakeholders’ trust so that the clinical trials community can utilize new technologies such as decentralized clinical trials to bring life changing therapies to market faster.

Chair

Jay Ferro

Speakers
JF

Jay Ferro

EVP, Chief Information, Product, & Technology Officer, Clario, United States

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum

1:30pm CDT

Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

James Francum, MBA, PMP

Speaker

Data Integrity Case Studies and Their Learnings for Enabling a Data-Driven Future
James Francum, MBA, PMP

How Can Digital Health Be Regulated and Still Deliver Needed Innovation?
Dane Stout


Speakers
JF

James Francum

Chief Executive Officer, Gxp-Cc, Germany
avatar for Dane Stout

Dane Stout

Consulting Director, Digital, NNIT, United States

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

1:30pm CDT

Consent is the Oil of Customer Engagement: How to Keep the Omnichannel Engine Running
Component Type: Session
Level: Basic

As organizations strive to provide personalized omnichannel experiences, an increasing amount of customer personal information is being collected across medical affairs engagement channels. The session focuses on the principles of consent management.

Learning Objectives

Articulate the importance of consent management in omnichannel planning; Align consent type with specific medical affairs engagement modalities; Define a practical framework for consent management within the medical affairs function.`

Chair

Sandeep Gantotti

Speakers
avatar for Sandeep Gantotti

Sandeep Gantotti

Associate Vice President, Enterprise Medical Solutions, Indegene Pvt Ltd, India
Sandeep Gantotti is a clinical pharmacist by background and Associate VP, Enterprise Medical at Indegene, Pvt Ltd, a leading multinational healthcare solutions provider. He has held positions of increasing responsibility in medical information, medical communications, and medical... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

1:30pm CDT

Patient Involvement Optimizes Clinical Protocol Design: Real-World Experiences and Insights
Component Type: Forum
Level: Intermediate

Patients affected by a disease are the experts of their lived condition and should have direct input into drug development. An internal, dedicated organizational role will empower patients with necessary decision making authority to lead change. This interactive forum will explore why and how to work with patients as internal subject matter experts to optimize the clinical trial design and participation experience.

Learning Objectives

Describe how FDA patient-focused drug development (PFDD) guidance documents illuminate the need for greater investment in enterprise patient-focused expertise; Identify how patient-lived experiences lend authenticity to protocol designs and to the patient journey in clinical trials; Discuss best practices to engage patient/caregiver perspectives in protocol design.

Chair

Stacy Hurt, MBA, MHA

Speakers
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Patient Advocacy Ambassador, Parexel, United States
Stacy Hurt, MHA, MBA is an award-winning 25 year pharma executive who bridges the industry/consumer gap as a stage IV cancer survivor and 24/7 caregiver to her son with a rare disease. Her unique professional and personal experience position her as an esteemed patient advocate as... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Forum

1:30pm CDT

Contemporary Challenges in Personalized Medicine and Companion Diagnostics
Component Type: Forum
Level: Intermediate

Precision medicine development has changed significantly in recent years, and new legislation exists that dramatically impacts development of these products. This session will outline current challenges in co-development and potential solutions.

Learning Objectives

Explain how use of biomarkers and co-development of drugs and diagnostics has changed over time; Outline the current challenges this presents and a roadmap for modernizing co-development frameworks; Explain how new legislation, specifically the implementation of the In Vitro Diagnostics Regulation in 2022, has had a dramatic impact on clinical trials of personalized medicines in Europe.

Chair

Megan Doyle, JD, MPH

Speakers
avatar for Megan Doyle

Megan Doyle

Global Policy Lead, Digital Health, Diagnostics, Oncology, Amgen, United States
Megan Doyle is an attorney and policy professional with 15 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 health... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: TranslationalScience-PrecisionMedicine, Forum

1:30pm CDT

Unleashing the Fearless Quality Professional
Component Type: Workshop
Level: Intermediate

How can we unleash our inner “Fearless Quality Professional”? This workshop will take a deep dive into the methodology, the value proposition, and application of competency models for quality functions; to maximize talent and mobilize the workforce.

Learning Objectives

Identify how competency models can maximize potential by identifying key success behaviors that will help us to reach the future state of quality in our industry; Develop skills to build a competency model for your organization; Discuss industry perspectives on competencies and apply coaching skills to maximize team potential.

Chair

Kathleen Purcell

Speakers
avatar for Kathleen Purcell

Kathleen Purcell

Head of QA Programs, Genentech, A Member of the Roche Group, Canada
Kathleen Purcell is the Head of Quality Assurance Programs at Roche/Genentech and is interested in transforming the traditional quality assurance mindset to embed industry-leading early quality interventions (QbD) that drive velocity and innovation in clinical trials. Kathleen has... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Workshop

1:30pm CDT

Combating Misinformation with Authoratative Medical Product Information
Component Type: Forum
Level: Basic

Combatting misinformation is a critical goal that many stakeholders can agree we need to address. This session will work through key advantages and challenges on how to achieve this. The panel will walk through efforts to date and what we can do next

Learning Objectives

Discuss how to start the conversation; Describe the key advantages and challenges from different stakeholder perspectives on how to address misinformation.

Chair

Lina AlJuburi, PharmD, MSc

Speakers
LA

Lina AlJuburi

Head, Global Regulatory Science and Policy - North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

1:30pm CDT

Novel Biomarkers and Surrogate Endpoints in a Rare Disease
Component Type: Forum
Level: Intermediate

Panelists will share their experience in utilizing novel biomarkers/ surrogate endpoints and provide lessons learned. The panel will then discuss the future of novel biomarkers and surrogate endpoints

Learning Objectives

Compare different experiences in using novel biomarkers; Identify best methods in using a novel biomarker.

Chair

Adora Ndu, JD, PharmD

Speaker

Rare Disease Endpoint Advancement Pilot Program: Stakeholder Perspectives on Success and Sustainability
Imein Bousnina, PharmD, MSc


Speakers
avatar for Imein Bousnina

Imein Bousnina

Program Director, US Regulatory Policy, Product Development Regulatory, Genentech, A Member of the Roche Group, United States
Imein Bousnina, Pharm.D, is a Program Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Imein trained as a pharmacist and holds an MSc in International Regulatory Affairs. Over her seven years at Roche-Genentech, she has specialized in FDA's regulation... 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 →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

1:30pm CDT

WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening
Component Type: Session
Level: Intermediate

The new WHO Listed Authorities (WLAs) framework offers a transparent system for National Regulatory Authorities (NRA) to decide which NRA they can rely upon. An update will be given by WHO and perspectives from some of the newly designated WLAs will highlight the main principles and expected global benefits of the scheme. Presentations will include a keynote speaker, WLA, and reliance to follow with a panel discussion with a regulatory and industry perspective.

Learning Objectives

Discuss regulatory systems strengthening activities which have a key role to play in terms of helping countries identify and address gaps using the benchmarking tool and build capacity to achieve a more stable maturity level; Describe regional efforts that play an important part for capacity building and reaching harmonization and convergence of regulatory requirements.

Chair

Samvel Azatyan, MD, PhD

Speakers
avatar for Samvel Azatyan

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 20 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

1:30pm CDT

International Collaboration for Pharmaceutical Quality and Manufacturing Agility
Component Type: Forum
Level: Intermediate

Regulatory and industry panelists, representing a global perspective, will discuss international collaboration efforts and opportunities to facilitate agility for manufacturers, enable reliance among regulators, and global submissions.

Learning Objectives

Discuss post-pandemic regulatory innovation and opportunities to support global submissions for pharmaceutical quality, more efficient post-approval changes, and manufacturing agility; Review ongoing international collaboration through ICH, ICMRA, IPRP, and PIC/s; Discuss the instrumental role of ICH topics such as Q12, Q9(R1), Q13, and Q2(R2)/Q14.

Chair

Amanda Marie Roache, MS

Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Forum

1:30pm CDT

Advances in Real-World Evidence: Randomized Clinical Trials Duplicate, Publication Scandal, and China’s Real-World Evidence Heaven
Component Type: Session
Level: Intermediate

We will illustrate some recent and unique progress of real-world evidence (RWE) studies in three directions: scientific research, clinical development and China market access.

Learning Objectives

Describe how multiple COVID-19 real-world evidence (RWE) papers were retracted and how experts have suggested criteria of how journal reviewers should evaluate real-world data (RWD)/RWE manuscripts; Discuss the most recent progress with the project RCT Duplicate as it has reached a milestone; Identify what the RWE heaven is as China has set a testbed for drug and medical device importing in Hainan Island.

Chair

Sheng Feng, PhD

Speakers
avatar for Sheng Feng

Sheng Feng

APAC RWE Head, Corporate Vice Pressident, Parexel, United States
Dr. Feng is trained in the US as a statistician and geneticist. In early years at Duke & Wash U, his research focused on precision medicine & RWE methodology. While working at Biogen & AbbVie, he led data science projects in drug development, from hypothesis generation, to trial design... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session

1:30pm CDT

Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drugs?
Component Type: Session
Level: Advanced

Coverage policies did not significantly differ for drugs approved via confirmatory trials versus those approved via accelerated pathway that also employ surrogate endpoints. This session describes the coverage dynamics of such drugs from 2020-2022.

Learning Objectives

Assess payer coverage trends in Medicare Part D for drugs approved via FDA’s accelerated approved pathway; Compare their coverage policies (tier placement and restrictions) to those that receive approval via FDA’s traditional pathway; Identify and describe the impact of specific surrogate endpoints employed by accelerated approved drugs that receive preferential payer coverage.

Chair

Hersh Vyas, PharmD

Speakers
HV

Hersh Vyas

Pricing and Market Access Associate, Parexel, United States

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Session

4:15pm CDT

Utilizing Wearable Biosensors to Better Manage Patient Safety During Immuno-Oncology Studies
Component Type: Forum
Level: Intermediate

Panelists will describe evidence from immuno-oncology (including CAR-T) and other cell and gene therapy studies on how remote monitoring with wearable sensors and AI-based predictive analytics is enabling better management of patient safety.

Learning Objectives

Explain how inflammation risks can be detected earlier than standard of care utilizing wearable sensors and predictive analytics; Summarize lessons learned from current immuno-oncology (including CAR-T) and other cell and gene therapy studies utilizing this technology; Illustrate how real-world data is optimizing benefit-risk profiles and supporting a shift from efficacy to effectiveness.

Chair

John Varaklis

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Forum

4:15pm CDT

Enabling the Use of Randomized Pragmatic Studies to Generate High Quality Real-World Evidence for Regulatory Decisions
Component Type: Forum
Level: Advanced

This session will discuss key considerations for designing and conducting a randomized pragmatic study to support a license application, including appropriate disease and regulatory settings, data quality, and operational considerations.

Learning Objectives

Identify how randomized pragmatic studies (RPS) differ from traditional clinical studies; Discuss ongoing activities which could facilitate the conduct of such studies; Explore opportunities and challenges offered by randomized pragmatic studies to enable regulatory decision making.

Chair

Gracy G Crane, PhD, MS

Speakers
avatar for Gracy Crane

Gracy Crane

Policy Lead, Roche, United Kingdom
Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

4:15pm CDT

What Patients and Care Partners are Saying about Hybrid and Decentralized Trials
Component Type: Forum
Level: Basic

This forum will reveal the insights gleaned from patients related to both decentralized and hybrid trial designs, and share best practices for conducting co-design sessions and obtaining patient feedback on a protocol.

Learning Objectives

Share patient feedback regarding decentralized clinical trials (DCT) and hybrid trial designs; Describe best practices for obtaining patient feedback on trial design; Outline benefits and challenges of DCT and hybrid designs from a patient perspective.

Chair

Valerie Powell, MS

Speakers
avatar for Valerie Powell

Valerie Powell

Chief Patient Officer, CorEvitas and EVP, Patient Experience, 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 →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

4:15pm CDT

Digital Endpoint Qualifications in Clinical Trials: Collaborations and Applications
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Brooke Casselberry, MS, RAC

Speaker

Driving Toward Global Collaboration in Novel Digital Endpoint Qualification
Lesley Maloney, PharmD

Securing Patients Compliance; Case Study of Risk-Based Quality Management Application in ePRO Primary Endpoint Clinical Trial
Tomasz Foks, MSc


Speakers
avatar for Brooke Casselberry

Brooke Casselberry

Associate Vice President, NNIT, 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 →
TF

Tomasz Foks

Associate Director, Risk-Based Quality Management, Astrazeneca, Poland
Tomasz Foks is Associate Director Risk-Based Quality Management in Centralized Monitoring at AstraZeneca. He has worked in clinical research for ten years, most recently as a certified Risk Manager leading RbQM process in multiple clinical studies in various therapy areas. Tomasz... Read More →
avatar for Lesley Maloney

Lesley Maloney

Director, Regulatory Policy - Digital Health and Integrated Solutions, Genentech, A Member of the Roche Group, United States
Lesley R. Maloney, Pharm.D., is Global Regulatory Policy Lead for Digital Health at Genentech/Roche. She is responsible for shaping the external regulatory environment on integrated and digital solutions, including use of digital health technologies in drug development for digitally-derived... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

4:15pm CDT

The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Wendy Charles, PhD

Speaker

The True Decentralization of Clinical Trials: Demonstrating the Real Implications of Blockchain and Self-Sovereign Identity
Hadil Es-Sbai

Benefits and Drawbacks of Blockchain Technology for Clinical Trial Retention and the Patient Experience
Aman Khera, MBA


Speakers
avatar for Wendy Charles

Wendy Charles

Chief Scientific Officer; Adjunct Faculty, Burstiq; Health Admin Program, CU Denver Business School, 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 Hadil Es-Sbai

Hadil Es-Sbai

Chief Executive Officer, Clinblocks B.V., Netherlands
Hadil has a background of 22+ years in clinical development and assumed several roles within the pharmaceutical and clinical contract research industries. He became an entrepreneur in 2006 and has since combined several functions that are all related to operations and innovation within... Read More →
avatar for Aman Khera

Aman Khera

Vice President, Global Head of Regulatory Strategy, Worldwide Clinical Trials, Canada
Aman Khera has earned her nickname: Rebel Regulator, a drug and device development professional, with over 26 years of experience in life sciences clinical research, advising biotech and pharma companies. With a deep foundation in global regulatory affairs and the life sciences industry... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

4:15pm CDT

Best Practices in Effective Gathering of Medical Information Industry Insights
Component Type: Session
Level: Intermediate

In this session, we will cover sources of industry insights and how to analyze data pertinent to the challenge at hand. We will explore examples of how medical information and contact center benchmarking data can be applied to make business smart decisions, creating a standardized approach to sharing of best practice, and identifying industry insights. Also, leveraging technology to more effectively analyze data and promote data informed decisions.

Learning Objectives

Outline the importance of data driven decisions and approaches in gathering key insight data; Describe from a department wide approach to revamping benchmarking process (from data gathering, to presentation, to creating a long term process).

