Innovation and Invention in Medical Devices Workshop Summary (2001) / Chapter Skim
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Appendix B: Speakers' Biographical Sketches
Appendix B: Speakers' Biographical Sketches
Pages 77-88
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From page 77... ...
at the Center for Devices and Radiological Health, FDA, which is responsible for the pre-market evaluation of the safety and effectiveness of medical devices.
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, a Washington, D.C.-based national trade association and the largest medical technology association in the world. AdvaMed represents more than 800 innovators and manufacturers of medical devices, diagnostic products, and medical information systems.
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From page 79... ...
In conjunction with colleagues at the Duke Databank for Cardiovascular Disease, he has written extensively about clinical and economic outcomes in chronic ischemic heart disease.
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He has received various prizes including the Washington State University Distinguished Alumni Award, the Intellectual Property Owner's Distinguished Inventor of the Year Award, the Chiron Corporation Biotechnology Research Award, the Association for Laboratory Automation Achievement Award, and the Jacob Heskel Gabbay Award in Biotechnology and Medicine. He serves on the Keystone Symposium Board of Directors, as well as on the board of directors of several scientific advisory companies.
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From page 81... ...
She directs the Data Coordinating Center for the NIH-supported REMATCH trial, comparing mechanical assist devices to medical management in end-stage heart failure. Before coming to Columbia in 1993, she directed the Program on Technological Innovation in Medicine at the Institute of Medicine, National Academy of Sciences.
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From page 82... ...
He has held senior positions in both domestic and international operations, including senior vice president and chief financial officer. He was named President of Baxter International in 1997.
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He was a board member, and Executive Committee member of the Health Industry Manufacturers Association, the founder and chairman of the Medical Device CEO Roundtable, a board member of the California Healthcare Institute, and a member of the Medical Technology Leadership Forum. He also served on the Editorial Advisory Board
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From page 84... ...
Tobias Massa, Ph.D., is Executive Director, Global Regulatory Affairs, Eli Lilly and Company, responsible for all regulatory aspects of chemistry, manufacturing, and controls for all Eli Lilly products, as well as submission coordination, labeling, and medical information. He is a member of numerous research and corporate executive steering committees in the areas of regulatory affairs, pharmaceutical development and manufacturing, preclinical and clinical research, and labeling.
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Kshitij Mohan, Ph.D., is Corporate Vice President for Baxter International, Inc. He is responsible for corporate research and technical services, including research centers in the United States and Europe, and for emerging technology ventures and technology strategy development.
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From page 86... ...
He has experience with application of high technology to medicine, through his work as a founder of InfraReDx, a start-up company dedicated to improving health care through photonics. Richard Nadeau, Ph.D., is the co-founder, chairman, and CEO of Cytometrics, Inc., a medical device company commercializing point-of-care clinical and diagnostic instrument systems that use its patented orthogonal polarization spectral imaging (OPS Imaging)
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From page 87... ...
in 19'84 as Vice President-Diagnostics Systems Group, a position he held through October 1993. In this capacity, he propelled the company's diagnostic business to a leadership position in the clinical laboratory market, making it one of the most profitable entities in the industry.
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From page 88... ...
His research interests include medical implant design and science, biomaterials, imaging, and heart failure. He is a Founding Fellow of the American Institute of Medical and Biological Engineering and a member of the National Academy of Engineering.
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