Steven B. Newhard

Steven B. Newhard joined Olatec’s Drug Development Team in July 2014 and became a member of the Scientific Advisory Board in November 2018. He is responsible for development and manufacturing of dapansutrile at CMOs undertaking with cGMP production of the active drug substance and drug product. Mr. Newhard has over 40 years of experience in the pharmaceutical and regulatory industry, including over 20 years as a senior executive responsible for quality operations and multiple years as a senior executive responsible for supply chain, technical operations, and product development. Prior to entering the industry, Mr. Newhard served as an employee of FDA for over 10 years. His pharmaceutical experience includes the development, submission and approval of multiple NDAs and ANDAs encompassing multiple dosage forms including tablet, parenteral and topical drug products. Mr. Newhard received his BS degree in Biology from Washington College in Chestertown, MD.