Appendix B
Biographical Sketches of the Workshop Speakers

Naomi Aronson, Ph.D., is the executive director of the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). She has overseen TEC’s development as a nationally recognized technology assessment program and an Evidence-based Practice Center (EPC) of the Agency for Healthcare Research and Quality (AHRQ). Dr. Aronson has directed over 300 technology assessments and 10 evidence reports for AHRQ. She has published articles in Annals of Internal Medicine, Journal of the National Cancer Institute, Cancer, Journal of the American College of Surgeons, Academic Radiology, Journal of Family Practice, and Gastrointestinal Endoscopy. She represented the private sector on a U.S. Agency for International Development team providing technical assistance to the Hungarian government on building evidence-based medicine capacity in the national health insurance system. She is a member of the Institute of Medicine Forum on Drug Discovery Translation and Development, and the Steering Committee of the Chicago-Area DEcIDE Research Center and the National Business Group on Health Committee on Evidence-Based Benefit Design. Previously, Dr. Aronson was a member of Northwestern University faculty, specializing in sociology of science and medicine. She was also a post-doctoral fellow in the Science, Technology and Society Program at the Massachusetts Institute of Technology and received research awards from the National Science Foundation and the American Council of Learned Societies. Dr. Aronson’s academic research focused on how the organization of scientific specialties in biomedical and clinical research affects the process of scientific discovery.



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Appendix B Biographical Sketches of the Workshop Speakers Naomi Aronson, Ph.D., is the executive director of the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). She has overseen TEC’s development as a nationally recognized technology assess- ment program and an Evidence-based Practice Center (EPC) of the Agency for Healthcare Research and Quality (AHRQ). Dr. Aronson has directed over 300 technology assessments and 10 evidence reports for AHRQ. She has published articles in Annals of Internal Medicine, Journal of the National Cancer Institute, Cancer, Journal of the American College of Surgeons, Academic Radiology, Journal of Family Practice, and Gastro- intestinal Endoscopy. She represented the private sector on a U.S. Agency for International Development team providing technical assistance to the Hungarian government on building evidence-based medicine capacity in the national health insurance system. She is a member of the Institute of Medicine Forum on Drug Discovery Translation and Development, and the Steering Committee of the Chicago-Area DEcIDE Research Center and the National Business Group on Health Committee on Evidence-Based Benefit Design. Previously, Dr. Aronson was a member of Northwestern University faculty, specializing in sociology of science and medicine. She was also a post-doctoral fellow in the Science, Technology and Society Program at the Massachusetts Institute of Technology and received research awards from the National Science Foundation and the American Council of Learned Societies. Dr. Aronson’s academic research focused on how the organiza- tion of scientific specialties in biomedical and clinical research affects the process of scientific discovery. 

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 DIFFUSION AND USE OF GENOMIC INNOVATIONS Alfred O. Berg, M.D., M.P.H., received his professional education at Washington University, St. Louis, the University of Missouri, Columbia, and the University of Washington, Seattle. He is board certified in Family Medi- cine and in General Preventive Medicine and Public Health, and was elected to the Institute of Medicine of the National Academy of Sciences in 1996. In 2004 he received the Thomas W. Johnson Award for career contribu- tions to family medicine education from the American Academy of Family Physicians. Dr. Berg’s research has focused on clinical epidemiology in primary care settings. He has served on many expert panels using evidence- based methods to develop clinical guidelines, including chairmanship of the United States Preventive Services Task Force, co-chair of the otitis media panel convened by the Agency for Health Care Policy and Research, chair of the CDC STD Treatment Guidelines panel, member of the AMA/CDC panel producing Guidelines for Adolescent Preventive Services, member of the Institute of Medicine’s Immunization Safety Review Committee, and chair of the Institute of Medicine’s Committee on the Treatment of Post- traumatic Stress Disorder. He currently chairs the CDC’s panel on Evalua- tion of Genomic Applications in Practice and Prevention. Wylie Burke, M.D., Ph.D., is professor and chair of the Department of Medical History and Ethics at the University of Washington. She received a Ph.D. in Genetics and an M.D. from the University of Washington and completed a residency in Internal Medicine at the University of Washington. She was a medical genetics fellow at the University of Washington from 1981 to 1982. Dr. Burke was a member of the Department of Medicine at the University of Washington from 1983 to 2000, where she served as asso- ciate director of the Internal Medicine Residency Program from 1988 to 1994 and as founding director of the University of Washington’s Women’s Health Care Center from 1994 to 1999. She was appointed chair of the Department of Medical History in October 2000. She is also an adjunct professor of Medicine and Epidemiology and an associate member of the Fred Hutchinson Cancer Research Center. She was a visiting scientist at the Centers for Disease Control and Prevention in 1998 and is a fellow of the American College of Physicians. She has served on the NIH National Advi- sory Council for Human Genome Research and the Secretary’s Advisory Committee on Genetic Testing. Dr. Burke’s research addresses the social, ethical and policy implications of genetic information, including genetic test evaluation, the development of practice standards for genetically based ser- vices and genetics education for health professionals. She is also the direc- tor of the University of Washington Center for Genomics and Healthcare Equality, a Center of Excellence in Ethical, Legal, and Social Implications (ELSI) research funded by the National Human Genome Research Institute. Dr. Burke is a member of the Institute of Medicine.