Chair

Barbara Shannon, PharmD

Speakers
BS

Barbara Shannon

Associate Director, Operations, PPD, Part of Thermo Fisher Scientific, United States
After graduating with a Bachelor's in Chemistry and a Doctorate of Pharamcy from The Ohio State University, I began my career as a pharmacist in the Washington DC area. I took a brief hiatus from the industry teaching high school math as a Teach For America corps member for 2 years... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

4:15pm CDT

How to Assess and Implement Patient Preferences in Decision-Making Along the Medical Product Life Cycle?
Component Type: Forum
Level: Intermediate

Patient preference studies (PPS) yield evidence about unmet needs and treatment outcomes that matter most to patients. This forum will discuss how to assess and implement PPS results so these can inform decision-making along the drug lifecycle.

Learning Objectives

Discuss examples of how patient preference studies (PSS) can inform decision-making at different stages during the drug life cycle; Describe best practices on how to assess and implement PPS results; Discuss the value and implementation of PPS results from different perspectives (regulatory, methodological and patient view).

Chair

Liese Barbier, PharmD, MS

Speakers
avatar for Liese Barbier

Liese Barbier

Postdoctoral researcher, KU Leuven, Belgium

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Forum

4:15pm CDT

What's Next in Precision Medicine? Translational Strategies for Dose Optimization in the Age of Project Optimus
Component Type: Session
Level: Intermediate

Representatives from industry, academia, and FDA will discuss translational strategies, provide regulatory considerations, and outline challenges and opportunities to inform trial designs for dose optimization under Project Optimus.

Learning Objectives

Describe successful approaches of translational strategies for dose optimization and identify what made them successful; Identify regulatory considerations in the context of biomarker development and dose optimization studies; Apply toolset to successfully implement translational strategies to support dose optimization in early oncology studies.

Chair

Christian Grimstein, PhD

Speakers
CG

Christian Grimstein

Senior Director, Translational Regulatory Affairs, Oncology Reg Science, AstraZeneca, United States

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: TranslationalScience-PrecisionMedicine, Session

4:15pm CDT

One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients
Component Type: Session
Level: Advanced

This session will include a focused discussion on industry/ health authority collaboration over 2022-2023 on transforming the standard approach to quality: enabling innovation by mitigating risks using quality briefs to build trust and confidence, with outcomes-based transparency.

Learning Objectives

Describe how quality briefs can be proactively shared with Health Authorities and adapted depending on the lifecycle stage/ filing approach taken; Discuss Health Authority reflections on the outcome-focused quality briefs based on experience during 2022-23 including links to quality by design principles on risk management and transparency with regulators.

Chair

Paula Walker, MA

Speakers
avatar for Paula Walker

Paula Walker

Quality Policy Chapter Lead, Product Development Quality Global Leadership, Roche Products Ltd., United Kingdom
Paula started as the Quality Policy Chapter Lead at Roche in Sept 22. Paula was formerly the Head of Compliance, GCP/GPvP/GLP & Expert Circle at the MHRA and Acting Head of Inspectorate between 2020-2022, having started at the MHRA in 2009 as a GCP Inspector. Paula has a BSc in Biomedical... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Session

4:15pm CDT

Emerging Therapies and Technologies and Leveraging Opportunities for Engaging with Medicine Regulators to Support Innovation
Component Type: Session
Level: Intermediate

This session aims to inform developers of innovative therapies & technologies, how they can interact with medicine regulators to seek support, and how regulators use these interactions to advance the system and prepare for their arrival.

Learning Objectives

Discuss the offer of early point of contact (EPOC) at the EMA; Identify topics in R&D that are suitable for EPOC interactions; Explain the potential added value of EPOC interactions for developers (direct and indirect benefits) and for regulators (medicine regulators, HTA and other official bodies); Identify how to create links and opportunities for public private partnership engagement.

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

4:15pm CDT

Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role
Component Type: Session
Level: Intermediate

The session analyzes the fundamental role ICMRA had during the pandemic in fostering regulatory cooperation and coordination globally, and the current work finalized at better preparation for future crises, stressing the importance of communication.

Learning Objectives

Describe why cooperation and coordination among regulators is essential during a global public health emergency of international concern such as the COVID-19 pandemic; Identify how the ICMRA provided global strategic leadership and directions during the pandemic; Discuss how ICMRA is using the lesson learned from the current pandemic to be better prepared for future public health emergencies.

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

4:15pm CDT

The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There?
Component Type: Forum
Level: Intermediate

The use of vaccine platforms holds great promise to advance regulatory science. The session discusses learnings from COVID-19, identifies opportunities and challenges to developing and regulating new vaccines, and looks ahead to what is possible.

Learning Objectives

Describe learnings from the COVID-19 pandemic regarding development and review of new platform vaccines; Define the opportunities and challenges to development; Review new platform and next generation vaccines.

Chair

Brenda Huneycutt, JD, PhD, MPH

Speakers
avatar for Brenda Huneycutt

Brenda Huneycutt

Director, Global Regulatory Policy, Merck & Co., Inc., United States
Brenda Huneycutt is a Director of Global Regulatory Policy with Merck, focusing on vaccine and antimicrobial regulatory policy. Prior to joining Merck, as a Director at FasterCures, a Center of the Milken Institute, she developed and executed on a variety of initiatives, including... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

4:15pm CDT

Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence
Component Type: Session
Level: Advanced

This session will describe challenges and opportunities in analytical development of cell and gene therapies, as well as US regulatory updates and the importance of international convergence in the development of cell and gene therapy products.

Learning Objectives

Discuss challenges in analytical development and testing for cell and gene therapies (CGT) (e.g. comparability, potency, impurities); Explain FDA’s benefit-risk assessments, expedited development pathways, and PDUFA VII for CGT products; Describe international convergence initiatives: PIC/s Annex 2A or WHO Consideration on regulatory convergence.

Chair

Maria Amaya, PhD, MS

Speakers
MA

Maria Amaya

Lead External Advocacy, North America, Genentech, A Member of the Roche Group, United States
Maria Amaya is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and CGMP regulatory pathways, and collaborate with internal... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session

4:15pm CDT

Supporting Providers in Value-Based Contracts: Machine Learning and Recursive Neural Networks for Outcomes and Treatment Journey Optimization
Component Type: Workshop
Level: Basic

Success of value-based contracting rests on supporting providers in aggregating, analyzing, and acting on patient data across care teams. Payors can leverage democratized machine learning and recursive neural networks for supportive provider partnerships. This workshop will systematically step through a simulated use-case to exemplify the application of democratized advanced analytics in collecting, analyzing, and acting on real-world patient data to algorithmically optimize the patient journey for success in a value-based world.

Learning Objectives

Describe how payers can use their analytical expertise to better support providers in value-based contracting; Discuss how to use machine learning to predict outcomes; Identify how to operationalize recursive neural networks for personalized care coordination to increase outcomes achievement across a patient panel; Describe how to align with value-based reimbursement policies to track trends toward clinical and financial goals.

Chair

Naquan Eric Ishman, MBA, MSc

Speakers
avatar for Naquan Ishman

Naquan Ishman

Principal Strategic Advisor - Commercial Life Sciences, SAS Institute, United States
Naquan Ishman is a Principal Commercial Life Sciences Industry Consultant at SAS, where he leads cross functional teams in the development of advanced analytics solutions for biopharmaceutical and medical devices companies. Previously, Naquan has held sales and leadership roles at... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Workshop

4:15pm CDT

Creating your Career Plan 101: A Practical Workshop
Component Type: Workshop
Level: Basic

In this workshop, a seasoned HR executive and clinical research and quality professional will share a systematic approach for creating a career plan. Attendees will be provided with tools to begin creating your own career plan.

Learning Objectives

Outline a systematic approach for defining a career plan; Identify publicly available tools to assess your career interests, skills, goals, strengths; Assess qualifications, experience and skills you will need to get your chosen job; Discuss how to begin creating a career plan.

Chair

Tywnia Brewton

Speakers
avatar for Tywnia Brewton

Tywnia Brewton

Executive 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 →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  13: ProfDevelopment, Workshop
 
Tuesday, June 27
 

8:30am CDT

Illuminating Risk Minimization Effectiveness Measurement
Component Type: Session
Level: Intermediate

This session will describe best practices for evaluating the effectiveness of additional risk minimization measures globally, and will include new models of healthcare provider and patient involvement in this effort.

Chair

Lubna Merchant, PharmD, MS

Speaker

Completing the Risk Management Cycle: Review of Risk Management Effectiveness Across US and EU
Lubna Merchant, PharmD, MS

A More Perfect Union: Overcoming Challenges in Risk Minimization Evaluation via New Models of Healthcare Providers and Patient Involvement
Meredith Smith, PhD, MPA, FISPE


Speakers
avatar for Lubna Merchant

Lubna Merchant

Director, Risk Management Center of Excellence, Pfizer Inc , United States
Lubna is a Director in the Risk Management Center of Excellence at Pfizer, Inc., where she is responsible for the strategy and implementation of risk management plans globally. Dr. Merchant provides global leadership in delivering innovative and strategic risk management excellence... Read More →
avatar for Meredith Smith

Meredith Smith

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States
Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

8:30am CDT

Ethical Considerations for Conducting Research During Times of Disruption
Component Type: Forum
Level: Advanced

This forum will weave together ethics-based insights from across the R&D spectrum as we evaluate the recent events of the global pandemic, conflict in eastern Europe, and the increasing frequency of climatic, natural disasters. The goal is to illuminate the ethical considerations that exist in questions related to operations, communication about research and science, access, and how those considerations can be used to drive best practices.

Learning Objectives

Describe the ethical considerations affecting industry decision making for clinical research during periods of disruption; Analyze the global research landscape and efforts to incorporate innovative approaches to trials across regions and inconsistent regulatory environments; Identify how to apply these learnings to relevant cases and identify best practices for managing this ethically complex space.

Chair

Karla Childers, MS

Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-based Science & Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

8:30am CDT

Innovating Patient Recruitment Through Pharmacy Channels
Component Type: Session
Level: Advanced

Innovative partnerships enable unprecedented speed and scale for patient recruitment activities. Direct case studies will show how targeted, just-in-time outreach via community pharmacy, clinic, and insurance outreach enables enrollment at scale.

Learning Objectives

Discuss how innovation in clinical trial recruitment can affect enrollment with direct case studies of accelerating and improving on patient enrollment via advanced methods; Introduce and debate concept of just-in-time patient recruitment at the appropriate time and channel for the patient.

Chair

Omar Abdelsamad, MBA

Speakers
OA

Omar Abdelsamad

Executive Director, Patient Recruitment, CVS Health, United States

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session

8:30am CDT

ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange
Component Type: Session
Level: Intermediate

This session will provide an overview of the ICH M11 initiative for a harmonized protocol with a focus on the data models to ensure consistency using an open, nonproprietary standard to enable electronic exchange of clinical protocol information.

Learning Objectives

Describe the current deliverables and the latest developments on ICH M11 guideline, protocol template, and technical specification; Explain content and information models supporting the exchange and storage of clinical data and content in a protocol; Describe the Standards Development Organization (SDO) engagement process to enable electronic information exchange.

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

8:30am CDT

The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives 
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

The Increasing Importance of Real-World Data to the Life Sciences Industry: Yet Will Synthetic Data Define the Future?
Nimita Limaye, PhD

A Case for Synthetic Data in Regulatory Decision-Making in Europe
Michael Batech, DrPH


Speakers
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States
V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience... Read More →
MB

Michael Batech

Senior Director of Science, Aetion, Inc., Germany
avatar for Nimita Limaye

Nimita Limaye

Research Vice President, Life Sciences R&D Strategy and Technology, IDC, United States
Nimita Limaye leads R&D Strategy and Technology at IDC Health Insights, providing research-based advisory and consulting services as well as market analysis on key topics within the Life Sciences industry. She is an executive business leader with more than two decades of life sciences... Read More →

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

8:30am CDT

Innovation Across Medical Affairs Throughout the Global Pandemic
Component Type: Session
Level: Basic

This session will discuss the wide array of digital innovation implementations during the COVID-19 pandemic within medical affairs across the pharmaceutical industry.

Learning Objectives

Evaluate innovation implemented within medical affairs functions across the pharmaceutical industry during the COVID-19 pandemic; Discuss the viability of any changes for future utilization.

Chair

David Zarif, PharmD

Speakers
DZ

David Zarif

Pharmaceutical Industry and Education Fellow, Genmab, Philadelphia College of Pharmacy, United States
David Zarif is a pharmacist by training completing his pharmacy degree from The Philadelphia College of Pharmacy. After completing his PharmD, Dr. Zarif went on to complete a two-year multidisciplinary post-doctoral fellowship with Philadelphia College of Pharmacy Pharmaceutical Industry... Read More →

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

8:30am CDT

Leveraging Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Erin Mulrooney, MSc, PMP

Speaker

How Project Data Visualization Facilitates Strategic Resource Planning on the Portfolio Level
Char Leung

Life Science Industry R&D Portfolio Analysis and Forecasting
Vladimir M Shnaydman, PhD

Applying the Principles of Decision Science to Guide Product Development Strategy
William Leaf-Herrmann, PhD


Speakers
WL

William Leaf-Herrmann

Partner, Strategic Decisions Group, United States
William is a partner at Strategic Decisions Group and leads SDG’s North American life science practice. He has 30 years of experience in developing corporate, therapeutic, product, and portfolio strategies for clients in the pharmaceutical and biotechnology industries. His clients... Read More →
CL

Char Leung

Director, Development Program Management, Genmab, United States
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 & Early Development Portfolio and Governance processes. Prior to rejoining Merck at the end of 2020, Erin was the Director of Portfolio Management and Operations... Read More →
avatar for Vladimir Shnaydman

Vladimir Shnaydman

President, ORBee Consulting, United States
Vladimir has BS & MS in EE & CS, MS in Applied Mathematics, and Ph.D. in Engineering. He contributed to many industries, such as biotechnology, computer systems development, water resources, telecommunications, transportation, and military applications. Dr. Shnaydman published more... Read More →

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjectManagement-StrategicPlanning, Session

8:30am CDT

International Regulatory Convergence and Collaboration
Component Type: Session
Level: Intermediate

Session participants will understand how international regulatory collaboration leads to convergence between regulators and enables faster international patient access. They will be able to understand different models of collaboration and their impact on convergence of international regulatory systems. Participants will hear case examples from Africa, Asia Pacific and LATAM regions to identify success factors and lessons learned that contribute to the successful use of international collaboration pathways for their international regulatory strategy and how it impacts on patient access.

Learning Objectives

Describe how international regulatory collaboration leads to convergence between regulators and enables faster international patient access; Describe different models of collaboration and their impact on convergence of international regulatory systems; Identify through case examples from Africa, Asia Pacific and LATAM regions to identify success factors and lessons learned.

Chair

Angelika Joos, MPharm

Speakers
avatar for Angelika Joos

Angelika Joos

Executive Director, Global Regulatory Policy, Merck Sharp & Dohme (Europe) Inc., Belgium
Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional... Read More →

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

8:30am CDT

Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed?
Component Type: Session
Level: Intermediate

Panelists will review recent policy reforms that enable and challenge efficient pediatric medicines development and will identify additional advocacy and policy needs for this topic.

Learning Objectives

Describe the current landscape of global pediatric medicines development; Identify areas where advancements in regulatory science may require policy reform to enable a holistic approach to global pediatric medicines development; Describe possible solutions to facilitate global harmonization efforts.

