Leadership Team

Michelle Usher, RAC

Michelle P. Usher is a seasoned biopharmaceutical professional with more than 30 years of drug development experience. Michelle’s expertise spans across multiple disciplines primarily in regulatory affairs, as well as compliance, program management and drug manufacturing.  Michelle has held various senior regulatory affairs management positions at small biotech firms and contract research organizations. In her positions in biotech with AcceleReg, LLC, Orphomed, Inc and Furiex Pharmaceuticals, she led the regulatory interactions, strategies and submissions for a variety of products in early to late stage development. While at Furiex, she was instrumental in the FDA approval of Viberzi®, including managing the NDA submission preparation, while leading the labeling and controlled substances scheduling negotiations with FDA.  Additionally, Michelle has over 15 years experience at various contract research organizations (PPD, Parexel and ClinTrials Research) where she authored and or submitted over 50 INDs and 8 NDAs. As head of the NA regulatory affairs department at PPD, Michelle participated as the regulatory lead in various development programs including within PPD’s compound partnering business and performed technical due diligence for both in-licensing opportunities and new business acquisitions.  Ms. Usher earned a BS in Chemistry from North Carolina State University and received her Regulatory Affairs Certification (RAC) in 1994.