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02: ClinTrials -ClinOps [clear filter]
Tuesday, June 14
 

10:00am CDT

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

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

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

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


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


Return to DIA 2022

Who should attend?

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

Learning Objectives

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



Moderators
avatar for Stephen Corson

Stephen Corson

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

Tuesday June 14, 2022 10:00am - 1:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
 
Thursday, June 16
 

2:00pm CDT

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

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

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

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



Download Registration Form
Registration Questions? Send Email
1.888.257.6457

Return to DIA 2021 

Who should attend?

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

Learning Objectives

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



Speakers
avatar for Brian Barnes

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States
Brian has 17 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Association of Clinical Research Organizations (ACRO) RBQM... Read More →
AH

Aryana Hosseinkhani

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

Holly Robertson

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

Michael Tucker

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


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

1:15pm CDT

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

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

Learning Objectives

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

Chair

Brian Barnes, MA

Speaker

Panelist
Nicole Stansbury

Panelist
Paula Jo Butler, MA

Panelist
Lauren Garson

Panelist
Jennifer Glonke Stewart, MBA



Speakers
avatar for Brian Barnes

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States
Brian has 17 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Association of Clinical Research Organizations (ACRO) RBQM... Read More →
avatar for Paula Butler

Paula Butler

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

Lauren Garson

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

Nicole Stansbury

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

Jennifer Stewart

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


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

1:15pm CDT

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

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

Learning Objectives

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

Chair

Marc Kaufman

Speaker

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

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

Adaptive Designs: CRO Perspective
Russell Reeve



Speakers
avatar for Marc Kaufman

Marc Kaufman

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

Haneen Mazahreh

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

Russell Reeve

Vice President, Biostatistics, IQVIA, United States
SW

Song Wang

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


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

1:15pm CDT

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

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

Learning Objectives

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

Chair

Jennifer Goldsack, MA, MBA, MS

Speaker

Industry Update
Ariel Dowling, PhD

Industry Update
Shruti Iyer, MS

Industry Update
Gillian Livock, MBA

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



Speakers
avatar for Ariel Dowling

Ariel Dowling

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

Jennifer Goldsack

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

Shruti Iyer

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

Gillian Livock

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

Alison Ritchie

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


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

1:30pm CDT

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

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

Learning Objectives

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

Chair

K. Kimberly McCleary
Samantha Roberts, PhD

Speaker

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

FDA Update
Robyn Bent, MS, RN

EMA Update
Francesco Pignatti, MD



Speakers
avatar for Yolanda Barbachano

Yolanda Barbachano

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

Robyn Bent

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

K. Kimberly McCleary

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

Francesco Pignatti

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

Samantha Roberts

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


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

2:30pm CDT

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

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

Learning Objectives

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

Chair

Liam Paschall


Speakers
avatar for Liam Paschall

Liam Paschall

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


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

4:00pm CDT

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

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

Learning Objectives

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

Chair

Nancy Tam, MS

Speaker

Industry Update
Madhavi Gidh-Jain, PhD

Industry Update
Mary Lynn Mercado, PhD



Speakers
avatar for Nancy Tam

Nancy Tam

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

Madhavi Gidh-Jain

Global Medical Writing and Document Management Head, Sanofi, United States
Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... Read More →
avatar for Mary Lynn Mercado

Mary Lynn Mercado

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


Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   04: MedAffairs-SciComm, Session
 
Tuesday, June 21
 

9:00am CDT

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

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

Learning Objectives

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

Chair

Jimmy Bechtel, MBA

Speaker

Industry Update
David Vulcano, MBA, RAC

Industry Update
Brooke Hanscom

Industry Update
Shannon Zelenka



Speakers
avatar for Brooke Hanscom

Brooke Hanscom

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

David Vulcano

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

Shannon Zelenka

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


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

9:00am CDT

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

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

Learning Objectives

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

Chair

James Lindsay Cobbs, RPh

Speaker

Panelist
Susan C. Winckler, JD, RPh

Panelist
Lola Fashoyin-Aje, DrMed, MPH

Panelist
Sanjeeve Bala, MD

Panelist
Tesheia H. Johnson, MBA, MPH



Speakers
SB

Sanjeeve Bala

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

James Lindsay Cobbs

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

Lola Fashoyin-Aje

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

Tesheia Johnson

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

Susan Winckler

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

Susan Winckler

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


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

9:00am CDT

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

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

Learning Objectives

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

Chair

Smit Patel, PharmD

Speaker

Panelist
Ariel Aguilo, MD

Panelist
Betsy Tschosik, PhD

Panelist
Elizabeth Nicki Bush, MHS

FDA Update
Michelle Campbell, PhD



Speakers
avatar for Ariel Aguilo

Ariel Aguilo

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

Elizabeth (Nicki) Bush

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

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
avatar for Smit Patel

Smit Patel

Program Director, Digital Medicine Society (DiMe), United States
Dr. Smit J. Patel, PharmD serves at the Digital Medicine Society (DiMe), a global non-profit organization dedicated to better health powered by digital medicine. His work focuses on applied approaches to the safe, effective, ethical, and equitable use of digital technologies to advance... Read More →
BT

Betsy Tschosik

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


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

9:15am CDT

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

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

Learning Objectives

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

Chair

Fia Westerholm, DVM, MSc

Speaker

Moderator
Sabine Haubenreisser, PhD, MSc

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

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

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



Speakers
avatar for Kristof Bonnarens

Kristof Bonnarens

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

Scott Feiner

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

Marianne Lunzer

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

Fia Westerholm

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


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

11:00am CDT

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

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

Learning Objectives

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

Chair

Jonathan Andrus, MS

Speaker

Industry Update
Jonathan Andrus, MS

Panelist
Megan Petrylak



Speakers
avatar for Jonathan Andrus

Jonathan Andrus

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

Megan Petrylak

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


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

11:15am CDT

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

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

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

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

Learning Objectives

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

Chair

Denise Messer, MA

Speaker

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

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



Speakers
avatar for Denise Messer

Denise Messer

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

Zachary Smith

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


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

11:15am CDT

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

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

Learning Objectives

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

Chair

Abbe Steel, MSc

Speaker

Panelist
Kimberley Kallsen, MPH

Panelist
Madeline Geday

Panelist
Sara Julian, MA, MLIS



Speakers
avatar for Valerie Powell

Valerie Powell

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

Kimberley Kallsen

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

Madeline Geday

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

Sara Julian

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


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

1:45pm CDT

#244: Planning and Conducting Efficient, High-Quality Decentralized Trials: A Multi-Stakeholder Initiative
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-567-L04-P ; CME 1.00; RN 1.00

Building on decentralized clinical trials work, this session offers multi-stakeholder insights, updated recommendations, and case examples for incorporating decentralized elements in trials, from tele-visits to mobile HCPs and D2P shipping.

Learning Objectives

Discuss new multi-stakeholder recommendations and best practices for effectively incorporating decentralized elements into clinical trials from the earliest stages of trial design; Identify current challenges to operationalizing decentralized elements, and opportunities to address these challenges in individual trials and programs, as well as through continued multi-stakeholder collaboration.

Chair

Megan Doyle, JD, MPH

Speaker

Planning and Conducting DCTs: An Industry Perspective
Reem Yunis, PhD

Patient Perspective
Philip John Green

FDA Perspective
Susanne R. Goldstein, MD



Speakers
SG

Susanne Goldstein

Medical Officer, ON, Office of New Drugs, CDER, FDA, United States
Currently, I am a Medical Officer at FDA, CDER, Division of Neurology Products, involved in the scientific and regulatory review of of investigational new drug applications. I received my BA in Psychology from Brown University and my MD form Brown University School of Medicine. I... Read More →
avatar for Philip Green

Philip Green

Steering Committee Patient Representative, CTTI, United States
Phil was diagnosed with ALS in August of 2018 and immediately dedicated himself to making a difference in the fight against ALS. Phil is active with multiple ALS organizations and institutions (Team Gleason, I AM ALS, Augie’s Quest, ALS TDI, ALS Cure Project, UW Medicine, ALSA... Read More →
avatar for Reem Yunis

Reem Yunis

Vice President, Digital Transformation Strategy, Medable, United States
Dr. Yunis is a scientist with multidisciplinary training and expertise in mechanism of diseases. She enjoys working in startups bringing forward long term vision and strategies. Reem is dedicated to modernizing clinical development by leading efforts at the intersection of technology... Read More →


Tuesday June 21, 2022 1:45pm - 2:45pm CDT
Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session

1:45pm CDT

#243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-566-L04-P ; CME 1.00; RN 1.00

This session will focus on examining how technology can be leveraged to make clinical trials more widely accessible, inclusive and efficient and how “intentionally collected data” from EHRs can be used for prospective clinical research. Join the DIA Good Clinical Practices & QA Community for a follow up round table discussion (session #256 RT) on Tuesday, June 21, 3:00pm - 4:00pm.

