BOULDER, Colo., Sept. 20, 2023 (GLOBE NEWSWIRE) — In an exciting move, OnKure, Inc., a dynamic clinical-stage biopharmaceutical company shaping the future of precision oncology, proudly introduces Dr. Ann Howell as its new Vice President of Regulatory Affairs. With a wealth of experience spanning both small and large biopharma enterprises, Dr. Howell has steered global regulatory strategies across diverse therapeutic landscapes, most notably in the realm of oncology.
Tony Piscopio, Ph.D., Co-Founder, President, and CEO of OnKure, expressed the company’s elation, stating, “Ann’s impressive track record in spearheading regulatory strategies, orchestrating NDA submissions, and facilitating global regulatory engagements for oncology projects makes her a valuable asset to our expanding clinical pipeline. As we push the boundaries in clinical research, Ann’s expertise will be instrumental in advancing our precision medicines, ultimately benefiting cancer patients worldwide.”
Before joining OnKure, Dr. Howell served as Vice President of Regulatory Affairs at Forma Therapeutics, Inc., where she played a pivotal role in the company’s regulatory department, driving critical strategies for rare disease and oncology development. Her leadership culminated in the successful NDA submission and approval of Rezlidhia, a groundbreaking treatment for relapsed or refractory AML. Following Forma’s acquisition by Novo Nordisk A/S in 2022, Dr. Howell led the integration efforts, aligning regulatory, clinical, biometrics, pharmacovigilance, and other development functions seamlessly.
Dr. Howell’s illustrious career also includes the role of Senior Director of Regulatory Affairs at Shionogi Inc., where she spearheaded U.S., European, and Japanese regulatory strategies. Her innovative approaches paved the way for expedited strategies and pathways. She has held influential regulatory affairs positions at Forest Laboratories, Inc., and Schering-Plough Corporation, leaving an indelible mark on the industry.
Dr. Howell boasts a remarkable track record of five NDA submissions with first-round approvals, successfully navigating FDA advisory committee meetings, and surmounting complex regulatory challenges, from pioneering endpoint development to conquering new approval pathways and labeling quandaries.
With academic credentials that include M.S. and Pharm.D. degrees from the University of Oklahoma and a post-doctoral fellowship at Rutgers University, Dr. Howell is primed to elevate OnKure’s innovative portfolio.
Dr. Howell expressed her enthusiasm, stating, “OnKure’s visionary portfolio, dedicated team, and commitment to advancing transformative oncology treatments are truly captivating. I eagerly anticipate collaborating with the OnKure team and applying my strategic, operational, and developmental acumen to bolster its flourishing portfolio.”
About OnKure Therapeutics
In the relentless pursuit of breakthrough cancer therapies, OnKure, Inc. stands at the forefront as a clinical-stage biopharmaceutical trailblazer. This visionary company is dedicated to unearthing and crafting best-in-class precision medicines, each meticulously designed to strike at the heart of cancer’s biological drivers.
Armed with a proven structure-based drug design platform, OnKure is constructing a robust pipeline of candidates that transcend tumor boundaries, offering a glimmer of hope to patients across diverse cancer types. These innovative therapeutics aren’t just about efficacy; they’re about achieving the optimal balance between effectiveness and tolerability, revolutionizing the way we combat cancer.
At the heart of OnKure’s groundbreaking portfolio lies ‘bocodepsin’ (OKI-179), an oral marvel in the form of a selective Class I HDAC inhibitor. This exceptional drug holds the promise to redefine the treatment landscape for Ras pathway mutated cancers, offering a glimpse into a future where cancer’s stronghold can be weakened.
But that’s not all. Meet ‘OKI-219,’ a selective PI3K alpha H1047R inhibitor—a precision weapon against one of cancer’s most formidable foes. With each development, OnKure inches closer to a future where cancer’s grip on lives is loosened.
Join us on this extraordinary journey as OnKure redefines the battle against cancer, one innovation at a time.