Chair

Christina Bucci-Rechtweg, MD

Speakers
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis Pharmaceuticals Corporation, United States
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy... Read More →

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

8:30am CDT

Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall
Component Type: Forum
Level: Intermediate

Hear directly from regulators about the newest programs and updates for review of generic drugs and pharmaceutical quality.

Learning Objectives

Describe new programs implemented by OGD and OPQ; Discuss GDUFA III Implementation.

Chair

Rachel Turow, JD, MPH

Speakers
avatar for Rachel Turow

Rachel Turow

Associate General Counsel, Regulatory Law and Policy; Head, US Regulatory Policy, Teva Pharmaceutical Industries Ltd., United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →

Tuesday June 27, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Forum

10:30am CDT

Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report
Component Type: Session
Level: Intermediate

will include implementation recommendations, planning for the use of the structured BR approach, and several case studies, using the usual collaborative consensus approach of CIOMS. Speakers will include CIOMS WG members from academia, regulatory authorities and industry.

Learning Objectives

Provide an update on the CIOMS Working Group XII benefit-risk balance for medicinal products; Describe the conduct of high quality, balanced, and comprehensive lifecycle benefit-risk assessments; Discuss strategic guidance on structured framework and benefit-risk methodologies to improve transparency and understanding amongst key stakeholders, including patients.

Chair

Ana-Claudia Ianos, MD

Speakers
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Safety Risk Lead MD Senior Director, Pfizer Inc, Switzerland
Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 12 years of... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

10:30am CDT

Good Recruitment Practice Under Regulation (EU) No 536/2014
Component Type: Session
Level: Intermediate

With the adoption of regulation (EU) No 536/2014 and a single submission, clinical trial sponsors will learn about the importance of changing the way we approach patient recruitment planning and execution for trials conducted in the EU.

Learning Objectives

Discuss regulation (EU) No 536/2014, its three year transition period, and its immediate impact on clinical trial patient recruitment and engagement; Describe how to navigate the new requirements, including having to submit recruitment plans as part of the single upfront submission - and the timelines for doing so.

Chair

Matthew Kibby, MBA

Speakers
avatar for Matthew Kibby

Matthew Kibby

President, Chief Strategy Officer, BBK Worldwide, United States
Matt Kibby is principal and president of BBK Worldwide. He has held a range of senior level positions in his 20-year tenure with the patient recruitment agency. He has had a formative impact on the sophistication of many of BBK’s breakthrough offerings – from enrollment feasibility... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session

10:30am CDT

The Future of Regulatory Submissions: Opportunities and Challenges
Component Type: Forum
Level: Intermediate

This forum will include a discussion on opportunities and challenges for future regulatory submissions and share knowledge and provide views to help overcome challenges in the areas of policy, technology, standards, data sovereignty and security, and records management. Panelists will include representatives from health authorities, industry, and non-profit organizations.

Learning Objectives

Describe the current regulatory submission mechanism; Explore opportunities for the future regulatory submission and data exchange, data sharing paradigm; Discuss challenges to implement changes from policy, technology, standard, data sovereignty and security, records management perspectives.

Speakers
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 →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum

10:30am CDT

Medical Storytelling Inserted Into All Aspects of Medical Affairs
Component Type: Session
Level: Basic

Raw science is often complicated and difficult to discuss verbally as is - it requires modification. The most beneficial method of communicating complicated science is through storytelling. However, scientists are not always adept storytellers. With input from several experts on storytelling, this session will leave participants with a desire to learn and apply the storytelling techniques shared within the session to their complicated and scientific data.

Learning Objectives

Describe the requirements for medical storytelling; Implement storytelling into scientific platforms and medical strategy.

Chair

J. Lynn Bass, PharmD, RPh

Speakers
avatar for J. Lynn Bass

J. Lynn Bass

Senior Director and Head, Medical Science Directors, Medexus Pharma, United States
With 23+ 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 →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

10:30am CDT

Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity
Component Type: Forum
Level: Intermediate

This forum experience will offer attendees the opportunity to address cultural biases through embracing cultural competence and patient centric tactics to positively impact clinical trial diversity.

Learning Objectives

Describe the positive and negative effects of specific patient engagement tactics; Discuss how to overcome the fear of saying the “wrong thing” while trying to do the right thing; Identify how to teach tangible best practices from a diverse panel of patient-centric clinical research professionals.

Chair

Alana Toi Johnson Miller

Speaker

Insights on Engaging a Diverse Cohort in Clinical Trials: Hiispanicc/Latino Patient Population
Sara Tylosky, MBA

Matters of Perspective: Learnings from Engaging Patients with Mental Health Conditions
Valerie Powell, MS


Speakers
avatar for Alana Miller

Alana Miller

Associate Director, Clinical Trial Diversity Program Lead, Merck & Co., Inc., United States
Experienced Global Clinical Operations Leader and Clinical Trial Diversity Expert with over 22 years of dedicated focus on "patient first" trial execution, clinical trial operational excellence, and passionate leadership. As Associate Director of Clinical Trial Diversity at Merck... Read More →
avatar for Valerie Powell

Valerie Powell

Chief Patient Officer, CorEvitas and EVP, Patient Experience, 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 →
avatar for Sara Tylosky

Sara Tylosky

Chief Executive Officer, Farmacon Global, United States
Experienced Global Executive with over 20 years of leading diverse teams in a fast-paced environments in both big and small pharmas. As CEO at Farmacon Global for the past 10 years, a strategic CRO with medical consultants to accelerate clinical research and market access projects... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Forum

10:30am CDT

The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases
Component Type: Forum
Level: Intermediate

This session will discuss the RDCA-DAP, a leading collaboratory working with the entire rare diseases ecosystem, including C-Path rare diseases public-private partnership, to advance solutions aiming at accelerating product development for rare diseases.

Learning Objectives

Discuss drug development bottlenecks and issues for rare diseases; Identify data science solutions for rare diseases; Describe the RDCA-DAP Collaboratory and how we work to facilitate product development both internally (through facilitation of solutions development from the Critical Path Institute rare diseases public-private partnerships) and externally with the entire ecosystem).

Chair

Alexandre Betourne, PharmD, PhD

Speakers
avatar for Alexandre Betourne

Alexandre Betourne

Executive Director, Critical Path Institute, United States
Alexandre Bétourné, PhD, PharmD, is Executive Director for the Rare Disease Cures Accelerator-Data and Analytics Platform initiative. Dr. Bétourné holds both a PhD and a PharmD from the University of Toulouse in France. Before joining C-Path, he worked with a team of senior U.S... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: TranslationalScience-PrecisionMedicine, Forum

10:30am CDT

IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback
Component Type: Forum
Level: Intermediate

This forum will present: 1) the vision of IMPALA and examples of IMPALA’s quality analytics products, 2) ongoing feedback from health authorities on the quality analytics methods, and 3) guidance on how sponsors and regulators can join IMPALA.

Learning Objectives

Summarize real-life examples of embedding R&D quality analytics methodologies and how these are used to complement, enhance, and accelerate traditional quality assurance practices; Identify, influence, and apply ongoing feedback from Health Authorities; Describe how to take steps (sponsors and Health Authorities) to join the IMPALA (IntercoMPany quALity Analytics) Consortium.

Chair

Michael Torok, PhD

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Forum

10:30am CDT

ANVISA Townhall
Component Type: Session
Level: Intermediate

In this session, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence and collaboration initiatives. The session will also invite questions from the audience

Learning Objectives

Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator.

Chair

Maria Cristina Mota Pina, MBA

Speakers
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Director, Regulatory Policy and Intelligence -Japan, Emerging Markets, Australia, Latin America Federation of Pharmaceutical Industry (FIFARMA), United States
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

10:30am CDT

International Harmonization of Real-World Data/Real-World Evidence Use and Acceptance by Health Authorities: Time to Make it Right!
Component Type: Session
Level: Intermediate

This session will address the latest international efforts to achieve global harmonization of real-world data (RWD)/real-world evidence (RWE) use and acceptance in regulatory decision making.

Learning Objectives

Discuss the current regulatory landscape: latest initiatives (FDA PDUFA VII RWE Commitments, EU Pharma Review, European Health Data Space, EMA-HMA Big Data Taskforce, etc); Describe the importance of the most recent international harmonization initiatives (ICMRA, ICH, CIOMS); Identify how the ICMRA's pledge look like to regulators and industry in practice.

Chair

Max Wegner, PharmD, RPh

Speakers
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 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

10:30am CDT

Patient Experience Data in the Label: Closing the Loop
Component Type: Session
Level: Intermediate

With the growing role of patient voice in drug development, sponsors are collecting a wealth of information. This session will explore successful strategies to getting Patient Experience Data in product labels and ways to improve it further

Learning Objectives

Describe the patient’s critical role and importance of communicating patient experience data (PED) in a patient-friendly manner; Discuss Regulators’ expectations on what is needed to support PED in the label; Assess from industry on navigating hurdles to have PED included in the label; Define how patient communication can be improved if PED is not included in the label; Outline other mechanisms available.

Chair

Allison Martin, MS

Speaker

Industry Perspective on Patient Relevant Data in the Label
Harpreet Sandhu, PharmD, PhD, MBA, MPharm


Speakers
AM

Allison Martin

Director, Regulatory Science and Policy, North America, Sanofi, United States
As a Director on Sanofi’s Global Regulatory Science and Policy (GRSP) North America team, Allison is responsible for advancing regulatory science and strategically engaging in regulatory policy efforts. In this role, Ms. Martin collaborates with internal and external stakeholders... Read More →
HS

Harpreet Sandhu

Director, Global Regulatory Affairs, Bayer Healthcare Pharmaceuticals, United States
Harpreet Sandhu is a Global Regulatory Strategist (GRS) in the Department of Regulatory Affairs Strategy at Bayer and is based in Whippany, NJ. In her role as GRS, she supports the product development teams in defining a science-driven assessment of development options, key considerations... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

10:30am CDT

Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment
Component Type: Forum
Level: Intermediate

Regulatory and industry panelists, representing a global perspective, will discuss efforts to modernize requirements for clinical trials, review lessons learned during the pandemic, and further opportunities for regulatory innovation.

Learning Objectives

Discuss post-pandemic regulatory innovation and opportunities for clinical development programs; Describe ICH E6(R3) draft guideline, good clinical practice, and enabling more innovative clinical trial design and conduct; Identify opportunities for global alignment to support global development programs taking into consideration lessons learned during the pandemic.

Chair

Amanda Marie Roache, MS

Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

10:30am CDT

A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines
Component Type: Session
Level: Advanced

The current session will outline high-level lessons learned from the ICMRA collaborative pilots focusing on CMC-related post-approval changes and hybrid inspections, in addition to updates on current ICMRA-ICH-IPRP and PIC/S collaborations.

Learning Objectives

Discuss the different working groups, ongoing activities, and identify suitable contacts responsible for progressing ongoing harmonization efforts to support the development of a global regulatory PQ KMS; Evaluate provisional lessons learned following the collaborative pilots focusing on CMC-related PAC and hybrid inspections.

Chair

Karl Cogan, PhD

Speaker

ICMRA PAC Pilot: Share Process and Learnings from Simultaneous PACMP Submission/Collaborative Review to 6 Health Authorities
Lisa Little-Tranter, MS


Speakers
KC

Karl Cogan

Scientist and Executive Assistant, Health Products Regulatory Authority, Ireland
avatar for Lisa Little-Tranter

Lisa Little-Tranter

Senior Director, CMC Global Biologics, Merck & Co., Inc., United States
Lisa Little-Tranter currently serves as Senior Director - Chemistry, Manufacturing & Controls supporting biologics at Merck. Lisa joined Merck in May 2020 and has over 30 years of pharmaceutical industry experience in manufacturing, quality and regulatory roles. Lisa currently provides... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality`, Session

10:30am CDT

The Full Picture: Innovative Software Tools for Data Insight Generation
Component Type: Session
Level: Basic

A picture is worth a thousand words. This session will introduce seven apps which enable the user to interactively display information of interest in the form of very powerful static and dynamic graphs.

Learning Objectives

Identify and interpret information of interest in an interactive way in daily statistical practice; Describe how to generate new insights in helping better understand the complex relationships under the clinical data and further drive the understanding of disease development, patient journey, and the impact of the treatments studied on the patient’s quality of life.

Chair

Erya Huang

Speakers
avatar for Erya Huang

Erya Huang

Associate Director Statistics, Bayer U.S. LLC, United States
Dr. Huang is the Associate Director at Bayer U.S. LLC. She has many years of experiences working on global drug developments and registrations. She is also the main contact person of the data visualization app center in Bayer North America since 2016, being passionate about introducing... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session

10:30am CDT

Is Mark Cuban Really Solving the Drug Pricing Problem?
Component Type: Session
Level: Advanced

This session will discuss whether new models for selling low-cost drugs are sustainable for the long term and scalable to help more patients and bring down drug prices.

Learning Objectives

Describe new approaches to work around the pharmacy benefit manager (PBM)Model and how they affect drug pricing; Discuss Mark Cuban’s approach to direct purchase and whether that is a long-term solution for more than a subsection of patients.

Chair

Rachel Turow, JD, MPH

Speakers
avatar for Rachel Turow

Rachel Turow

Associate General Counsel, Regulatory Law and Policy; Head, US Regulatory Policy, Teva Pharmaceutical Industries Ltd., United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Session

1:15pm CDT

Novel Methods for Signal Identification for Medicines and Medical Devices
Component Type: Session
Level: Intermediate

For many years signal detection in large databases has been based around standard disproportionality approaches. In this session MHRA and FDA will discuss novel approaches that they have been exploring for detection of safety issues on medicines and medical devices, and give their views on the future landscape for signal detection.

Chair

Phil Tregunno

Speakers
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over eighteen years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

1:15pm CDT

Hot off the Press: Site Challenges and Solutions in Workforce and Technology
Component Type: Forum
Level: Intermediate

Sites face several challenges on a daily basis. More important than identifying challenges is also exploring solutions. This session will use data to help support conclusions around what can be done to solve technology and workforce at the site.

Learning Objectives

Develop deeper understanding of the challenges sites are facing as it pertains to their current workforce through data-backed discussion; Discuss the direction technology is headed and how that will affect sites, using data to support the conclusions; Establish solutions that can be implemented for both workforce and technology challenges.

Chair

Jimmy Bechtel, MBA

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 →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

1:15pm CDT

Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape
Component Type: Forum
Level: Intermediate

Tracking the range of decentralized trial initiatives is challenging, but critical to ensure redundancy is avoided and hand-offs created. This forum addresses meta-collaboration, including representation from many of the initiatives leading change.

Learning Objectives

Describe the role of collaborations to improve adoption and address shared challenges; Discuss the roles of various collaborations addressing decentralized trials and how they fit together; Discuss updates on the progress of various initiatives meant to ease the global adoption of decentralized trials.

Chair

Craig H Lipset, MPH

Speakers
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 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

1:15pm CDT

Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives
Component Type: Session
Level: Intermediate

Data Analysis and Real-World Interrogation Network (DARWIN EU®) is the EU medicines regulators’ real-world evidence (RWE) network. It will boost the capacity for RWE use and strengthen decision-making in medicines regulation. Links to FDA’s SENTINEL and ICH are explored.

