Founded in 2011 by ex-Pfizer R&D executives and healthcare investors, Thetis is a biopharmaceutical company developing novel Resolvin-based therapies for inflammatory bowel disease and other GI disorders.
Mr. Mathias has more than 25 years of experience in the healthcare industry as an entrepreneur, investor and banker. For 15 years prior to joining Thetis full-time as CEO, Mathias was a senior partner at Carter Morse & Mathias, a boutique investment banking firm based in Southport, Connecticut. He previously was a senior vice president in the Healthcare Group at GE Equity Capital, Chief Operating Officer of Diabetes Support Systems, and executive vice president of Premier Healthcare, an healthcare focused private equity firm. Mr. Mathias has an MBA from the Yale School of Management, a BA in Economics from Harvard College, and was a Fulbright Fellow in economic development.
Dr. Sciavolino has extensive experience in the pharmaceutical industry, including a distinguished 35 year career at Pfizer Global R&D. At Pfizer, Dr. Sciavolino held various management roles and responsibilities in drug discovery, development, registration and licensing, culminating in a role as Vice President of R&D Operations, in which he oversaw a team of 1,000 scientists in the United States, Europe and Asia. He was the enabling force behind two of Pfizer’s most notable franchises, Zithromax and Celebrex. After leading the discovery chemistry team responsible for the initial macrolide antibiotic research, he served as principal investigator leading the Phase I evaluation of 11 compounds in first-in-human (FIH) studies, which led to the identification and development of Zithromax, an antibiotic considered one of the most important new drugs of the 20th century. He also played a major role in the licensing of Celebrex, a COX-2 inhibitor that reached $3 billion in peak annual sales globally.
Dr. Sciavolino has served on numerous editorial boards including Annual Reports in Medicinal Chemistry, Antimicrobial Agents and Chemotherapy and the Journal of Antibiotics. Dr. Sciavolino has more than 30 issued patents and has a Ph.D. in organic chemistry from the University of Michigan and B.S. in Pharmacy from St. John’s University.
Dr. Brian Harvey has extensive industry, regulatory and clinical expertise in GI diseases. He previously was Vice President of U.S. Regulatory Strategy at Pfizer (2012-2015) and Vice President of U.S. Regulatory Policy at Sanofi Aventis (2007-2012). Prior to joining industry, Dr. Harvey worked at the U.S. Food & Drug Administration, most recently as director of FDA’s Division of Gastroenterology Products. Dr. Harvey led the regulatory review for NDA and BLA submissions of major breakthrough drugs for the treatment of IBD in adults and children, including adalimumab (Humira®), infliximab (Remicade®), and mesalamine (Lialda®). Throughout his FDA career, Dr. Harvey remained a practicing clinician at the Anne Arundel Medical Center in Maryland.
Dr. Harvey graduated with honors from Middlebury College in Vermont. He earned his Ph.D. in biochemistry and M.D. degree at the University of Connecticut. Prior to joining the FDA, he conducted post-doctoral research at Harvard Medical School, followed by his internal medicine internship and residency at Boston’s Beth Israel Hospital and a three-year gastroenterology fellowship at the Johns Hopkins Hospital in Baltimore, MD.
Dr. Harris’ expertise is drug development in gastroenterology and liver disease. He has served as a consultant to numerous biotechs and pharmaceutical companies for early and late-stage clinical development, regulatory strategy, product licencing (in-licensing and out-licensing), and market assessment. His role as a consultant has spanned all stages of drug development, from the pre-IND space to NDA filing, and beyond. In this capacity, he has designed and managed early and late-stage clinical trials in North America, Eastern and Western Europe, India, Bangladesh, and Australia and drug development programs in gastroparesis, idiopathic constipation, opioid induced constipation, irritable bowel syndrome, secretory diarrhea, cholera, ulcerative colitis, and Crohn’s disease. Dr. Harris was author of the Phase 3 program that resulted in the approval of Fulyzaq® (crofelemer) for HIV-associated diarrhea in 2012. The pivotal, registrational trial was the first adaptive trial methodology accepted by the FDA under Special Protocol Assessment (SPA).
He also oversaw the clinical program that lead to CE Mark approval of Zyva™ (spherical carbon adsorbent) in Europe for diarrhea-predominant IBS that same year. He has served as Chief Medical Officer (CMO) to various start-ups and biotech companies, including Avaxia Biologics, Ocera Therapeutics, and Napo Pharmaceuticals. He also acted as Interim CMO at Tranzyme Pharmaceuticals (NASDAQ:TZYM) in 2011.
