Amanda McEwen has over 14 years of experience in clinical research that spans work in academia, contract research organizations, and several Boston-area small-to-mid-size biotechnology companies. Throughout her career, Amanda has held roles of increasing responsibility within the Clinical/Regulatory Development space across a range of therapeutic areas including rare, neurodegenerative, respiratory, infectious, and metabolic diseases. Her experience includes a variety of therapeutic product types, including combination products, most notably a novel dry powder inhalation therapy to treat motor issues in Parkinson’s patients, Inbrija™, approved by the FDA and EMA. Amanda has a particular affinity for early phase work and has played pivotal roles in shepherding several programs from the bench to the clinic, most recently in her previous role as Vice President of Clinical Development of Nocion Therapeutics, where she successfully led the efforts to complete Nocion’s first Phase 1 study amidst the backdrop of the emerging SARS-CoV-2 pandemic. In addition to her work in industry, Amanda serves as an adjunct faculty member for Northeastern University’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, specializing in courses on the strategic and technical considerations for IND and NDA/MAA submissions and Pharmacovigilance regulations and best practices. Amanda holds a BA in Psychology from the College of the Holy Cross and a Master of Research Methods in Psychology degree from the University of York.
