Agenda Details

Learn more about sessions and presentations at the 26th Annual Meeting

Detailed Program

Accelerated Approval for Cell and Gene Therapies

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.

Session Details


Daniela Drago, PHD. Aurion Biotech, MA


Natalia Shunmugan, PhD. Ultragenyx Pharmaceutical Inc., CA

Considerations for Accelerated Approval for Gene Therapy

Shelby Elenburg, MD. Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Adminis...

Bluebird’s Experience with Accelerated Approval and Efficacy Data - Discussion on the Skysona (eli-cel) Experience

Leslie Wilder. , CA

The Scientific Underpinnings of Accelerated Approval: Validity of Biomarkers and Clinical Data to Demonstrate Relevance

Aaron Seth Kesselheim, MPH, MD, JD. Harvard University, MA


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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