Conference Program

Panel Discussion Followed by COVID-19 Therapeutic and Vaccine Perspectives (303714)

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Sejong Bae, University of Alabama at Birmingham  
Rafia Bhore, Regeneron Pharmaceuticals, Inc. 
Min Lin, AstraZeneca 
*Thamban Illath Valappil, FDA 
Ye Yang, US Food and Drug Administration 

Keywords: challenges, opportunities, COVID-19, therapeutics and vaccines

Following the presentations by Bhore Rafia (Industry), Ye Yang (FDA/CBER), Thamban Valappil (FDA/CDER), we would like to engage in an interactive discussion with the audience. Representatives from the industry, FDA, and academia are joining the conversation. We hope to discuss different aspects of COVID-19 therapeutic and vaccine submissions in a biopharmaceutical regulatory setting with special attention to the statistical challenges and opportunities for clinical trials. It has posed enormous design challenges to statisticians who need to adapt to the ultra-fast development pace, while holding to the statistical principles for conducting interpretable clinical trials. We also would like to hear back from the audience about their experiences and questions addressing these challenges.