Boulder, Colorado –September 20th, 2023 — OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today announced the appointment of Ann Howell as Vice President of Regulatory Affairs. Dr. Howell 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.
“We are delighted to welcome Ann to the OnKure team,” said Tony Piscopio, Ph.D., Co-Founder, President and Chief Executive Officer of OnKure. “Ann has an impressive background in leading the regulatory strategies for numerous product developments and subsequent NDA submissions, in addition to expertise overseeing global regulatory interactions for oncology development projects. As we progress our growing pipeline in the clinic, we are confident that Ann will provide important contributions, helping us develop the next generation of precision medicines to benefit cancer patients worldwide.”
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.
“OnKure’s portfolio, people, and dedication to advancing transformative oncology treatments quickly captured my attention and drew me in,” said Dr. Howell. “I am eager to begin collaborating with the OnKure team and leveraging my unique strategic, operational, and development expertise to support its growing portfolio.”
About OnKure Therapeutics
OnKure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancer. Using a proven structure-based drug design platform, the Company is building a robust pipeline of tumor-agnostic candidates that are designed to achieve optimal efficacy and tolerability. OnKure is currently developing bocodepsin (OKI-179), an oral, selective Class I HDAC inhibitor for the treatment of Ras pathway mutated cancers, in addition to OKI-219, a selective PI3K alpha H1047R inhibitor.