While any drug development program can face regulatory hurdles, developing cellular and gene therapies often presents unique challenges. 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, you 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
Speakers:
William Lee Ph.D.
Vice President, Cell and Gene Therapy 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. He has worked on Phase I and Phase II clinical study design for devices, small molecule drugs, and biologics. Dr. Lee is also experienced in the writing, design, and execution of pre-clinical studies, and the preparation of Investigational New Drug applications.
Brandon Burch Ph.D.
Director, Scientific Writing & Regulatory Affairs
Dr. Burch has over eight years of experience with a primary focus on regulatory affairs, medical and scientific writing, and project management. He has helped prepare and coordinate INDs, NDAs, and BLAs across a variety of drug classes and therapeutic areas including a program for a novel cellular therapy. His experience includes regulatory strategy and submissions, program assessments, and authoring regulatory, scientific, and technical documents.