Learning Objectives

Discuss the rationale, database model applied, and utility for the DARWIN EU network; Describe international collaboration in real-world evidence (RWE) as context for national and regional efforts to build RWE capacity.

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

1:15pm CDT

Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!)
Component Type: Session
Level: Intermediate

The panel of experts will present technology improvements as well as the adapted processes that foster speed, consistency, and quality – ultimately the most respectful and defensible presentation of participant-level data.

Learning Objectives

Describe new technologies in use for participant narratives and metrics associated with these; Discuss the required process improvements for narrative authoring.

Chair

Robin Whitsell

Speakers
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 of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

1:15pm CDT

Measuring Impact of Patient Engagement Across Research and Development
Component Type: Session
Level: Intermediate

How can the impact of patient-informed medicines development be measured? There is a growing need to measure the impact of patient engagement on R&D productivity. This session will describe methodology to establish key performance indicators (KPIs) and metrics that reflect value and impact of patient engagement across R&D.

Learning Objectives

Describe broad scale, fully integrated R&D patient engagement, processes, and infrastructure needed to collect and assess impact of patient engagement; Identify key performance indicators (KPIs) and metrics that reflect the value and impact of patient informed R&D, health value translation models.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speakers
avatar for Victoria DiBiaso

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, Sanofi, France
Vicky has 20+ years of clinical research experience. She holds a Master of Public Health and is a nurse by training. She has been awarded the distinction as one of the Top 20 Industry Innovators for her efforts to integrate insights from patient communities and clinical trial institutions... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Session

1:15pm CDT

Using Artificial Intelligence to Illuminate Predictive Relationships and Discover Biomarkers from Clinical, Molecular, and Digital Data
Component Type: Session
Level: Advanced

This session provides an overview of current advancement in processing and integrating clinical, molecular and digital data for biomarker discovery; and enumerates sophisticated machine learning algorithms to build robust predictive model.

Learning Objectives

List highly complex and multi-modal data collected from patients; Identify cutting edge technology to process and integrate omics and digital data; Discuss advanced analytics and sophisticated machine learning method facilitate biomarker discovery.

Chair

Yilin Xu, PhD

Speakers
YX

Yilin Xu

Senior Manager, AbbVie, United States
Yilin Xu works as Senior Manager in Data Science and Analytics at AbbVie. Yilin has over 15 years of experience in cellular oncology and genomics applied to molecular drivers of human diseases. She is an experienced research scientist with extensive bioinformatic and data science... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: TranslationalScience-PrecisionMedicine, Session

1:15pm CDT

Getting Things Done in Drug Development Using Agile Practices
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Nancy Watanabe, MS, PMP

Speaker

Utilizing an Agile Approach in REMS Contact Center Set-Up and Hyper-Care
Mohit Kapoor, RPh

What are Agile Approaches in Pharmaceutical Industry?
Yasuo Fukushima, PhD


Speakers
avatar for Yasuo Fukushima

Yasuo Fukushima

Director, Daiichi Sankyo, Inc., United States
Dr. Yasuo Fukushima is a project manager of new drug developmen at Daiichi Sankyo Inc., and responsible for global drug development of a antibody-drug conjucate for cancer treatment. His background is Ph.D. for pharmaceutical science, and he has over 20 years of experience in the... Read More →
MK

Mohit Kapoor

Director-Project Management and Operations Strategy, COD Research, United States
avatar for Nancy M Watanabe

Nancy M Watanabe

Consultant, Self-Employed, United States

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjectManagement-StrategicPlanning, Session

1:15pm CDT

Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections
Component Type: Session
Level: Intermediate

Hear about MHRA and FDA expectations on quality management systems for aRMM and REMS programs and their oversight by regulatory authorities via inspections. This will be supplemented by case studies, best practice examples and industry perspectives.

Learning Objectives

Describe the regulatory expectations of implementing a robust quality management system to support additional risk minimization measures in the UK and the US; Apply learning points and best practice examples from inspection findings to improve compliance in your organization; Discuss how prospective quality planning supports the availability of safe products to patients.

Chair

Paula Walker, MA

Speaker

The Impact of Pharmacovigilance Inspection-Readiness in Ghana
George Sabblah, MPH


Speakers
GS

George Sabblah

Head of Department of Safety Monitoring, Food and Drugs Authority , Ghana
avatar for Paula Walker

Paula Walker

Quality Policy Chapter Lead, Product Development Quality Global Leadership, Roche Products Ltd., United Kingdom
Paula started as the Quality Policy Chapter Lead at Roche in Sept 22. Paula was formerly the Head of Compliance, GCP/GPvP/GLP & Expert Circle at the MHRA and Acting Head of Inspectorate between 2020-2022, having started at the MHRA in 2009 as a GCP Inspector. Paula has a BSc in Biomedical... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Session

1:15pm CDT

Asia Town Hall
Component Type: Session
Level: Intermediate

“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 countries; Discuss activities based on convergence in Asian countries; Identify findings from each Asian countries' perspectives.

Chair

Nobumasa Nakashima, PhD

Speakers
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 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

1:15pm CDT

Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions
Component Type: Forum
Level: Intermediate

This session will discuss timely new resources for sponsors seeking to employ digital health technologies (DHTs) in clinical trials, with a focus on addressing practical questions that arise during implementation.

Learning Objectives

Describe new, available resources for sponsors looking to employ digital health technologies (DHTs) within a single drug development program; Discuss these resources and how to apply them to use of a DHT in clinical trials; Identify gaps and where future resources are needed to advance the use of DHTs in clinical trials and drug development.

Chair

Megan Doyle, JD, MPH

Speakers
avatar for Megan Doyle

Megan Doyle

Global Policy Lead, Digital Health, Diagnostics, Oncology, Amgen, United States
Megan Doyle is an attorney and policy professional with 15 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 health... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

1:15pm CDT

One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot!
Component Type: Session
Level: Intermediate

We will present a post-approval change regulatory reliance pilot launched worldwide in 2022 in collaboration with WHO (Global and LATAM entities), Health Canada and PEI (Germany/Europe).

Learning Objectives

Describe our experience of a post-approval change regulatory reliance pilot to enable reliance between national regulatory authorities.

Chair

Lyne Le Palaire, MSc

Speakers
LL

Lyne Le Palaire

Quality Advocacy Leader, Sanofi, France

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session

1:15pm CDT

Quality in the Real World: Diagnosing and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data
Component Type: Session
Level: Intermediate

Data collected during routine care have variable quality and missingness. This panel outlines statistical and design approaches to analyzing and accounting for the effect of less-than-perfect data quality when reused for real-world evidence studies.

Learning Objectives

Identify inaccuracies, gaps, and informative missingness in patient records collected during clinical care; Describe how data quality can be evaluated and accounted for by novel statistical approaches when intended to be reused in real-world evidence (RWE) studies; Discuss advantages, challenges, and trade-offs in selecting datasets appropriate for RWE analyses.

Chair

Jan Horsky, PhD, MA

Speakers
avatar for Jan Horsky

Jan Horsky

Scientific Data Strategy Director, Parexel International, United States
Dr. Horsky is an informaticist with two decades of experience in health research. He leads real world evidence studies and has evaluated electronic health records systems, clinical decision support and other health information technology for clinical care and research. He served as... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session

1:15pm CDT

The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives?
Component Type: Forum
Level: Intermediate

The session will discuss inflation reduction act (IRA) impact on market conditions, including the signal sent to developers and the unintended consequences to patient access to innovative treatments. The speakers will provide the economic, patient, and industry perspectives.

Learning Objectives

Explain how pricing reforms included in the Inflation Reduction Act (IRA) will work; Identify the type of medicines and conditions that are likely to be affected • To discuss its potential consequences on the market conditions, in particular on patients and pharmaceutical developers, and relevant learnings from the US and European experience of price regulation.

Chair

Graham Cookson, DrSc

Speaker

Implications of the 2022 US Inflation Reduction Act on Biosimilar Lifecycle Management
Alexander Gee


Speakers
avatar for Graham Cookson

Graham Cookson

Honorary Visiting Professor, City, University of London; Chief Executive, Office of Health Economics, United Kingdom
Professor Graham Cookson is Chief Executive of the Office of Health Economics, the world's oldest and most prestigious health economics research organisation. He is an Honorary Professor of City University, London and a Fellow of the Royal Statistical Society. An econometrician and... Read More →
avatar for Alex Gee

Alex Gee

Senior Director, Pricing and Access, Parexel, United Kingdom
Alex is a Senior Director in the Pricing and Market Access team, with over 25 years' experience in healthcare, including 10 years in consulting. Alex has engaged in multiple global projects, ranging from early phase in rare diseases through to generic defense for blockbuster brands... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Forum

1:15pm CDT

Demystifying the Common Legal Agreements, Key Terms, and Pitfalls for Non-Legal Professionals
Component Type: Session
Level: Intermediate

Confidentiality disclosure, master service, and sponsored research agreements are commonly used for business collaborations. In this session, we will cover key terms, risks, negotiation tactics and identify triggers to engage further legal support.

Learning Objectives

Identify commonly used legal agreements for business collaborations and how to identify which one is the best fit in each situation; Describe the key terms in these legal agreements and their strategic and operational implication; Describe how to empower attendees to identify pitfalls and seek deeper legal expertise, as needed; Develop competence in understanding and negotiating legal agreements.

Chair

Aditi Khurana, MBA, PMP, RAC

Speaker

Investing in the Future of our Industry
Jessica Federer, MPH


Speakers
avatar for Jessica Federer

Jessica Federer

ex-CDO, Bayer, United States
Jessica is an investor and board member adept at deploying technology to make meaningful advancements for both business and society. She was one of the first Chief Digital Officers in the pharma industry, leading the digital transformation for Bayer A.G. across the Pharmaceutical... Read More →
AK

Aditi Khurana

Director, Project Management, Asher Bio, United States
Aditi Khurana, is the Director of Project Management at Asher Biotherapeutics. She is a Project Management Professional (PMP) and is certified in Global Regulatory Affairs (RAC). She holds a Bachelors in Neuroscience from University of California, Los Angeles (UCLA) and a Masters... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  13: ProfDevelopment, Session

4:00pm CDT

Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way?
Component Type: Workshop
Level: Intermediate

Participants will have the opportunity to identify challenges on the preparation and maintenance of pharmacovigilance agreements (PVAs) and apply pharmacovigilance agreements optimization initiative solutions to simulated real-life situations, to provide delegates with helpful tools for their future work on PVAs.

Learning Objectives

Identify and discuss the key challenges in managing the pharmacovigilance agreements lifecycle; Discuss pharmacovigilance agreement (PVA) optimization solutions and tools to resolve issues related to PVAs; Identify and discuss other tools and solutions that may be applied to simplify PVAs.

Chair

Yvonne Gibble, BSN, MSN

Speakers
YG

Yvonne Gibble

Executive Director, Pharmacovigilance Licensing and Business Development, Merck & Co., Inc, United States
Yvonne is the Executive Director, Pharmacovigilance (PV) Partner and Strategy Management for Merck & Co. Inc., Rahway NJ and has 22 years of pharmaceutical experience, with 15 years in PV licensing. Yvonne leads a team who are accountable for the negotiation and alliance management... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Workshop

4:00pm CDT

Smarter Approaches to Pharmacovigilance Challenges
Component Type: Session
Level: Intermediate

This session will describe recent advances in a number of pharmacovigilance areas, including controlled distribution systems, safety registries, and the use of indication data in safety signal assessment.

Chair

Alan Hochberg

Speaker

Design Considerations When Digitizing a Controlled Distribution System
Andrew Hobbs

Combining a Site Network and Nested Sub Study Approach to a Safety Registry for Increased Patient Retention
Abbe Steel, MSc

Effect or Expect? Understanding your Indicated Population to Contextualize Safety Signals
Ashley Howell, PhD, MPH


Speakers
AH

Andrew Hobbs

Managing Partner, Axian Consulting Limited, United Kingdom
Andrew is a Managing Partner and founder of Axian Consulting Ltd. Axian are committed to improving patient safety outcomes by working with industry and regulators to deliver innovation through technology enabled services in risk management and minimisation. Prior to founding Axian... Read More →
avatar for Alan Hochberg

Alan Hochberg

Principal Scientific Enablement Director, Scientific Enablement and Processes, Genentech, A Member of the Roche Group, United States
Alan Hochberg is a Scientific Enablement Leader at Genentech, 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 →
AH

Ashley Howell

Pharmacoepidemiologist, Regeneron, United States
AS

Abbe Steel

Chief Growth Officer, CorEvitas, United States
Ms. Steel has more than 33 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 founded HealthiVibe, a patient centricity company which... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

4:00pm CDT

Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers and Clinical Care?
Component Type: Forum
Level: Basic

After regulatory approval, products still need coverage and clinical adoption. We will assess trial design elements and examples of pragmatic trials to understand whether pragmatic trials may simultaneously meet the needs of all three.

Learning Objectives

Define features of pragmatic and explanatory trials; Identify advantages and disadvantages of pragmatic and explanatory trials for regulatory bodies and payers; Discuss downstream impacts on different trial designs on choice of therapy in clinical practice, particularly providing personalized care tailored to individual patient characteristics and circumstances.

Chair

Elise Berliner, PhD

Speakers
EB

Elise Berliner

Global Senior Principal for Real World Evidence Strategy, Cerner Enviza, United States

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

4:00pm CDT

The Many Faces of In-Trial Interviews: Navigating Operational and Scientific Waters to Optimize Value for Clinical Trials
Component Type: Session
Level: Basic

This session presents the value of in-trial interviews and considers operational and scientific issues that determine their success. A case study approach will be used to highlight key decisions at different timepoints in the trial.

Learning Objectives

Describe the different types of in-trial interviews that can be conducted to contextualize traditional clinical and PRO data; Identify operational and scientific challenges associated with each interview type used; Appraise decisions about when and how to implement in-trial interviews to best suit your associated clinical trial timing and objectives.