Learning Objectives

Identify how technology can be useful in making clinical trials more inclusive; Recognize how EHR-derived data can contribute to the design and conduct of clinical trials; Discuss the potential for prospective data to be captured at the point of care through the EHR.

Chair

Neal Meropol, DrMed

Speaker

Regulatory Perspective
Donna Rivera, PharmD, MSc

Industry Perspective
Kent Thoelke

Investigator Perspective
Stephanie L. Graff, MD, FACP



Speakers
avatar for Neal Meropol

Neal Meropol

Vice President of Research Oncology, Flatiron Health, United States
Neal J. Meropol, MD is a medical oncologist, clinical investigator and outcomes researcher who serves as Vice President of Research Oncology at Flatiron Health. In this role, he provides scientific and clinical leadership in leveraging Flatiron’s technology platforms to close the... Read More →
avatar for Stephanie Graff

Stephanie Graff

Assistant Professor, Brown University; Director of Breast Oncology Program, Brown University
Dr. Stephanie Graff, MD, FACP is Director of Breast Oncology at Lifespan Cancer Institute, Legorreta Cancer Center at Brown University in Providence, Rhode Island. She serves as co-lead of Breast Cancer Translational Research Disease Working Group and Assistant Professor of Medicine... Read More →
avatar for Donna Rivera

Donna Rivera

Associate Director for Pharmacoepidemiology, OCE, FDA, United States
Donna R. Rivera, PharmD., MSc., is the Associate Director of Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory... Read More →
KT

Kent Thoelke

Former Chief Innovation Officer, ICON, Consultant, Ireland


Tuesday June 21, 2022 1:45pm - 2:45pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   03: Data-Tech in Clinical Trials, Session

2:00pm CDT

#250: Patients as Central Partners in COA Design
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-571-L04-P ; CME 1.00; RN 1.00

Co-designing with representative patient populations can enable the selection of COAs/PROs that are most relevant to patients and care givers. Participants will learn the background, reasoning, and technical process for bringing patients into drug development.Attendees will attend a panel discussion with FDA and Industry discussing where in the process patient engagement strategies assisted in shaping selection and implementation.

Learning Objectives

Discuss relevance of core COAs/PROSs to patient/caregivers of different ages, disease stages, demographics, and patient populations differentially impacted by social determinants of health ; Describe a process which enables adaptation of existing or creation of novel core COAs/PROs to align with disease state progression and innovation as well as potentially shifting patient perspectives.

Chair

Terrell Baptiste, MBA

Speaker

Conversations are Happening Whether you are There or Not: Using Social Media to Develop Meaningful Clinical Endpoints
Bill Byrom, PhD

FDA Update
Michelle Campbell, PhD

Patients as Central Partners in COA Design: Looking Beyond Semi-Structured Interviews
Denise Globe, MHS, PhD

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
Ji Li, MD, PhD



Speakers
TB

Terrell Baptiste

Associate Director, Regulatory Policy and Intelligence, Gilead Sciences, Inc., United States
Terrell Baptiste, Regulatory Policy and Intelligence, Gilead Sciences represents the Regulatory Affairs and Development organization to support and advise regulatory strategies that leverage innovative regulatory programs. He has a track record of successfully forging collaborations... Read More →
avatar for Michelle Campbell

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
avatar for Denise Globe

Denise Globe

Head, HEOR, Gilead Sciences, Inc., United States
Denise Globe has 30 years of experience in health care with a focus on quantitative policy research and direct research experiences in disease management including the outcomes, process, financing and delivery of care. A particular focus has been on assessing the impact of disease... Read More →
avatar for Ji Li

Ji Li

Reviewer, Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Ji Li is a primary reviewer at the Division of Clinical Outcome Assessment at the U.S. FDA. Dr. Li reviews the use of clinical outcome assessments in IND/NDA/BLA applications that are intended to support labeling claims of medical product development programs. Dr. Li also reviews... Read More →


Tuesday June 21, 2022 2:00pm - 3:00pm CDT
Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum

2:00pm CDT

#253: Efforts to Improve Diversity of Clinical Trial Participants
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-575-L04-P ; CME 1.00; RN 1.00

This session will provide an overview of initiatives, collaborations, and partnerships from industry, regulators, and other stakeholders to enhance the diversity of clinical trial participants.

Learning Objectives

Describe efforts to promote diverse clinical trial participation and how they will be realized; Discuss how to develop cross functional collaborations within companies and engage with regulators to achieve diversity goals; Identify considerations to establish a robust reproducible framework for assessing trial diversity and planning for improvements.

Chair

Kim Ribeiro, MS, MT

Speaker

Improving Diversity of Health Disparities Clinical Trials with Community-Based Organization Engagement
Barbara Goodman, MBA

Industry Update
Ramona Burress, PharmD

FDA Update
Jamie Renee Brewer, MD



Speakers
JB

Jamie Brewer

Acting Clinical Team Lead, DO3, OOD, CDER, FDA, United States
Jamie Brewer, MD, is a medical oncologist and Acting Clinical Team Lead in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Food and Drug Administration (FDA). Dr. Brewer joined the FDA in 2018 and previously served as a clinical reviewer on the Genitourinary... Read More →
avatar for Ramona Burress

Ramona Burress

Head of Patient Insights and Engagement, Takeda Pharmaceuticals, United States
Ramona Burress, PharmD is Head of Patient Insights and Engagement – Center for Health Equity and Patient Affairs at Takeda. Prior to joining Takeda, Ramona Burress served as a Director, Diversity & Inclusion in Clinical Trials at Janssen. This in role, she led external stakeholder... Read More →
avatar for Barbara Goodman

Barbara Goodman

President and Chief Executive Officer, Cures Within Reach, United States
Barbara Goodman leads Cures Within Reach and its mission of funding the testing of approved therapies in new indications. She has 25 years of healthcare/life sciences experience, focused on strategic growth initiatives at both for-profit/nonprofit corporations. Prior to CWR, she led... Read More →
avatar for Kim Ribeiro

Kim Ribeiro

Head, Diversity and Patient Inclusion, Clinical Development Solutions, AbbVie, United States
Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategy development for patient engagement, recruitment and retention planning as well as digital outreach and raising clinical... Read More →


Tuesday June 21, 2022 2:00pm - 3:00pm CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

3:00pm CDT

#256 RT: Round Table Discussion: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations
Component Type: Session
Level: Basic

Join the DIA Good Clinical Practices & QA Community for a round table discussion tied to session #243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations (Tuesday, June 21, 1:45pm - 2:45pm.) Space is limited.

Chair

Terry Katz, MS


Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →


Tuesday June 21, 2022 3:00pm - 4:00pm CDT
Room 375 A Zone 1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

4:15pm CDT

#268: Life Science Research Innovation Powered by Real-World Data
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-22-581-L04-P ; CME 1.00; RN 1.00

Real-world data (RWD) is increasingly easier to access, regulators are supportive of its use to improve drug development and success stories are being published at an ever expanding pace. This session will both provide an update as to where external control arms are in the respective life and hype cycles of adoption and provide a lens into the future of computer modeling leveraging RWD. This session includes case studies and learnings from ECA/In Silico implementations and will address if there is any future in classic randomized clinical trial (RCT) designs.

Learning Objectives

Describe how life science drug development is changing because of innovation powered by RWD; Apply novel biosimulation in the development new molecular entities and associated safety and risk mitigation strategies including expanded indications; Discuss the hype around ECAs/SCAs and where they best fit.

Chair

Keith Wenzel

Speaker

The Hype Cycle of Synthetic, External Control Arms and a Lens into the Future of Randomized Controlled Trials
Manish Khatri

Novel In Silico Clinical Trial for NME, SrLC, REMS, and Expanded Approval of Marketed Products
Jeffrey Difrancesco, MBA, MSc



Speakers
JD

Jeffrey Difrancesco

Executive Vice President and Chief Life Science Officer, Tabula Rasa Healthcare Inc, United States
Jeffrey DiFrancesco, M.Eng, M.Sci., SSMBB, is the Executive Vice President and Chief Life Science Officer at Tabula Rasa HealthCare in Moorestown, N.J. With over thirty-five years of technology, healthcare, and life science experience, Mr. DiFrancesco specializes in commercializing... Read More →
avatar for Manish Khatri

Manish Khatri

Director, Scientific Lead - data42, Global Drug Development, Novartis, Switzerland
Manish has focused his career with laser focus on making the science of medicines data driven. He has expertise in integrating data & technology with pharmaceutical R&D. His career spans CRO industry and R&D analytics consulting companies both in traditional clinical development and... Read More →
avatar for Keith Wenzel

Keith Wenzel

Volunteer, DIA Study Endpoints Community, United States
Mr. Wenzel worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working with... Read More →


Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   03: Data-Tech in Clinical Trials, Session
  • Level Advanced
  • Featured Topics RWD-RWE
  • Level Advanced
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Session

4:15pm CDT

#269: Strategic Planning in Selecting the Right Countries and Sites for Clinical Trials
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-582-L04-P ; CME 1.00; RN 1.00

Global clinical trials are a core pillar of many pharmaceutical product development strategies. But, selecting the right countries considering the various attributes of success and regulatory needs is essential. This session will discuss processes for making country inclusion recommendations along with the different factors to consider when deciding on country inclusion or exclusion.

