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Session 5: Positive Regulatory Decisions Enabled by Real -World Evidence
Session Chair(s)
David Martin, MD, MPH
Vice President, Global Head RWE
Moderna, United States
Brian Bradbury, DrSc, MA
Vice President, Center for Observational Research
Amgen, United States
The ability to generate RWE that can enable a regulatory decision is no small feat. As we have learned during the discussions at this and in previous conferences, through direct engagement with regulators and from insights gleaned in the literature, “regulatory-grade” RWE is a very high standard. In this session we will take a deeper dive into a number of successful use cases where manufactures have generated decision-enabling RWE that has led to a positive regulatory decision (i.e., regulatory grade RWE).
Learning Objective : - Recognize the regulatory & clinical development context that made an RWE-enabled development strategy attractive
- Highlight the selection of data & methods that were fit-for-purpose & the early interactions that promoted regulatory alignment
- Review various information requests received as regulatory agencies pressure tested key findings
- Understand the nature of the approval/authorization decision & the basis for considering RWE fit-for-purpose
Speaker(s)
Speakers
Rob Kalesnik-Orszulak, PharmD
Bristol Myers Squibb, United States
Senior Director, Global Regulatory Strategy
Speaker
Tzu-Chieh (Jay) Lin, PhD, MPharm
Amgen, United States
Observational Research Director
Speaker
Nicole Kellier-Steele, PhD, MPH
Eli Lilly and Company, United States
Senior Director - Global Patient Safety