Former FDA GI Division Director and V.P. of U.S. Regulatory Strategy at Pfizer to Guide Clinical and Regulatory Development of Thetis IBD Programs
BRANFORD, CT – (GlobeNewswire – May 7, 2018) – Thetis Pharmaceuticals LLC (“Thetis”), a biopharmaceutical company developing first-in-class, immuno-resolving small molecule drugs to treat inflammatory bowel disease (IBD), announced today that Brian E. Harvey, MD, PhD, has joined the company as Senior Medical Director.
“Our lead drug candidate TP-317 is a promising new therapeutic option for ulcerative colitis patients with mild-to-moderate disease as an alternative to escalation to biologics and other aggressive, immunosuppressive drugs. Dr. Harvey has extraordinary skill and experience as a regulator, clinician and industry executive, and will provide important leadership to move our program into clinical investigation. At FDA, he led the regulatory review and approval of important IBD products including Humira, Remicade and Lialda, enabling him to provide unique insight in this space,” said Gary Mathias, Chief Executive Officer.
Dr. Harvey commented, “I believe TP-317 has the potential to fundamentally change the IBD treatment paradigm. There is a high unmet medical need for safe, oral therapies to treat ulcerative colitis patients who are not well controlled on mesalamine, as an alternative to immunosuppressive agents. TP-317 represents a mechanistically novel approach that is based on activating innate pathways to resolve inflammation and promote mucosal healing, a major emerging focus of IBD medical management.”
About Brian Harvey
Dr. Harvey brings to Thetis three decades of extensive experience as a clinician, regulator, pharmaceutical executive and patient advocate. Most recently, Dr. Harvey served as Vice President of U.S. Regulatory Strategy at Pfizer, with a key role in designing the successful Phase III pivotal trial for Xeljanz® for the treatment of ulcerative colitis. As Vice President of U.S. Regulatory Policy at Sanofi-Aventis, he established the company’s FDA Liaison Office and procedures for agency interactions. Prior to joining industry, Dr. Harvey worked at the U.S. Food & Drug Administration (FDA), most recently as Director of the Division of Gastroenterology Products, where he oversaw the review of important IBD drug and biological products. Throughout his FDA career, Dr. Harvey remained a practicing clinician at Anne Arundel Medical Center in Annapolis, Maryland. He completed his Gastroenterology Fellowship at Johns Hopkins and Internal Medicine Residency at Beth Israel Hospital-Harvard.
Thetis is a biopharmaceutical company developing novel immuno-resolving therapies for the treatment of IBD. Leveraging its proprietary HEALER™ technology platform, Thetis unlocks the robust pharmacology of endogenous bioactive lipids, overcoming the stability, manufacturing, formulation and patentability hurdles that have limited their development as pharmaceutical agents. Thetis’ lead drug candidate, TP-317, is a proprietary new molecular entity that delivers Resolvin E1, an endogenous lipid autacoid that offers a new approach to IBD treatment based on promoting inflammation resolution and mucosal healing. TP-317 has the potential to be a safe, oral therapy for induction and maintenance of remission in ulcerative colitis patients that are not well controlled with first-line therapy, as an alternative to aggressive immunosuppressive agents.
For more information, please visit Thetis Pharmaceuticals’ website (www.thetispharma.com) and follow Thetis on Twitter (@thetispharma).
Aaron Mathias, Director of Business Development
Original publication: http://www.globenewswire.com/news-release/2018/05/07/1497743/0/en/FDA-Industry-Veteran-Brian-E-Harvey-MD-PhD-Joins-Thetis-Pharmaceuticals-as-Senior-Medical-Director.html