Clinquest - Your Partner From Bench to Market

Clinquest Team

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.

Cornelis H. Wortel, M.D., Ph.D.
Founder and CMO

Education:

University of Amsterdam Medical School, M.D.
University of Amsterdam, Ph.D. University of Amsterdam, Academic Medical Center, Department of Internal Medicine; Internal Medicine (infectious diseases)
Ruprecht Karls-Universitaet, Heidelberg, Germany; Resident and Research Fellow, Cardiology
University of Amsterdam, Academic Medical Center, Department of Intensive Care; Department of Hemostasis, Thrombosis, Atherosclerosis and Inflammation Research

Academic Position:

Visiting Associate Professor of Medicine, Department of Cardiovascular and Critical Care Medicine, Rush University, Chicago, Ill.

Dr. Wortel has more than 15 years of experience in the development of biopharmaceuticals and innovative medical technologies and in international academic and industrial pharmaceutical research. He is experienced in developing international medical operations under stringent Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) standards. Dr. Wortel is also internationally recognized for his expertise in the design and analysis of clinical trials.

Dr. Wortel previously served as senior executive for medical research at various biopharmaceutical companies, such as Centocor, Inc., Repligen Inc., Procept Inc. and Alkermes, Inc. During his tenure at Centocor, Dr. Wortel was responsible for the development of Remicade®. At Alkermes, he was responsible for the development of Nutropin DepotTM(in collaboration with Genentech).

Dr. Wortel also has a strong teaching background in academia, as well as in industrial alliances. He has published widely, presented and chaired many national and international meetings and was selected as an honored member of the International Who's Who in 1995.

Jose E. Gonzalez, Ph.D.
President and CEO

Education:

University of Miami, Coral Gables, FL. BS Chemistry
Purdue University, Lafayette, IN. Ph.D. Biochemistry
National Institute of Health, Laboratory of Molecular Biology, Bethesda, MD, Research Staff Fellow

Dr. Gonzalez has over 20 years of operations and general management experience in first-tier biotechnology and pharmaceutical companies, including manufacturing, process and formulation development, quality control and assurance, engineering, facilities, purchasing, distribution and sales.

As a Director at The Upjohn Company, he developed novel biotechnology products, and improved, and supported the worldwide cGMP manufacture of all antibiotics and steroids products of the company. At Enzon, he was responsible for the process development and cGMP manufacturing of Adagen®, and the launch of Oncaspar®. He guided the timely development and successful transfer of the manufacturing process of Peg-Intron™, the first pegylated form of Interferon, to Schering-Plough. At Hybridon, he lead the development of large scale cGMP manufacturing of second generation oligonucleotides, and at Alkermes, he was responsible for the successful development of commercial manufacturing and support of Risperdal-Consta® through NDA approval in collaboration with Johnson and Johnson. In addition, he had oversight of the development of Vivitrol®, and Exenatide LAR in collaboration with Amylin Pharmaceuticals.

In these companies, he improved and evolved quality systems with an emphasis on reliability and prevention, root-cause analysis, rapid response, and cross-functional problem-solving teams. Also, he streamlined manufacturing by introducing metrics for error-free operations, and guaranteed release times. Key to his accomplishments is his ability to forge highly motivated organizations with people, processes, structures, and cultures dedicated to all-around quality execution and legacy creation.

David W. Thomas, Ph.D.
Preclinical R&D Planning

Education:

University of Kansas, B.A.
University of Colorado, Ph.D.

Dr. Thomas specializes in technology evaluation and preclinical development of drugs for clinical testing. At Clinquest, Dr. Thomas provides services for the assessment of technology for future development or licensing and acquisition, as well as management consultation and preparation of presentations to investors. He also provides expertise in preclinical animal modeling and safety testing, assay design for detection and biological activity of drug substances, protein drug optimization and protein manufacturing.

Dr. Thomas has more than 30 years of experience in biological research and has published more than 100 original scientific articles. He is also named as an inventor on more than 60 patents. For the last 14 years, he has been a senior executive in the biotechnology industry and was responsible for new drug discovery and preclinical development. His drug discovery experience is with both protein drugs and particularly antibodies and in the discovery of small molecule drugs that inhibit ligand/receptor interactions. Dr. Thomas also has preclinical drug development experience with animal models and safety testing, assay development and implementation, protein manufacturing, product characterization, evaluation of clinical targets and preparation of INDs.

