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


Tuesday, June 8


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:

12:00 – 12:05 PM 

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

Enter this session:

12:05 – 12:50 PM 

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

Enter this session:

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:

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:

2:50 – 3:20 PM


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:

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:

An access link will be provided to attendees via email upon registration.

If you are registering on behalf of someone else, the link to access the webinar will go to the email address provided at the point of registration.

Those registering on the day of the webinar will receive an access link via email upon successful payment.


We use Zoom to conduct webinars which works on most devices. You may participate in the webinar on a mobile device via the Zoom App or by dialing in. If you require the dial in information, please contact Maura Schatz at [email protected].

Test your device:


Webinar recordings are sent via email as soon as we are able to process and verify the quality of the recording. This usually occurs within 3 business days of a webinar broadcast.

If multiple people at your organization wish to participate from separate devices, each will be required to purchase access.