Hyman, Phelps & McNamara, P.C. Welcomes Former FDA and Biotechnology Executive Gayatri Rao as Director

Hyman, Phelps & McNamara, P.C. (HPM), the nation’s largest law firm dedicated exclusively to FDA and life sciences law, is pleased to announce that Gayatri Rao, M.D., J.D., M.B.E. has joined the firm as a Director.

Dr. Rao brings a rare combination of experience spanning, nearly a decade of leadership at the U.S. Food and Drug Administration, executive leadership within the biotechnology industry and private practice.  Her practice focuses on advising biotechnology and pharmaceutical companies on FDA regulatory strategy and medical product development, with particular experience guiding innovative therapies for rare diseases from early development through market approval.

Most recently, Dr. Rao served as Chief Regulatory Officer and Chief Development Officer at Rocket Pharmaceuticals, where she led regulatory and development strategy across multiple gene therapy programs. During her tenure, she played a key leadership role in the development and FDA approval of KRESLADI™ (marnetegragene autotemcel), gaining firsthand experience navigating the scientific, regulatory, and commercial challenges facing emerging biotechnology companies.

Prior to joining Rocket Pharmaceuticals, Dr. Rao spent nearly ten years at FDA, including seven years as Director of the Office of Orphan Products Development. In that role, she oversaw the Orphan Drug Designation Program, helped implement the Rare Pediatric Disease Priority Review Voucher Program, and worked to advance orphan drug policy and international regulatory collaboration. Earlier in her FDA career, she served as Associate Chief Counsel, advising the agency on medical devices, combination products, human subject protection, and other complex regulatory matters.

“Gayatri’s career reflects the kind of multidisciplinary experience that our clients need to shape and propose innovative development programs to FDA. Her leadership at OOPD and in biotechnology gives her an exceptional understanding of the scientific, regulatory, and strategic decisions at every stage of development, from Pre-IND through approval. We are thrilled to welcome her to HPM, where her experience will further elevate our work helping clients advance much-needed therapies for patients with rare diseases,” said James Valentine, J.D., M.H.S., Director at HPM.

Dr. Rao’s multidisciplinary background uniquely positions her to counsel clients on every stage of the product lifecycle.  Her experience as both a regulator and industry executive provides clients with practical, business-focused guidance informed by firsthand decision-making.

“I am thrilled to join Hyman, Phelps & McNamara,” said Dr. Rao. “Throughout my career, I have been passionate about helping bring innovative therapies to patients, particularly those with rare diseases and significant unmet medical needs. HPM’s unparalleled reputation in FDA law and regulatory strategy make it an ideal place to continue serving clients as they navigate today’s increasingly complex regulatory landscape.”

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

With Dr. Rao’s addition, HPM continues to expand its nationally recognized capabilities in FDA regulatory law, gene therapy, biologics, orphan drug development, and strategic counseling for life sciences companies.