Beth Mellen, MS, MBA

Beth Mellen is the chief regulatory officer at Stoke Therapeutics, where she is responsible for overseeing the company’s regulatory strategy.

Beth is an experienced biotechnology executive with almost three decades in global drug development strategy and execution. Her broad scope of experience spans various therapeutic areas, including neurology, oncology, hematology, and autoimmune diseases.  Throughout her career, Beth has successfully advanced a diverse portfolio of medicines in rare diseases and oncology, including cell and gene therapies. Prior to joining Stoke, Beth was vice president, Regulatory & Quality at Voyager Therapeutics where she oversaw all regulatory and quality development for a wide variety of neurological programs. As the head of Cell and Gene Therapies Global Regulatory Strategy at Vertex Pharmaceuticals, she led teams in developing innovative global regulatory strategies for their cell and gene pipeline, including Casgevy®, a first-in-class gene therapy for sickle cell disease and beta thalassemia and zimislecel, a first-in-class cell therapy for type 1 diabetes. Prior to Vertex, Beth was senior director of global regulatory at Takeda, where she successfully facilitated the approval of several new drug applications. Earlier in her career, Beth spent more than a decade in regulatory at small biotech companies.

Beth holds a BS in Animal Science from the University of Massachusetts at Amherst, an MS in Regulatory Affairs from Massachusetts College of Pharmacy and Health Sciences, and an MBA from Simmons University.