Learning Objectives

Describe the critical attributes commonly included in strategic country selection for global trials; Discuss other elements (regulatory, marketing, diversity and inclusion) should be considered; Identify common data sources used to make country inclusion decisions; Discuss future areas for exploration, including use of real-world data.

Chair

Earl Seltzer, MBA

Speaker

Strategic Global Feasibility Considerations: Past, Present, Future
Stathis Stathelos, MPharm, MSc, PMP

Moving Data-Enabled Strategy to Execution: Innovative Pathways to Success
Nicole Turner, MBA

Integration of Real-World Claims Data to Inform Strategic Decisions for Trial Planning
Jeff Fairbairn, MBA

Aggregating Disparate Data Sources to Develop a Well Rounded Trial Strategy
Jason Gagner, MBA, MS



Speakers
avatar for Jeff Fairbairn

Jeff Fairbairn

Vice President, Account Strategy, Komodo Health, United States
Mr. Fairbairn is an AVP, Account Strategy at Komodo Health, where he helps sponsors and CROs optimize site selection and accelerate patient recruitment using Komodo's unrivaled data. Prior to Komodo, Jeff had operational roles at Decision Resources Group (2 years) and Parexel (10... Read More →
JG

Jason Gagner

Director, Data Services, Parexel, United States
As a Director in the Scientific Data Organization (SDO) at Parexel, Jason is responsible for the oversight and management of scientific data solution development, scientific data project start-up within the Americas, and global real world data strategies. Jason is the lead contact... Read More →
avatar for Earl Seltzer

Earl Seltzer

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

Stathis Stathelos

Director, Strategic Feasibility and Analytics - Oncology Team Lead, AstraZeneca, United Kingdom
A highly motivated professional in Global Pharmaceutical Development with clinical Pharmacist background. I have more than 16 years of experience in the pharmaceutical industry across several roles in CROs, Biotech and Pharma. Having started my career in clinical trial operations... Read More →
avatar for Nicole Turner

Nicole Turner

Director, Oncology Data Science Portfolio Management, Global Development, Janssen R&D, LLC, United States
Nicole is responsible for leading and executing the Data Science strategy for clinical trial feasibility and analytical process optimization at Janssen. Prior to this role, Nicole served as the Immunology Global Therapeutic Area Head in the Feasibility Center of Excellence. Prior... Read More →


Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

4:15pm CDT

#270: Recommendations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-583-L04-P ; CME 1.00; RN 1.00

This session provides insight into key success factors for implementing BYOD studies that incorporate personal digital health technologies. We will discuss early identification and stakeholder engagement, study design including informed consent and recruitment strategies, outcomes, endpoints, and technology selection, data management and statistical considerations to meet regulatory requirements.

Learning Objectives

Describe key success factors for implementing BYOD studies that incorporate personal digital health technologies; Discuss early identification and stakeholder engagement, study design including informed consent and recruitment strategies, outcomes, endpoints, and technology selection, data management and statistical considerations to meet regulatory requirements.

Chair

Marie Mc Carthy, MBA, MSc

Speaker

Industry Update
Elena Izmailova, PhD

Considerations for Successful Deployment of Bring Your Own Device (BYOD) Approach in Clinical Studies
Charmaine Demanuele, PhD



Speakers
MM

Marie Mc Carthy

Digital Endpoint Lead, Novartis, Ireland
With over 12 years’ experience supporting the use of digital health technologies in drug development studies and clinical research. I have spent these years not only evangelizing the value and benefit of digital endpoints derived from digital health technologies but also supporting... Read More →
avatar for Charmaine Demanuele

Charmaine Demanuele

Senior Director, Head of Digital Medicine & Translational Imaging Statistics, Pfizer Inc, United States
Dr. Charmaine Demanuele is Senior Director, Head of Digital Medicine and Translational Imaging Statistics, Worldwide Research, Development and Medical at Pfizer. Charmaine received her first degree in Electrical Engineering from the University of Malta, and her Ph.D. in Neuroscience... Read More →
avatar for Elena Izmailova

Elena Izmailova

Chief Scientific Officer, Koneksa, United States
Elena Izmailova, PhD (Chief Scientific Officer) leads scientific strategy and partnerships at Koneksa Health Inc with over 25 years of experience in academic and industry research. Her academic appointments include Harvard Medical School and MIT. She is a co-founder of the Digital... Read More →


Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   02: ClinTrials -ClinOps, Session
  • Level Advanced
  • Featured Topics Digital
  • Level Advanced
  • Feature Topics Digital
  • Credit Type ACPE, CME, RN
  • Tags Session

4:15pm CDT

#272: Fit-for-Purpose Patient Preference Studies: Emerging Recommendations from IMI PREFER
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-585-L04-P ; CME 1.00; RN 1.00

This session provides a fit-for-purpose approach to developing preference studies, informed by emerging PREFER recommendations and select case studies. Examples from case studies highlight lessons learned by those involved in preference research, including how decision-makers and patient research partners were involved.

Learning Objectives

Identify content of emerging PREFER recommendations on patient preference studies; Demonstrate application of select emerging best practice for design and conduct of preference studies; Discuss importance of involving stakeholders in patient preference studies.

Chair

Kristin Bullok, PhD

Speaker

PREFER Recommendations on Patient Preference Studies
Kristin Bullok, PhD

Practical Applications of Preference Study Design and Conduct
Carol Mansfield, PhD

Regulatory Perspective
Laura Lee Johnson, PhD



Speakers
avatar for Kristin Bullok

Kristin Bullok

Benefit-Risk Management Scientist, Global Patient Safety, Eli Lilly and Company, United States
Kristin Bullok, PhD, is a research scientist in benefit-risk management at Eli Lilly and Company, Global Patient Safety. Since joining Lilly, she has years of combined experience in conducting structured benefit-risk assessments, consulting on patient preference trade-off studies... Read More →
avatar for Laura Lee Johnson

Laura Lee Johnson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
avatar for Carol Mansfield

Carol Mansfield

Senior Economist and Head, Health Preference Assessment, RTI Health Solutions, United States
Carol Mansfield, PhD, is a Senior Economist and Head in the Health Preference Assessment group at RTI Health Solutions, where she conducts stated-preference studies for pharmaceutical applications. She has more than 25 years of experience conducting research related to health and... Read More →


Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  05: Patient Engagement, Session |   02: ClinTrials -ClinOps, Session
 
Wednesday, June 22
 

9:00am CDT

#302: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-22-594-L04-P ; CME 1.00; RN 1.00

Similar to CROs, many patient advocacy organizations (PAOs) provide services to advance therapeutic R&D programs in alignment with their missions. Case studies of successful PAO engagements and best practices for these partnerships will be discussed. Join the DIA Patient Engagement Community for a follow up round table discussion (session #355 RT) on Wednesday, June 22, 3:00pm - 4:00pm.

Learning Objectives

Identify patient advocacy organizations (PAOs) with high-quality resources and expertise to contribute to the success of your therapeutic development program; Compare the process of working with PAOs to working with traditional CROs and academic partners; Create efficiencies in your pipeline by building positive relationships with PAOs early and throughout the development of your programs.

