APPENDIX B
BIOGRAPHIES OF SPEAKERS AND SESSION CHAIRS

Barbara D. Boyan is professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Institute of Technology and Emory University. She also serves as the deputy director for research for the Georgia Tech/Emory Center for the Engineering of Living Tissues and holds the Price Gilbert, Jr. Chair in Tissue Engineering. Previously, Dr. Boyan was professor and director of research in the department of orthopedics at the University of Texas Health Science Center in San Antonio. Dr. Boyan’s research expertise is in bone mineralization and her laboratory is among the top bone and cartilage cell biology groups in the orthopedic and oral health fields. Her specific research interests include: mechanism of action of hormones and growth factors in chondrocytes and osteoblasts; normal and pathologic calcification; tissue engineering; and response of cells to biomaterials. Dr. Boyan is a founder of Biomedical Development Corp., OsteoBiologics, Inc., and Othonics, Inc., as well as a charter member of the Texas Technology Transfer Association and the BIO Council of Biotechnology Centers. Dr. Boyan holds eight patents and is the author of approximately 300 peer-reviewed papers, book chapters, and reviews.

James W. Burns is senior vice president of biosurgery research and development at Genzyme Corporation, where he has worked since 1986. He is responsible for product development in the areas of surgical adhesion prevention, ophthalmic biomaterials, tissue engineering, drug delivery, and implant biocompatibility. Previous positions held at Genzyme include scientific director of biopolymers research and development, and vice president of biomaterials and surgical products research. In addition, Dr. Burns was a research fellow in the Materials Science and Engineering Department of the University of Florida, working on drug delivery and surface modification of intraocular lenses. Dr. Burns holds 14 U.S. 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. Food and Drug Administration’s advisory panel on general and plastic surgery devices.



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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices APPENDIX B BIOGRAPHIES OF SPEAKERS AND SESSION CHAIRS Barbara D. Boyan is professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Institute of Technology and Emory University. She also serves as the deputy director for research for the Georgia Tech/Emory Center for the Engineering of Living Tissues and holds the Price Gilbert, Jr. Chair in Tissue Engineering. Previously, Dr. Boyan was professor and director of research in the department of orthopedics at the University of Texas Health Science Center in San Antonio. Dr. Boyan’s research expertise is in bone mineralization and her laboratory is among the top bone and cartilage cell biology groups in the orthopedic and oral health fields. Her specific research interests include: mechanism of action of hormones and growth factors in chondrocytes and osteoblasts; normal and pathologic calcification; tissue engineering; and response of cells to biomaterials. Dr. Boyan is a founder of Biomedical Development Corp., OsteoBiologics, Inc., and Othonics, Inc., as well as a charter member of the Texas Technology Transfer Association and the BIO Council of Biotechnology Centers. Dr. Boyan holds eight patents and is the author of approximately 300 peer-reviewed papers, book chapters, and reviews. James W. Burns is senior vice president of biosurgery research and development at Genzyme Corporation, where he has worked since 1986. He is responsible for product development in the areas of surgical adhesion prevention, ophthalmic biomaterials, tissue engineering, drug delivery, and implant biocompatibility. Previous positions held at Genzyme include scientific director of biopolymers research and development, and vice president of biomaterials and surgical products research. In addition, Dr. Burns was a research fellow in the Materials Science and Engineering Department of the University of Florida, working on drug delivery and surface modification of intraocular lenses. Dr. Burns holds 14 U.S. 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. Food and Drug Administration’s advisory panel on general and plastic surgery devices.

