Please find the session links next to their corresponding agenda item.

Wednesday, June 9


12:00–12:05 PM

FDLI Welcome and Announcements
Laura A. Brown, Director, Educational Programs, FDLI

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12:05–12:50 PM

Featured Speaker
Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania

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1:05–2:05 PM

Regulation of Gene and Cell Therapy Manufacturing
Mo Heidaran, Vice President, Technical, Parexel International
Lawrence Starke, Global Regulatory Affairs (CMC) Policy and Intelligence, Cell & Gene Therapy, Novartis Pharmaceutical Company
Moderated by Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP

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2:05–2:35 PM


2:35–3:20 PM

Ensuring Regenerative Therapy Product Compliance with FDA
Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP
Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, CBER, FDA
Moderated by Kalah Auchincloss, SVP and Deputy General Counsel, Greenleaf Health, Inc.

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3:35 – 4:20 PM

Gene and Cell Therapy Coverage, Reimbursement, and Pricing
Rochelle Fink, Senior Health Science Project Manager, CDRH, FDA
Michael Werner, Partner, Holland & Knight LLP
Moderated by Catherine A. Brandon, Partner, Arnold & Porter LLP

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4:20 PM

Closing Remarks and Adjournment

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