Chair

Hollie Schmidt, MS

Speaker

Patient Perspective
Danielle Kerkovich, PhD

Industry Perspective
Melissa Dupont

Patient Perspective
Richard Mohs, PhD



Speakers
avatar for Melissa Dupont

Melissa Dupont

R&D Patient Engagement Lead, Sanofi, United States
Melissa's role is part of the Patient Informed Development and Health Value Translation Team, she is overseeing primarily the Neurology portfolio. This role is the face of Sanofi R&D to external Patient Advocacy organizations. A major responsibility of this role is to drive the patient... Read More →
DK

Danielle Kerkovich

Director of Research Development and Partnerships, International Fibrodyslasia Ossificans Association (IFOPA), United States
Ask Danielle about nonprofit medical research foundation strategies and you'll get a lively discussion of how building a well-informed, multifaceted strategy is the difference between expensive hope and real progress. In my role with the International Fibrodysplasia Ossificans Progressiva... Read More →
avatar for Richard Mohs

Richard Mohs

Chief Scientific Officer, Global Alzheimer’s Platform Foundation, United States
Richard C. Mohs is the Chief Science Officer for the Global Alzheimer’s Platform (GAP) Foundation, a patient-centered, non-profit organization enhancing the speed and quality of clinical trials for Alzheimer’s disease. He retired in 2015 from Eli Lilly and Company where he held... Read More →
avatar for Hollie Schmidt

Hollie Schmidt

Vice President of Scientific Operations, Accelerated Cure Project, United States
Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →


Wednesday June 22, 2022 9:00am - 10:00am CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   05: Patient Engagement, Forum

9:00am CDT

#303: Grappling with Uncertainty: Pediatric Gene Therapy Trials and Ethics
Component Type: Workshop
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-22-595-L04-P ; CME 1.00; RN 1.00

Gene therapy research in pediatric patients faces a number of ethical concerns. Trial sponsors must ensure that clinical trials are conducted ethically and balance stakeholder needs and priorities. This workshop will include facilitators from a multidisciplinary working group on ethical issues related to pediatric GT research and distribute realistic cases to groups.

Learning Objectives

Examine common ethical issues currently facing pediatric gene therapy research; Identify how different stakeholder communities may differ in their stances on these issues; Evaluate proposed responses on the part of sponsors.

Chair

Lesha D. Shah, MD, FAPA

Speaker

Facilitator
Emma James, PhD

Facilitator
Cara Hunt, MA



Speakers
CH

Cara Hunt

Research Associate, NYU Grossman School of Medicine, United States
Ms. Hunt a staff an associate researcher in NYU Grossman School of Medicine’s Division of Medical Ethics. She has a demonstrated interest in translating topics of ethical concern into content of relevance to patient populations and increasing transparency of gene therapy clinical... Read More →
avatar for Emma James

Emma James

Vice President of Medical and Patient Affairs, Encoded Therapeutics, United States
Emma James is VP, Medical & Patient Affairs at Encoded Therapeutics, a biotech company developing gene therapies for CNS disorders. She obtained her PhD from the University of Oxford, after completing research at its Nuffield Department of Medicine and Wellcome Trust Centre for Human... Read More →
avatar for Lesha D. Shah

Lesha D. Shah

Assistant Professor; Medical Director, Icahn School of Medicine at Mount Sinai, United States
Dr. Shah is Assistant Professor of psychiatry and the Medical Director of Child, Adolescent & Family Services at the Icahn School of Medicine at Mount Sinai, with dual board certification in psychiatry and child and adolescent psychiatry. She co-chairs the Pediatric Gene Therapy... Read More →


Wednesday June 22, 2022 9:00am - 10:00am CDT
Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Workshop |   06: PreClinical Dev-EarlyPhaseCR, Workshop

9:00am CDT

#304: Transformation of the Data Manager to the Data Scientist
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-596-L04-P ; CME 1.00; RN 1.00

This session will share perspectives and examples of digitally-enabled data processes and how they can accelerate timelines. Utilizing data during the clinical trial budgeting process is very important and allows for a strategic and compliant approach to your financial management.

Learning Objectives

Outline ways digitally enabled data processes can streamline and reduce cycle times for data management; Identify lessons learned for data management during the pandemic and how they can be applied to the future state; Assess what might stay the same and where the most realistic advantages are to be had for data management to see progress; Describe how to utilize data to gain complete control and visibility into your trial budgeting.

Chair

Katrina Rice, MS

Speaker

What the Future State Really Looks Like for Clinical Data Leaders
Katrina Rice, MS

How Data Scientists Bring Insights and Visibility to Clinical Trial Budgeting
Shelley Douros



Speakers
SD

Shelley Douros

Senior Director, Product Management, Clinical Trial Financial Management, Medidata, a Dassault Systèmes company, United States
avatar for Katrina Rice

Katrina Rice

Chief Delivery Officer, Data Services, eClinical Solutions, United States
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 20 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much... Read More →


Wednesday June 22, 2022 9:00am - 10:00am CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   02: ClinTrials -ClinOps, Session

9:15am CDT

#308: Community and Patient Engagement: Putting Research into Context
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-598-L04-P ; CME 1.00; RN 1.00

Through moderated discussion and audience interaction, this panel will define community and patient engagement, explain the relationship between them, and show how they can add critical context to diversify clinical research participation.

Learning Objectives

Define and differentiate community engagement versus patient engagement; Describe patients and community engagement principles approaches and metrics along a continuum, and identify relevant frameworks for both to apply in research; Identify how community engagement approaches enable deeper understanding of patient context to meaningfully engage diverse patients in clinical research.

Chair

Mary Murray, MBA, MS

Speaker

Industry Update
Kate Wilson

Patient Update
Marie LeGrand, MPH



Speakers
ML

Marie LeGrand

Senior Director of Mission Delivery and Health Equity, Multiple Sclerosis Association of America, United States
Marie LeGrand is the Senior Director of Mission Delivery and Health Equity for the Multiple Sclerosis Association of America, with a background in public health and experience in disease prevention, health promotion, health policy, and population medicine. She is responsible for program... Read More →
avatar for Mary Murray

Mary Murray

Vice President, Collaborative Action Networks, National Minority Quality Forum, United States
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →
KW

Kate Wilson

Head of Health Equity, Global Clinical Operations, Biogen, United States
Kate Wilson is the Head of Health Equity in Global Clinical Operations at Biogen. Kate has over 20 years of experience in clinical research with an undergraduate degree in Chemistry. She’s held multiple roles within Global Clinical Operations at and worked across many therapeutic... Read More →


Wednesday June 22, 2022 9:15am - 10:15am CDT
Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum

11:00am CDT

#318: Rare Disease Data Sharing: A Value Proposition
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-608-L04-P ; CME 1.00; RN 1.00

This session will provide an opportunity for key stakeholders, including regulators, product developers and patients to discuss various experiences with data sharing, and how data sharing can inform disease characterization and trial designs.

Learning Objectives

Describe FDA’s efforts to encourage data sharing; Discuss the benefits of data sharing in the pre-competitive space; Discuss how data sharing can inform disease characterization and trial designs.

Chair

Michelle Campbell, PhD

Speaker

Academic Update
Klaus Romero, MD, MS

FDA Update
Robyn Bent, MS, RN

Industry Update
Jane Larkindale, PhD



Speakers
avatar for Robyn Bent

Robyn Bent

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

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
avatar for Jane Larkindale

Jane Larkindale

Vice President, Clinical Science, PepGen Inc., United States
Jane Larkindale is Vice President of Clinical Science at PepGen, a company developing enhanced delivery oligonucleotide therapeutics for Duchenne muscular dystrophy and myotonic dystrophy. She has dedicated the past 15 years to accelerating therapy development for rare diseases, with... Read More →
avatar for Klaus Romero

Klaus Romero

Chief Science Officer, Critical Path Institute, United States
Klaus Romero MD, MS, FCP is a clinical pharmacologist and epidemiologist by training, with 15 years combined experience in academic clinical research. Dr. Romero has been with C-Path since December of 2007, and during his tenure, he has helped lead clinical pharmacology, pharmacoepidemiology... Read More →


Wednesday June 22, 2022 11:00am - 12:00pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session

11:00am CDT

#319: Ensuring Diversity in Clinical Trials
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-609-L04-P ; CME 1.00; RN 1.00

The new draft guidance released by FDA in April 2022 encourages stakeholders in clinical research to develop and implement plans to ensure diversity in clinical trials. In this session, we will present and discuss original research conducted by Tufts CSDD on staff diversity at investigative sites, worldwide, which explores the relationship between staff diversity and clinical trial volunteer participation. This session will also offer an inside view into approaches that have been piloted and/or applied to overcome lack of diversity and representation in clinical research. First is a case study in which a multi-stakeholder collaborative approach was applied to increase diversity in the recruitment of volunteer participants for a neurology trial at Queen Mary University of London. This will be followed by a presentation on a scalable approach to patient navigation that aids in increasing recruitment of underrepresented populations among clinical trial participants—currently being developed and piloted by Genentech. The session will close with a panel discussion focused on potential approaches to support greater patient and staff diversity in clinical trials.

Learning Objectives

Describe the current state of diversity at clinical research sites and the factors that may be influencing it; Explore the relationship between staff diversity and clinical trial volunteer participation; Assess the benefits of direct patient outreach platforms and multi-stakeholder partnerships; Identify a new way to support patient navigation and increase patient diversity.