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices Paul Citron recently retired as vice president of technology policy and academic relations at Medtronic, Inc., where he had worked since 1972. His responsibilities included identifying and addressing public policy matters that affect medical technology innovation and working with leading biomedical engineering institutions. 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. Citron was a research fellow in the Department of Neurology at the University of Minnesota. He is the author of numerous publications and holds several patents in medical device pacing. He is the recipient of numerous awards, including the IEEE Young Electrical Engineer of the Year (1979), the Invention of Distinction award from Medtronic (1980) for his role as coinventor of the tined pacing lead, and two Governor’s Awards for Excellence from the American College of Cardiology. Mr. Citron is a member of Tau Beta Pi and Eta Kappa Nu, a Fellow of the Medtronic Bakken Society, and a Founding Fellow of the American Institute of Medical and Biological Engineering (AIMBE). Mr. Citron was elected to the National Academy of Engineering in 2003. J. William Costerton is director of the Center for Biofilm Engineering at Montana State University-Bozeman, a position he has held since 1993. Previous academic experience included 23 years at the University of Calgary, as associate professor of biology, professor of biology, AOSTRA Research Chair in Microbiology, and NSERC Industrial Research Chair in Microbiology. Prior to that, Dr. Costerton was assistant professor of microbiology at MacDonald College of McGill University and a postdoctoral fellow at Cambridge University. In addition, he served as Dean of Science at Baring Union College in Punjab, India, for 9 years. Dr. Costerton’s research has dealt with biofilms in a wide variety of environments: mountain streams, industrial systems, and medical devices implanted in humans. He is the author of over 575 publications and in 2002 was added to the Institute for Scientific Information’s Highly Cited list. He is the recipient of numerous honors and awards including: Excellence in Surface Science Award from the Surfaces in Biomaterials Foundation (2002); Isaak Walton Killam Memorial Prize for Scientific Achievement (1990); and Sir Frederick Haultain Prize for Outstanding Achievement in the Physical Sciences (1986). He is a Fellow of the American Association for the Advancement of Science. Richard D. Coutts is the medical director for orthopedics at Sharp HealthCare and a practicing physician in a San Diego orthopedic group. In addition, he is an adjunct professor at the University of California at San Diego and codirector of a joint reconstruction fellowship. Dr. Coutts’ medical training includes an M.D. from the University of California at Los Angeles Medical

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices School; a residency in orthopedic surgery at the San Diego County University Hospital; a fellowship in orthopedic research at the Nuffield Orthopaedic Center in Oxford, England; and a clinical and research fellowship at the Massachusetts General Hospital, Harvard Medical School, where he studied joint reconstruction. He has published 200 articles, abstracts, and book chapters, and has been active in a number of professional societies, including as president of the Orthopaedic Research Society; president of the Hip Society; member of the board of directors of the American Academy of Orthopaedic Surgeons (AAOS); chair of the AAOS Council of Musculoskeletal Specialty Societies; and chair of the board and vice president of grants at the Orthopaedic Research and Education Foundation. He is currently the president of the board of directors for the Malcolm and Dorothy Coutts Institute for Joint Reconstruction and Research. Crystal Cunanan is director of tissue engineering at Arbor Surgical Technologies, Inc. Previously, she was manager of the Biosciences Group at Edwards Lifesciences Corporation. She has over 18 years of industrial experience in the area of permanently implanted devices. Her research has focused on all modes of interaction between biomedical devices and the body. 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 material-biological interactions, such as cell adhesion, migration, toxicity, and wound healing; and the identification of cross-functional requirements and their integration into successful project plans. Ms. Cunanan holds 10 U.S. patents and is the author of over 40 papers, presentations, and published abstracts. She is active in several professional societies, including the Board of the Surfaces in Biomaterials Foundation, the American Society for Artificial Internal Organs, and the American Chemical Society. She has served on the Industrial Advisory Board of the Massachusetts Institute of Technology and the Georgia Institute of Technology Tissue Engineering Research Center, and has served as chair of the Industrial Advisory Board Committee of the University of Washington Engineered Biomaterials (UWEB) Engineering Research Center. Joshua J. Jacobs is Crown Family Professor and associate chair for academic programs in the Department of Orthopaedic Surgery at Rush Medical College, as well as the director of the Section of Biomaterials. In addition, he is an adjunct professor in the Department of Civil and Environmental Engineering at the McCormick Technological Institute of Northwestern University. His medical training includes an M.D. from the University of Illinois Medical School; 2 years of General Surgical Training at the University of Illinois/Cook

