Back to Agenda
Session 10: Enhancing Drug Development with Early Benefit-Risk Strategies and Decision-Driven Visualizations
Session Chair(s)
Mengchun Li, MD, MPA
Senior Director, Clinical Research, Infectious Disease
Merck & Co., Inc., United States
Building on the foundation of the Benefit Risk Assessment session in the 2024 conference, this session on Benefit Risk Assessment in 2025 aims to further advocate for the adoption and implementation of early benefit/risk considerations in drug development, highlighting structured Benefit Risk Assessment and the deployment of decision-oriented visualization approach. The speakers will share real examples of how structured Benefit Risk Assessment might be implemented, and how to implement benefit risk considerations in protocol design and ongoing decision-making starting from early stage of clinical development. The speaker will also present decision-oriented visualizations to facilitate and drive early proactive discussions of what and how to assess benefit risk tradeoffs.
Learning Objective : At the conclusion of this session, participants should be able to:- Apply and implement early benefit/risk considerations in earlier stage of drug development
-
Discuss how to follow structured Benefit Risk Assessment throughout the Clinical Development stage into post marketing
- Employ decision enhanced visualizations to facilitate good decision making
Speaker(s)
Speaker
Leo Plouffe, MD
Gilead Sciences, United States
Head of Global Patient Safety
Structured Benefit-Risk Assessment in AstraZeneca
Jiyoon Park
AstraZeneca, United States
Safety Data Scientist, Global Patient Safety
Speaker
Ellen M Janssen, PhD
Janssen Research & Development LLC, United States
Director, Global Epidemiology, Benefit-Risk Assessment
Have an account?