Day 1

Day 2



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


This course is pending CLE approval in Virginia and Ohio. During the course, there will be periodic polling to ensure you are still listening. This will let us know if you completed the necessary hours to receive CLE credit. Please email [email protected] at the end of the conference to obtain forms.

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

We will be using Zoom Webinars to conduct this Introductory course. If you have any technical issues throughout the course, please visit the Zoom Help Center here:

Yes. Please contact Coleen Carney at [email protected] if you require dial-in numbers.