S. Mishima Gerhart
Chief Regulatory Officer
Ms. Gerhart joined Pliant in October 2023 as Chief Regulatory Officer.
Ms. Gerhart is a recognized leader in the biotechnology and pharmaceutical industries who brings over 20 years of global regulatory expertise and experience leading cross-functional teams across multiple therapeutic areas. Ms. Gerhart previously held the role of Chief Regulatory Officer and Head of Quality at Taysha Gene Therapies where she established and grew the regulatory and quality organizations and was responsible for all US and Ex-US regulatory interactions. Prior to Taysha, Ms. Gerhart held senior regulatory roles at Sanofi, serving as Vice President and Head of North America and Global Labeling where she led teams across multiple therapeutic areas including rare diseases, oncology, diabetes, cardiovascular and vaccines. Ms. Gerhart also held the position of Vice President and Head of Regulatory Affairs, China, and Emerging Markets where she managed a 500+ person organization and was responsible for all pre-commercial and commercial-stage products across numerous therapeutic areas and geographies. Prior to this, Ms. Gerhart was Head of Regulatory at Genzyme and held regulatory positions of increasing seniority at AbbVie, Reata Pharmaceuticals, Pfizer/ Wyeth, AstraZeneca, and Wyeth.
Ms. Gerhart received a M.S. in Quality Assurance and Regulatory Affairs from Temple University and a B.S. from Kutztown University majoring in biology and minoring in chemistry.