Chair

Robert N. Krupnick, PhD, MA

Speakers
avatar for Robert Krupnick

Robert Krupnick

Senior Principal, Qualitative Research CoE Lead, Patient Centered Solutions, IQVIA, United States
Dr. Krupnick leads the Qualitative Research Center of Excellence for the Patient Centered Solutions Team at IQVIA. He is a psychologist with over 25 years of experience as an insights research and consulting professional, largely focused on strategic pharmaceutical and biotech assignments... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session

4:00pm CDT

IDMP and Data Harmonization Methods: How Your Company will be Impacted
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

No Patient Left Behind: Global Dossier
Ciby Joseph Abraham, PhD

Five Ways that Every Company will be Impacted by IDMP Data Standards
Niels Buch Leander, PhD


Speakers
avatar for Ciby Abraham

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States
Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States
V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience... Read More →
avatar for Niels Leander

Niels Leander

Associate Vice President, Global Head of Regulatory Affairs, NNIT, Denmark
Niels Buch Leander is leading Regulatory Affairs and Safety at NNIT, responsible for NNIT's delivery and business development within Regulatory Affairs and Safety. He is revenue responsible for 100+ consultants and people management responsible for 40+ RA and Safety business consultants... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

4:00pm CDT

SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Brooke Casselberry, MS, RAC

Speaker

Is SMART on FHIR the Key to Unlocking Real-World Data?
Mary Lou McCoy

Patient Registries in the Era of Electronic Health Record Big Data
Elise Berliner, PhD


Speakers
EB

Elise Berliner

Global Senior Principal for Real World Evidence Strategy, Cerner Enviza, United States
avatar for Brooke Casselberry

Brooke Casselberry

Associate Vice President, NNIT, 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 →
ML

Mary Lou McCoy

Digital Marketing Director, OpenClinica, United States

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

4:00pm CDT

Generating Patient Insights to Inform Health Policy Issues: Policy Patient Engagement Research Councils (PERCs)
Component Type: Forum
Level: Basic

We conducted patient focus groups to study patient experience with unintended consequences of healthcare programs and health policies such as co-pay coupons and accumulators, non-medical switch, utilization management, and out of pocket costs. In this forum, we will present perspectives around how we developed and executed this novel policy/patient engagement approach—from the policy research perspective, the population health perspective, and the patient engagement perspective—and discuss the importance of developing the capabilities to study patient perspectives and how these insights influence and guide many different aspects around policy, population health, and market access strategies.

Learning Objectives

Discuss the critical importance of generating patient-level insights into U.S. healthcare policy and policy-position development; Identify patients’ perspectives and experiences to understand how public healthcare policies impact their health outcomes, financial health, and mental health; Interpret and apply the findings into patient-centered policy development, strategies, and communications.

Chair

Bridget Doherty, MPH

Speakers
avatar for Bridget Doherty

Bridget Doherty

Director, Market Access Scientific and External Strategy, Janssen Scientific Affairs, United States
Bridget Doherty, MPH, is director of Market Access Scientific and External Strategy at Janssen Scientific Affairs where she develops evidence and insights around U.S. healthcare policies and their impact on patient access and outcomes. She has held leadership roles within scientific... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Forum

4:00pm CDT

An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward?
Component Type: Session
Level: Intermediate

Recent advances in digital health and digital tools can help overcome challenges associated with cell and gene therapies (CGTs). The predictive power of artificial intelligence (AI), better diagnostic abilities and virtual twins can help address many of the issues. This interactive session will discuss such advances and their practical application in the "real world" and illustrate how digital health technologies can address the challenges faced by CGTs and explore what exactly these digital health technologies are.

Learning Objectives

Evaluate the inherent challenges associated with cell and gene therapies (CGTs), which make the manufacturing, clinical trial process, and regulatory considerations more complex than for traditional therapies; Identify whether digital health tools can help address some of the uncertainties and difficulties associated with CGTs; Illustrate some examples of digital health tools and how they can help fill the gaps.

Chair

Marie Manley

Speakers
avatar for Marie Manley

Marie Manley

Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP, United Kingdom
Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: TranslationalScience-PrecisionMedicine, Session

4:00pm CDT

Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation
Component Type: Session
Level: Advanced

Audience should have intermediate to advanced knowledge of GxP and of data analytics

Chair

Timothe Menard, PharmD, MSc

Speaker

Leveraging the Power of Natural Language Processing for Quality Assurance Activities
Kelly Kwon, MPH

Application of Data Science, Text Analytics, and Machine Learning to Derive Insights from Clinical Quality and Compliance Data
Meera Nagaria, MS


Speakers
avatar for Kelly Kwon

Kelly Kwon

Data Scientist, Genentech, A Member of the Roche Group, United States
avatar for Timothe Menard

Timothe Menard

Head Quality Data Science and Bioethics Coach, PDQ, F. Hoffmann-La Roche, Switzerland
Timothé Menard started his industry career in 2009 in Pharmacovigilance (PV) and had different roles in PV (operational and strategic) that brought him to live in various parts of the world (Switzerland, S'pore and Germany). He joined Roche as a GCP/PV auditor in 2015 and dived into... Read More →
avatar for Meera Nagaria

Meera Nagaria

Data Scientist, Johnson and Johnson, United States

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Session

4:00pm CDT

Globally Accelerating the Drive to eLabeling for All
Component Type: Session
Level: Intermediate

The rapid increase in digitalization of our everyday life indicates that time is right for e-labeling. The many advantages that e-labeling offers support this but several technological and legislative hurdles remain. This session will discuss how these hurdles can be overcome by looking at best practices from around the globe.

Learning Objectives

Describe the current state of play regarding the technological development of ePI; Discuss future trends of required legislative readiness.

Chair

Koen Nauwelaerts, PharmD, PhD, MBA

Speaker

Electronic Labeling: How Have We Done and Where are We Going?
Rie Matsui, RPh

e-PI: Moving Towards a Digital and Green Transformation
Isabelle Colmagne-Poulard, PharmD, MBA, MSc


Speakers
avatar for Isabelle Colmagne-Poulard

Isabelle Colmagne-Poulard

Head, International Global Regulatory Affairs & Scientific Policy, Merck KGaA, Switzerland
Isabelle has joined Merck Serono since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She is actively engaged in international regulatory policy as member of IFPMA Biotherapeutics WG and IFPMA Regulatory Strategy Committee since 2015. She... Read More →
avatar for Rie Matsui

Rie Matsui

Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan, Japan
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

4:00pm CDT

PMDA Town Hall
Component Type: Session
Level: Intermediate

PMDA is implementing new regulations to promote regulatory sciences and accelerate product developments based on “4Fs”, the priorities. In this session, PMDA will share the latest details regarding its policies and initiatives.

Learning Objectives

Recognize latest information on the Pharmaceuticals and Medical Devices Agency’s activity and Japanese regulations in medical products area; Discuss issues on medical products regulation with senior PMDA officials.

Chair

Nobumasa Nakashima, PhD

Speakers
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 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

4:00pm CDT

Quality Aspects of FY23-28 User Fee Agreements
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Demetra Macheras, MBA

Speaker

PDUFA VII Challenges and Opportunities: FDA and Industry Perspectives
Cecilia Tami, PhD


Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, Inc., United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S. and Canada regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and final regulatory... Read More →
CT

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, A Member of the Roche Group, United States

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session

4:00pm CDT

Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology
Component Type: Session
Level: Advanced

This session will present approaches to enhance endpoints in cancer trials from a clinical and patient perspective, in particular approaches that consider trade-offs between time spent in different disease and treatment states.

Learning Objectives

Describe opportunities for incorporating patient preferences and multi-state models into cancer drug development and evaluation; Discuss new approaches to enhance the patient-focus of traditional endpoints in oncology.

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session

4:00pm CDT

Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions
Component Type: Forum
Level: Intermediate

This forum will present examples of how real-world data ( RWD) can be used to generate evidence for reimbursement and coverage decisions. A panel of experts will facilitate a broad discussion with topics ranging from specific use cases to general best practices.

Learning Objectives

Describe best practices for using real-world data (RWD) and real-world evidence (RWE) that are intended for coverage and formulary decisions; Understand the appropriate use of RWE for supplementing clinical trial data in value-based analyses; Recognize the complexity of analyzing the effects of coverage decisions on patient outcomes.

Chair

Michael J Munsell, PhD

Speakers
MM

Michael Munsell

Director of Research, Panalgo, United States
Michael Munsell, PhD, is the Director of Research at Panalgo, where he is responsible for managing internal and collaborative research in a variety of fields, including health economics, outcomes research, and data science/machine learning, as well as contributing to the development... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Forum
 
Wednesday, June 28
 

8:30am CDT

Advancing PV in Africa
Component Type: Session
Level: Intermediate

to be updated

Learning Objectives

to be updated

Chair

Leslie Sam

Speaker

Implementing Good Pharmacovigilance Practice Requirements in Low- and Middle-Income Country: Ghana’s Experience
George Sabblah, MPH

The Impact of Pharmacovigilance Strategic Transformations: Three African Countries Case Studies
George Sabblah, MPH

The Impact of the Transformation of the Nigerian Pharmacovigilance Reporting and Surveillance Systems for Marketed Products
Moji Christianah Adeyeye, MPharm, RPh


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 →
GS

George Sabblah

Head of Department of Safety Monitoring, Food and Drugs Authority , Ghana
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 →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

8:30am CDT

Using Real-World Data to Evaluate Safety Signals
Component Type: Session
Level: Intermediate

This session will cover advances in the use of real-world data for the rapid and effective evaluation of emerging safety signals.

Chair

Jeffrey Brown, PhD

Speaker

Using Real-World Data to Support Pharmacovigilance Signal Refinement and Evaluation Activities
Jeffrey Brown, PhD

Current Practice and Opportunities for Rapid Use of Real-World Data (RWD) in Safety Signal Assessment
Vaishali Patadia, MPH


Speakers
JB

Jeffrey Brown

Chief Scientific Officer, TriNetX, United States
Jeffrey Brown, PhD, Chief Scientific Officer at TriNetX and Lecturer (parttime) at Harvard Medical School (HMS), is an internationally recognized expert in the use of real-world data to support the evidentiary needs of regulatory agencies and medical product sponsors. He has 25+ years... Read More →
avatar for Vaishali Patadia

Vaishali Patadia

Executive Director, Signal Mgt and Risk Mgt; TransCelerate Lead, Amgen, United States
Vaishali Patadia, PhD, MPH, MBA is an Executive Director, Head of Signal Management and Risk Management Center of Excellence, Global Patient Safety in Amgen. She is also the lead for TransCelerate’s Rapid Signal Assessment using Real World Data workstream. Dr. Patadia has 22+ years... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

8:30am CDT

Returning Individual Participant Data: A Cultural and Operational Shift Towards Personalized Clinical Trial Options
Component Type: Forum
Level: Intermediate

Many global stakeholders are seeking to develop solutions for patients and study participants who wish to become more informed decision makers when it comes to their care options, including clinical trials as a potential option. A forum convening key industry thought leaders already working in this space will expalin how they can serve to raise awareness, share best practices, and establish much needed support to achieve long term objectives that will ultimately lead to a future state where patients and study participants are fully engaged in their health care systems, including clinical research.

Learning Objectives

Discuss pragmatic strategies for improving personalized flexible clinical trial options for returning certain types of individual participant data to those who opt into receiving it without impacting data integrity, confidentiality, safety, and drug approval timelines; Identify opportunities designed to empower informed participants to help with personal decision making.

Chair

Jean Sposaro, LLM

Speakers
JS

Jean Sposaro

Director Global Business Lead, Industry Collaborations: TransCelerate Program Le, Bristol Myers Squibb, United States
Healthcare Provider, Researcher, Patient Advocate and Regulatory Policy & Law Professional committed to advancing science through high quality data driven evidence-based collaboration designed to put all patients' unmet needs central to the research & development of safe and effective... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

8:30am CDT

Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making
Component Type: Forum
Level: Intermediate

Through use cases, this forum will explore a tool to assess real-world data (RWD) quality that helps meet regulatory expectations and facilitate a discussion with Health Authorities regarding their expectations for the submission of patient-level data and for inspections.

Learning Objectives

Describe considerations in the publicly available real-world data (RWD) audit readiness considerations tool supporting audits of RWD used for regulatory decision-making; Discuss the regulatory expectations for the submission of patient-level data and for inspections using case studies to facilitate discussion.

Chair

Abi Seifert, MBA

Speakers
AS

Abi Seifert

Global Head, Clinical and PV QA, Novartis Pharmaceutical Corporation, United States
Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum

8:30am CDT

The Rapidly Changing Landscape of Data Collection and its Implications for Clinical Data Management
Component Type: Forum
Level: Intermediate

An expert panel will discuss how data acquisition in clinical trials is changing, what new opportunities and challenges arise for clinical data management teams, and how they need to respond to deliver high-quality analysis-ready data, faster.

Learning Objectives

Discuss how the evolution in data acquisition technologies and decentralized trials impacts data management teams; Describe how to apply new technologies to streamline clinical data review and cleaning; Create a roadmap for adopting the next generation of clinical data management skills, processes, and technologies.

Chair

Teresa Fishburne, MBA

Speakers
avatar for Teresa Fishburne

Teresa Fishburne

Vice President, Strategy and Transformation, Medidata, United States
Teresa leads Medidata’s Strategy & Transformation Team and is responsible for the delivery and execution of comprehensive and complex solutions for Pharmaceutical and Medical Device companies, globally. Teresa has over 20 years' experience in Clinical Operations including 10+ years... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum

8:30am CDT

Writing Summary Documents for Rare Disease Submissions: Unique Challenges
Component Type: Session
Level: Intermediate

Rare diseases are heterogenous and most involve very few patients. Data to support these NDAs comes from multiple sources posing unique challenges in preparing clinical summaries. This session aims to explore and brainstorm potential solutions.

Learning Objectives

Recognize challenges in preparing clinical summary documents for New Drug Applications (NDAs); Analyze the differences and gaps relative to NDAs based on adequately powered controlled studies; Initiate plan of action including contingency planning; Identify stakeholders (internal and external) to engage.

Chair

Anjana Bose, PhD

Speakers
AB

Anjana Bose

Director, Global Submissions, Certara/Synchrogenix, United States
With a career spanning over 30 years in the pharmaceutical industry, Dr. Bose has extensive experience across clinical development, data analytics, regulatory writing, and leadership role in regulatory submissions. During last 15 years, she has led New Drug Applications and Biologic... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

8:30am CDT

Leveraging Project Management Skills for Significant Drug Development Deliverables
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Michael Orsini, PhD

Speaker

Building a Clinical Development Plan That Everyone Can Understand and Use
Michael Orsini, PhD

Project Management Tools and Competency Skills That Can Aid in Addressing Key Challenges Faced During Market Applications
Ivy Nyarko


Speakers
IN

Ivy Nyarko

Project Manager, Dr. Reddy's, United States
Accomplished Project Leader with robust full-cycle pharmaceutical project management experience and a history of success guiding teams through R&D, regulatory filings, and commercial planning. Proven success facilitating collaboration among dynamic cross-functional global teams, ensuring... Read More →
avatar for Michael Orsini

Michael Orsini

Director, Global Project Management and Leadership, Daiichi Sankyo, Inc, United States
Dr. Michael Orsini is the lead PM and portfolio manager at Daiichi Sankyo for the ENHERTU indications other than breast cancer, referred to as Gastric, Gynecologic, Lung and More. Prior to joining Daiichi Sankyo, Dr Orsini was an Associate Director at Merck, where he led the initiation... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjectManagement-StrategicPlanning, Session

8:30am CDT

Strategies for Benefit-Risk Analysis in Regulatory Submissions
Component Type: Workshop
Level: Intermediate

This workshop will introduce practical approaches to qualitative and quantitative benefit-risk assessment and communication, and illustrate interactively some methods and best practices on how to include these in regulatory submissions.

Learning Objectives

Describe pros and cons of different approaches for benefit-risk assessment in regulatory submissions; Discuss how to practice some qualitative and quantitative benefit-risk assessment approaches.

