Denise Gavin

Company: FDA

Job title: Director - Office of Gene Therapy

Bio:

Denise Gavin, Ph.D., is the Director of the Office of Gene Therapy, in the Office of Therapeutic Products at the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. Dr. Gavin developed her expertise in gene therapy through over 20 years at FDA, fellowships at the University of North Carolina – Gene Therapy Center and at the National Institute of Neurological Disorders and Stroke at NIH. Dr. Gavin and her OGT team evaluate product quality, establish standards and collaborate with stakeholders to assure the safety, purity and potency of gene therapy products.

Seminars:

Panel Discussion: Harmonizing a Complex Regulatory Environment 12:00 pm

Reviewing areas of similarities and differences in approaches to streamlining clinical development, including in the use of global expedited programs Identifying areas of whitespace for global regulatory convergence Outlining the collaborative steps needed to encourage regulatory convergenceRead more

day: Regulatory - AM

Clarifying the Regulatory Guidance on Manufacturing Process Changes 2:00 pm

Outlining FDA processes for considering manufacturing changes for both investigational and licensed gene therapy products Highlighting common downfall areas where drug sponsors fail to demonstrate comparability Best practices for drug sponsors to communicate any process changes during drug development and in-marketRead more

day: Manufacturing - PM