William (Bill) Duffell:
CLASS OF 1978
East Brunswick High SchoolClass of 1978
East brunswick, NJ
East Brunswick High SchoolClass of 1978
East brunswick, NJ
Millbrook Middle SchoolClass of 1974
Raleigh, NC
William (Bill)'s Story
Bill was in the drama club and chior at ENHS.
William (Bill) H. Duffell, Jr. was recently Sr. Vice President of Global Government Affairs for Gambro (based in Stockholm, Sweden) after having served as Gambroÿs VP of Global Regulatory & Quality Assurance. Dr. Duffell has over 25 years of experience in regulatory, quality and clinical research with both small Venture Capital 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 a 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 by raising funding to take intellectual properties from the bench, through proof of concept, clinical and regulatory hurdles, and into commercial sales while securing timely CMS and 3rd party reimbursement. Dr. Duffell provided strategic and crisis leadership in the development and defense...Expand for more
of a number of high profile medical products including breast implants, innovative biomaterials for the treatment of urological disorders and GMP violations resulting in import bans, warning letters and product recalls.
Dr. Duffell has twice served on FDA Advisory Panels ÿ ENT and Hematology / Pathology Advisory Panels ÿ and in January 2006 Dr. Duffell was confirmed by the White House and HHS Secretary Michael Leavitt as a member of one his committees in his Office of Public Health & Emergency Preparedness. Dr. Duffell is active on several AdvaMed (the primary trade association for medical device manufacturers) and is an active 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.
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