Virtual Lunch & Learn: Introduction to Drug Regulation and the IND Process Part 1

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 3-part series is 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.

The program is designed as a 3-part series:

Part 1 will introduce the history of drug development in the U.S. and the Investigational New Drug (IND) application process, which enables the introduction of investigational products into clinical studies. The IND application process and procedures will be presented, and the phases of clinical development will be reviewed. We will discuss the importance of regulatory strategy and interactions with the Food and Drug Administration (FDA) in the overall development program for pharmaceutical products.

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.

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.

Don’t miss out on this opportunity to gain a deeper understanding of drug development and regulatory strategy—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