Chair

Maria I. Florez, MA

Speaker

Investigative Site Staff Diversity: A Global Assessment and Implications for Patient Engagement and Recruitment
Maria I. Florez, MA

Using a Direct Patient Outreach Platform to Drive Recruitment and Increase Diversity in a Parkinson’s Disease ‘At-Risk’ Cohort Study
Alastair Noyce, MD, PhD, MRCP, MSc

Enhanced Patient Support for Recruitment and Retention
Esther Marfo, MSc



Speakers
avatar for Maria Florez

Maria Florez

Senior Consultant, Tufts Center For the Study of Drug Development, Tufts Univers, United States
Maria Florez studies the practices, strategies, attitudes, and incentives driving innovation in the pharmaceutical R&D process, as well as the impact of digital transformation in clinical research. Maria has been a researcher, consultant, and advisor in the healthcare sector for over... Read More →
avatar for Esther Marfo

Esther Marfo

Project Leader, Hoffmann La Roche, Canada
Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. With over 15 years’ experience in the industry, Esther has predominantly worked in clinical trial management as well as data management roles across Europe, North America... Read More →
avatar for Alastair Noyce

Alastair Noyce

Reader in Neurology and Consultant Neurologist, Queen Mary University and Barts Health NHS Trust, United Kingdom
Alastair is a Reader in Neurology and Neuroepidemiology at the Wolfson Institute of Population Health, Queen Mary University of London, and a Consultant Neurologist at Barts Health. He is Lead of the Preventive Neurology Unit at the Wolfson Institute. Alastair graduated from Barts... Read More →


Wednesday June 22, 2022 11:00am - 12:00pm CDT
Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   05: Patient Engagement, Session

11:00am CDT

#321: FHIR in Clinical Research
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-611-L04-P ; CME 1.00; RN 1.00

This forum will assess where fast healthcare interoperability resources (FHIR) can play a role in clinical research. Experts will provide examples of success, share best practices and discuss a reference architecture for gathering data via FHIR.

Learning Objectives

Discuss examples of FHIR in clinical research; Describe best practices from industry experts.

Chair

Derk Arts, MD, PhD

Speaker

Panelist
Samuel W. Hume, MS

Panelist
Mike Ward

Panelist
Meredith Zozus, PhD



Speakers
avatar for Derk Arts

Derk Arts

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

Samuel Hume

Vice President, Data Science, CDISC , United States
Sam Hume leads the CDISC Data Science team who develops tools and standards that support clinical and translational research. Sam directs delivery of the CDISC Library, co-leads the Data Exchange Standards team, and serves as a leader of CORE. Additionally, he oversees the CDISC Open-Source... Read More →
avatar for Mike Ward

Mike Ward

Associate Director, eSource Capabilities, Eli Lilly and Company, United States
MZ

Meredith Zozus

Professor; Division Chief and Director, Clinical Research Informatics, University of Texas Health Science Center, United States
Meredith is a Professor, Division Chief and Scientific Director of Clinical Research Informatics for the University of Texas Health Science Center at San Antonio. She is the lead PI of the ACE-RWD program.


Wednesday June 22, 2022 11:00am - 12:00pm CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   02: ClinTrials -ClinOps, Forum

11:15am CDT

#329: Complex Innovative Design: What’s in Name? A Global Perspective on the Changing Design Landscape
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-618-L04-P ; CME 1.00; RN 1.00

This session will feature international regulators describing the options open for having a Complex Innovative Design agreed. The focus will be on the success of the recent FDA pilot programme, and the current options available through the EMA.

Learning Objectives

Describe the aspects of FDA Complex Innovative Design and be able to foresee how to apply them to their own products; Recognize global differences in the pathways available and the possibility to achieve global harmonisation on complex innovative designs.

Chair

Andrew Thomson, PhD, MA, MS

Speaker

Moderator
Benjamin Hofner, PhD

FDA Update
Dionne Price, PhD

Sponsor Perspective on Interacting with the FDA CID Program: A Case Study
Marius Thomas, PhD



Speakers
avatar for Benjamin Hofner

Benjamin Hofner

Head of Biostatistics, Paul-Ehrlich-Institut, Germany
Benjamin Hofner is Head of Section Biostatistics at the Paul-Ehrlich-Institut (PEI). In this role he is involved in the assessment of Marketing Authorisation Applications and Clinical Trial Applications and provides Scientific Advice to stakeholders. He is Additional Assessor at the... Read More →
avatar for Dionne Price

Dionne Price

Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section... Read More →
MT

Marius Thomas

Senior Principal Biostatistician, Novartis, Switzerland
Marius Thomas, PhD is currently working as a Senior Principal Biostatistician in the Neuroscience development unit of Novartis. Since joining Novartis, he has worked on various projects in the area of multiple sclerosis. Before joining Novartis, Marius was an early-stage researcher... Read More →
avatar for Andrew Thomson

Andrew Thomson

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


Wednesday June 22, 2022 11:15am - 12:15pm CDT
Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Forum |   02: ClinTrials -ClinOps, Forum

11:15am CDT

#330: Leveraging Real-World Evidence to Address Diversity Gaps in Randomized Clinical Trials: Regulatory, Clinical, and Other Considerations
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-619-L04-P ; CME 1.00; RN 1.00

If randomized clinical trials (RCTs) are enlarged to address treatment benefits and risks in subgroups of interest, they will take longer to complete. This forum considers regulatory, clinical and pharma use of real-world evidence to supplement RCT to address diversity. This forum will be a lively panel discussion with perspectives from the regulatory, clinical, and biopharmaceutical perspective, focusing on best ways to fill these evidence gaps including use of real-world evidence.

Learning Objectives

Summarize the trade-offs between running larger more diverse clinical trials and time to trial completion and product approval; Explain how the lack of diversity in clinical trials impacts the reliability of evidence-based care algorithms; Describe one or more ways that real-world evidence can contribute to understanding diversity and how that would extend what is learned from trials.

Chair

Nancy A. Dreyer, PhD, MPH, FISPE

Speaker

Panelist
Cathy W Critchlow, PhD, MSc

Panelist
Wayne Batchelor, MD, MHS, FACC

Panelist
John Concato, MD, MPH, MS



Speakers
WB

Wayne Batchelor

Director of Interventional Heart Program, Research and Innovation, Inova, United States
Dr. Wayne Batchelor currently serves as the Director or Interventional Cardiology, Director of Interventional Cardiology Research, Innovation and Education and Associate Director of the Inova Heart and Vascular Institute in Fairfax, VA and Adjunct Professor of Medicine at Duke Un... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency... Read More →
avatar for Cathy Critchlow

Cathy Critchlow

Vice President, R&D Data Strategy, Amgen, United States
Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer & SVP, IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA Real World Solutions and Adjunct Professor of Epidemiology at Univ of N Carolina at Chapel Hill. She leads the IQVIA Center for Advanced Evidence Generation and is a fellow of both the International Society for Pharmacoepidemiology... Read More →


Wednesday June 22, 2022 11:15am - 12:15pm CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  14: DIAmond, Forum |   09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum

12:45pm CDT

#336 CH: Reviewing FDA's Draft Guidance on PROs in Oncology Trials: How This Affects Future Measurement Strategy and Study Designs
Component Type: Workshop
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 selection.

Learning Objectives

Identify if existing gold standard measures are fit for purpose; Explore the impact of the guidance on PRO selection and adaptation; Discuss how to optimize study designs to meet the requirements of the guidance, and what this means practically for patients and sites.

Chair

Bill Byrom, PhD


Wednesday June 22, 2022 12:45pm - 1:15pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

1:45pm CDT

#342: Democratizing Data for Cancer Research and Real-World Evidence Generation
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-622-L04-P ; CME 1.00; RN 1.00

This forum will explore how collaboration and improved access to data across the cancer research and healthcare data ecosystem can lead to innovations in diagnosis and treatments. A panel of high-level experts from industry, academia and data-focused non-profits will provide their viewpoints on the data sharing landscape, progress to date, lessons learned, and ideas to ensure future sustainable success.

Learning Objectives

Describe the cancer research and healthcare data landscape; Discuss the importance of collaboration across key stakeholder groups; Explore innovative ideas for future success, especially around diagnosis and treatment.

