Stella Lee, PhD.

Senior Scientist, , OTP, OGT, CBER at FDA

Speaker

Stella Lee is a CMC reviewer in the Office of Therapeutic Products (OTP), CBER. She is primarily responsible for reviewing gene therapy products, including ex vivo genetically modified cells. Since joining FDA in 2015, Stella has evaluated a diverse range of product applications across different centers within the agency. At the Center for Veterinary Medicine (CVM), she reviewed applications for animal biotechnology products including those incorporating genome editing and helped establish the regulatory framework for animals with intentional genomic alterations. Stella earned her Ph.D. in Human Genetics and Molecular Biology from Johns Hopkins University School of Medicine.