Preconference Primer
Preconference Primer (Virtual)
Overview of FDA and Regulatory Processes
Steven S. Tjoe, Partner, Goodwin Procter LLP
Elizabeth Mulkey, Associate, Goodwin Procter LLP
Wednesday, October 18
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:20 PM
Introduction to FDA Review and Approval of Biological Products
Rebecca Williams, Senior Associate, Ropes & Gray LLP
12:20–12:35 PM
Break
12:35–1:50 PM
Regulation of Biological/Product Development
Matthew Hegreness, Partner, Covington & Burling LLP
1:50–2:05 PM
Break
2:05–3:20 PM
Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Tina Papagiannopoulos, Counsel, Foley Hoag LLP
Matthew Piscitelli, Associate, Foley Hoag LLP
3:20–3:35 PM
Break
3:35–4:50 PM
Biological Product Approval, Vaccines, Emergency Use Authorization
Christina M. Markus, Partner, King & Spalding LLP
Jessica Greenbaum, Counsel, King & Spalding LLP
Thursday, October 19
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:20 PM
Biosimilar Biological Products
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
12:20–12:30 PM
Break
12:30–1:30 PM
Post-Approval Pharmacovigilance
Nathan A. Beaver, Partner, Foley & Lardner LLP
Kyle Y. Faget, Partner, Foley & Lardner LLP
1:30–1:40 PM
Break
1:40–2:40 PM
Regulation of Biological Manufacturing
Seth Olson, Associate, Latham & Watkins LLP
2:40–2:50 PM
Break
2:50–3:50 PM
Regulation of Biological Product Marketing
Jur Strobos, Partner, Potomac Law Group
3:50–4:00 PM
Break
4:00–5:00 PM
Violations, Enforcement, and International Issues
Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
5:00 PM
Adjournment