Chair

Bron Kisler

Speaker

Panelist
Samuel Volchenboum, MD, PhD, MS

Panelist
William Louv, PhD

Panelist
Robert Stephen Miller, MD, FACP

Panelist
Karla Childers, MS



Speakers
avatar for Bron Kisler

Bron Kisler

Senior Advisor, Clinical Research Data Sharing Alliance, United States
Most recently, Bron has worked with the Founders and Board of Directors for the Clinical Research Data Sharing Alliance to launch this new non-profit alliance in 2021. He is globally recognized for his leadership in clinical research and international standards development with more... Read More →
WL

William Louv

Chief Executive Officer, Project Data Sphere, United States
Bill was named Chief Executive Officer of the CEO Roundtable on Cancer effective March 2022 after serving as Interim CEO since January 2022. He joined Project Data Sphere in April 2018, bringing with him broad leadership experience in statistics, epidemiology, and information technology... Read More →
avatar for Robert Miller

Robert Miller

CMO, ASCO
Robert S. Miller, MD, FACP, FASCO, FAMIA is a medical oncologist and informaticist who is Chief Medical Science Officer, CancerLinQ®, a health technology platform for oncology developed by the American Society of Clinical Oncology (ASCO) to improve quality of cancer care and advance... Read More →
SV

Samuel Volchenboum

Co-Founder, Chief Medical Officer, Litmus Health, United States
Dr. Volchenboum is an associate professor of pediatrics and the associate chief research informatics officer for the Division of Biological Sciences at the University of Chicago. He is the Dean of Masters Programs, and he designed and launched the UChicago Master’s in Biomedical... Read More →


Wednesday June 22, 2022 1:45pm - 2:45pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum

1:45pm CDT

#341: New Approaches to Site Selection in Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-621-L04-P ; CME 1.00; RN 1.00

In the drug development space, there is a growing expectation demanding pharmaceutical companies generate more evidence by conducting increased number of clinical trials due to increased regulatory requirements ensuring patient safety. One of the biggest speed limiting steps in clinical trials, is patient enrollment. Selecting the right sites would potentially accelerate the overall enrollment and ultimately the clinical development timeline. We can identify and prioritize sites for clinical trials by predicting key metrics that define a site’s overall performance, including, site start-up time and enrollment rate. The traditional way of identifying sites to participate in a study could be a combination of referral, working relationship or data-driven approach like identifying sites that have had prior experience conducting trials in similar indication and analyzing their historical average performance. While field knowledge is irreplaceable, we can better leverage the data using advanced analytical techniques like machine learning and feasibility studies influencing data-driven decision making.

Learning Objectives

Describe various solutions to identify high-performing countries and sites for clinical trials; Discuss various factors influencing site performance in clinical trials; Describe how to make data-driven decision in site selection for clinical trials.

Chair

Dinesh Kumar Subbarayalu, MS

Speaker

A Machine Learning-Based Approach to Identify Highly Efficient Sites to Prioritize for Clinical Trial
Dinesh Kumar Subbarayalu, MS

Streamlining the Feasibility Process to Enhance Site-Sponsor Collaboration and Accelerate Cycle Times
Kavitha Lokesh



Speakers
KL

Kavitha Lokesh

Vice President, Head of LS R&D Delivery and Products and Platforms, Cognizant Technology Solutions, United States
Kavitha Lokesh is VP, Head of LS R&D Delivery and Products & Platforms. She is a global business leader with a track record of delivering mission-critical products and solutions. Kavitha has over 25 years of IT industry experience and has held multiple leadership roles at Cognizant... Read More →
avatar for Dinesh Kumar Subbarayalu

Dinesh Kumar Subbarayalu

Data Scientist, AbbVie, Inc., United States
Dinesh Kumar is a data enthusiast who is currently working as a Data Scientist at AbbVie, North Chicago. Dinesh has a Masters in Business Analtics from the University of Illinois. Dinesh has been at AbbVie for 4 years as part of Clinical Analytics team supporting selection, activation... Read More →


Wednesday June 22, 2022 1:45pm - 2:45pm CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

1:45pm CDT

#345: Statistical Issues in Master Protocols: Beyond Type I Error and Concurrent Controls
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-631-L04-P ; CME 1.00; RN 1.00

Platform trials combine the advantages of multi-arm trials with the flexibility of classical drug development based on independent studies. We will highlight the main statistical issues and cover both the European regulatory and industry perspective.

Learning Objectives

Describe the main statistical challenges in platform trials; Discuss the role of clinical trial simulations when designing master protocols; Identify the key aspects when planning and analyzing platform trials.

Chair

Alex Sverdlov, PhD

Speaker

Master Protocols: Considerations from EU-PEARL and the European Regulatory Network
Benjamin Hofner, PhD

Challenges in the Execution of Platform Trials in the Pharmaceutical Industry and What we Have Learned from EU-PEARL and the COVID-19 Pandemic
Peter Mesenbrink, PhD

Academic Update
Martin Posch, PhD



Speakers
avatar for Benjamin Hofner

Benjamin Hofner

Head of Biostatistics, Paul-Ehrlich-Institut, Germany
Benjamin Hofner is Head of Section Biostatistics at the Paul-Ehrlich-Institut (PEI). In this role he is involved in the assessment of Marketing Authorisation Applications and Clinical Trial Applications and provides Scientific Advice to stakeholders. He is Additional Assessor at the... Read More →
avatar for Peter Mesenbrink

Peter Mesenbrink

Executive Director of Biostatistics, Novartis Pharmaceuticals Corporation, United States
Peter Mesenbrink, PhD is an Executive Director of Biostatistics at Novartis Pharmaceuticals Corporation in East Hanover, New Jersey. Peter received his BS in Mathematics from UVM in 1989 and a PhD in Statistics from NCSU in 1995. He joined Novartis in 1995 and is currently Therapeutic... Read More →
avatar for Martin Posch

Martin Posch

Professor, Medical University of Vienna, Austria
Martin Posch is professor for medical statistics at the Medical University of Vienna. From 2011-2012 he worked as statistical expert at the European Medicines Agency (London, UK) in the Human Medicines Development and Evaluation sector, where he contributed to guideline development... Read More →
avatar for Alex Sverdlov

Alex Sverdlov

Senior Director, Biostatistics, Novartis, United States
Alex Sverdlov has worked as a statistical scientist in the biopharmaceutical industry since 2007. He is currently neuroscience disease area lead statistician in early clinical development at Novartis. Alex has been involved in active research on adaptive designs for clinical trials... Read More →


Wednesday June 22, 2022 1:45pm - 2:45pm CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session

3:00pm CDT

#355 RT: Round Table Discussion: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs
Component Type: Session
Level: Basic

Join the DIA Patient Engagement Community for a round table discussion tied to session #302: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs (Wednesday, June 22, 9:00am - 10:00am.) Space is limited.

Chair

Mary Murray, MBA, MS


Speakers
avatar for Mary Murray

Mary Murray

Vice President, Collaborative Action Networks, National Minority Quality Forum, United States
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →


Wednesday June 22, 2022 3:00pm - 4:00pm CDT
Room 375 A Zone 1 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

4:15pm CDT

#366: Development of Standard Core Sets of Clinical Outcome Assessments and Related Endpoints
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-634-L04-P ; CME 1.00; RN 1.00

This session will provide an opportunity for key stakeholders, including regulators, product developers, instrument developers, and patients to discuss various experiences with the development of the core sets.

Learning Objectives

Describe FDA’s efforts to support the development of core sets of clinical outcome assessments; Outline the benefits of core outcome sets; Discuss learnings from the FDA’s grant program.

Chair

Robyn Bent, MS, RN

Speaker

Moderator
Ebony Dashiell-Aje, PhD

Industry Update
R.J. Wirth, PhD

Industry Update
Elizabeth Nicki Bush, MHS

FDA Update
Michelle Campbell, PhD



Speakers
avatar for Robyn Bent

Robyn Bent

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

Elizabeth (Nicki) Bush

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

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
avatar for R.J. Wirth

R.J. Wirth

CEO, Vector Psychometric Group, LLC, United States
R.J. Wirth is Chief Executive Officer, co-Founder, and a managing partner at VPG. Dr. Wirth received his PhD in quantitative psychology / psychometrics from the historic LL Thurstone Psychometric Laboratory at University of North Carolina – Chapel Hill. For nearly two decades, Dr... Read More →


Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session

4:15pm CDT

#367: Local Conduct for Global Clinical Trials: Focus on Japan, Latin America, and Africa
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-635-L04-P ; CME 1.00; RN 1.00

Global clinical trials are a necessity for any development company with registration and marketing aspirations. The pharmaceutical markets of Japan, Latin America, and Africa each have unique attributes that warrant consideration for developers looking to study and eventually market products locally. This session will discuss key considerations for each market as well as observed changes to the local landscape that have come as a result of the COVID-19 pandemic.

Learning Objectives

Describe updates on trial conduct in Latin America, Japan, and Africa to include regulatory considerations, opportunities for innovation, and the changes to local study conduct as a result of the COVID-19 pandemic; Discuss perspectives on the future development landscape in these markets.

