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Session 8: Leaping Forward: The Future of Real-World Evidence
Session Chair(s)
Nirosha M. Lederer, PhD, MS
Head, US Government Partnerships; Senior Director, RWE Strategy
Aetion, United States
Jingyu (Julia) Luan, PhD
Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D
AstraZeneca, United States
In the past two days, this conference has reviewed the proliferation of real-world data sources and technological advances that have spurred innovative uses of real-world data and real-world evidence by sponsors in product development and regulators in product evaluations. In this capstone session, we discuss the future trends for RWE. Potential topics may include:
- How can RWE continue to improve the efficiency of drug development?
- What should we do to expand the use of RWE in common disease areas?
- How can we use RWE to enhance patient focused drug development and clinical trial diversity?
- What novel technologies can address challenges in the use and evaluation of real-world data and evidence for regulatory decision-making?
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe key anticipated trends in RWD and RWE
- Recognize future opportunities to leverage RWD and RWE in generating RWE for regulatory decision-making
- Be aware of the challenges that may be encountered when novel technologies are used to generate RWD/RWE
Speaker(s)
PDUFA VII
Lucy Vereshchagina, PhD
PhRMA, United States
Vice President, Science and Regulatory Advocacy
Synthetic Data and Data Operationalization Advancements
Wendy Turenne, MS
Aetion, United States
Senior Vice President, Real World Data & Delivery Operations
Digital Medicine and RWE
Sarah Sheehan, MPA
Digital Medicine Society (DiMe), United States
Program Lead
Panelists
Charles Lee, MBA, MS
AstraZeneca, United States
Executive Regulatory Science Director
Panelist
John Concato, MD, MPH, MS
FDA, United States
Associate Director for Real-World Evidence Analytics, OMP, CDER
Virtual Panelist
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
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