Preconference Primer
Preconference Primer (Virtual)
Overview of FDA and Regulatory Processes
Michelle Divelbiss, Associate, Covington & Burling LLP
Wednesday, October 26
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
Jewell Martin, Associate Director for US Regulatory Policy, BioMarin Pharmaceutical Inc.
12:20–12:30 PM
Break
12:30–1:45 PM
Regulation of Biological/Product Development
Elizabeth Trentacost, Associate, Arnold & Porter LLP
1:45–1:55 PM
Break
1:55–3:10 PM
Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Gail Javitt, Partner,Hyman, Phelps & McNamara, PC
3:10–3:20 PM
Break
3:20–4:35 PM
Biological Product Approval, Vaccines, Emergency Use Authorization
Jessica Greenbaum, Counsel, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP
Thursday, October 27
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:20 PM
Biosimilar Biological Products
William Holtz, Principal, Leavitt Partners, LLC
12:20–12:30 PM
Break
12:30–1:15 PM
Post-Approval Pharmacovigilance
Nathan A. Beaver, Partner, Foley & Lardner LLP
1:15–1:25 PM
Break
1:25–2:25 PM
Regulation of Biological Manufacturing
Christopher Fanelli, Partner, Sidley Austin LLP
2:25–2:35 PM
Break
2:35–3:35 PM
Regulation of Biological Product Marketing
Nathan A. Beaton, Associate, Latham & Watkins LLP
Kathryn Culver, Associate, Latham & Watkins LLP
3:35–3:45 PM
Break
3:45–5:00 PM
Violations, Enforcement, and International Issues
Rebecca Williams, Associate, Ropes & Gray LLP
5:00 PM
Adjournment
