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DIA/FDA Oligonucleotide-Based Therapeutics Conference

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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

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)

Peter W. Marks, MD, PhD

Preparing the Field: Efforts to Expedite COVID-19 Vaccine Development

Peter W. Marks, MD, PhD

  • Director, Center for Biologics Evaluation and Research
  • FDA, United States
Jacqueline Miller, MD

Presentation

Jacqueline Miller, MD

  • Senior Vice President, Therapeutic Area Head, Infectious Diseases
  • Moderna, United States
Paul Rohlfing

Vaccine Development at the Speed of Science

Paul Rohlfing

  • Executive Director, Global CMC, Regulatory Affairs
  • Pfizer, Inc., United States

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