Chair

Earl Seltzer, MBA

Speaker

Clinical Research in Latin America: The Know-Hows of Successful Patient Enrollment and Engagement Strategies
Sara Tylosky, MBA

Navigating Clinical Development Landscape and Turning Innovation into Success in Japan
Edward Ian, MBA

Planning and Conduct of Clinical Trials in Africa: Where are We in 2022?
Pierre Brichot, MS



Speakers
avatar for Earl Seltzer

Earl Seltzer

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

Edward Ian

Senior Executive Officer, Mediscience Planning Inc., Japan
Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →
avatar for Pierre Brichot

Pierre Brichot

Founder, MCT, Tunisia
Founder of MCT, Regional CRO specialized in Middle East and Africa. MCT has more than 140 team members based in the following countries : Tunisia, Egypt, Lebanon, Morocco, Jordan, UAE, Oman, Saudi Arabia, Senegal, Gambia, Ivory Coast, Ghana, Sierra Leone, Mali, Benin, Nigeria, Uganda... Read More →


Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session

4:15pm CDT

#368: Sneak Peak: First Share from Initiatives of a Global Collaboration to Address Barriers to Decentralized Trial Scale and Adoption
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-636-L04-P ; CME 1.00; RN 1.00

This forum will discuss how our alliance priorities are designed to improve the global adoption of decentralized research to improve study access and efficiency. The foundation for this mission is a common nomenclature & definitions for decentralized trials.

Learning Objectives

Describe the common nomenclature and definitions for decentralized research as defined through a global multistakeholder collaboration; Identify key performance indicators and benchmarks that highlight the productivity and impact of decentralized trials; Evaluate a Decentralized Research Readiness Framework considerate of change management best practices for sponsors, CROs, and sites.

Chair

Craig H Lipset, MPH

Speaker

Panelist
Jared Klingeisen

Panelist
Dawn Brockett, MPA

Panelist
Jane Myles, MS

Panelist
Alicia Staley, MBA, MS

Panelist
Amir Kalali, MD



Speakers
avatar for Dawn Brockett

Dawn Brockett

Head of Community and Partnerships, CNS Summitt, United States
Dawn Brockett is Head of Community and Partnerships for CNS Summit. She is a member of the leadership team of the Changing the Norm initiative of the Decentralized Trials & Research Alliance (DTRA). She is a patient advisor on an Anorexia Nervosa trial and adjunct faculty at Boise... Read More →
avatar for Amir Kalali

Amir Kalali

Co-Chair, Decentralized Trials and Research Alliance (DTRA), United States
Dr. Kalali is a physician scientist, recognized globally as a leading innovator at the intersection of life sciences and technology, and a convener of collaborative high impact forums. He is a board director of both private and publicly traded companies and advises companies in the... Read More →
avatar for Jared Klingeisen

Jared Klingeisen

Senior Vice President, Medable, United States
Jared serves as Senior Vice President at Medable. Since joining the company in 2018, Jared has successfully founded Medable’s delivery teams and built the operational model used to deliver more than 150+ trials hybrid and decentralized trials worldwide. He also led the formation... Read More →
avatar for Jane Myles

Jane Myles

Program Director, Decentralized Trials and Research Alliance (DTRA), United States
Jane has over 25 years of experience improving clinical trials and patient experiences. She has focused on driving innovation in trial design and execution to accelerate getting medicines to patients. Jane transitioned from molecule focus to portfolio focus about 14 years ago, first... Read More →
avatar for Alicia Staley

Alicia Staley

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


Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum

4:15pm CDT

#369: Approaches to Addressing Diversity and Inclusion in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-22-637-L04-P ; CME 1.00; RN 1.00

In this session, using illustrative case examples, we will present recommendations and resources to help sponsors earn the trust of minority patient populations to increase the likelihood of their participation in digital/medicine clinical research.

Learning Objectives

Identify specific barriers preventing the inclusion of underrepresented patient segments in clinical trials; Design inclusive best practices into product development and clinical trial design.

Chair

Susan M Dallabrida, PhD

Speaker

Novel Digital Mechanisms for Increasing Diversity in Clinical Trials
Susan M Dallabrida, PhD

Driving Inclusion in Digitized Clinical Trials: A Toolkit
Yashoda Sharma, PhD

Using Real-World Data and AI/ML for Clinical Trial-Site Matching to Simultaneously Improve Enrollment Rate and Diversity
Lucas Glass, MA, MS

Novel Digital Mechanisms for Increasing Diversity in Clinical Trials
Steve Wimmer, MA



Speakers
avatar for Susan Dallabrida

Susan Dallabrida

Chief Executive Officer, SPRIM Consulting and Obviohealth, United States
Dr Dallabrida is the CEO of SPRIM, Chairman of the Obviohealth Advisory Board, and Board member with PulseNMore. She has over 28 years of experience in clinical trials and outcomes optimization. Her focus is on optimizxing the the signal to noise ratio for efficiacy and safety outcomes... Read More →
avatar for Lucas Glass

Lucas Glass

Vice President of Analytics Center of Excellence, IQVIA, United States
Lucas Glass runs the IQVIA Analytics Center of Excellence (ACOE). The ACOE is a team of over 200 data scientists that research, develop, and operationalize machine learning and data science solutions within the R&D space. The ACOE leverages hundreds of global real world and commercial... Read More →
avatar for Yashoda Sharma

Yashoda Sharma

Program Director, Digital Medicine Society, United States
I have applied my training in genetics and academic research to managing large interdisciplinary research programs. Through my work with the All of Us Research Program and IBD Genetics Consortium I have a deep understanding of the opportunities and challenges facing research and health... Read More →
SW

Steve Wimmer

Director of Partnerships, 1nHealth, United States
Steve is the Director of Partnerships for 1nHealth. He brings a wide-ranging scope of experience to his role, having worked previously in digital marketing, e-commerce, and education. Steve is primarily responsible for assessing the feasibility of digital channels for meeting recruitment... Read More →


Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   02: ClinTrials -ClinOps, Session |   12: Value-Access, Session

4:15pm CDT

#377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives?
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-645-L04-P ; CME 1.00; RN 1.00

The choice of endpoints for oncology trials requires balancing multiple and often competing objectives, like validity, feasibility, etc. In this session we’ll explore strategies for optimal endpoint selection from different perspectives.

Learning Objectives

Identify different estimands and attributes for efficacy endpoints in cancer clinical trials; Describe the different perspectives and trade-offs involved in the choice of endpoints; Discuss strategies for optimizing the choice of endpoint based on a survey of decision makers and examples of global cancer drug development.

Chair

Francesco Pignatti, MD

Speaker

Results of the EMA Survey on PFS as a Clinical-Benefit Endpoint
Douwe Postmus, PhD, MSc

Endpoint Selection Strategies to Address the Needs of Multiple Decision Makers Globally
Amy McKee, MD

Trial Objectives and Endpoint Selection Considerations in the Cancer Drug Development
Rajeshwari Sridhara, PhD



Speakers
avatar for Amy McKee

Amy McKee

CMO and Global Head, Oncology Center of Excellence, Parexel International, United States
Dr. McKee worked for over 10 years at the U.S. Food and Drug Administration most recently in the role of Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, OHOP, CDER. Dr. McKee was the signatory authority for products within Office of... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

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

Douwe Postmus

Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands
Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →
avatar for Rajeshwari Sridhara

Rajeshwari Sridhara

Senior Biostatistician Consultant, Oncology Center of Excellence, FDA, FDA, United States
Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products in the Oncology Center of Excellence and Center for Drug Evaluation and Research. As a leader in the field, she routinely... Read More →


Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session |   05: Patient Engagement, Session
 
Thursday, June 23
 

9:15am CDT

#403 CH: Who Should Be in the Room to Discuss Risk-Based Quality Management (RBQM) for a Clinical Trial Protocol?
Component Type: Workshop
Level: Basic

Clinical operations, statistics, medical monitors, and other functions manage portions of a trial. But are they collectively defining critical processes and variables per risk-based quality management as cited by ICH? Who should be in the room?

Learning Objectives

Discuss how Risk-Based Quality Management (RBQM) is more than Risk Based Monitoring (RBM). ICH E6 includes risk identification, evaluation, control, communication, review, and reporting; Describe how clinical operations can drive the discussion, but critical variables and processes are owned by many functions who need to understand, attend, engage and collaborate; Present results of GCP-QA RBQM awareness survey.

Chair

Terry Katz, MS


Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →


Thursday June 23, 2022 9:15am - 9:45am CDT
Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616

10:00am CDT

#405: How the Heck do I Get this Digital Endpoint to Work in my Clinical Trial? Nuts and Bolts for Trials Teams
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-648-L04-P ; CME 1.00; RN 1.00

This panel will discuss how the Playbook Clinical Trials Dossier has the action-oriented tools you need to help deploy a digital clinical measure in your clinical trial. Learn to use them to make better decisions faster.

Learning Objectives

Describe the optimal approach to selecting, developing, and deploying fit-for-purpose, meaningful digital clinical measures across clinical research; Determine right questions and when to ask while operationalizing digital clinical measures into a clinical trial; Apply the resources in The Playbook's Clinical Trials Dossier to navigate the multi-stakeholder process of planning for and running a clinical trial.

