HighTide Therapeutics, Inc. is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional therapies with poly-indications across metabolic and digestive diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for nonalcoholic steatohepatitis (NASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). HTD1801, the company’s lead drug candidate, received Fast Track designation from the U.S. for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.
Mission：Focus on patient‑centric drug development to bring total and optimal benefits to patients
Vision: Become a leading and respected globally integrated biotech company
· Simplicity is the ultimate sophistication
· Mind and hand
· All for one and one for all, united we stand
· Resilient growth
· Think win/win
Senior Vice President of Regulatory Affairs and Quality Assurancelearn more
● Hepatologist with 30+ years of experience in international trials, board-certified in internal medicine, gastroenterology and transplant hepatology.
● Past president (2014) and governing board member (2010-2015) of the American Association for the Study of Liver Disease (AASLD).
● Advisor and committee member with the US FDA, CDC, and NIH.
● Professor of Internal Medicine and Chief of Hepatology, Division of Gastroenterology and Hepatology at Saint Louis University.
● Former Deputy Director and Acting Division Director, Anti-inflammatory and Analgesic Drug Product of FDA CDER.
● Board-certified gastroenterologist and board-certified internist.
● Medical Director for Pinnacle Clinical Research and President of Summit Clinical Research.
● Visiting Professor of Hepatology at Radcliffe Department of Medicine, University of Oxford.
● Past Associate Editor for Hepatology and currently Associate Editor for Alimentary Pharmacology and Therapeutics.
● Recently retired Colonel in the United States Army with 20 years of service, serving as the Gastroenterology Consultant to the Army Surgeon General. Board certified in both Internal Medicine and Gastroenterology.
● Director, Liver Institute NW, Washington State University;
● Steering Committee Co-Chair, PSC Forum.
● Ms. Melincoff has over 25 years of leadership experience in the biotechnology and pharmaceutical industries.
● Her experience has spanned public and private company boards, venture financing, business development, licensing, mergers and acquisitions, research operations, marketing, and product management.
● Ms. Melincoff previously served as Senior VP of Business Development at Shire Pharmaceuticals. She also served as board member of Tobira Therapeutics when it was acquired by Allergan.
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