Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More
March 5–6, 2024 Virtual Course
Agenda
Agenda Subject to Change
All times are in Eastern Time
2024 Curriculum Advisor:
Barbara A. Binzak Blumenfeld, Partner, Buchanan Ingersoll & Rooney PC
Preconference Primer (Virtual)
Overview of FDA and Regulatory Processes
Patrick C. Gallagher, Partner, Duane Morris LLP
Tuesday, March 5
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, Director of US Regulatory Policy, BioMarin Pharmaceutical Inc.
12:20–12:35 PM
Break
12:35–1:50 PM
Regulation of Biological/Product Development
Natasha V. Leskovsek, Of Counsel, Cooley 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
3:35–5:00 PM
Biological Product Approval, Vaccines
Elizabeth Trentacost, Senior Associate, Arnold & Porter LLP
Wednesday, March 6
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:20 PM
Biosimilar Biological Products
Krista Hessler Carver, Partner, Covington & Burling LLP
12:20–12:30 PM
Break
12:30–1:30 PM
Post-Approval Pharmacovigilance
David L. Rosen, 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
Kathryn Culver, Associate, Latham & Watkins LLP
3:50–4:00 PM
Break
4:00–5:00 PM
Violations, Enforcement, and International Issues
David L. Chesney, Principal and GM, DL Chesney Consulting, LLC
5:00 PM
Adjournment