In addition, Dr. Thomas has extensive experience in evaluating technologies and companies for merger/acquisition activities and in raising capital. He was a key member of the road show team that netted more than $200 million in an initial public offering.

John M. Naples
Chief Financial Officer/Treasurer

Education:

St. Joseph's College; B.S.B.A.
Western New England College; M.B.A.

Since joining Clinquest, Mr. Naples has been instrumental in executing key financing activities including the Company's Series A investment, the institution and expansion of the Company's Credit Facilities, and the Company's acquisition of a Netherlands' Contract Research Organization.

Mr. Naples is responsible for business and strategic planning, finance and accounting, support and modeling for fundraising and deal structures. He directs overall financial policies, financial functions (accounting, budgeting, reporting, credit, insurance, tax and treasury), facilities and human resources. He also administers client advice in the areas of finance, business strategy, competitive landscape and fundraising

Mr. Naples has more than 25 years of diversified financial experience. He has worked with both public and private companies and has spent 15 years in the biotechnology industry.

Prior to joining Clinquest, Mr. Naples served as controller/assistant corporate secretary at the Institute of Molecular Biology, Inc. (IMB), in Worcester, Mass., and is currently the acting president at IMB, which is in a “mothballed” state. He was also the controller at Hybridon, Inc., in Cambridge and Milford, Mass. and the controller at Neptune Pharmaceuticals, Inc. (now Phytera, Inc.) and Aphios Corporation. In addition, he assisted with the preparation of SEC Filings and Bankruptcy Filings with Cambridge Biotech Corporation, which is now Aquila Biopharmaceuticals, a wholly owned subsidiary of Antigenics, Inc.

Mr. Naples has also held various positions with an independent testing lab, vehicle manufacturer and Fortune 50 corporation and, at the same time, was a part-time college professor in accounting at Nichols College. He is Finance Committee Chairman of Saint Joan of Arc Church, a past chapter president of the Institute of Management Accounts, a Paul Harris Fellow of the Worcester Rotary Club and a former director of Family Services of Central Massachusetts.




