Virtual Lunch & Learn: FDA Programs to Facilitate and Expedite Development of New Drugs

Join us for an engaging and informative Virtual Lunch & Learn series, where we will dive deep into the key aspects of drug development in the U.S. This is the last installment of our 3-part series designed to provide a comprehensive understanding of the critical steps, strategies, and regulatory considerations that drive successful pharmaceutical product development. Whether you're new to the industry or looking to expand your knowledge, this series will offer valuable insights into the regulatory landscape and the processes that shape the future of medicine.

Part 3 will present the mechanisms that exist to expedite approval of products in the U.S. for the treatment of life-threatening diseases and conditions. The goal of these programs is to accelerate the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternatives. The benefits of each program will be reviewed, and the data requirements for successful application will be discussed.

Reserve your spot today!

Speaker:

Dr. Elizabeth Gordon is a regulatory affairs expert with 34 years of experience in the pharmaceutical industry and FDA, specializing in drug and biologics development with particular expertise in rare diseases and orphan products. Her career spans leadership roles at several pharmaceutical companies, including Design Therapeutics, Amplyx Pharmaceuticals, and Lumena Pharmaceuticals. As Senior Vice President of Regulatory Affairs at various companies, she has overseen development of novel therapies ranging from antifungal agents to gene-targeted treatments for rare degenerative disorders. Her experience includes six years at the FDA, where she helped develop policy for biological products regulation across both the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. Dr. Gordon holds a Ph.D. in Microbiology from the University of Rhode Island, a B.A. from the University of New Hampshire, and an Executive M.S. in Technology Management from the University of Maryland.

Sponsored by RAIN Catalysts

This program was organized by Oregon Bioscience Incubator. http://www.otradi.org