Resources

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

 

Tuesday, June 8

Sponsor

Bonus Session: A Primer on Regenerative Medicine Science and Recent Breakthroughs
Heather C. Hatcher, Regulatory Scientist, Womble Bond Dickinson (US) LLP
Collin Stabler, Senior Associate, Exponent, Inc.
Moderated by Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC

Watch this session: https://fdli.vids.io/videos/709ddbb5181be7c5f9/regenerative-medicine-conference-day-1-session-1-bonus-session

FDLI Welcome and Introduction
Amy Comstock Rick
, President & CEO, FDLI

Watch this session: https://fdli.vids.io/videos/ac9ddbb5191de5c425/regenerative-medicine-conference-day-1-session-2-welcome-and-keynote

Keynote Address
Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA

Watch this session: https://fdli.vids.io/videos/ac9ddbb5191de5c425/regenerative-medicine-conference-day-1-session-2-welcome-and-keynote

Updates on FDA’s Comprehensive Regenerative Medicine Policy Framework
Wilson W. Bryan
, Director, Office of Tissues and Advanced Therapies, CBER, FDA
Lauren A. Miller
, Senior Counsel, AbbVie
Moderated by Joanne Hawana, Member, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Watch this session: https://fdli.vids.io/videos/069ddbb51711e3c28f/regenerative-medicine-conference-day-1-session-3-updates-on-fdas-comprehensive-regenerative-medicine-policy-framework

Global Regulatory Collaborations in Search of Cell and Gene Therapy Harmonization
Joan Wilmarth Blair, Senior Advisor for International Affairs, CBER, FDA
Victoria Palmi Reig, Senior Product Lead, Office of Advanced Therapies and Therapies for Immune and Inflammatory Diseases, European Medicines Agency
Moderated by Cristiana Spontoni, Partner, Jones Day

Watch this session: https://fdli.vids.io/videos/ac9ddbb61d1fe5c125/regenerative-medicine-conference-day-1-session-4-global-regulatory-collaborations-in-search-of-cell-and-gene-therapy-harmonization

Gene Therapy Clinical Development Considerations
Mantej (Nimi) Chhina
, Senior Director & Head, Global Regulatory Policy, BioMarin Pharmaceutical Inc.
Ilan Irony, Deputy Director, Division of Clinical Evaluation and Pharmacology/Toxicology, CBER, FDA
Gopa Raychaudhuri, Senior Scientist, Office of the Center Director, CBER, FDA
Moderated by Michael N. Druckman, Partner, Hogan Lovells US LLP

Watch this session: https://fdli.vids.io/videos/119ddbb61d19e3c898/regenerative-medicine-conference-day-1-session-5-gene-therapy-clinical-development-considerations

Standardization of Regenerative Therapies
Judy Arcidiacono, Regulatory Affairs Specialist, Office of Tissues and Advanced Therapies, CBER, FDA
Fouad Atouf, Vice President, Global Biologics, U.S. Pharmacopeia
Robert Shaw, Executive Director, Standards Coordinating Body
Moderated by Deborah L. Livornese, Director, Hyman, Phelps & McNamara, PC

Watch this session: https://fdli.vids.io/videos/449ddbb61d1aecc5cd/regenerative-medicine-conference-day-1-session-6-standardization-of-regenerative-therapies

Wednesday, June 9

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

Watch this session: https://fdli.vids.io/videos/ea9ddbb61f19ecca63/regenerative-medicine-conference-day-2-session-1-welcome-and-featured-speaker

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

Watch this session: https://fdli.vids.io/videos/ea9ddbb61f19ecca63/regenerative-medicine-conference-day-2-session-1-welcome-and-featured-speaker

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

Watch this session: https://fdli.vids.io/videos/4d9ddbb61e1fe3c1c4/regenerative-medicine-conference-day-2-session-2-regulation-of-gene-and-cell-therapy-manufacturing

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.

Watch this session: https://fdli.vids.io/videos/ac9ddbb61e1de8cd25/regenerative-medicine-conference-day-2-session-3-ensuring-regenerative-therapy-product-compliance-with-fda

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

Watch this session: https://fdli.vids.io/videos/119ddbb61e1ae6cd98/regenerative-medicine-conference-day-2-session-4-gene-and-cell-therapy-coverage-reimbursement-and-pricing

On-demand content can be played back on most devices.

 

CLE credit is not currently available for pre-recorded sessions.