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Workshop

8:30am CDT

Strategies to Make the Right Virtual Connection: Play and Learn
Component Type: Workshop
Level: Basic

Are you looking for effective ways to expand your virtual network? How do you select who to reach out to? How do you make your message stand out and make meaningful connections? Come and play a networking game to find out.

Learning Objectives

Discuss the inherent challenges of networking in a virtual setting; Identify through a networking game the characteristics and the recipe of successful professional networking; Apply the three strategies of improving virtual connections: keep an open mind, identify common interests and think broadly about what you can give.

Chair

Sara Tylosky, MBA

Speakers
avatar for Sara Tylosky

Sara Tylosky

Chief Executive Officer, Farmacon Global, United States
Experienced Global Executive with over 20 years of leading diverse teams in a fast-paced environments in both big and small pharmas. As CEO at Farmacon Global for the past 10 years, a strategic CRO with medical consultants to accelerate clinical research and market access projects... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  13: ProfDevelopment, Workshop

10:30am CDT

Opportunities to Improve Risk Minimization Outcomes with Behavioral Science
Component Type: Session
Level: Intermediate

The outcomes of additional risk minimization measures (aRMM or REMS ETASU) could be improved through the application of learnings from behavioural and implementation science, providing MAHs with more effective, easily measurable programs.

Learning Objectives

Describe how additional risk minimization measures could benefit from the application of principles from behavioral and implementation sciences; Discuss which models/theories frameworks may be most applicable for improving the outcomes of additional risk minimization measures; Identify and explore the potential of behavioral and implementation sciences in aRMM.

Chair

Marie-Claire Wilson, MD, MA

Speakers
avatar for Marie-Claire Wilson

Marie-Claire Wilson

Engagement Manager, Axian Consulting, United Kingdom
Marie-Claire is an Engagement Manager at Axian Consulting with nearly 15 years’ experience of life science consulting across a range of pharmaceutical companies and business areas. Recently she has focused on product risk management, looking at new ways for MAHs to achieve their... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

10:30am CDT

Registries Aren’t Always the Answer: Novel Designs for Executing Post-Market Pregnancy Requirements
Component Type: Forum
Level: Intermediate

In this forum, a panel of experts will discuss current study design gaps in regulatory guidance on post-market pregnancy studies, the challenges of executing traditional pregnancy registries, and alternative study designs and methods.

Learning Objectives

Identify and discuss limitations of traditional pregnancy registries to fulfill post-market pregnancy studies for conditions when use of the medicinal product is discouraged among pregnant women, when the condition is rare overall or rare among women of child-bearing potential; Propose and compare novel designs and methods to execute pregnancy studies more efficiently.

Chair

Isha Mehta, MPH

Speakers
avatar for Isha Mehta

Isha Mehta

Senior Manager, Pharmacoepidemiology, Regeneron, United States
Isha Mehta is a Senior Manager on the Pharmacoepidemiology team at Regeneron Pharmaceuticals where she oversees two global, post-marketing pregnancy studies. Before joining Regeneron, she previously worked as a Senior Principal Epidemiologist at Biogen where she contributed to several... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Forum

10:30am CDT

Best Practices for Managing Rare Disease Trials in Latin America as an Emerging Trial
Component Type: Session
Level: Intermediate

Rare disease trials in Latin America impose unique challenges for all stakeholders in clinical research. Assisting patient access to treatments requires the understanding of the cultural, societal, logistical, regulatory and other particularities. This session will discuss the strategies that may be applied in clinical research for better access for rare disease patients.

Learning Objectives

Describe the unique challenges of access to treatments for rare disease patients in Latin America; Discuss strategies for better access in rare disease clinical research in emerging markets.

Chair

Sara Tylosky, MBA

Speakers
avatar for Sara Tylosky

Sara Tylosky

Chief Executive Officer, Farmacon Global, United States
Experienced Global Executive with over 20 years of leading diverse teams in a fast-paced environments in both big and small pharmas. As CEO at Farmacon Global for the past 10 years, a strategic CRO with medical consultants to accelerate clinical research and market access projects... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session

10:30am CDT

Leveraging Data Scientists and Data Managers with Evolving Protocol Designs  
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Speaker

The Importance of Having Clinical Data Managers as a Key Part of the Protocol Design Process
Joby John, DDS

Level Up: How Clinical Data Management Can Leverage Data Science and Statistics Principles to Evolve
Derek Lawrence

Embracing Clinical Data Science Within Your Organization
Sas Maheswaran


Speakers
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 →
avatar for Joby John

Joby John

Senior Director, Clinical Data Systems and Services, Clario, United States
Dr Joby John is a versatile Clinical Research executive with over 20 years of experience in managing end to end clinical services like EDC, CDM, SDTM, SAS, IWRS, eTMF to name a few. She has worked with a wide array of global Pharma companies, CROs and FSPs in setting up and managing... Read More →
DL

Derek Lawrence

Senior Director, Clinical Data & Programming, TrialSpark, United States
Derek is the Director of Clinical Data & Programming at TrialSpark and has over 13 years of experience in clinical research, with strong focus in biometrics, programming, systems implementation & integration, and software development. Prior to joining TrialSpark, Derek spent his career... Read More →
SM

Sas Maheswaran

Principal Engagement Consultant, Medidata, United Kingdom

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

10:30am CDT

Operationalizing Real-World Data: Methods, Acceptance, and Future Hopes 
Component Type: Session
Level: Intermediate

to be determined

Learning Objectives

to be determined

Chair

Wendy Charles, PhD

Speaker

Operationalizing Real-World Data Linkages in a Real-World Clinical Trial
Vera Mucaj, PhD

Leveraging the Braintrust: How Communities of Practice Can Drive Acceptance of Real-World Evidence for Regulatory Decision-Making
Virginia Acha, PhD, MSc

New Sources of Real-World Data: Lessons Learned and Future Hopes
Tatyana Fedotova, PhD


Speakers
avatar for Virginia Acha

Virginia Acha

AVP, Global Regulatory Policy, Merck Sharp & Dohme LLC, United States
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better... Read More →
avatar for Wendy Charles

Wendy Charles

Chief Scientific Officer; Adjunct Faculty, Burstiq; Health Admin Program, CU Denver Business School, 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 Tatyana Fedotova

Tatyana Fedotova

Director, Global Data, Platforms and Partnerships, Johnson & Johnson, United States
avatar for Vera Mucaj

Vera Mucaj

Chief Scientific Officer, Datavant, United States
Vera is the Chief Scientific Officer at Datavant. She leads a team focused on developing the technical product, and defining key use cases for connected health data in research. Vera is a research scientist by training, and holds a BA in Biochemistry from Harvard College, and a PhD... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

10:30am CDT

Is the Hype Real? Real-Life User Experience of Medical Writing Artifcial Intelligence Tools for Clinical Study Reports Production
Component Type: Session
Level: Intermediate

In this session, a medical writer with more than 25 years of experience describes the ways in which an artifical intelligence (AI) tool that is used to assist medical writers in preparing clinical study reports (CSRs) has changed her life as a medical writer. Small case studies will be presented to explain how the tool is applied in the writing process.

Learning Objectives

Describe how an artificial intelligence tool for medical writing is being integrated into the day-to-day life of medical writers; Identify how this tool is changing the process of planning, writing, and thinking about documents, with a focus on clinical study reports.

Chair

Julia Forjanic-Klapproth, PhD

Speakers
avatar for Julia Forjanic-Klapproth

Julia Forjanic-Klapproth

Senior Partner/President, Trilogy Writing & Consulting, Germany
After receiving her PhD in Developmental Neurobiology, Julia became a medical writer in 1997. In 2002, she co-founded Trilogy Writing & Consulting, a company specialized in medical writing of regulatory documentation. As Senior Partner and CEO, she continues to bring her enthusiasm... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

10:30am CDT

Combining Qualitative and Quantitative Research to Generate Within-Patient Meaningful Changes in Clinical Outcome Assessments
Component Type: Session
Level: Intermediate

This session presents a summary (using case studies) of the key considerations in quantitative and qualitative approaches to establishing meaningful change thresholds (MCTs), and the optimal methods of presenting this data to various stakeholders.

Learning Objectives

Describe the derivation of within-patient meaningful change thresholds (MCTs) in clinical outcome assessments (COAs) using qualitative and quantitative approaches; Explain the role of triangulation; Identify how to graphically present MCT data.

Chair

Stephanie Rhoten, PhD

Speakers
SR

Stephanie Rhoten

Associate Director, IQVIA, United States
Dr. Rhoten is an Associate Director at IQVIA, Patient Centered Analytics, and has over seven years of experience in quantitative methods and data analytics. Her expertise converges upon statistically assessing clinical trial endpoints and and validating clinical outcome assessments... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Session

10:30am CDT

What Can ICH Bring to the Future of Model-Informed Drug Development (MIDD)?
Component Type: Session
Level: Intermediate

MIDD can enhance the efficiency of drug development and regulatory decision-making. The ICH M15 guideline aims to enable the further integration and consistent use of MIDD. This session will cover the associated objectives, scope, and priorities.

Learning Objectives

Discuss current approaches, best practices, and future opportunities to enhance global drug development and regulatory decision-making through the use of model-informed approaches; Identify aligned positions from the ICH M15 IWG.

Chair

Erin Greene, JD

Speakers
EG

Erin Greene

Senior Manager, Regulatory Policy, Pfizer Inc, United States

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: TranslationalScience-PrecisionMedicine, Session

10:30am CDT

PI 1572 Responsibility and Oversight in Decentralized Clinical Trials
Component Type: Session
Level: Intermediate

Decentralized clinical trials (DCTs) are becoming more common, yet there is uncertainty about principal investigator (PI) responsibilities under Form 1572. This session will offer insights into issues encountered with PI oversight of decentralized elements.

Learning Objectives

Discuss issues that drive principal investigator (PI) oversight and responsibility in modern clinical trials where research and data gathering activities are no longer confined to the traditional site model; Describe findings from a survey of sponsors’ and investigators’ experiences with PI oversight under the 1572 form in decentralized clinical trials (DCTs).

Chair

Pamela Tenaerts, MD, MBA

Speakers
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 →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Session

10:30am CDT

25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness?
Component Type: Session
Level: Intermediate

Confirmatory evidence is an under recognized path in FDA’s legal authority to approve drug marketing applications. An exploration of recent FDA actions and policy statements reveal how FDA is applying this 25-year old aspect of the law.

Learning Objectives

Discuss and analyze factors that affect applicability of the confirmatory evidence statutory standard; Recognize translational and clinical aspects of a drug development program that may have potential utility as part of a confirmatory evidence strategy.

Chair

Charles G. Raver, JD

Speakers
avatar for Charles Raver

Charles Raver

Associate Attorney, Hyman, Phelps & McNamara, PC, United States
Charles G. Raver is a food and drug law attorney who assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. His practice supports clients throughout... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

10:30am CDT

Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations?
Component Type: Forum
Level: Intermediate

FDA’s Project Optimus emphasizes the importance of dose optimization oncology. Often, oncology drugs are studied in combination with other therapies. This session will focus on dose optimization for combinations and challenges still to be addressed.

Learning Objectives

Explain how FDA expectations for dose optimization may be challenging for combinations; Discuss practical approaches for dose optimization in combinations and current challenges; Discuss unanswered questions and next steps for advancing dose optimization in this context.

Chair

Jacqueline Kline, PhD

Speakers
avatar for Jackie Kline

Jackie Kline

Vice President, Global Regulatory Affairs Oncology, Amgen, United States
Jackie Kline has worked in pharmaceutical and biotech research and development for over 25 years and currently serves as Vice President of Global Regulatory Affairs Oncology at Amgen. With a comprehensive understanding of global regulatory requirements, approval pathways and an aptitude... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

10:30am CDT

Health Canada Town Hall
Component Type: Forum
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Alysha Croker, PhD

Speakers
avatar for Alysha Croker

Alysha Croker

Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada
Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

10:30am CDT

Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains
Component Type: Session
Level: Intermediate

This session will address one of the major hurdles for implementing reliance pathways-how to ensure that relying countries receive the same product as the reference country? Regulators and industry representatives will discuss based on real-life examples.

Learning Objectives

Discuss the importance of product sameness for reliance and learn about the joint industry position on product sameness; Identify real-life examples for global supply chains of multinational companies and understand how sameness of products is ensured; Describe different stakeholder perspectives and what needs to be done to build the trust which will enable the use of reliance.

Chair

Susanne Ausborn, PhD

Speakers
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session

10:30am CDT

Patient-Focused Drug Development in Rare Disease Endpoint Selections
Component Type: Session
Level: Intermediate

There are many challenges facing the new drug development for rare diseases. Overcoming these challenges and therefore to achieve optimal drug development for rare disease require implementations of innovative design and analysis methods as well as strategic collaborations among regulatory, sponsors, physicians, institutions, and patients and patient groups. For this session, we will focus on one critical need in rare disease new drug development-endpoint selections.

Chair

Susan Wang, PhD

Speakers
avatar for Susan Wang

Susan Wang

Global Head of Biostatistics and Data Sciences Inflammation, Boehringer Ingelheim Pharmaceuticals Inc., United States
Dr. Susan Wang is the global head of biostatistics and Datas Sciences in inflammatory diseases at Boehringer-Ingelheim Pharmaceuticals, Inc., in Ridgefield, Connecticut. She has many years of experiences working on global drug developments and registrations as a lead statistician... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session

10:30am CDT

How Real-World Data from Wearable Biosensors and Artifical Intelligence (A)I-Based Analytics Is Enabling the Shift from Efficacy to Effectiveness
Component Type: Forum
Level: Intermediate

We will review how incorporating continuous real-world patient data from wearable biosensors and artificial intellegence (AI)-based analytics into the entire product lifecycle is creating a “flywheel effect” of improved, data-driven R&D and commercial decision-making.

Learning Objectives

Examine how incorporating continuous real-world patient data from wearable sensors and artificial-intelligence (AI)-based analytics into product lifecycles is enabling the shift from efficacy to effectiveness, leading to better, data-driven decision-making; Discuss how new technologies are bridging translational medicine and value-based medicine to better support patient, regulator, payer, and provider needs.

Chair

John Varaklis

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Forum

1:15pm CDT

Operationalizing FDA Medical Queries
Component Type: Session
Level: Intermediate

This session will introduce new FDA guidance focused on enhancing safety analytics and discuss how cross-industry working groups have been preparing the ecosystem for operationalizing them: FDA Medical Queries and Standard Safety Tables and Figures.

Learning Objectives

Describe operationaling FDA medical queries, standard safety tables, and figures (whitepapers); Describe adverse events groupings in safety (points to consider); Identify aggregate safety assessment planning (process); Discuss an interactive safety graphics (toolkit).

Chair

Greg Ball, PhD

Speakers
avatar for Greg Ball

Greg Ball

Owner and Consultant, ASAP Process Consulting, 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 →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

1:15pm CDT

Regulatory Insights into Decentralized Clinical Trials
Component Type: Session
Level: Basic

The COVID-19 pandemic improved the acknowledgement and concept of decentralized clinical trials (DCT). We will share our guidance on conducting clinical trials during COVID-19 pandemic and our insights into decentralized clinical trial.

