MANAGEMENT - Kowa Research Institute


		Management



		Claus Kühl, M.D., Ph.D President Kowa Research Institute Dr. Claus Kühl, M.D., Ph.D., is an expert in internal medicine and endocrinology, with special knowledge of diabetes and its complications. Additionally, Dr. Kühl is a proven business leader, successfully leading various corporate functions and business divisions, including drug discovery, drug development, marketing, and general management. Early in his career as a physician, Dr. Kühl established research laboratories at two hospitals and supervised research, diagnostic and educational activities. With Novo Nordisk A/S of Copenhagen, Denmark, he led several of the company's critical divisions, including drug discovery, the pharmaceutical division, the diabetes care division, the diabetes care strategy unit, and world-wide medical and regulatory affairs. He also served as Chairman of the W.H.O. affiliated Steno Diabetes Center in Copenhagen, Denmark. Before joining Kowa Research Institute, Dr. Kühl was President and CEO at BioStratum where he raised $48 million in private financing, moved Pyridorin™ into Phase IIb trials for diabetic kidney disease and had the IND for Angiocol™ approved by the FDA. Dr. Kühl also served for four years as the President of ZymoGenetics, a genomics-driven biology based discovery and development company in Seattle, Washington. He is the author of multiple scientific articles, book chapters and published abstracts, and Dr. Kühl has made over 100 presentations at major international scientific meetings and conferences. Dr. Kühl joined Kowa Research Institute, Inc. as its President in 2003.





		Gary Gordon, M.B.A., M.D. SVP, Operations Kowa Research Institute Dr. Gordon has over 15 years of experience in the pharmaceutical industry, holding senior management roles in finance, business development and operations. Prior to joining Kowa, Dr. Gordon was the VP, Finance and Business Development and CFO of BioStratum. During his tenure, he established corporate partnerships for the company’s diabetes and cancer drug candidates and successfully raised several rounds of private financing. Prior to moving to RTP, he co-founded and was the CFO of Sentinel Biosciences, a Palo Alto-based company focused on new pathogen discovery and diagnostic development. At Sentinel, Dr. Gordon was responsible for all licensing and finance activities and directed the general operations of the company until its acquisition by Roche in 1999. Dr. Gordon also held business development and marketing positions at Genelabs Technologies and Warner Lambert. Dr. Gordon received a B.A. in Genetics from the University of California at Berkeley, and an MD from Cornell University Medical Center. In 1992, he earned an MBA with a major in finance from Columbia University.




		Roger E. Morgan, M.D., FACS Chief Medical Officer Kowa Research Institute Dr. Morgan has 15 years clinical experience as a general and trauma surgeon, in addition to a critical care specialist. He graduated Magna Cum Laude from Duke University with an AB degree in biochemistry and then matriculated at University of Illinois College of Medicine where an MD was granted. General Surgery and Critical Care Fellowship training was acquired at Michigan State University and University of Pittsburgh, following which he became double board-certified in General Surgery and Critical Care Medicine. He held a faculty position at Eastern Virginia Medical School prior to entering private practice in Raleigh in 1993. In 1997 he joined Quintiles, a contract research organization, achieving the position of Senior Director, Internal Medicine Therapeutics, in the department of Medical and Scientific Services. Since 2002 he has been Director of Medical Affairs at the cancer cooperative group American College of Surgeons Oncology Group, located at Duke University. He held a faculty appointment of assistant research professor in the Department of Surgery during this time. Dr. Morgan has pursued active research projects throughout his career, has published publications in scientific journals and presented at several scientific conferences. Professional society memberships include the American College of Surgeons, Drug Information Association and the American Association of Pharmaceutical Physicians. Dr. Morgan also is a Fellow, American College of Surgeons.




		Ross Laderman, MPH Senior Director, Regulatory Affairs Kowa Research Institute Ross Laderman, MPH has extensive experience in regulatory affairs, both as a regulator and as an industry executive. He started his career at the Food and Drug Administration after completing his undergraduate degree at MacMurray College. During his 25 years with the FDA, Mr. Laderman served in a number of positions of increasing responsibility, first as a field investigator and, during his last 10 years, as Deputy Director, Division of Scientific Investigations in CDER. He has been involved with the full spectrum of drug regulatory programs and policies and is recognized as an expert in the application and regulatory evaluation of GMP, GLP and GCP compliance and programs. He also played an active role in ICH collaborations and served as an expert advisor to the World Health Organization. In addition, Mr. Laderman has participated in various forums sponsored by RAPS, DIA, FDLI, PhRMA and others. After leaving the FDA, Mr. Laderman became Vice President, Regulatory Affairs at Guilford Pharmaceuticals and later, he became the lead regulatory affairs officer at Delsys Pharmaceutical Corp., PRA International and BioStratum before joining Kowa Research Institute. Mr. Laderman received his MPH in Health Policy & Management from Johns Hopkins University and has taken post-graduate training at several other distinguished institutions. Mr. Laderman’s professional society memberships include RAPS, DIA and FDAAA. Mr. Laderman is a member of Kowa Research Institute’s senior management team and is the principal interface with the FDA and responsible for all U.S. regulatory affairs activities.




		Vasudev P. Anand, Ph.D., DABT Director, Preclinical Development Kowa Research Institute Dr. Anand has 10+ years experience in pharmaceutical preclinical safety assessment and development of Rx and OTC drugs. He started his career in contract toxicology research at Toxikon Corporation, followed by positions of increasing responsibility at Boston Scientific Corporation, Idenix Pharmaceuticals (a Novartis affiliate), and most recently at McNeil Consumer and Specialty Pharmaceuticals/Johnson and Johnson, where he was Associate Director of Preclinical Development. He has several years experience in preclinical regulatory submissions for the development of Rx and OTC drugs, and has been involved in submission of several IND’s and NDA’s. Dr. Anand holds a Bachelor’s degree in Zoology (Chemistry and Botany) and a Master’s degree in Environmental Toxicology from the University of Madras, India. Subsequently he earned a Master’s degree in Environmental Science from Southern Illinois University in Edwardsville, IL, followed by a PhD in Toxicology from Rutgers University, New Brunswick, NJ, and the University of Medicine and Dentistry at New Jersey, where his doctoral research involved investigations of Glutathione S- Transferase isozymes in neurotoxicity mechanisms. He has since been actively involved in several industry research projects leading to publications and presentations. Dr. Anand is a Diplomat of the American Board of Toxicology since 2001 and is also an elected member of the General Toxicology and Medical Device Compatibility Expert Committee of the United States Pharmacopoeia since 2000. He is also a full member of both the Society of Toxicology and the American College of Toxicology.