Day 1

All times are in Eastern time

Prerecorded

Overview of FDA and Regulatory Processes
Patrick C. Gallagher, Partner, Duane Morris LLP

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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.

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12:20–12:35 PM

Break

12:35–1:50 PM

Regulation of Biological/Product Development
Natasha V. Leskovsek, Of Counsel, Cooley LLP

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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

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3:20–3:35 PM

Break

3:35–5:00 PM

Biological Product Approval, Vaccines
Elizabeth Trentacost, Senior Associate, Arnold & Porter LLP

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