Andrew Harmon
Chief, Gene Therapy Branch 1 @FDA
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WORK HISTORY
Chief, Gene Therapy Branch 1 @FDA
EDUCATION
University of Delaware
B.S., Cell and Molecular Biology, Genetics
UCLA
Ph.D., Molecular, Cell, and Developmental Biology
SKILLS
ABOUT ANDREW HARMON
Branch Chief and CMC regulatory reviewer of investigational and licensed viral vectors and genetically modified cell products in FDA\'s Office of Gene Therapy CMC. Deep subject matter expertise in the manufacturing regulations and expectations that must be met to get a novel gene therapy product into clinical trials and across the finish line to license approval and commercialization. 10+ years of experience in the FDA ecosystem, including 7+ years focused on CMC regulatory affairs for complex biologics and 2+ years of experience as a Team Leader and Supervisor providing secondary (concurring) review of complex advanced biologic products (viral vector gene therapies, in vivo genome editing products, therapeutic cancer vaccines, etc.). PhD in stem cell biology from UCLA, with postdoctoral training in virology at FDA CBER. Living the dream in federal middle management.*Follows and adds on LinkedIn do not equal endorsements.
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