Opening Plenary: From Data to Decisions: The Expanding Role of Real‑World Evidence in Regulatory Submissions

Thursday, March 5, 2026

9:00 AM - 10:00 AM East Coast USA Time

Room: Constellation CDEF

Panelist(s)

MB

Marie Bradley

Senior Advisor, Real-World Evidence, Office of Medical Policy
The U.S Food and Drug Administration
Seema S. Betigeri, PhD

Executive Director, Global Regulatory Affairs
Merck & Co., Inc
Michelle Yu Kite, MS (she/her/hers)

Director of Global Strategy, Oncology
Pfizer
Lockwood G. Taylor, PhD, MPH

Head of Regulatory Strategy
Flatiron Health
Dona O'Neil, MPH, CCRP

Associate Director, Medical & Scientific Affairs
BD

Moderator(s)

Erin K. Grath, BS, MS

Associate Vice President
Agilent Technologies

Slides

Description: As regulatory agencies increasingly embrace real‑world evidence (RWE) to support product approvals, label expansions, and post‑market commitments, pharmaceutical and medical device developers face both new opportunities and new expectations. This session brings together leaders across industry and regulatory science to explore how RWE is being generated, evaluated, and applied in regulatory submissions today. Panelists will discuss evolving global expectations, data quality and methodological standards, risks involved in the use of real-world data (RWD), as well as emerging approaches that can strengthen confidence in RWD for regulatory use. Attendees will gain a practical understanding of what it takes to develop fit‑for‑purpose RWE and how to build organizational capabilities that anticipate the future state of evidence generation.