Virtual Lunch & Learn: FDA Meetings-Strategies for Success

As part two of our three-part Virtual Lunch & Learn series on U.S. drug development, this session will focus on the critical role of FDA interactions in a successful pharmaceutical development strategy.

Part 2 will provide a more in-depth understanding of communications with the FDA to facilitate successful product development. We will discuss the different types of interactions and meetings available to sponsors during critical points in the regulatory and strategic product development process. Positive and productive interactions are important to the program; these interactions and associated timelines need to be considered in the overall development program. Interactions help the sponsor to understand the role of the FDA and product-specific offices and, more importantly, provide feedback and guidance on the development program.

Join us for this essential session to learn how to optimize FDA interactions, navigate regulatory touchpoints, and integrate agency feedback into a streamlined development strategy.

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