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Mary Newman is the CEO and Founder of Alchemy-Development Partners where she provides strategic advice to small companies focused on developing treatments for serious and rare diseases with high unmet needs. Most recently, she served as Chief Development Officer at Taysha Therapeutics overseeing development program operations, program management, as well as translational sciences. Prior to Taysha, Mary 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. She has more than 35 years of experience in regulatory affairs and research and development within the biotechnology industry. Prior to joining Audentes, Mary served as the Senior Vice President, Regulatory Affairs 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 previously held various management positions with increasing responsibility in Regulatory Affairs at BioMarin Pharmaceutical, Inc., Berlex Inc. (now Bayer HealthCare Pharmaceuticals Inc.), and Sequus Pharmaceuticals, Inc. (now Johnson & Johnson). While at BioMarin, Ms. Newman oversaw the development and approval of Kuvan® for the treatment of phenylketonuria (PKU), Naglazyme® for mucopolysaccharidosis (MPS) VI, and supported the final approval of Aldurazyme® for MPS I. She has also held various research and development leadership roles in oncology, neurology, pulmonary, and antifungal therapeutic areas. Ms. Newman has served as a board member of Vedere Bioscience II and as an advisor to the board of directors of Chameleon Biosciences. Mary holds a B.S. in Physiology from Oregon State University.