Thursday, April 2
9:05– 9:15 AM
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, Food and Drug Law Institute (FDLI)
Laura Brown, Director, Educational Programs, FDLI
9:15 – 10:00 AM
Dr. Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA
This panel will explore definitions, types of products, mechanisms of action, and potential benefits associated with the rapidly innovating field of regenerative medicine. Speakers will discuss FDA’s comprehensive regenerative medicine policy framework, the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) under Public Health Service Act Sections 351 and 361, how FDA’s regulation of regenerative medicine therapies interacts with the practice of medicine, and the impact the end of FDA’s pending enforcement discretion period for certain HCT/Ps in November 2020 will have on companies.
Catherine M. Cook, Executive Vice President, Drugs and Biological Products, Greenleaf Health, Inc.
Julia C. Tierney, Chief of Staff, Center for Biologics Evaluation and Research, FDA
Moderated by Denise Esposito, Partner, Covington & Burling LLP
11:00 – 11:15 AM
12:30 – 1:30 PM
2:45 – 3:00 PM
Closing Remarks and Adjournment