Learning Objectives

Describe the regulatory insights into decentralized clinical trial; Discuss the Asian experience of decentralized clinical trial and digital tools use in the trial.

Chair

Hsin-Jung Chuang, MS, RPh

Speakers
HC

Hsin-Jung Chuang

Associate Reviewer, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Taiwan

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session

1:15pm CDT

Today’s Episode of Clinical Research Talk Explores Clinical Adjudication and Practical Applications of Artifical Intelligence and Natural Language Processing
Component Type: Session
Level: Basic

Clinical adjudication by experienced third parties offers important safeguards for patients. Learn how it can lend compelling support for drug or device approvals and hear the latest uses for artificial intelligence (AI) and natural language processing (NLP) with special emphasis on protected health information (PHI) de-identification.

Learning Objectives

Explain when a study should include a clinical event committee to adjudicate event types; Describe the value of artificial intelligence (AI) and natural language processing (NLP) in saving time and money for sites and sponsors.

Chair

Ahlam Samad

Speakers
AS

Ahlam Samad

Brand Communications Manager, Clario, United States

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session

1:15pm CDT

Managing BYOD and Wearables in Clinical Trials: Sustainable Data Collection
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

Implementation of Wearables in Clinical Trials: Lessons from the eCOA Consortium
Scottie Kern

How Much Data is Too Much Data? Optimizing Sustainable Data Collection from Wearable Sensors
Ben Schlatka

Benefits and Challenges of Bring-Your-Own-Device for Collecting Patient-Reported Outcomes in Medical Product Development
Julia K. Garcia, PhD, MS


Speakers
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States
V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience... Read More →
avatar for Julia K Garcia

Julia K Garcia

Director, Patient-Centered Outcomes Research, AbbVie, United States
Julia K. Garcia, PhD, MS is a Director in the Patient-Centered Outcomes Research group at AbbVie, Inc. She is a subject matter expert on patient experience data particularly the development, implementation, and analysis of patient-reported outcomes and strategic communication of these... Read More →
avatar for Scottie Kern

Scottie Kern

Executive Director, eCOA Consortium, Critical Path Institute, United Kingdom
A patient-based clinical technologies expert with over 25 years of clinical research experience, Scottie serves as the Executive Director of the eCOA Consortium at Critical Path Institute. Beginning his career in clinical data management, Scottie first encountered ePRO technology... Read More →
BS

Ben Schlatka

Vice President, Digital Biomarker Solutions, Sensor Cloud, Medidata, United States

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

1:15pm CDT

Estimands and Designing of the Clinical Trial and Protocol Structure
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Robin Whitsell

Speakers
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 of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

1:15pm CDT

Capturing the Patient Voice Using Longitudinal Qualitative Research Methods in Medical Product Development
Component Type: Workshop
Level: Intermediate

Non-traditional qualitative methods (e.g., longitudinal qualitative interviews) have the potential to generate in-depth insights that are valuable to support medical product development across the lifecycle and during regulatory review. This workshop will explore practical considerations for study design and implementation (including benefits considerations for preserving clinical trial data integrity). Perspectives from research experts, regulatory, and patient representatives will be shared and key working models will be explored through case studies. Polling questions will help facilitate audience participation and inquiry.

Learning Objectives

Explore the use of non-traditional qualitative methods to inform regulatory review; Discuss best practices and key considerations for designing and implementing longitudinal qualitative research (LQR) in clinical trials; Explore patient, industry, and research expert perspectives on practical LQR study design and feasibility considerations.

Chair

Ebony Dashiell-Aje, PhD

Speakers
avatar for Ebony Dashiell-Aje

Ebony Dashiell-Aje

Executive Director and Head, Patient Centered Outcomes Science, BioMarin Pharmaceutical Inc., United States
Dr. Dashiell-Aje is a leading expert in clinical outcome assessment (COA) design and implementation, advising on COAs, study endpoint issues and regulatory science. As a health outcomes researcher and methodologist, Dr. Dashiell-Aje is driven by her passion for public health and promoting... Read More →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Workshop

1:15pm CDT

Fostering Cross-Functional Team Success with Project Management and Alliance Management Best Practices
Component Type: Session
Level: Intermediate

Project managers can benefit from alliance management best practices and vice versa. Cross-functional leadership requires leveraging both project management (PM) and alliance management (AM) skills, employing sound business acumen, and fostering strong cross-functional teamwork.

Learning Objectives

Optimize leading teams and delivering business objectives by honing project management (PM) and alliance management (AM) skills; Identify best practice PM and AM competencies to improve cross-functional teamwork, strategic thinking, and negotiations; Leverage PM and AM tools to support rapid, informed decision making, improvecommunications, and strengthen influencing without authority.

Chair

Susan Carino, MBA, MS, PMP, RAC

Speakers
avatar for Susan Carino

Susan Carino

Principal Consultant, Integrated Project Management Company, Inc., United States
Susan Carino is a Principal Consultant with Integrated Project Management Company. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She leads diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics... Read More →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjectManagement-StrategicPlanning, Session

1:15pm CDT

Industry and Regulators’ Experience with the Implementation and Use of Remote Consent
Component Type: Session
Level: Intermediate

This session will describe how our experience, both for industry and regulators, using electronic methods for obtaining consent has shifted in recent years. The COVID-19 pandemic served as a catalyst for the adoption of various methods to support enrollment into clinical trials during this period. Industry and regulator perspectives on best practices for the adoption of electronic and remote mechanisms for obtaining informed consent in clinical trials will be discussed including, potential benefits, possible pitfalls, and associated regulatory expectations.

Learning Objectives

Discuss regulatory expectations regarding implementation of electronic and remote methods of obtaining informed consent; Identify insights into regulatory and industry experiences using electronic and remote informed consent.

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Session

1:15pm CDT

FDA Rare Disease Town Hall
Component Type: Session
Level: Intermediate

Despite both old and new initiatives and incentives to encourage orphan drug development, the challenges of doing so persist. Senior FDA leaders discuss scientific and regulatory issues, current trends, new programs, and future opportunities.

Learning Objectives

Identify key FDA regulatory programs and policies to support development of drugs for rare diseases. Integrate opportunities for expedited programs and other regulatory pathways into development programs for orphan drugs Recognize and report on hot topics and key regualtory trends in the rare disease arena

Chair

James Valentine, JD, MHS

Speakers
avatar for James Valentine

James Valentine

Director, 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 →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

1:15pm CDT

The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act
Component Type: Session
Level: Advanced

Biosimilars and interchangeable biologics (IC’s) have global development programs. But regulatory requirements are far from harmonized. This creates challenges for biosimilars and interchangeable products and may affect their development, especially in the US. What is the future of this burgeoning industry? This session will find out!

Learning Objectives

Discuss the impact of the inflation reduction act on biosimilar development in the US and globally; Identify regulatory requirements around the globe on interchangeability and evidence-generation to determine if streamlined development is possible; Describe a real-world evidence approach to demonstrating interchangeability.

Chair

Rachel Turow, JD, MPH

Speakers
avatar for Rachel Turow

Rachel Turow

Associate General Counsel, Regulatory Law and Policy; Head, US Regulatory Policy, Teva Pharmaceutical Industries Ltd., United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

1:15pm CDT

Evolving Global Landscape for Addressing Drug Shortages: Innovative Strategies in the Area of Regulatory and Technology
Component Type: Session
Level: Intermediate

This session will highlight the changing global landscape for addressing drug shortages, with a focus on FDA and EMA regulatory requirements and initiatives, and eLabeling as an example of an innovative digital solution.

Learning Objectives

Describe how regulatory and digital innovations improve drug shortage prevention; Discuss regulator insights on progress: FDA to share progress on implementing drug shortages and quality-related initiatives relating to drug shortage prevention; EMA or leading industry expert to demonstrate how eLabeling can be an effective tool in preventing drug shortages.

Chair

Janelle Derbis, PharmD

Speakers
avatar for Janelle Derbis

Janelle Derbis

Associate Director, Regulatory Affairs, Merck Sharp & Dohme LLC, United States

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session

1:15pm CDT

Opportunities and Issues with Existing Analytical Technologies for Safety Monitoring of Ongoing Clinical Studies
Component Type: Forum
Level: Intermediate

We review how ongoing study safety review process typically proceeds, focusing on some limits and how to get beyond them. With two examples we explore the limits further and propose a procedural and analytic framework to expand study safety reviews.

Learning Objectives

Review how safety monitoring is conducted for ongoing randomized studies; Describe the need for augmenting current individual patient-data review with aggregate reviews; Identify currently available methods for aggregate review and the need to incorporate their purpose and use into study data review plans; Discuss with the audience their experiences and reaction to proposals.

Chair

Ed Whalen, PhD

Speakers
EW

Ed Whalen

Senior Director, Biostatistics, Pfizer Inc, United States
Ed Whalen has worked in the industry for 31 years and partially focused on safety related questions both at the project level and in general for the last 15 years. His background has covered drug development primarily in CNS and pain with some prior experience in anti-infectives... Read More →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Forum

1:15pm CDT

Real-World Data: Maximizing Value and Quality Through End-to-End Patient Centricity
Component Type: Session
Level: Basic

Real-world data (RWD) are valuable for research, but the patients behind the data are often disconnected from its use. This session offers case studies to highlight how patient-centric RWD practices can be used to demonstrate value to patients and sponsors alike.

Learning Objectives

Describe end-to-end patient centricity and how it connects to patient, clinical, and economic value; Identify specific value drivers supported through increased patient-centricity in the generation and application of real-world data (RWD); Discuss opportunities for increasing patient-centricity in the generation and application of RWD.

Chair

Meghan Tierney, PhD, RN

Speakers
avatar for Meghan Tierney

Meghan Tierney

Senior Clinical Scientist, PicnicHealth, United States
Meghan is a Senior Clinical Scientist with PicnicHealth. She holds a PhD in nursing, and her 10+ year career has involved direct patient care, site-based clinical trial operations, investigator-initiated patient outcomes research, and the generation and application of patient-centric... Read More →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Session

1:15pm CDT

Performance, Interrupted: Examining Diversity, Equity, and Inclusion Dynamics that can Impact Team Performance in Drug Development
Component Type: Workshop
Level: Intermediate

The interactive workshop will provide an opportunity to unpack and discuss how workplace microaggressions can impact team and organizational performance in drug development.

Learning Objectives

Discuss findings from a recent study examining diversity, equity, and inclusion (DEI) gender and racial dynamics among professionals in drug development, highlighting how certain dynamics can hinder team performance; Describe how to raise participants’ awareness of various forms of DEI dynamics by working through real-life examples and scenarios based on the study; Identify solutions to reduce the barriers that may be hinder effective team performance.

Chair

Jennifer Y Kim, PhD

Speakers
avatar for Jennifer Kim

Jennifer Kim

Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Assistant Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining how diversity, equity and inclusion dynamics impact individual, group, and organizational outcomes... Read More →

Wednesday June 28, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  13: ProfDevelopment, Workshop

4:00pm CDT

Assessing Safety in Rare Disease Gene Therapy
Component Type: Session
Level: Intermediate

Gene therapies offer unprecedented opportunities to address rare diseases, but these opportunities bring new safety challenges. In additional to organ toxicities, there is the potential for transmission of a viral vector to others, or integration of the payload gene in to the patient's genome with possible formation of neoplasms. These novel concerns are raised in a setting of small patient populations and the need for decades-long follow up in some cases, and thus require creative solutions from the Safety organization. This session will discuss the creative approaches to gene therapy safety that are being developed as these products move through development to the market.

Chair

Alicia Gilsenan, PhD, FISPE

Speakers
avatar for Alicia Gilsenan

Alicia Gilsenan

Vice President, Epidemiology, RTI Health Solutions, United States
Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she... Read More →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

4:00pm CDT

Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation
Component Type: Session
Level: Intermediate

ACT EU and the successful launch of the clinical trial regulation will optimise and modernise clinical research and development in the EU. The session presents how Europe is embracing change and contrasts with U.S. CTTI.

Learning Objectives

Describe how ACT EU is providing the platform to optimize clinical research and development and foster innovation; Discuss how the clinical trial regulation was launched in 2022 propelling the EU into an era of modernization for clinical trial submission and assessment, to benefit sponsors, regulators, and patients; Compare the EU initiative with the perspective of the U.S.

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session |   09: Regulatory, Session

4:00pm CDT

Patient-Generated Health Data and Real-World Evidence: How Can They Be Used to Accelerate Patient Engagement and Diversity?
Component Type: Session
Level: Intermediate

This session will explore the opportunities and challenges of involving diverse patient population representatives in the generation, collection and analysis of patient-generated health data (PGHD) as well as in real-world evidence studies from the perspectives of industry and patients.

Learning Objectives

Discuss the concept of patient-generated health data (PGHD) and how it relates to real-world evidence (RWE); Describe the ways in which PGHD and RWE can be used to facilitate patient engagement efforts throughout drug development and in the post-authorization setting with diverse patient populations.

Chair

Meredith Smith, PhD, MPA, FISPE

Speakers
avatar for Meredith Smith

Meredith Smith

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States
Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Session

4:00pm CDT

Leading Cross-Functional Teams Through Mergers, Divestments, and Acquisitions
Component Type: Session
Level: Intermediate

This forum will present key elements of project management in mergers, divestments, and acquisitions and how important this element is for both buyer and seller to have the right resources and processes to achieve the targeted business goals.

Learning Objectives

Discuss practicing project management fundamentals; Describe managing organizational functions for successful mergers, divestments, and acquisitions; Identify risks and issues and desribe how to apply best practices for mitigation and resolution.

Chair

Claudine Galea, MA

Speakers
avatar for Claudine Galea

Claudine Galea

Associate Director, Regulatory Affairs, Syneos Health, United Kingdom
Over 17 years of experience in Regulatory Affairs in both pharmaceutical and medical device fields. Major experience in Project Managing Regulatory and Patient Safety workstreams for Divestment and Acquisition projects, Project Managing big LCM projects, Internal Auditing (ISO9001... Read More →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjectManagement-StrategicPlanning, Session

4:00pm CDT

Quality by Design for Real-World Evidence Studies
Component Type: Forum
Level: Intermediate

This session will engage an expert panel in a discussion on a number of data-quality focused areas of real-world evidence (RWE) studies. Data providers, curators, sponsors, policy organizations, and regulators will discuss and align on different tool.

Learning Objectives

Describe inherent challenges to data quality in real-world evidence studies; Evaluate implications of recent regulatory agency guidelines on real- world data quality; Describe quality-focused solutions to improve the quality of real-world evidence studies.

Chair

Chelsea O'Connell, MSc

Speaker

Assessing the Reliability of Real-World Data and Real-World Data Sources: A Sponsor Problem?
Jason Wakelin-Smith


Speakers
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 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 →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Forum

4:00pm CDT

Mobilizing Cooperation with the African Medicines Agency
Component Type: Forum
Level: Intermediate

Following the selection of Rwuanda as the host for the Headquarters of African Medicines Agency (AMA) and the appointment of Director General, AMA will be ready to take off. We will hear the work of different stakeholders as they work to make AMA a reality.

Learning Objectives

Discuss the journey of operationalising the African Medicines Agency, and insights of the partners support in strengthening regulatory systems in Africa.

