Session: C2: Drug Quality Lifecycle: Current Regulatory Concerns

Live Q&A (C2)

Tuesday, September 28, 2021

14:37 – 15:00 EDT

Setting the stage for the approval of a quality product application requires the establishment of CMC standards in an application and the selection of manufacturing facilities capable of producing a quality product throughout the product lifecycle. The SARS-CoV-2 pandemic has highlighted the demands of accelerated and streamlined CMC development timelines associated with supplying a quality product to patients without manufacturing delays and disruptions – and doing this while paralleling rapid clinical development timelines. This session will discuss aspects that can allow for streamlining CMC product development and facilitate the submission of a quality application to the FDA. Critical early decisions for the selection of manufacturing facilities and the use of appropriate manufacturing technologies will be discussed.

Moderator(s)

Patricia F. Hughes, PhD

Senior Scientific Advisor, CDER
U.S. FDA
Silver spring, Maryland, United States

Panelist(s)

Gang Chen, PhD

Vice President
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York, United States
Pamela C. De Moor, MS, PhD

Senior Director, Formulations and Drug Product Development
Vir Biotechnology, Inc
Palo Alto, California, United States
Michele Lastro, MS, PhD

Executive Director
Regeneron Pharmaceuticals, Inc.
Fonda, New York, United States

Regulatory Panelist(s)

Maria T. Gutierrez Lugo, PhD

Supervisory Chemist, CDER
U.S. FDA
Silver Spring, Maryland, United States