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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

Session 4: Use of Real-World Evidence for Pre-Marketing Regulatory Decision Making: Current and Future

Session Chair(s)

Judith  Maro, PhD, MS

Judith Maro, PhD, MS

  • Assistant Professor, Department of Population Medicine
  • Harvard Medical School and the Harvard Pilgrim Health Care Institute, United States
Yuan-Li  Shen, DrPH

Yuan-Li Shen, DrPH

  • Deputy Division Director, Division of Biometrics V, OB, OTS, CDER
  • FDA, United States
Ram  Tiwari, PhD, MS

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


Lihua  Yue, PhD

Real-World Evidence Experience in Cell Therapy Submission: Lessons Learned

Lihua Yue, PhD

  • Associate Director, Biostatistics
  • Bristol-Myers Squibb, United States
John  Concato, MD, MPH, MS

FDA’s Real World Evidence Program

John Concato, MD, MPH, MS

  • Associate Director for Real-World Evidence Analytics, OMP, CDER
  • FDA, United States
Weili  He, PhD

Key Considerations in the Use of RWE for Regulatory Decisions

Weili He, PhD

  • Senior Director, Head of Global Medical Affairs Statistics
  • AbbVie, United States