Yesterday, U.S. Food & Drug Administration (FDA) Commissioner Dr. Stephen M. Hahn joined BIO Digital for a fireside chat to discuss collaboration and COVID-19 response efforts.
FDA is seeking to review COVID-19 products “as fast as we can,” said Dr. Hahn. They are prioritizing science-based solutions with a “rolling” approach, focusing on those with the greatest chance of approval, and there's a lot of engagement with developers and manufacturers. (Reuters has more on what to expect.)
Public-private partnership has been important. “What’s been remarkable about this is the speed with which this pandemic came upon us and the significant number of unknowns, but how remarkable the response has been from the biopharma community in collaboration with regulators and the FDA,” he said.
Collaboration between companies is important, too. “There has been incredible alignment, collaboration, and cooperation among...the private sector. This is usually a very competitive environment but what I’ve seen is a really significant lean-in of industry to work together in sharing information,” he continued.
Post-COVID clinical development will be “very different.” Dr. Hahn said we should consider domestic manufacturing of medical products, and flexibility around existing clinical trials. (Bloomberg Law has more on what he said about the outlook for trials.)
Did you miss it? Catch up on the BIO Digital Live Blog or watch the session recording (if you’re registered) here.
The conversation with FDA continues today, with a town hall featuring Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research (CBER), and Dr. Peter Stein, Director of CDER’s Office of New Drugs (OND).
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