Mary Newman


Ms. Newman serves as a regulatory affairs expert consulting on many ophthalmology programs creating development strategies for small molecules, biologics, devices and gene/cell therapies. Her deep experience helps clients to navigate regulatory requirements for US FDA and EU EMEA submissions for clinical studies, global regulatory authority meetings and product registration. Most recently, Ms. Newman was the Chief Development Officer at Taysha Gene Therapies overseeing program and portfolio management, translational sciences, and development operations (clinical operations, biometrics, vendor management, medical writing and pharmacovigilance operations). Prior to that she was the Senior Vice President of Regulatory Affairs at Astellas Gene Therapies (formerly Audentes Therapeutics) overseeing global regulatory strategic development, all primary regulatory agency interactions, and regulatory compliance for Audentes’ development candidates. Prior to joining Audentes, Mary was Senior Vice President, Regulatory Affairs, CMC and Quality Assurance at SARcode Bioscience Inc., an ophthalmology company where she oversaw the development of Xiidra® for the treatment of dry eye disease. She has more than 35 years of experience in regulatory affairs and research and development within the biotechnology industry, focusing on ophthalmology and rare diseases with high unmet medical needs and has held management positions, with increasing responsibility in Regulatory Affairs at BioMarin Pharmaceutical, Inc., Berlex Inc. and Sequus Pharmaceuticals, Inc. Ms. Newman is an independent member of the Board of Directors at Vedere II Inc., an optogenetics company focused on vision restoration, and serves as an advisor to the board of directors of Chameleon Biosciences. Mary holds a B.S./MS in Physiology from Oregon State University. 

Recent Publications

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