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Navigating Regulatory Strategies for Cellular & Gene Therapies
Join us on February 16th at 1:00pm ET for a webinar discussing key regulatory strategies important to first-in-human trials for cellular and gene therapies. Brandon Burch, Ph.D., Director of Scientific Writing & Regulatory Affairs and William Lee, Ph.D., Vice President of Cell and Gene Therapy Development will lead the session.

While any drug development program can face regulatory hurdles, developing cellular and gene therapies often presents unique challenges. As knowledge and experience expand in this area, the FDA and global regulatory agencies continue to assess and refine their thinking on how to regulate and guide the development of these innovative treatments.

Small and midsize biotech and pharma companies developing cellular and gene therapies should begin to understand critical nuances for successful regulatory meetings and submissions and how they impact strategic decisions during the product development lifecycle. At the end of this webinar, attendees should have a better understanding of:

• Regulatory requirements to initiate clinical trials for cellular and gene therapy submissions in the US and EU
• Differences in product submissions for cellular and gene therapies vs. small molecule drugs
• How to apply the Target Product Profile to guide product development

Dr. Lee has over 25 years of research and industrial experience in gene therapy, cellular immunology, and therapeutic vaccines, and 15 years in regulatory affairs. Dr. Burch has over 8 years of experience with a primary focus on regulatory affairs, medical and scientific writing, and project management.

Feb 16, 2022 01:00 PM in Eastern Time (US and Canada)

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