DIA/FDA Biostatistics Industry and Regulator Forum

Session Chair(s)

Brenda Crowe, PhD

• Associate Vice President, Statistics
• Eli Lilly and Company, United States

Vaccine development was greatly accelerated during the COVID-19 pandemic and has resulted in the authorization of several different COVID-19 vaccines globally. This acceleration was achieved without sacrificing the quality, safety, or efficacy of the development process. Understanding the methods used to achieve this is informative. Additionally, the availability of extensive post-authorization safety surveillance networks and methodologies helped achieve this accomplishment.

Learning Objective : At the conclusion of this session, participants should be able to:

• Describe some of the techniques used to accelerate COVID-19 vaccine development
• Discuss the broad considerations for safety and efficacy of authorized COVID-19 vaccines
• Explain the different surveillance methods being employed to ensure the safety of deployed vaccines

Speaker(s)

Speaker

Peter W. Marks, MD, PhD

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