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Session 2: Plenary Session: When Innovation and Need Meet: Development of COVID-19 mRNA Vaccines
Session Chair(s)
Scott Henry, PhD
Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
The mRNA vaccine efforts took a giant leap forward with the success of the COVID-19 vaccine programs at Moderna and Pfizer/BioNTech in 2020. This herculean effort was accomplished through not only technological innovation, but the close and collaborative interaction with Regulatory Agencies to make the process as efficient as possible. This session will present some of the experience and lessons-learned from the perspective of the clinical trial management, CMC manufacturing, and review of dossiers.
Speaker(s)
Preparing the Field: Efforts to Expedite COVID-19 Vaccine Development
Peter W. Marks, MD, PhD
FDA, United States
Director, Center for Biologics Evaluation and Research
Presentation
Jacqueline Miller, MD
Moderna, United States
Senior Vice President, Therapeutic Area Head, Infectious Diseases
Vaccine Development at the Speed of Science
Paul Rohlfing
Pfizer, Inc., United States
Executive Director, Global CMC, Regulatory Affairs
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