The senior members of Clinquest's team represent the depth and breadth of our knowledge and expertise. Our experience, professionalism and energy set Clinquest's standards of unparalleled commitment and flexible expertise.
James G. Thomasch
CEO & President, Clinquest Inc.
Mr. Thomasch recently joined Clinquest as CEO in May 2011. He is responsible for directing and overseeing all company activities in the areas of product development consulting, clinical trial implementation services and post-market approval compliance, reporting and pharmacovigilance safety monitoring activities.
Mr. Thomasch has more than 20 years of medical industry experience directing both privately-held and publicly-held companies in top operational and financial management positions. He served as Senior Vice President and Chief Financial Officer of PLC Medical Systems, Inc. prior to joining Clinquest. He also previously served as President and Chief Operating Officer of the XRE division of Trex Medical Corporation, a Thermo Electron Company.
Mr. Thomasch holds a BS in Management from Boston College, Carroll School of Management, has done graduate work at both Bentley University and Babson College and is a licensed CPA in the state of Massachusetts.
Cornelis H. Wortel, M.D., Ph.D.
CMO, Clinquest Inc.
Dr. Wortel is the founder of Clinquest. With more than 20 years of experience in the development of biopharmaceuticals and innovative medical technologies, Dr. Wortel has guided Clinquest from a small start-up organization to a successful Healthcare Product Development Service Provider.
Dr. Wortel’s experience includes both international academic and industrial pharmaceutical research. He has served as a senior medical research executive for several biopharmaceutical companies, including Centocor, Inc., Repligen Inc., Procept Inc. and Alkermes, Inc. During his tenure at Centocor, Dr. Wortel was responsible for the development of Remicade®, and at Alkermes, he was responsible for the development of Nutropin DepotTM (in collaboration with Genentech). His industry experience includes the oversight of international medical operations under stringent SOP and GCP standards, and he is internationally recognized for his expertise in the design and analysis of clinical trials. In addition to his industry alliances, Dr. Wortel serves as a Visiting Associate Professor for the Department of Cardiovascular and Critical Care Medicine at Rush University.
Dr. Wortel trained at the University of Amsterdam, and received his PhD in Immunology in 1993. His academic experience also includes training in the specialties of Cardiology, Hemostasis, Thrombosis, Atherosclerosis and Inflammation Research. He has published widely, presented and chaired many national and international meetings.
John M. Naples
Chief Financial Officer / Treasurer, Clinquest Inc.
Since joining Clinquest in 2001, Mr. Naples has been instrumental in executing key financing activities, including the acquisition of a CRO based in the Netherlands. Mr. Naples has more than 25 years of diversified financial experience in both public and private companies, including 15 years in the biotechnology industry.
Mr. Naples is responsible for business and strategic planning, finance and accounting, as well as support and modeling for fundraising and deal structures. He directs overall financial policies and functions, as well as facilities and human resource management. He also administers client advice in the areas of finance, business strategy, competitive landscape and fundraising.
After receiving his MBA from Western New England College, Mr. Naples has held various financial positions at the Institute of Molecular Biology, Inc., Hybridon, Inc. (now Idera Pharmaceuticals, Inc.), Neptune Pharmaceuticals, Inc. (now Phytera, Inc.) and Aphios Corporation.
John A. McLane, Ph.D.
Vice-President of Clinical and Regulatory Affairs, Clinquest Inc.
Dr. McLane has over 20 years of progressive experience in all phases of global development with both large and small pharmaceutical companies. His knowledge basis has lead full development projects with over 50 clinical programs and to successful INDs, NDAs and EMEA/CTA applications. Key strengths include the early development of clinical and regulatory strategies, and negotiating with regulatory officials.
As a group leader of international life cycle development teams in Dermatology and Neurology, Dr. McLane has developed and implemented complete medical regulatory, clinical, and marketing strategies and programs in these therapeutic areas. He was the initial developer of novel vitamin D derived compounds for psoriasis at Roche. He was a group leader for NDA filings in Parkinson’s and Alzheimer Diseases.
Additional development activities include developing business rationale, teams, programs, and strategies for early clinical candidates in metabolic diseases, respiratory and oncology areas. He has also successfully completed in- and out-licensing reviews and negotiations including those for orphan indications. He possesses particular expertise in the initial formation and development of new start-ups and early clinical companies and has provided major contributions to business plans and presentations to venture capitalists for significant fund-raising.
Dr. McLane received his M.S. and Ph.D from the University of Rhode Island and his postdoctoral training at the Yale University School of Medicine. His prior positions also included VP Pharmaceutical Development (Ariston Pharmaceuticals, Inc.);VP of Clinical and Regulatory Affairs (Milkhaus Laboratory, Inc.); Co-Founder (Catalyst Oncology); Director of Early Strategic Planning (Hoffman-La-Roche); and Director of Medical Science and Safety Teams (Roche Laboratories).
Rolf Jan Rutten, MSc.
Managing Director, Clinquest Services BV
Mr. Rutten is responsible for all activities of the European subsidiary of Clinquest Group. Clinquest Services provides high quality data management, biostatistics and pharmacovigilance services.
Previously he was Director of Pharmaceutical and Corporate Development at Clinquest Pharmaceutical Innovations (PI). In that position he was responsible for building, developing and partnering Clinquest PI’s development pipeline as well as for initiating and structuring Clinquest participation in Enceladus BV.
Mr. Rutten has 14 years of experience in management, business development and marketing in the biotechnology industry. From 2003 to 2006, Mr. Rutten was the Business Development Director at TNO Pharma. His responsibilities included worldwide business development and commercial exploitation of IP portfolio, building external network in biomedical domain, and maintaining focused IP portfolio. He has experience with large and small biotechnology organizations (TNO Pharma, Kreatech Biotechnology BV and Intervet) in the U.S., Netherlands, Asian Pacific, India, Canada, and Mexico. Additionally, he has consultancy work experience under his own company (EuroBioventures). He was also a co-founder of Audion Therapeutics, a company targeting hearing loss and of Dybly, a cardiovascular therapeutics company based in Basel, Switzerland.
Mr. Rutten received his Masters in Biotechnology (majoring in biochemistry and virology) from the University of Wageningen in the Netherlands.