Development, Clinical Research, Quality Assurance, Regulatory Affairs, Reimbursement For New Technologies, Product Launch And Denver, Product Liability

gov denver, Mar 14, 2005

William (Bill) H. Duffell, Jr., Ph.D. is presently responsible for Regulatory and Government Affairs for Gambro BCT (Blood Component Technologies) in Denver, Colorado.  Dr. Duffell has 23 plus years of experience with both small Venture Capitol companies and large multi-billion dollar corporations in the pharmaceutical, medical device and biotech industries.  His experience includes business development for new innovative medical products, research and development, clinical research, quality assurance, regulatory affairs, reimbursement for new technologies, product launch, field sales support and product liability.  He has brought a variety of medical products to market in domestic, European and Asian countries.  Prior to joining Gambro, he served as an Officer and Vice President for Cyberonics, Inc. where he was responsible for developing and launching a novel new implantable therapeutic product for treating several Central Nervous System (CNS) disorders.  Dr. Duffell is an entrepreneur who has devoted his career to strategic global product and business development taking patented intellectual properties from the bench, through proof of concept, clinical and regulatory hurdles, and into commercial sales.  Dr. Duffell has provided strategic and crisis leadership in the development and defense of a number of high profile medical products including breast implants, innovative biomaterials for the treatment of urological disorders and implantable cranial neurostimulators

Dr. Duffell has twice been appointed by the Commissioner of the Food and Drug Administration to serve as Industry Representative on Advisory Panels and presently is a member of FDA?s Hematology and Pathology Advisory Panel.  Dr. Duffell is an active participant on several AdvaMed (the primary trade association for medical device manufacturers) task force groups and is a member in the Regulatory Affairs Professional Society (RAPS) and the Food and Drug Law Institute (FDLI).    In October, 1998, Dr. Duffell was called upon by Congressmen Tom Bliley and John Dingell to testify at a full Committee hearing on the Implementation of the Food and Drug Administration Modernization Act (FDAMA) and its impact on the development and market introduction of medical products and reimbursement for new technology healthcare products.  In 1999, he was again called upon by both the U.S. Congress and the U.S. Senate, to provide an Industry update and a progress report on the implementation of FDAMA and to address global business issues affecting the healthcare industry.  

Dr. Duffell received his B.S. in Biology from Rutgers University and his doctorate in Business Administration / Behavioral Sciences from Clayton University