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Well Characterized Biologics & Biological Assays
November 1-3, 2022
College Park Marriott Hotel & Conference CenterHyattsville, Maryland, USA

Andrew Harmon
Gene Therapy CMC Reviewer at FDA CBER

Profile

Dr. Andrew Harmon is a CMC Reviewer in the Division of Cellular and Gene Therapies at the FDA’s Center for Biologics Evaluation and Research (CBER) and is responsible for regulatory review of INTERACT, pre-IND, IND, and BLA submissions for viral vectors and genetically modified cell therapy products. Dr. Harmon received his PhD from the University of California, Los Angeles (UCLA) and came to the FDA in 2014 as a postdoctoral researcher studying immune responses to viral gene therapy vectors. He transitioned to regulatory review activities in 2017 and is an active participant in intra-agency working groups, meetings, and conferences focused on advancing cell and gene therapy products.

Agenda Sessions

  • FDA Address: Potential Challenges Throughout the Development Process for Cell & Gene Therapies

    3:00pm
  • Regulatory Town Hall

    12:40pm