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Session 7: Lessons Learned From Development of Vaccines and Therapeutics in Response to COVID-19
Session Chair(s)
Cynthia Schnedar, JD
Principal, Regulatory Compliance, Greenleaf Health Inc., United States
This session will focus on lessons learned from the expedited CMC development of vaccines and therapeutics in response to the COVID-19 pandemic. The session will discuss how sponsors expedited the development of vaccines and therapies; how regulators facilitated an accelerated pathway for these products; and what lessons can be learned for the future. The session will focus on the CMC development of these products and will cover the benefits of a rolling review process and the application of Real World Evidence in the rollout of vaccines.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the key strategic pressure points for expedited CMC development for novel vaccines and therapeutics
- Understand the tools FDA is using to create expedited pathways
- Strategize on how lessons learned from the pandemic can be implemented in the future
Speaker(s)
Barbara Allen, PHD
, International Quality Expert, United States
Speaker
Roger Nosal, PHD
Vice President, Head of Global CMC, Pfizer Inc, United States
Speaker
Norman W. Baylor, PHD, MS
Board Chairman, Biologics Consulting Group, Inc., United States
Speaker
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