Why Attend

Preliminary Agenda

CLE

Tuesday, June 8

11:00–11:45 AM
Bonus Session: A Primer on Regenerative Medicine Science and Recent Breakthroughs

12:00–12:05 PM
FDLI Welcome and Introduction
Amy Comstock Rick, President & CEO, FDLI

12:05–12:50 PM
Keynote Address
Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA

1:05–1:50 PM
Updates on FDA’s Comprehensive Regenerative Medicine Policy Framework

2:05–2:50 PM
Global Regulatory Harmonization of Cell and Gene Therapies

2:50–3:20 PM 
Break

3:20–4:20 PM
Clinical Development of Regenerative Medicines

4:35–5:20 PM  
Standardization of Regenerative Therapies

Wednesday, June 9

12:00–12:05 PM
FDLI Welcome
Laura A. Brown, Director, Educational Programs, FDLI

12:05–12:50 PM
Featured Speaker

1:05–1:50 PM
Regulation of Gene and Cell Therapy Manufacturing

1:50–2:20 PM
Break

2:20–3:05 PM
Interacting with FDA Throughout the Regenerative Medicine Product Lifecycle

3:20–4:05 PM
Gene and Cell Therapy Coverage, Reimbursement, and Pricing

4:05 PM
Closing Remarks and Adjournment