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THE US GRANT, a Luxury Collection Hotel, San Diego

Nov 10, 2022 7:00 AM - Nov 11, 2022 12:30 PM

326 Broadway, San Diego, CA 92101

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 5: Positive Regulatory Decisions Enabled by Real -World Evidence

Session Chair(s)

David  Martin, MD, MPH

David Martin, MD, MPH

Vice President, Global Head RWE

Moderna, United States

Brian  Bradbury, DrSc, MA

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


Rob  Kalesnik-Orszulak, PharmD


Rob Kalesnik-Orszulak, PharmD

Bristol Myers Squibb, United States

Senior Director, Global Regulatory Strategy

Tzu-Chieh (Jay)  Lin, PhD, MPharm


Tzu-Chieh (Jay) Lin, PhD, MPharm

Amgen, United States

Observational Research Director

Nicole  Kellier-Steele, PhD, MPH


Nicole Kellier-Steele, PhD, MPH

Eli Lilly and Company, United States

Senior Director - Global Patient Safety

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