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Session 10: Unlock the Future of RWE: Shaping the Next Era of Regulatory-Grade RWE
Session Chair(s)
Jaclyn Bosco, MPH, FISPE
Vice President & General Manager, Global Head of Epidemiology & Scientific Strat, IQVIA, United States
This panel brings together leading voices from academia, industry, and regulatory science—Nancy A. Dreyer, Sebastian Schneeweiss, Khaled Sarsour, and Marie Bradley—to explore how real-world evidence is reshaping the future of drug development, regulatory decision-making, and patient access. Drawing on diverse perspectives, the discussion will examine evolving methodological standards, data reliability, and the increasing expectations for RWE in global regulatory frameworks. Panelists will highlight emerging use cases across the product lifecycle, from early development to post-market evaluation, and address barriers to broader adoption. Attendees will gain forward-looking insights into how to operationalize RWE strategies that align with scientific rigor and regulatory requirements in a rapidly evolving landscape.
Learning Objective : At the conclusion of this session, participants should be able to: - Discover RWE trends shaping regulatory decisions over the next 3–5 years
- Hear future regulatory perspectives and pinpoint gaps for submissions
- Take away actions to build a future-ready RWE strategy in 6–12 months
Speaker(s)
Nancy Dreyer, MPH, FISPE
Founder, Dreyer Strategies LLC, United States
Speaker
Representative Invited
Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology, Harvard Medical School and Brigham and Women's Hospital, United States
Speaker
Khaled Sarsour, PhD, MPH
Global Head, RWD Hematology-Oncology, Genentech, A Member of the Roche Group, United States
Speaker
Representative Invited
Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER, FDA, United States
Speaker
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