Gayatri R. Rao

Gayatri Rao, M.D., J.D., M.B.E., advises biotechnology and pharmaceutical companies on FDA regulatory strategy and medical product development from early translation through approval, with a particular focus on rare diseases. As a seasoned FDA and biotechnology executive, she brings firsthand experience in regulatory decision-making and product development to provide practical, business-focused counsel. Drawing on her unique combination of legal, medical, and ethical expertise, she helps clients navigate complex regulatory challenges with a multidisciplinary perspective.

Prior to joining the firm, Dr. Rao served as Chief Development Officer and later Chief Regulatory Officer at Rocket Pharmaceuticals, a commercial-stage gene therapy company focused on rare, life-threatening diseases. She led the end-to-end development of multiple gene therapy programs, guiding products from early translation through clinical development and regulatory submissions, including the FDA approval of KRESLADI™ (marnetegragene autotemcel).

Earlier in her career, Dr. Rao spent nearly a decade at the FDA, including seven years as the Director of the Office of Orphan Products Development (OOPD). In that role, she oversaw the Orphan Drug Designation Program, during which approximately 1900 drugs received orphan drug designation and 250 were granted orphan exclusivity. She spearheaded implementation of the Rare Pediatric Disease (RPD) Priority Review Voucher Program (PRV), issuing the first 100 RPD designations that ultimately led to the first 9 RPD PRVs.  She also played a leading role in shaping orphan drug policy and fostering international regulatory partnerships. She joined FDA an Associate Chief Counsel in FDA’s Office of Chief Counsel, where she advised on combination products, medical devices, human subject protection, and other complex regulatory matters.

Dr. Rao began her career in the Food and Drug and Healthcare Practice Groups at a Washington, DC law firm, where she handled complex internal investigations, advertising and promotion, and manufacturing quality systems issues for life sciences companies.

Dr. Rao earned her M.D. from Rutgers New Jersey Medical School, J.D. from the University of Pennsylvania Law School, and Master of Bioethics from the University of Pennsylvania School of Medicine.  She is admitted to practice in the District of Columbia and New York.