Mark A. De Rosch
Mark A. De Rosch, PhD, FRAPS,
Dr. De Rosch was most recently Chief Operating Officer at Aura Biosciences overseeing Regulatory Affairs, CMC / Technical Operations, Program & Portfolio Management, Medical Device Innovation, and Information Technology (IT). While at Aura, he contributed to Aura becoming a public company and growing from about 20 employees to about 70 employees to support Phase 3-readiness. Prior to joining Aura, Dr. De Rosch was Chief Regulatory Officer at Epizyme, Inc. where he assisted Epizyme in receiving accelerated approval in the US for its first drug, TAZVERIK®, in 2 oncology indications. Prior to Epizyme, he was Senior Vice President of Regulatory, Quality, and Medical Writing at Nightstar Therapeutics, Inc., a gene therapy company specializing in treatment of inherited retinal disease that was acquired by Biogen in 2019. Prior organizations include Akebia Therapeutics, Voisin Consulting Life Sciences, Inspiration Biopharmaceuticals, Vertex Pharmaceuticals, Berlex Laboratories, Diatide, and Mallinckrodt. At Vertex, Dr. De Rosch led the regulatory strategy and marketing approvals in the US and EU for Kalydeco®, the first drug to treat the underlying cause of cystic fibrosis. He has a BS in Chemistry/Biochemistry from the University of Wisconsin-Parkside, and an MS and PhD in Inorganic Chemistry from the University of California, San Diego. Dr. De Rosch was designated as a Fellow of the Regulatory Affairs Professional Society (FRAPS) in 2017.