Founded by ex-Pfizer R&D executives and healthcare entrepreneurs, Thetis is a biopharmaceutical company developing novel pro-resolving therapies for inflammatory diseases.
Mr. Mathias has more than 30 years of experience in the healthcare industry as an entrepreneur, investor and banker. Over the course of his career, he has raised over $250 million in debt and equity for pharmaceutical and healthcare technology and services companies. For 15 years prior to joining Thetis full-time as CEO, Mr. Mathias was a senior partner at the investment bank Carter Morse & Mathias (Southport, Connecticut), where he led the bank’s Healthcare Group. 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, a healthcare focused private equity firm.
He has served on the board of various organizations in the healthcare space, including the Connecticut Venture Group, Western Connecticut Health Network, Diabetes Support Systems and Dome Imaging Systems. He also served as Chairman of the Alliance of International Corporate Advisors (AICA), a network of investment banks in the Americas, Europe and Asia focused on mid-market M&A transactions and capital raises.
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 gastrointestinal and liver 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®). He is currently Senior Vice President of Regulatory and Scientific Affairs at the Global Liver Institute, a non-profit organization focused on improving the lives of patients with liver diseases.
Dr. Harvey graduated with honors from Middlebury College in Vermont. He earned his Ph.D. in lipid 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. Throughout his FDA career, Dr. Harvey remained a practicing clinician at the Anne Arundel Medical Center in Maryland.
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.
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.
Robert J. Guttendorf, R.Ph, Ph.D. is a Senior Consultant, DMPK, at Aclairo Pharmaceutical Development Group, Inc. in Vienna, VA. Dr. Guttendorf provides scientific, regulatory, strategic planning, and due diligence advice and support for drug discovery and development. He has held leadership positions in small biotech and large pharmaceutical companies, including Director of Discovery and Preclinical Development at Pfizer Global R&D and Parke-Davis Pharmaceutical Research, Scientific Strategy Advisor at Pfizer, Vice President of Pharmacology and Biopharmaceutics at Advancis (Middlebrook) Pharmaceutical Co., and Vice President of Pharmacology and Experimental Therapeutics at Sequoia Pharmaceuticals. He has directed ADME/PK support for discovery through NDA across a variety of therapeutic areas, overseeing numerous nonclinical pharm-tox and clinical pharmacology programs, and a host of regulatory submissions. At Parke-Davis/Pfizer, he helped pioneer the implementation of higher throughput ADME/PK screening approaches in drug discovery and was instrumental in defining best practices for DMPK in drug discovery and development. In addition, he led Pfizer’s Global PDM organization in evaluating and implementing new strategies to enhance the quality and R&D survival of exploratory development candidates. He has presented and published numerous papers on various topics in ADME/PK, including the strategic use of ADME data to improve drug discovery and development. He received a B.S. in Pharmacy from West Virginia University and a Ph.D. in Pharmaceutical Sciences from the University of Kentucky.
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.
Dr. Singh is a Pharmaceutical R&D executive with over 30+ years of experience in all phases of product development including discovery, development, technology transfer, and product life-cycle management. As a Vice President, Quality Operations & CMC Regulatory at Keryx Biopharmaceuticals, she was responsible for the overall strategic and operational activities in ensuring quality and regulatory compliance in the production and analysis of clinical trial materials. She was also responsible for all aspects of CMC documentation and regulatory activities in support of investigational and registrational submissions.
As an Executive Director at Bristol-Myers Squibb, she led a diverse organization requiring detailed and thorough review of technical information for Quality and GMP Compliance, CMC Technical Documentation, and Environment, Health & Safety. She provided strategic thinking and long range planning for groups involved in strategic planning and development portfolio analysis.
Dr. Singh has extensive experience in the preparation of CMC section of global investigational (IND/CTA), registrational (NDA/MAA/BLA) and LCM submissions for small molecules and biologics, regulatory agency interactions such as end-of-phase 2 and pre-NDA meetings with the FDA, and regulatory agency inspections.
Dr. Singh received her Ph.D. in Organic Chemistry from Massachusetts Institute of Technology, and subsequently did postdoctoral work at Oxford University. She has published 17 papers and holds 5 patents.