Preconference Primer
Preconference Primer (Virtual)
Overview of FDA and Regulatory Processes
Monica Groat, Counsel, Latham & Watkins LLP
Keira Murphy, Associate, Latham & Watkins LLP
Preconference Primer (Virtual)
Biological Product Approval, Vaccines, Emergency Use Authorization
Jessica Greenbaum, Counsel, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP
Tuesday, March 7
10:30 AM–11:00 AM
Registration
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, Associate, Ropes & Gray LLP
12:20–12:45 PM
Lunch
12:45–2:00 PM
Regulation of Biological/Product Development
Elizabeth Trentacost, Associate, Arnold & Porter LLP
2:00–2:10 PM
Networking Break
2:10–3:25 PM
Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Barbara Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC
Wednesday, March 8
10:30 AM–11:00 AM
Registration
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:20 PM
Biosimilar Biological Products
Aziz Burgy, Partner, Axinn, Veltrop & Harkrider LLP
12:20–12:45 PM
Lunch
12:45–1:30 PM
Post-Approval Pharmacovigilance
Abeba Habtemariam, Partner, Arnold & Porter LLP
1:30–1:40 PM
Networking Break
1:40–2:40 PM
Regulation of Biological Manufacturing
Christopher Fanelli, Partner, Sidley Austin LLP
2:40–2:50 PM
Networking Break
2:50–3:50 PM
Regulation of Biological Product Marketing
Paul S. Gadiock, Of Counsel, Wilson Sonsini Goodrich & Rosati
James R. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati
3:50–4:00 PM
Networking Break
4:00–5:00 PM
Violations, Enforcement, and International Issues
Sonia W. Nath, Partner, Cooley LLP
5:00 PM
Adjournment