		Clinquest Team 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. Cornelis H. Wortel, M.D., Ph.D. Founder and CMO Education: University of Amsterdam Medical School, M.D. University of Amsterdam, Ph.D. University of Amsterdam, Academic Medical Center, Department of Internal Medicine; Internal Medicine (infectious diseases) Ruprecht Karls-Universitaet, Heidelberg, Germany; Resident and Research Fellow, Cardiology University of Amsterdam, Academic Medical Center, Department of Intensive Care; Department of Hemostasis, Thrombosis, Atherosclerosis and Inflammation Research Academic Position: Visiting Associate Professor of Medicine, Department of Cardiovascular and Critical Care Medicine, Rush University, Chicago, Ill. Dr. Wortel has more than 15 years of experience in the development of biopharmaceuticals and innovative medical technologies and in international academic and industrial pharmaceutical research. He is experienced in developing international medical operations under stringent Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) standards. Dr. Wortel is also internationally recognized for his expertise in the design and analysis of clinical trials. Dr. Wortel previously served as senior executive for medical research at various biopharmaceutical companies, such as Centocor, Inc., Repligen Inc., Procept Inc. and Alkermes, Inc. During his tenure at Centocor, Dr. Wortel was responsible for the development of Remicade®. At Alkermes, he was responsible for the development of Nutropin DepotTM(in collaboration with Genentech). Dr. Wortel also has a strong teaching background in academia, as well as in industrial alliances. He has published widely, presented and chaired many national and international meetings and was selected as an honored member of the International Who's Who in 1995. Jose E. Gonzalez, Ph.D. President and CEO Education: University of Miami, Coral Gables, FL. BS Chemistry Purdue University, Lafayette, IN. Ph.D. Biochemistry National Institute of Health, Laboratory of Molecular Biology, Bethesda, MD, Research Staff Fellow Dr. Gonzalez has over 20 years of operations and general management experience in first-tier biotechnology and pharmaceutical companies, including manufacturing, process and formulation development, quality control and assurance, engineering, facilities, purchasing, distribution and sales. As a Director at The Upjohn Company, he developed novel biotechnology products, and improved, and supported the worldwide cGMP manufacture of all antibiotics and steroids products of the company. At Enzon, he was responsible for the process development and cGMP manufacturing of Adagen®, and the launch of Oncaspar®. He guided the timely development and successful transfer of the manufacturing process of Peg-Intron™, the first pegylated form of Interferon, to Schering-Plough. At Hybridon, he lead the development of large scale cGMP manufacturing of second generation oligonucleotides, and at Alkermes, he was responsible for the successful development of commercial manufacturing and support of Risperdal-Consta® through NDA approval in collaboration with Johnson and Johnson. In addition, he had oversight of the development of Vivitrol®, and Exenatide LAR in collaboration with Amylin Pharmaceuticals. In these companies, he improved and evolved quality systems with an emphasis on reliability and prevention, root-cause analysis, rapid response, and cross-functional problem-solving teams. Also, he streamlined manufacturing by introducing metrics for error-free operations, and guaranteed release times. Key to his accomplishments is his ability to forge highly motivated organizations with people, processes, structures, and cultures dedicated to all-around quality execution and legacy creation. David W. Thomas, Ph.D. Preclinical R&D Planning Education: University of Kansas, B.A. University of Colorado, Ph.D. Dr. Thomas specializes in technology evaluation and preclinical development of drugs for clinical testing. At Clinquest, Dr. Thomas provides services for the assessment of technology for future development or licensing and acquisition, as well as management consultation and preparation of presentations to investors. He also provides expertise in preclinical animal modeling and safety testing, assay design for detection and biological activity of drug substances, protein drug optimization and protein manufacturing. Dr. Thomas has more than 30 years of experience in biological research and has published more than 100 original scientific articles. He is also named as an inventor on more than 60 patents. For the last 14 years, he has been a senior executive in the biotechnology industry and was responsible for new drug discovery and preclinical development. His drug discovery experience is with both protein drugs and particularly antibodies and in the discovery of small molecule drugs that inhibit ligand/receptor interactions. Dr. Thomas also has preclinical drug development experience with animal models and safety testing, assay development and implementation, protein manufacturing, product characterization, evaluation of clinical targets and preparation of INDs. In addition, Dr. Thomas has extensive experience in evaluating technologies and companies for merger/acquisition activities and in raising capital. He was a key member of the road show team that netted more than $200 million in an initial public offering. John M. Naples Chief Financial Officer/Treasurer Education: St. Joseph's College; B.S.B.A. Western New England College; M.B.A. Since joining Clinquest, Mr. Naples has been instrumental in executing key financing activities including the Company's Series A investment, the institution and expansion of the Company's Credit Facilities, and the Company's acquisition of a Netherlands' Contract Research Organization. Mr. Naples is responsible for business and strategic planning, finance and accounting, support and modeling for fundraising and deal structures. He directs overall financial policies, financial functions (accounting, budgeting, reporting, credit, insurance, tax and treasury), facilities and human resources. He also administers client advice in the areas of finance, business strategy, competitive landscape and fundraising Mr. Naples has more than 25 years of diversified financial experience. He has worked with both public and private companies and has spent 15 years in the biotechnology industry. Prior to joining Clinquest, Mr. Naples served as controller/assistant corporate secretary at the Institute of Molecular Biology, Inc. (IMB), in Worcester, Mass., and is currently the acting president at IMB, which is in a “mothballed” state. He was also the controller at Hybridon, Inc., in Cambridge and Milford, Mass. and the controller at Neptune Pharmaceuticals, Inc. (now Phytera, Inc.) and Aphios Corporation. In addition, he assisted with the preparation of SEC Filings and Bankruptcy Filings with Cambridge Biotech Corporation, which is now Aquila Biopharmaceuticals, a wholly owned subsidiary of Antigenics, Inc. Mr. Naples has also held various positions with an independent testing lab, vehicle manufacturer and Fortune 50 corporation and, at the same time, was a part-time college professor in accounting at Nichols College. He is Finance Committee Chairman of Saint Joan of Arc Church, a past chapter president of the Institute of Management Accounts, a Paul Harris Fellow of the Worcester Rotary Club and a former director of Family Services of Central Massachusetts.