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Session 4: Use of Real-World Evidence for Pre-Marketing Regulatory Decision Making: Current and Future
Session Chair(s)
Judith C. Maro, PhD, MS
Assistant Professor, Department of Population Medicine
Harvard Medical School, United States
Yuan-Li Shen, DrPH
Division Director, Division of Biometrics IX, OB, OTS, CDER
FDA, United States
Ram Tiwari, PhD, MS
Head of Statistical Methodology
Bristol Myres Squibb , United States
Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions in recent years. The 21st Century Cures Act, passed in 2016, places additional focus on the use of the RWD to support regulatory decision making. The purpose of this session is to discuss the use of the RWD to support regulatory submission in a pre-marketing setting. The current progress and future prospect of using RWE, approaches/methods to optimize the utility of RWE, and examples of using RWD to support a submission will be discussed. The applicability and limitation of using RWE will also be examined per regulatory and industry’s point of views.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss recent pre-market regulatory activities related to RWE/RWD
- Identify quality and validity concerns of using RWD in current pre-licensure submissions
- Evaluate methodologies or approaches to expand the use of RWD in premarket submissions
Speaker(s)
Real-World Evidence Experience in Cell Therapy Submission: Lessons Learned
Lihua Yue, PhD
Bristol-Myers Squibb, United States
Associate Director, Biostatistics
FDA’s Real World Evidence Program
John Concato, MD, MPH, MS
FDA, United States
Associate Director for Real-World Evidence Analytics, OMP, CDER
Key Considerations in the Use of RWE for Regulatory Decisions
Weili He, PhD
AbbVie, United States
Senior Director, Head of Global Medical Affairs Statistics
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