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Session 2: Approaches to Patient Engagement in Benefit-Risk Assessment Throughout the Product Life Cycle
Session Chair(s)
Rebecca Noel, DrPH, MPH
Executive Director, Benefit-Risk Assessment
Eli Lilly, United States
Cynthia Rice
Senior Vice President, Advocacy and Policy
Juvenile Diabetes Research Foundation (JDRF), United States
Drug development takes place in a highly regulated environment with development timelines built into the process. In this environment, how and when should patient engagement occur as benefits, risks, and balance are being assessed?
This session will go into deeper detail about the points during the product cycle at which benefits and risks are assessed and balanced. For each key point or stage, the group will discuss what decisions must be made, who are the stakeholders most involved, effective and cutting edge methods for expression of patient preferences and perspectives, approaches for patient engagement, objectives of communication among key stakeholders, and uncertainties around information used for assessment. The impact of uncertainty on decision-making processes, including the need to understand patient tolerance for uncertainty, will be explored in more detail.
Speaker(s)
Patient Engagement in the Development and Peri-approval Stages
Bray Patrick-Lake, MS
FDA, United States
Senior Digital Health Specialist, DDH, CDRH
Patient Engagement in the Development and Peri-approval Stages
Juhaeri Juhaeri, PhD
Sanofi, United States
Vice President and Head, Epidemiology and Benefit-Risk Evaluation
Patient Engagement in the Development and Peri-approval Stages
Kathryn O'Callaghan
FDA, United States
Assistant Director for Strategic Programs, CDRH
Patient Engagement in the Post-approval Stage
Richard Hermann, DrMed, MD, MPH
AstraZeneca, United States
Safety Science Physician, CMO Organization
Panel Q&A
United States
Patient Engagement in Individual Decision-making
Liana Fraenkel
Yale University School of Medicine, United States
Professor of Medicine
Panel Q&A
United States
Panel Discussion: A Candid Conversation About Uncertainty
FDA Speaker Invited
FDA, United States
Bray Patrick-Lake, MS
FDA, United States
Senior Digital Health Specialist, DDH, CDRH
Patricia Furlong, BSN
Parent Project Muscular Dystrophy, United States
Founding President and Chief Executive Officer
John F. P. Bridges, PhD
Ohio State University College of Medicine, United States
Professor, Departments of Biomedical Informatics
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Takeda, United States
Vice President, Head of Medical Safety, Marketed Products
Liana Fraenkel
Yale University School of Medicine, United States
Professor of Medicine
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