Proceedings from the Workshop on Science-Based Assessment Accelerating Product Development of Combination Medical Devices (2004) / Chapter Skim
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APPENDIX B: Biographies of Speakers and Session Chairs
APPENDIX B: Biographies of Speakers and Session Chairs
Pages 31-38
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From page 31... ...
patents and is the author of 22 journal publications and 5 book chapters on topics including drug delivery, prevention of postoperative adhesions, and molecular weight determination of hyaluronate. He is the recipient of the President's Award from Genzyme Corporation, as well as a Fellow of the American Institute for Medical and Biological Engineering; a visiting advisory board member for the Materials Science and Engineering Department of the University of Florida; an adjunct assistant professor in the Department of Bioengineering at Clemson University; and he has served on the U.S.
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From page 32... ...
Previous positions held at Medtronic include vice president of science and technology, vice president of ventures technology, vice president of applied concepts research, and director of applied concepts research. Prior to his tenure at Medtronic, Mr.
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From page 33... ...
Specific topics have included: the chemistry, design, testing, and qualification of polymeric and biopolymeric implant materials, such as silicones, silicone copolymers, acrylates, hydrogels, collagen, and hyaluronic acid; the development of new in vivo and in vitro models to study materialbiological interactions, such as cell adhesion, migration, toxicity, and wound healing; and the identification of cross-functional requirements and their integration into successful project plans.
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From page 34... ...
Prior to joining FDA, he was an assistant professor and research engineer in the Department of Orthopaedic Surgery at the University of Cincinnati, where he undertook basic and applied orthopedic research in implant evaluation, tissue engineering, and orthopedic surgery resident education. Before that, Mr.
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From page 35... ...
In addition, he is an adjunct assistant professor at the University of Maryland, Baltimore County. He has extensive expertise in coronary stents, in balloon angioplasty and its effects on coronary arteries, and in medical device regulatory requirements, device evaluation, and materials science.
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From page 36... ...
Previous positions held include professor of medicine at the Mayo Medical School; director of the Center for Applied Vascular Biology and Interventions at the Mayo Clinic; consultant for the Division of Cardiovascular Diseases and Internal Medicine at the Mayo Clinic; chief cardiologist and cardiopulmonary research chief at the U.S. Air Force School of Aerospace Medicine; and U.S.
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From page 37... ...
In addition, she is clinical visiting professor of pathology at Georgetown University, George Washington University, and Maryland University, as well as clinical research professor of pathology at Vanderbilt University. Previous positions have included: associate professor of pathology and chief of autopsy pathology at Vanderbilt University; chair of cardiovascular pathology and staff pathologist at the Armed Forces Institute of Pathology; and Fellow at the National Heart, Lung, and Blood Institute.
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From page 38... ...
. Her research expertise lies in the areas of: accelerated aging of absorbable suture; the development of standards for determining the safety of medical devices in magnetic resonance imaging scanners; studies examining device issues related to the cleaning, reprocessing, and reuse of single-use devices; and reviews of bench testing of a range of medical devices, in particular a number of endovascular grafts.
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