SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases, today announced the appointment of James Kirwin, MBA, as Chief Operating Officer. In this role, Mr. Kirwin will lead the identification and negotiation of clinical trial study agreements, collaboration with CMC and regulatory teams, and the development of GMP clinical trial materials with Contract Development and Manufacturing Organizations.
Mr. Kirwin is a seasoned biopharmaceutical clinical operations leader with over 20 years of experience in directing research and innovation at global pharmaceutical companies as well as emerging biotechnology start-ups. Mr. Kirwin’s wealth of expertise spans across multiple managerial and operational functions, including research and development of pre-clinical and clinical assets and the management of complex, high-performing teams.
“As we advance SFA-002 and other therapeutic candidates through the clinic, Jim will be an integral member of our team in managing all aspects of Clinical Development Operations. With his exceptional ability to execute strategy with cross-functional teams across a variety of diseases, Jim will bring organizational excellence to SFA Therapeutics as Chief Operating Officer,” said Dr. Ira Spector, Chief Executive Officer of SFA Therapeutics. “Jim’s strategic direction will be essential to contributing to SFA’s mission to bring safe and effective drugs to patients suffering from inflammatory and immunologic conditions.”
“As Chief Operating Officer of SFA Therapeutics, I look forward to applying my clinical operations and managerial skillsets to develop industry-leading operations in order to execute clinical trials of SFA-002 and other therapeutic candidates. SFA Therapeutics’ novel platform has the potential to tailor many biosynthetic compounds with target-specific adjuvants, and I welcome the chance to help drive this disruptive science through the clinic to patients in need of safer, more efficacious treatments,” commented James Kirwin, Chief Operating Officer of SFA Therapeutics.
Most recently, Mr. Kirwin served as the Executive Director, Global Head of Clinical Operations at Arvinas, where he designed and built the clinical operations organization and initiated clinical programs in breast and prostate cancer as well as neuromuscular diseases. He ensured the smooth transition of the Vepdegestrant breast cancer program to Pfizer in a collaborative development agreement. Prior to this, Mr. Kirwin was the Vice President, Clinical Development Operations and Clinical Alliances at Iterum Therapeutics where he oversaw the anti-infectives global clinical trial program which consisted of three Phase III studies across 240 sites and 2,000 patients. Mr. Kirwin has also held senior positions at Intercept Pharmaceuticals, Taiho Oncology, Medtronic Spine and Biologics, Intrexon Corporation, Pfizer, Wyeth Pharmaceuticals, and AstraZeneca.
Mr. Kirwin received his undergraduate degree in Microbiology and Molecular Biology from Pennsylvania State University and his MBA from the University of Delaware.
About SFA Therapeutics
SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases. Based on breakthrough research licensed from Temple University, SFA Therapeutics’ platform has the potential to develop safer and more efficacious treatments for a number of chronic inflammatory diseases by uniquely tailoring the effects of patented formulations with target-specific adjuvants. Its lead asset, SFA-002, an HDAC inhibitor in immune cells, is approaching Phase 2 clinical trials and has shown promising Phase 1a and Phase 1b results for the treatment of psoriasis. SFA Therapeutics has also received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), with or without fibrosis. SFA Therapeutics has an Orphan Disease Designation from the FDA for SFA-001 in the treatment of hepatocellular carcinoma, the most prevalent form of liver cancer.
SFA Therapeutics is headquartered in Jenkintown, Pennsylvania. Please visit www.sfatherapeutics.com to learn more.
