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Learn more about sessions and presentations at the 26th Annual Meeting
Wednesday, May 17 2023 08:00 AM – 09:45 AM PT
The Accelerated Approval pathway has received significant public attention in recent years, and is likely to play an important role in future cell and gene therapy approvals. This session will first address what accelerated approval is, including its scientific underpinnings and how it has been used in the CGT space. The session will then turn to forward-looking and in-depth panel discussion (~45 minutes) on the future of Accelerated Approval.
08:00 AM – 09:45 AM - Room 515 AB
Daniela Drago, PHD. Aurion Biotech, MA
Natalia Shunmugan, PhD. Ultragenyx Pharmaceutical Inc., CA
08:01 AM – 08:20 AM - Room 515 AB
Shelby Elenburg, MD. Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Adminis...
08:20 AM – 08:40 AM - Room 515 AB
Leslie Wilder. , CA
08:40 AM – 09:00 AM - Room 515 AB
Aaron Seth Kesselheim, MPH, MD, JD. Harvard University, MA
09:00 AM – 09:45 AM - Room 515 AB
Peter Marks. Food & Drug Administration, Silver Spring, MD
Aaron Seth Kesselheim. , MA
Leslie Wilder. bluebird bio, CA
Adora Ndu, PharmD, JD. Bridgebio, MD
Courtney Silverthorn, PhD. Foundation for the National Institutes of Health, North Bethesda, MD
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