Mary Newman

Mary Newman is currently an Executive Advisor for Regulatory Affairs at Chameleon Biosciences. Before that, they were a consultant for M. Newman Consulting, where they focused on developing global regulatory and drug development strategies for small companies, with a specific focus on rare disease and ophthalmologic drug products. Prior to that, they were the Senior Vice President for Regulatory Affairs/CMC/Quality at SARcode Bioscience Inc., which was acquired by Shire in April 2013. At SARcode, Mary was a key member of the senior management team and was responsible for building and managing the Regulatory, NonClinical, CMC, Quality and Compliance functions, personnel and systems. Mary successfully engineered outcomes of key Regulatory meetings with FDA and EU health authorities for the Phase 3 Clinical and CMC programs. In addition, they led an experienced CMC team to develop efficient, scaleable syntheses, achieve COGs targets and strengthen IP position. Mary also solved a key formulation stability issue to result in a room temperature stable product. Mary has experience interfacing with current investors and prospective partners in product or corporate acquisition efforts and potential partnered development projects.

Mary Newman has a Bachelor of Science in Physiology from Oregon State University.