chelsea therapeutics interna
(CHTP:NASDAQ CM)

Executive Profile*

Background*

Dr. William D. Schwieterman, Bill, M.D. is the Founder of Tekgenics Inc., and serves as its President. Dr. Schwieterman has been the Chief Medical Officer of Chelsea Therapeutics International since November 2009 and serves as its Vice President. He serves as an Advisor of Avidia Inc., and has been an Independent Consultant for biotech and pharmaceutical companies since July 2002. He is a veteran of the National Institutes of Health. He is an expert in the design of ... clinical trials for a wide range of therapeutic agents, including in the areas of regenerative medicine and tissue repair. Prior to his work at Tekgenics, Dr. Schwieterman served as Chief of Medicine, Division of Clinical Trial Design and Analysis and the Immunology and Infectious Disease branch of the Center for Biologics Evaluation and Research and Senior Supervisor at the U. S. Food and Drug Administration. He was responsible for an outcome clinical trial design, which assesses the design of clinical development plans for novel investigational biologic agents to elicit meaningful data on product safety and efficacy. He spent twelve years at Food and Drug Administration and oversaw product development for numerous biological therapies. He was instrumental at Food and Drug Administration in generating one of the first guidance documents for sponsors of manipulated autologous structural cell therapies, and helped lay the foundation at it for how these products were to be both regulated and reviewed. Dr. Schwieterman served as the Head of Regulatory Advisory Services of Dyax Corp. since January 20, 2005. He served as a First Chief of the Medicine Branch. He worked with sponsors for the development of new agents for pulmonary medicine, neurology, sepsis, hepatitis, rheumatology, infectious disease, solid organ transplantation and wound-healing, among other areas. He has been a Director of OXiGENE, Inc since June 27, 2007. He served as a Director of Chelsea Therapeutics International Ltd. from June 2008 to November 2009. He serves as a Member of Research and Development Advisory Board of Tengion Inc. and as a Member of Medical Advisory Board of Velcura Therapeutics Inc. He served as a Member of Scientific Advisory Board of Tengion Inc. He served as a Member of Advisory Board of PharmaEngine Inc. Dr. Schwieterman served as a Member of Advisory Board of Chelsea Therapeutics International Ltd. He is a Member of the American College of Rheumatology and the Regulatory Affairs Professional Society. He also helped author the Agency's "Good Review Practices' for investigational products-and was instrumental in the development of several guidance documents. He is a board-certified Internist and Rheumatologist. He was a Senior Staff Fellow at the National Institute of Arthritis and Musculoskeletal Diseases at National Institutes of Health, where he did both scientific and clinical work in the area of systemic lupus erythematosus and was a Fellow at the National Cancer Institute where he worked to advance the understanding of immunodeficiency disorders. He is trained in Rheumatology National Institute of Arthritis and Musculoskeletal Diseases. His research training was obtained at the National Institutes of Health in Bethesda Maryland. He holds a B.S. and M.D. from the University of Cincinnati and his Internship and Residency programs were completed at Mt. Sinai Hospital in New York City.

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