Andrew Harmon

Dr. Andrew Harmon is Chief of Gene Therapy Branch 1 in FDA CBER’s Office of Therapeutic Products (OTP). He supervises a team of CMC reviewers who are responsible for regulatory review of INTERACT, pre-IND, IND, and BLA submissions for viral vector gene 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 has been in leadership roles since 2022. He is also an active participant in intra-agency working groups, meetings, and conferences focused on advancing cell and gene therapy products.