Day 1

 

Day 2
Resources

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

 

Tuesday, June 8

Sponsor

11:00–11:45 AM

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

Enter this session: https://fdli.zoom.us/j/99213982384

12:00 – 12:05 PM 

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

Enter this session: https://fdli.zoom.us/j/98034755485

12:05 – 12:50 PM 

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

Enter this session: https://fdli.zoom.us/j/98034755485

1:05 – 1:50 PM 

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.

Enter this session: https://fdli.zoom.us/j/99955774734

2:05 – 2:50 PM

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

Enter this session: https://fdli.zoom.us/j/97498391727

2:50 – 3:20 PM

Break

3:20 – 4:20 PM

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

Enter this session: https://fdli.zoom.us/j/94300994534

4:35 – 5:20 PM

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

Enter this session: https://fdli.zoom.us/j/98895370530

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