Chair

Jeanne Chung, MBA

Speaker

Digital Clinical Measures: Tools to Make Better Decisions Faster
Matt Biggs

Developing Novel Endpoints Using Voice Measurement
Jessica Robin, PhD

Current Challenges of Digital Clinical Measures in Drug Development
Jie Ren, PhD



Speakers
avatar for Matt Biggs

Matt Biggs

Vice President of Applied Science, ActiGraph, United States
At ActiGraph, I'm a member of our Scientific Department which specializes in digital health technologies. Over the past 10 years, I've had the opportunity to assist clinical trials, national cohort studies, and scientific research globally. With a focus on sensor selection, technology... Read More →
avatar for Jeanne Chung

Jeanne Chung

Program Lead, Digital Medicine Society (DiMe), United States
Jeanne is Program Lead at Digital Medicine Society (DiMe) bringing strategy, execution and innovation through her investment banking, management consulting, and entrepreneurship experience. She currently leads DATAcc - the digital health measurement collaborative community of 50 member... Read More →
avatar for Jie Ren

Jie Ren

Principal Scientist, Global Digital Analytics and Technologies, Merck & Co., Inc., United States
Jie champions digital endpoint development efforts and supports the implementation of digital health technologies in clinical development at Merck.
avatar for Jessica Robin

Jessica Robin

Director, Clinical Research, Winterlight Labs, Canada
At Winterlight Labs, I lead our clinical research program, which includes internal validation and development research, academic collaborations and clinical trials. In this role, I oversee study design, design analysis plans and help communicate the results of our studies relating... Read More →


Thursday June 23, 2022 10:00am - 11:00am CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum
  • Level Intermediate
  • Featured Topics Digital
  • Level Intermediate
  • Feature Topics Digital
  • Credit Type ACPE, CME, RN
  • Tags Forum

10:00am CDT

#406: The PCORnet Response to COVID-19: The Importance of Partnerships, Data, and Digital Innovations to Provide Fast Answers
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-649-L04-P ; CME 1.00; RN 1.00

Learn how researchers across the country responded rapidly and collaboratively to answer key questions about COVID-19 by using PCORnet resources including a flexible coordinating center, a common data model, research-ready networks, and more!

Learning Objectives

Describe how PCORnet, a national resource where health data, research expertise, and patient insights are available to deliver answers can be used in a variety of research contexts; Discuss how PCORnet was used to answer COVID-19 questions quickly across three different projects using electronic health data and digital technologies to support remote trials and rapid surveillance.

Chair

Adrian Hernandez, MD, MHS

Speaker

Panelist
Emily O'Brien, PhD

Panelist
Thomas W Carton, PhD, MS

Panelist
Mark J Pletcher, MD, MPH



Speakers
avatar for Thomas Carton

Thomas Carton

Chief Data Officer, Louisianna Public Health Institute, United States
As Chief Data Officer and former Director of Health Services Research for the Louisiana Public Health Institute, Dr. Carton leads multiple teams that conduct various types of health services research that span health services research, quality improvement, and population health. As... Read More →
avatar for Adrian Hernandez

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute (DCRI), United States
Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →
EO

Emily O'Brien

Associate Professor, Duke University, United States
Emily O'Brien, PhD, is an epidemiologist and health services researcher at the Duke Clinical Research Institute and associate professor in the Department of Population Health Sciences at the Duke University school of Medicine. Her research focuses on comparative effectiveness, patient-centered... Read More →
MP

Mark Pletcher

Professor, University of California San Francisco, United States
Mark Pletcher is Professor and Interim Chair of Epidemiology and Biostatistics at the University of California, San Francisco.


Thursday June 23, 2022 10:00am - 11:00am CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   02: ClinTrials -ClinOps, Session

10:00am CDT

#407: Methodologies Used to Aggregate Real-World Data and Clinical Trial Data
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-650-L04-P ; CME 1.00; RN 1.00

This session will provide an overview of tokenization methodology and principles to aggregate real-world data and clinical trial data. We will also present findings where real-world data might be useful for patient characterization with preliminary data, describe the data sources used, outline the technologies leveraged, and conclude with lessons learned.

Learning Objectives

Describe data tokenization and the application in clinical trials; Recognize the scenarios under which real-world data might be useful for patient characterization; Identify data sources that could be integrated and perform analyze to generate patient insights and how they might be integrated into clinical trials.

Chair

Aman Thukral, MPharm, MS

Speaker

Tokenization in Clinical Trials: When, Why, and Key Learnings
Aman Thukral, MPharm, MS

Integration of Claims, Electronic Health Records, and Genomic Lab-Based Data to Study Novel Patient Populations
Sivakumar Gowrisankar, PhD

Academic Update
Mehdi Najafzadeh, PhD

Industry Update
Vera Mucaj, PhD



Speakers
avatar for Sivakumar Gowrisankar

Sivakumar Gowrisankar

Director, Genomic Medicine, Parexel International, United States
Sivakumar Gowrisankar, PhD is a director in the translational medicine group at Parexel International. His work focusses on integrating genetics into drug discovery and development, including preclinical and all phases of clinical trials. He has a broad range of expertise in genetics... Read More →
avatar for Mehdi Najafzadeh

Mehdi Najafzadeh

Assistant Professor of Medicine, Harvard; Decision Scientist, Brigham and Women's Hospital, United States
Mehdi Najafzadeh PhD, MSc, MA, is an Assistant Professor of Medicine at Harvard Medical School and a decision scientist in the Division of Pharmacoepidemiology and Phamacoeconomics at the Brigham and Women’s Hospital. Dr. Najafzadeh leads “PREdictive modeling and Decision analysis... Read More →
avatar for Aman Thukral

Aman Thukral

Director, Global Head-Digital Operations and Clinical Systems, AbbVie, Inc., United States
Aman Thukral is the Head of Clinical Systems and Digital Operations at AbbVie. In this position, Aman is responsible for leading clinical systems such as EDC, IRT, ePRO, CDR, Medical Coding. Also, he manages the implementation and roll-out of novel digital technologies at AbbVie... Read More →


Thursday June 23, 2022 10:00am - 11:00am CDT
Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   02: ClinTrials -ClinOps, Session

10:00am CDT

#413: Where Next? Targeting Value Assessment and Contracting Optimizing Adoption, Use, and Payment for Technologies and Therapies in Care
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-22-656-L04-P ; CME 1.00; RN 1.00

The session uses case studies illustrating the practical pathways for evolving value-based contracting (VBC) to enhance clinical, financial, functional, and operational outcomes.

Learning Objectives

Apply methods, metrics, data integration and analytics – including digital health – to define value in use for specific consumers and payers; Discuss how to integrate a framework of ongoing value assessment into care process to improve clinical, financial, and operational outcomes across stakeholders.

Chair

David Wierz, MA

Speaker

A New Way to Determine Value: Leveraging Public Health to Better Identify Value-Based Interventions
Brian Arthur Smith, Esq, JD, MPH



Speakers
BS

Brian Smith

Fellow, Oak Ridge Institute For Science and Education (ORISE), United States
Brian A. Smith, JD, MPH, is an attorney and ORISE Fellow at the Centers for Disease Control and Prevention (CDC). Brian focuses his work and research on public health law and policy, with emphasis on healthcare regulations, rare disease policy, and drug laws. He has previously served... Read More →
avatar for David Wierz

David Wierz

Principal - Health Sciences, Exponent, United States
David J. Wierz focuses on optimizing commercial strategy, value in use, market access & payment for the life sciences. He leverages data and analytics to create strategic roadmaps for clinical development, product commercialization and in-market management. David links work in the... Read More →


Thursday June 23, 2022 10:00am - 11:00am CDT
Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  12: Value-Access, Session |   02: ClinTrials -ClinOps, Session
 
Monday, June 26
 

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 Clinical, France
Peter has distinguished himself as a clinical development professional with a strategic focus in leading global operations that support the optimization of biopharmaceutical research and investigator relationships. Based in Paris, he is the Senior Vice President of Clinical Solutions... 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 Associate 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

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, US Patient Engagement, Novartis, 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; Principal, eCOA Science, Signant Health , United Kingdom
Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 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

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
 
Tuesday, June 27
 

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 and 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

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

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

Managing Partner, Clinical Innovation Partners, United States
Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the... 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

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
avatar for Elise Berliner

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
 
Wednesday, June 28
 

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
avatar for Jean Sposaro

Jean Sposaro

Director, Global Drug Development Operations,Industry Collaborations, 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

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

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
avatar for Hsin-Jung Chuang

Hsin-Jung Chuang

Associate Reviewer, TFDA, Taiwan
Ms. Hsin-Jung Chuang holds a master's degree in pharmacy from China Medical University and is currently involved in the regulatory review of investigational new drugs (INDs). Her responsibilities include evaluating INDs for compliance with regulatory standards. Additionally, she participates... Read More →


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

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

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
 
Thursday, June 29
 

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
 

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