Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More

March 5–6, 2024       Virtual Course

Preliminary 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