This webinar covers key regulatory strategies important to first-in-human trials for cellular and gene therapies. While any drug development program can face regulatory hurdles, developing cellular and gene therapies often presents unique challenges.
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 versus small molecule drugs
- How to apply the Target Product Profile to guide product development
Meet the Presenters
Brandon Burch, M.S., Ph.D.
Director, Scientific Writing & Regulatory Affairs
Dr. Burch has over 8 years of experience with a primary focus on regulatory affairs, medical and scientific writing, and project management. Dr. Burch has participated in numerous IND, NDA (505(b)(1) and 505(b)(2)), and BLA submissions across a multitude of therapeutic areas and drug classes, including cellular therapies. Dr. Burch’s experience includes overall regulatory strategy; FDA meeting support; program assessments; regulatory submission authoring; and authoring a diverse array of other regulatory, scientific, and technical documents.
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.