He is currently on the faculty of Georgetown University School of Medicine where he directs the course on drug development in the Masters Program of the Georgetown-Howard University Center for Clinical and Translational Science, which is funded through a CTSA award from the National Institutes for Health. Dr. Harris is a graduate of Harvard College and Harvard Medical School, and holds an MS in Population Health and Administrative Medicine from the University of Wisconsin Medical School.
Dr. Van Zandt is an accomplished synthetic organic and medicinal chemist with more than 20 years of experience in large and small pharmaceutical company environments. Before founding New England Discovery Partners through which he supports Thetis, Michael was a department head for The Institute for Pharmaceutical Discovery (IPD), where he co-led the aldose reductase project team which ultimately resulted in the identification and clinical development of lidorestat for treatment of diabetic complications (Phase II). Before joining IPD, Michael was a medicinal chemist at the pharmaceutical division of Bayer, where he played a prominent role in the discovery of tanomastat, a first-in-class MMP inhibitor for treatment of osteoarthritis and cancer that progressed through Phase III clinical development. Michael is an inventor on more than 30 issued patents and author on more than 20 publications in peer-reviewed journals. He is a frequent reviewer for the Journal of Medicinal Chemistry and Bioorganic Medicinal Chemistry Letters. Michael received his Ph.D. in Organic Chemistry with a minor in Biochemistry while working with Professor Carl R. Johnson at Wayne State University.
Dr. Hanley is a biomedical scientist with a background in molecular genetics, genomics, and cancer biology. His doctorate was completed under the mentorship of Dr. Daniel W. Rosenberg at UConn Health, where his research focused on the etiology and prevention of colorectal cancer. His primary work explored the role of folate and other methyl donor nutrients in colonic neoplasia, and examined the effects of dietary methyl donor restriction on tumorigenesis in the ApcΔ14/+ mouse model of familial adenomatous polyposis. In addition, he led projects characterizing DNA methylation defects in human aberrant crypt foci, the earliest precursors to colorectal cancer, and utilized metabolomic profiling to identify novel targets for CRC prevention and treatment. Prior to his PhD, he received a BS in Biology from Union College.
Seasoned pharmaceutical executives across key disciplines.
Dr. Christopher Cimarusti brings strong leadership experience in pharmaceutical discovery, development and manufacturing gained over a 37 year career at Squibb Corporation and Bristol-Myers Squibb. As a discovery chemist, Dr. Cimarusti synthesized the anti-hypertensive nadolol and the antibiotic aztreonam for the first time and designed their commercial processes. As a discovery leader, he co-led the antibiotic effort with Richard Sykes and became Director of Organic Chemistry for the Squibb Institute for Medical Research. Subsequently, he was responsible for all biological and chemical process development within Squibb Corporation, including technology transfer directly to manufacturing, monitoring ongoing production and optimization of existing processes. After the merger with Bristol-Myers, he became Vice President of Process R&D within the Pharmaceutical Research Institute. He was appointed Senior Vice President, Pharmaceutical Development and led a global staff of 1,200 engaged in the CMC disciplines for small and large molecules. He also had responsibility for global Clinical Supply Operations, Project Management and Portfolio Management.
Dr. El-Hage was a pharmacology/toxicology reviewer and supervisor in the Center for Drug Evaluation and Research at FDA. Leadership positions included supervisory pharmacologist in the Division of Metabolism and Endocrinology Products (DMEP), and Associate Director of Pharm/Tox. Dr. El-Hage is an expert on drugs indicated for the treatment of endocrine and metabolic diseases and has extensive experience with biotechnology, biosimilar products, and carcinogenicity study evaluation and planning. Her consultation as a regulatory toxicologist covers all CDER divisions.
Dr. Lipper has 30+ years of experience in research and development in the pharmaceutical industry. Prior to his present consulting work, Dr. Lipper held international line-management responsibility for Pharmaceutics R&D with Bristol Myers Squibb over a 24 year career. His experience spans the entire R&D pipeline, from compound selection through technology transfer and marketed product support. Dr. Lipper began his industrial career with Pfizer Central Research, Groton, CT, where he was primarily involved with liquid and sterile product development for human and veterinary pharmaceutical products. Dr. Lipper has a PhD in Pharmaceutical Chemistry from the University of Michigan and B.S. in Pharmacy from Purdue University.
Dr. Moehlenkamp brings over 16 years of development experience with Bristol-Myers Squibb. He has a PhD in pharmacology and is a board certified toxicologist. He has extensive study director/monitor experience, led or supported multiple small and large molecule development programs within diverse therapeutic areas, demonstrated expertise in developing compounds in virology, performed nonclinical safety due diligence reviews, and played pivotal operational and managerial roles in both nonclinical toxicology study conduct and CRO oversight. At Aclairo, Jeff is a senior consultant who designs and support nonclinical safety programs including regulatory document preparation and design, monitor, and interpret GLP studies.