Speakers
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 →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

4:00pm CDT

Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally
Component Type: Session
Level: Intermediate

A panel will educate listeners on the benefits and best practices for regulators relying on regulatory decisions of other regulators. The outcome of the session will provide an overview of policy opportunities to advance application of reliance.

Learning Objectives

Describe key challenges and discuss potential solutions to enhance utilization of regulatory reliance mechanisms globally; Describe the positive impact to regulators in implementing and employing regulatory reliance mechanisms where regulators rely on regulatory decisions of other regulators; Assess how to foster discussions and education on the use and value of regulatory reliance mechanisms.

Chair

Virginia Beakes-Read

Speaker

Public Assessment Reports and the Articulation of Benefit and Risk: Are These Transparent Enough for Use in Reliance Reviews?
Magda Bujar, PhD, MSc


Speakers
avatar for Ginny Beakes-Read

Ginny Beakes-Read

Executive Director, Global Regulatory and R&D Policy, Amgen, United States
Ms. Beakes-Read is Exec Dir, Global Regulatory and R&D Policy at Amgen. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Eisai leading the Global Regulatory... 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 →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

4:00pm CDT

Patient and Quality Impacts of Restrictions on the Use of Titanium Dioxide (TiO2) in Medicines
Component Type: Forum
Level: Intermediate

The forum will focus on patient and quality impacts of eliminating titanium dioxide from medicines. A panel discussion with internationally recognized experts will allow diverse viewpoints to be heard and explored. Audience participation is encouraged.

Learning Objectives

Recognize the unique functional properties of titanium dioxide and the safety profile of this common pharmaceutical excipient; Describe the evolving regulatory landscape associated with the use of TiO2 as an opacifier / pigment in medicines; Summarize the quality and patient impacts resulting from restrictions on the use of titanium dioxide as an excipient.

Chair

Bruno Hancock, PhD

Speakers
avatar for Bruno Hancock

Bruno Hancock

Head of Materials Science, Pfizer Inc, United States
Bruno C. Hancock is head of the global pharmaceutical materials science group at Pfizer Inc. At Pfizer he has worked in the areas of formulation development, powder technology, pharmaceutical materials science, drug product process development & technology transfer, and computational... Read More →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Forum

4:00pm CDT

From 1000's of Tables to Summarizing Clinical Trials Graphically
Component Type: Session
Level: Advanced

This session will bring representatives from FDA who issued most recent FDA Medical Queries (FMQs) and Standard Safety tables, listings, and figures (TFLs) as well as experts from US and Europe working on open source tools to graphically summarize data.

Learning Objectives

Describe unique graphs that succinctly summarize complex analyses; Discuss open source tools to visually inspect, analyze, and summarize data.

Chair

Munish Mehra, PhD, MS, MSc

Speakers
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 →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session

4:00pm CDT

Critically Thinking Organization: An Action-Oriented Workshop for Leaders
Component Type: Workshop
Level: Intermediate

This workshop provides leaders with the insights to recognize when and how to develop an organization’s critical thinking skills. Interactive, role-based hypothetical clinical trial scenarios will be explored.

Learning Objectives

Distinguish the need for enhancing critical thinking skills; Apply examples of behaviors that leaders should exemplifyto create understanding of and drive critical thinking behaviors for organization; Identify and recommend coaching methods leading to improved critical thinking behaviors and performance.

Chair

Michael Torok, PhD

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  13: ProfDevelopment, Workshop
 
Thursday, June 29
 

8:30am CDT

Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open Sourced Tool
Component Type: Session
Level: Intermediate

This session introduces the program safety analysis plan (PSAP) allowing reviewers an effective way to perform annual aggregate safety review across a compound. Utilizing an interactive ‘real time’ application gives the ability to continuously review the safety profile.

Learning Objectives

Describe the program safety analysis plan (PSAP) concept and how it applies to drug development and aggregate safety analysis; identify how to ble implement the PSAP in their organization; Recognize the importance and utility of an interactive application to perform ongoing aggregate safety review.

Chair

Robert (Mac) Gordon, MS

Speakers
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Director, Biostatistics, Janssen Research & Development, LLC, United States
Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career, including membership in several multi-disciplinary... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session

8:30am CDT

Effective Use of Intelligent Automation in Clinical and Regulatory
Component Type: Forum
Level: Intermediate

Panelists share how they use intelligent automation technologies across R&D to improve business performance (e.g., efficiency, speed to market and regulatory compliance), use cases they have implemented, and the value / benefits realized to date.

Learning Objectives

Identify how sponsor companies are reaping value from their intelligent automation (IA) initiatives across R&D; Differentiate between use cases that provide greater value from those that are not worth pursuing; Discuss approaches for planning and implementing IA technologies that consider people, process, and technology aspects, and avoiding or mitigating common risks or issues.

Chair

Cary Smithson, MBA

Speakers
avatar for Cary Smithson

Cary Smithson

Director Regulatory Solutions, Phlexglobal, A Pharmalex Company, United States
Cary Smithson is the Director of Regulatory Solutions at Phlexglobal, a PharmaLex company, and has over 25 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum

8:30am CDT

A Global Sponsor Perspective on Implementation of the New EU Clinical Trials Regulation
Component Type: Session
Level: Intermediate

This session presents a case study on Sponsor preparation for EU CTR readiness and reflect on path forward for sponsors conducting trials in the EU. It will focus on key issues experienced by sponsors while planning and implementing CTR.

Learning Objectives

Define key regulatory changes as a result of EU CTR; Summarize main issues experienced so far by sponsors; Identify key risks associated with EU CTR and compare different approaches to risk management; Translate cross functional change management tools used in this implementation project for future changes in regulatory landscape.

Chair

Emma Kincaid

Speakers
EK

Emma Kincaid

Manager, Clinical Trial Excellence, Global Regulatory Affairs Development Strate, Alexion, AstraZeneca Rare Disease, United States
Emma Kincaid is currently Manager, Clinical Trial Excellence, Global Regulatory Affairs at Alexion, AstraZeneca Rare Disease. Emma Kincaid has 5 years of experience working in clinical research. She joined Alexion in 2019 and has since then been motivated to help advance innovative... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session

8:30am CDT

The Value of Patient-Centric Communication Strategies
Component Type: Session
Level: Intermediate

Communication strategies that are patient centric, offered in plain language, delivering meaningful content and recognizing the contribution of study participants can deliver improved outcomes for all stakeholders. This session will highlight presentations that offer best practices for going beyond requirements in communicating study information and results to study participants and include a moderated discussion and Q&A.

Learning Objectives

Recognize opportunities to provide patient centric communications throughout drug development; Discuss ways to express gratitude to study participants;vDiscuss strategies for ensuring your study materials are in plain language and providing meaningful content (e.g., recruitment notices, informed consent documents and result communications).

Chair

Jennifer Farmer, MS

Speaker

Returning Results to Patients: Not Just a Regulatory Requirement with a Grace Period
Jill McNair, MBA

Developing an Attitude of Gratitude: The Importance of Showing Gratitude to Clinical Trial Participants
Peter Schaeffer, MBA, PMP

Examining the Value and Utility of Clinical Trial Listings on ClinicalTrials.Gov for Patients and the Public
Kenneth Getz, MBA


Speakers
avatar for Jennifer Farmer

Jennifer Farmer

Chief Executive Officer, Friedreich`S Ataxia Research Alliance (FARA), United States
Jennifer Farmer is the Chief Executive Officer of the Friedreich’s Ataxia Research Alliance (FARA). She is one of the founders and the coordinator for the Collaborative Clinical Research Network in FA. In her current role at FARA as CEO, she helps to carry out the strategic mission... 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 the Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research... Read More →
avatar for Jill McNair

Jill McNair

Chief Growth Officer, CISCRP, United States
Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Health Communication Services at CISCRP. In this role, she oversees a team dedicated to helping sponsor companies provide trial results summaries in plain language to study volunteers. She is passionate... Read More →
PS

Peter Schaeffer

Digital and Process Optimization Leader, GlaxoSmithKline, United States
Pete Schaeffer has worked in the Pharmaceutical industry for approximately 20 years in both the Pre-Clinical and Clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs and collaborated with teams to... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Session

8:30am CDT

Crafting the Message: Driving Drug Development Through Compelling Governance Interactions
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Claire Blanchette, PMP

Speaker

Current Project Management Changes and The Future Projectized Business Environment
Nancy Styple


Speakers
NS

Nancy Styple

Project Management Leader, Bayer, United States
Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjectManagement-StrategicPlanning, Session

8:30am CDT

FDA Sponsor Interaction: Best Practices and New PDUFA Formal Meetings
Component Type: Session
Level: Basic

FDA and Industry joint dialogue session to discuss FDA and sponsor-specific best practices to ensure interactions with FDA are efficient, timely, and productive

Learning Objectives

Discuss FDA and industry's new PDUFA VII commitments regarding scientific dialogue between sponsors of applications and the FDA; Describe new thinking and ideas on interaction with the Agency will be explored in tandem with industry’s responsibility (per PDUFA VII) to collect sponsor specific best practices for meeting management.

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session

8:30am CDT

International Medical Device Regulators Forum (IMDRF) and Technological Innovation: How International Medical Device Harmonization is Impacting Drug Strategy
Component Type: Forum
Level: Intermediate

With the fast-moving pace of innovation, this forum focuses on how medical device regulatory harmonization activities on emerging technologies are impacting drug strategy.

Learning Objectives

Assess potential impact of the International Medical Device Regulators Forum (IMDRF) regulatory frameworks on drug strategy and align device regulatory requirements as part of a broader drug development program; Discuss drivers, priorities, and challenges for medical device regulatory harmonization and standardization of emerging technologies; Describe IMDRF process for regulatory harmonization and opportunities for stakeholder engagement.

Chair

Ryan Hoshi, PhD, MBA, MSc

Speakers
RH

Ryan Hoshi

Director, Regulatory Policy and Intelligence, AbbVie, United States
Ryan Hoshi is Director of Regulatory Policy & Intelligence at AbbVie and serves as the global policy lead for medical devices, combination products, personalized medicine, digital health, and advanced therapies. Before joining AbbVie, Ryan served as an international policy analyst... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

8:30am CDT

Demystifying Statistical Concepts for ANYONE Involved with Clinical Trials
Component Type: Workshop
Level: Basic

Group activities and slide-based learning will be used to introduce commonly used statistical concepts that are used in the analysis of clinical trials in a simple, easy to understand manner for anyone involved in clinical trials.

Learning Objectives

Explain basic statistical concepts; Identify the appropriate statistical analysis for a given outcome; Discuss assumptions and limitations of analysis methods with a study team, including Statisticians; Assess the clinical importance of statistical results.

Chair

Stephen Corson, PhD

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Workshop

9:45am CDT

Reporting of Pre- and Postmarket Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B Standards
Component Type: Workshop
Level: Intermediate

This workshop will include information about reporting of premarket and postmarket safety reports to be submitted in ICH E2B (R3) format to FAERS. The presenters will discuss the regional data elements and the implementation plan for reporting safety reports to FAERS.

Learning Objectives

Recognize that FDA will require reporting of Investigational New Drug (IND) and postmarket safety reports to be submitted in ICH E2B (R3) format to FAERS via the FDA Gateway or using the safety reporting portal; Identify how sponsors will be able to submit IND-exempt BA/BE safety reports to FAERS through the FDA Gateway; Describe regional data elements, that are key for safety reporting.

Thursday June 29, 2023 9:45am - 10:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Workshop

9:45am CDT

The Other Side of the Table: Drug Development Professionals Share Their Experiences Participating as Patients in Trials
Component Type: Forum
Level: Basic

What is it like to actually be a patient? Drug development professionals share profound and unexpected insights from their experiences as actual research participants. Panelists from industry will share experiences being clinical trial participants, detailing what it was like to go through the process of enrollment, informed consent, site visits, technology used, and other aspects of being an actual participant in a trial.

Learning Objectives

Discuss profound and unexpected insights into clinical trial innovation; Describe thought provoking ideas about clinical trials that only an industry professional, as patient, could yield; identify a desire to participate as clinical research participant oneself.

Chair

Sheila Mahoney Jewels, MBA

Speakers
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

Drug Development Multi-Functionalist, 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 →

Thursday June 29, 2023 9:45am - 10:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum

9:45am CDT

Process Automation and Artificial Intelligence in the Field: Practical Applications
Component Type: Session
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Michelle Hoiseth

Speaker

Global Clinical Supply Management Using Robotic Process Automation
Bashir Ahmed, PhD

Harnessing Real-World Data: The Clinical Use of Machine Learning and Artificial Intelligence in the Field
Jaime Smith, PhD, MA


Speakers
avatar for Bashir Ahmed

Bashir Ahmed

Executive Director, IT, Discovery and Development Business Partner, Incyte Corporation, United States
avatar for Michelle Hoiseth

Michelle Hoiseth

General Manager, United States
Michelle has 34 years of clinical research experience in a range of capacities including project management, portfolio management, strategic partnerships, and business leadership. Her experiences creating complete product development plans, designing novel regulatory pathways to approval... Read More →
JY

Jaime Y. Smith

Global Head, Scientific Data, Parexel, United States
Dr. Jaime Smith is the Global Head of Scientific Data for Parexel. Dr. Smith's commercial experience spans more than 16 years and is broad and deep in designing and implementing RWD studies and promoting health equity; using ML and advanced statistics; generating RWE through data... Read More →

Thursday June 29, 2023 9:45am - 10:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Session

9:45am CDT

Statistical Applications of Machine Learning (ML) and Artificial Intelligence (AI) in Drug Development and Success Stories of Application
Component Type: Session
Level: Intermediate

Traditional statistical methods used in drug development fit predefined models to existing data and then draw conculsions from it. Machine learning (ML)/artificial intelligence (AI) looks at finding complex patterns in data by using different statistical methods that those applied to date in drug development. This session will share some of the models used and success stories in ML/AI as applied to drug development.

Learning Objectives

Discuss the application of natural language processing (NLP) for extraction of summaries from clinicaltrials.gov, literature reviews, etc.; Describe CDRH's experience of review of devices and applications using ML/AI; Identify how to utilize historical clinical trials and real-world data to create knowledge that can maximize desired safety and efficacy results in future trials.

Chair

Munish Mehra, PhD, MS, MSc

Speakers
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 →

Thursday June 29, 2023 9:45am - 10:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session
 
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  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
    • Exh Hall Community Area
    Exhibit Hall
    Exhibit Hall Booth #1719
    Exhibit Hall Theater #1
    Exhibit Hall Theater #2
    Exhibit Hall Theater #3
    Level 3 F2 Entrance
    Meeting Rm Lobby Level 1
    Meeting Room Lobby
    Room 175
    Room 176
    Room 178
    Room 179
    Room 180
    Room 183 A
    Room 183 B
    Room 183 C
    Room 184
    Room 185 AB
    Room 185 CD
    Room 186
    Room 187
    Room 375 A Zone 1
    Room 375 A Zone 2
    Room 470 A
    Room 470 B
    Room 471 A
    Room Skyline 375 CDE
    Skyline Ballroom Foyer
    TBD
    Virtual