2022 Policy Summit Agenda
(subject to change)
This year’s Policy Summit will offer a variety of stakeholder perspectives on hot topics and how they inform policies that impact the cell and gene therapy field.
Check back to this page for more agenda information as speakers are confirmed!
Policy Summit Co-Chairs: Diane Berry, PhD, Sarepta Therapeutics & Keith Wonnacott, PhD, LEXEO Therapeutics
Monday September 26, 2022
9:00 – 10:30 a.m.: Supporting Innovative CGT Development
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RMAT in 2022: Updates and Learnings
Wilson Bryan, MD, FDA OTAT
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New Endpoints and Biomarkers in Supporting CGT Development
Adora Ndu, PharmD, JD, BridgeBio
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The Bespoke Gene Therapy Consortium: Increasing Accessibility of Gene Therapies for Rare Diseases
Courtney Silverthorne, Foundation for the National Institutes of Health
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Moderator: Daniela Drago, PhD, Aurion Biotech
10:30 – 10:45 a.m.: Break
10:45 a.m. – 12:00 p.m.: Panel on PDUFA Reauthorization
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PDUFA VII: CBER Updates
Wilson Bryan, MD, FDA OTAT
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Moderator: Keith Wonnacott, PhD, LEXEO Therapeutics
12:00 – 1:30 p.m.: Lunch
1:30 – 2:45 pm: Panel on Diversity in Cell and Gene Therapy Development
2:45 – 3:15 p.m.: Break
3:15 – 4:30 p.m.: Panel on Accelerated Approval
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Developer Viewpoint on Accelerated Approval
Diane Berry, PhD, Sarepta Therapeutics
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Moderator: Jeremy Allen, Spark Therapeutics
Tuesday September 27, 2022
9:00 – 10:15 a.m.: Panel on Coverage and Reimbursement for Cell and Gene Therapies
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Payer Decisions that Impact Patient Access
Kollet Koulianos, National Hemophilia Foundation
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Moderator: Francesca Cook, REGENXBIO
10:15 – 10:30 a.m.: Break
10:30 a.m. – 12:00 p.m.: CMC Applications and Hurdles for Gene and Cell Therapies
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