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices County Hospital Program; orthopedic training at the Combined Harvard Orthopaedic Residency Program, where he also served as a research fellow in the H. H. Uhlig Corrosion Laboratory at the Massachusetts Institute of Technology; and a fellowship in Adult Reconstructive Orthopaedic Surgery at Rush-Presbyterian-St. Luke’s Medical Center. Dr. Jacob’s major research focus is on the biocompatibility of permanent orthopedic implants, particularly joint replacement devices. He is a member of the American Institute for Medical and Biological Engineering (AIMBE) and chair of the American Society for Testing and Materials Committee F04 on Medical and Surgical Materials and Devices. Aric Kaiser is expert biomedical engineer and regulatory review scientist in the Restorative Devices Branch, Office of Device Evaluation, Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA). He has 9 years of experience in the regulation of medical devices with particular expertise in the review of orthopedic devices involving cross-cutting issues in spinal implants, tissue-engineered orthopedic products, and regulatory/legal matters. 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. Kaiser designed and tested hip and knee replacements as a research engineer with Biomechanical Research, Inc. Amy J. LaForte is director of regulatory affairs at Stryker Biotech, where she has worked for over 5 years. With more than 10 years of experience in the research and development and regulation of novel devices and biologics, Dr. LaForte has been responsible for regulatory clearance of new products in the fields of imaging, cardiology, neurology, oncology, and, most recently, orthopedics. She was instrumental in the first market approvals for a bone morphogenetic protein product worldwide. Stephen G. LaRiviere is senior manager of the composite and nondestructive evaluation (NDE) groups in the manufacturing research and development department at The Boeing Company. His responsibilities include the development of a fundamental understanding of composites and NDE technologies; the development of low-cost, reliable materials and processes; and the implementation of technologies into the Boeing production and support system. He has worked in the research department of Boeing for 23 years in support of product development, production systems, and in-service product support. He is a Fellow of the American Society of Non-Destructive Testing.

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices William McKay is vice president of research at Sofamor Danek, a subsidiary of Medtronic, Inc. He has over 20 years of research and development experience in the field of orthopedics, working for the past 16 years on the development of bone graft substitutes. He was involved with the first osteoconductive bone graft substitute that received premarket approval from the U.S. Food and Drug Administration (FDA) for use in long bone fresh fractures. Approval was based on a prospective randomized clinical trial (Collagraft). Recently, he has worked to obtain FDA premarket approval for the first osteoinductive bone-morphogenetic-protein bone graft replacement (BMP-2) for use in spinal fusions (the INFUSETM bone graft developed by Medtronic Sofamor Danek). Mr. McKay is continuing research and development to seek expanded indications for BMP-2 using new carriers and doses. H. Semih Oktay is president and founder of CardioMed Device Consultants, a regulatory and engineering consulting firm. 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. Prior to founding CardioMed, Dr. Oktay was vice president of regulatory affairs and engineering at MicroMed Laboratories, Inc. His responsibilities there included providing engineering and regulatory consulting services to the medical device and related industries and managing the East Coast office. Prior to that, Dr. Oktay worked for 6 years as an expert mechanical engineer and scientific reviewer for the U.S. Food and Drug Administration in the Office of Device Evaluation, Center for Devices and Radiological Health, Division of Cardiovascular and Respiratory Devices, and Interventional Cardiac Devices Branch. Anthony Ratcliffe is president and chief executive officer of Synthasome, Inc., a new company focused on the research and development of tissue-engineered products. Prior to forming Synthasome, he worked for six years at Advanced Tissue Sciences, where he served as vice president for research. Previous positions include associate professor of orthopedic biochemistry at Columbia University, where he taught for 9 years, and senior research scientist at the Kennedy Institute for Rheumatology in London. His research has been focused on connective tissue biochemistry, musculoskeletal research, tissue engineering, and reparative medicine. Dr. Ratcliffe is the author of more than 100 published papers. He is active in a number of professional societies and has served as: member of the board of directors of the Orthopaedic Research Society; member of various study sections for the National Institutes of Health; chair of the Grant Review Committee for the Orthopaedic Research and Education Foundation; and chair of the Tissue Engineering Committee for the American Society for Testing and Materials.

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices James Rutledge is president of DataVision, a company that performs statistical consulting and training. He has over ten years of experience with teaching and consulting, and specializes in teaching powerful statistical tools to nonstatisticians. Most recently, he has been performing Six Sigma training and consulting at companies such as AlliedSignal, General Electric, Raytheon, and SONY. Previously, he served as a missile launch officer in the U.S. Air Force, where he was the senior instructor responsible for training 200 launch officers, and as an assistant professor in the U.S. Air Force Academy, where he taught courses on probability and statistics. Dr. Rutledge also has extensive research experience, with his collaborative research on breast cancer acknowledged as being one of the motivating factors for changing national screening policy. Dr. Rutledge is a member of the Omega Rho and Pi Mu Epsilon honor societies; a member of the American Statistical Association, where he has served as president of the Colorado-Wyoming chapter; and he is an American Society for Quality Certified Quality Engineer. Ronald A. Sahatjian is the senior member of scientific staff at Boston Scientific Corporation, a position he has held for 15 years. During that time, his achievements have included pioneering a program in drug delivery devices; pioneering work in the development of materials for balloon angioplasty catheters, bioactive coatings, materials compatible with magnetic resonance imaging, and endovascular procedures under magnetic resonance imaging guidance. In addition, Dr. Sahatjian has organized a research and development effort at Boston Scientific focused on less invasive neurosurgery that has led to primary IP positions and new products in aneurysmal therapies, and therapies for occlusive and hemorrhagic stroke. Dr. Sahatjian’s work has led to over 30 patents and numerous awards. Robert S. Schwartz is medical director of the Minnesota Cardiovascular Research Institute at the Minneapolis Heart Institute. 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. Air Force Major (Medical Corps) and Flight Surgeon. His medical training includes a post-graduate degree in cardiology and internal medicine from the Mayo Graduate School of Medicine. Dr. Schwartz has published numerous papers and has served on the editorial board of the Proceedings of the National Academy of Sciences. He is active in the American Heart Association, the Council on Clinical Cardiology, and the Society for Cardiac Angiography and Interventions. He is a Fellow of the American College of Cardiology and a recipient

