Ann Howell is the Vice President of Regulatory Affairs of OnKure, Inc. She brings an abundance of experience managing regulatory affairs activities for both small and large biopharmaceutical companies, with global regulatory responsibilities across a variety of therapeutic areas, including oncology. Prior to OnKure, Dr. Howell served as Vice President of Regulatory Affairs at Forma Therapeutics, Inc. At Forma, she built a regulatory department and oversaw critical regulatory strategies for the development programs in rare disease and oncology, including Forma’s first NDA submission and approval for Rezlidhia for the treatment of relapsed or refractory AML. After the acquisition of Forma by Novo Nordisk A/S in 2022, Dr. Howell also served as the Integration Lead to integrate regulatory, clinical, biometrics, pharmacovigilance and other development functions. Previously, she was the Senior Director of Regulatory Affairs at Shionogi Inc., where she led U.S., European and Japanese regulatory strategies and was key in the development and execution of innovative expedited strategies and pathways. She also held regulatory affairs positions of increasing responsibility at Forest Laboratories, Inc. and Schering-Plough Corporation. Throughout her career, Dr. Howell has successfully led five NDA submissions with first round approvals, managed a successful FDA advisory committee meeting, and guided teams through complex regulatory challenges, including novel endpoint development, new approval pathways and labeling challenges. She holds M.S. and Pharm.D. degrees from the University of Oklahoma and completed a post-doctoral fellowship at Rutgers University.