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices of the Andreas Gruentzig Award for Basic Research in Coronary Restenosis, Thoraxcenter. Renu Virmani is chair of the Department of Cardiovascular Pathology at the Armed Forces Institute of Pathology. 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. Dr. Virmani’s expertise lies in the evaluation of interventional devices, sudden death with special interest in atherosclerotic disease, right ventricular dysplasia, valvular heart disease, vasculitis, and primary cardiac tumors. Her achievements include the establishment of an independent stent laboratory that processes at least 100 stents per month and evaluates many different cardiac devices, and the development of a state-of-the-art immunohistochemical laboratory. Her medical training includes an M.D. from Lady Hardinge Medical School, Delhi University, India; training in pathology at Meerut and Lady Hardinge Hospital, New Delhi, India; a visiting fellowship at the National Heart, Lung, and Blood Institute; and a residency at George Washington University. Dr. Virmani has published over 300 peer-reviewed manuscripts and over 100 book chapters and reviews. In addition, she has coedited five cardiovascular pathology books, one cardiovascular pathology atlas, and a fascicle on primary cardiac tumors. John T. Watson is director of the Clinical and Molecular Medicine Program in the Division of Heart and Vascular Diseases at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. Since 1976, he has had pivotal responsibilities and oversight at the NHLBI regarding implantable devices, such as ventricular assist devices and the total artificial heart. Prior to joining NHLBI, Dr. Watson served as chair of the Graduate Studies Program in Biomedical Engineering at the University of Texas Health Sciences Center, assistant professor in the Departments of Surgery and Physiology, and systems engineer at Ling-Temco-Vought. Dr. Watson is the recipient of numerous awards and honors. He was elected to the National Academy of Engineering in 1998 for his work enabling human mechanical artificial heart research. Darin J. Weber is acting chief of the Cellular Therapy Branch, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA) where he has worked since 1996. This Branch is responsible for the regulatory oversight of somatic cell therapy products, such as tumor vac-

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices cines, islet cell transplantation, xenotransplantation, and cell/tissue-based combination products. Dr. Weber is a member of the Multi-Agency Tissue Engineering Science Working Group and serves on a number of FDA task groups involved in developing regulatory policy for human tissues and cellular therapies. Previously at FDA, Dr. Weber served as regulatory scientist officer in the Division of Cellular and Gene Therapies, Office of Therapeutics Research and Review. In this capacity, he reviewed and developed policy on product manufacturing and product safety for somatic cell therapies. Prior to joining FDA, he worked at Rocky Mountain Laboratories, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Dr. Weber holds the rank of Lieutenant Commander in the U.S. Public Health Service Commissioned Corps and has received numerous honors and awards for his service, including the Young Scientist of the Year Award (2001). Leonard J. Weber is the John L. Aram Professor of Business Ethics at Gonzaga University. In addition, he is on the faculty of the University of Detroit Mercy, where he has taught since 1972 and where he served for many years as the director of the Ethics Institute. He also serves as an ethics consultant to health care organizations. Dr. Weber is the principal author of a column on case studies in ethics published in the journal Clinical Leadership and Management Review, and the associate editor for articles related to justice and business ethics in health care for the 3rd edition of the Encyclopedia of Bioethics. He is the author of over 70 articles and has recently published a book on business ethics in health care. He is a past president of the Medical Ethics Resource Network of Michigan. Terry O. Woods is a mechanical engineer in the Office of Science and Technology, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA). 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. She completed postdoctoral work in the Division of Mechanics and Materials Science in the Center for Devices and Radiological Health, with her research focusing on creep and fatigue behavior of intracranial aneurysm clips.