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 APPENDIX B Robert M. Califf, M.D., is vice chancellor for clinical research and professor of medicine in the Division of Cardiology at Duke. Former director of the Duke Clinical Research Institute, he became head of the Duke Translational Medicine Institute in 2006. A native of South Carolina, Califf graduated from Duke University, summa cum laude and Phi Beta Kappa, in 1973 and from the Duke University School of Medicine in 1978, where he was selected for Alpha Omega Alpha. He completed his internship and resi- dency at the University of California at San Francisco and his fellowship in cardiology at Duke University. He is board-certified in internal medicine (1984) and cardiology (1986) and is a fellow of the American College of Cardiology (1988). Califf has served as an editor for the first and second editions of the landmark textbook, Acute Coronary Care, published by Mosby Inc., and is the editor in chief of Mosby’s American Heart Journal. He is a section editor for the Textbook of Cardiovascular Medicine and has been an author or coauthor of more than 600 peer-reviewed journal articles. He is a contributing editor for theheart.org, an online informa- tion resource for academic and practicing cardiologists. Dr. Califf’s role as Director of the Duke Translational Medicine Institute, which is funded in part by an NIH Clinical and Translational Science Award (CTSA), includes service as co-chairman of the Principal Investigators Steering Committee of the CTSA. Annetine Gelijns, Ph.D., is co-director (with Alan Moskowitz) of the Inter- national Center for Health Outcomes and Innovation Research (InCHOIR), and an associate professor of Surgical Sciences in the Department of Sur- gery, College of Physicians and Surgeons, and the Division of Health Policy and Management of the Mailman School of Public Health, Columbia University, New York City. She is also a division chief in the Department of Surgery. Her current research focuses on measurement of the long-term clinical outcomes and economic impact of clinical interventions, patient safety research, and the factors driving the development and diffusion of medical technology. She has special expertise in cardiovascular disease, particularly in the design, coordination, and analysis of multi-center left ventricular assist devices (LVAD) trials. She has been the director of the Data Coordinating Center for the National Institutes of Health (NIH)- sponsored REMATCH trial, and is the principal investigator (PI) or co-PI of several newer generations of LVAD trials. She also will direct the Data Coordinating Center for the SCCOR grant on the biology of long-term LVAD implantation, for which NIH funding is pending. Before coming to Columbia in 1993, she directed the Program on Technological Innovation in Medicine at the Institute of Medicine, National Academy of Sciences. Dr. Gelijns has been a consultant to various national and international organizations, including the World Health Organization (WHO) and the

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 DIFFUSION AND USE OF GENOMIC INNOVATIONS Organization for Economic Cooperation and Development (OECD), Paris, France. She holds a Ph.D. from the medical faculty and the department of science policy, University of Amsterdam, and a master’s degree in law from the University of Leyden, the Netherlands. Brad Gray joined Genzyme Genetics, a division of Genzyme Corporation, in September 2006 as vice president of Business and Strategic Develop- ment. In this role, Brad leads the efforts to grow Genzyme’s laboratory diagnostic testing services through licensing and acquisition. In addition, he works closely with other members of the management team to strengthen the existing business and strategically invest in building Genzyme’s premier reference lab. Previously, he held several positions within Genzyme’s Corpo- rate Development group, including leading Genzyme Ventures, a corporate venture capital fund focused on furthering the business development goals of Genzyme Corporation. Prior to joining Genzyme in November 2004, he was an engagement manager in the Boston office of McKinsey & Com- pany, a management consulting firm. During his four years at McKinsey, he worked with senior healthcare executives in the United States and Europe on a broad range of issues including pharmaceutical and diagnostic prod- uct strategy, post-merger integration, organization design, and operational turnarounds. He holds a B.S. in Chemical Engineering from the Massachu- setts Institute of Technology and a B.A. in Economics & Management from Oxford University, where he studied as a Marshall Scholar. Stuart Hogarth is a visiting research fellow at the Institute for Science and Society at the University of Nottingham. His research interests include the innovation processes in the drugs and diagnostics industries and the regu- latory issues emerging from novel healthcare technologies. He is working on a Wellcome Trust funded project examining policy issues in the evalua- tion of clinical genetic tests for common complex conditions. The project’s forthcoming report examines the policy options for improving both the regulatory landscape for genetic tests and the incentives needed to encour- age test developers to generate high-quality clinical data. For this work he has received an FDA Leveraging/Collaboration Award. He was lead author of a recent report for Health Canada on international developments in the regulation of pharmacogenomics and a briefing for the Human Genetics Commission on the regulation of commercial genetic testing services in the United Kingdom. He participated in the drafting of the OECD’s guidelines on quality assurance for molecular genetic testing. Deborah Marshall, Ph.D., M.H.S.A., is an associate professor in the Depart- ment of Epidemiology and Biostatistics at the Centre for Evaluation of Medicine at McMaster University in Canada. She has managed numerous

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 APPENDIX B health economics studies including prospective evaluations and decision analysis models for a variety of health conditions. Dr. Marshall is also the vice president of Global Health Economics and Outcomes Research at i3 Innovus, where she is responsible for scientific leadership in health economics and outcomes research. She previously worked in government, academic and industry research settings commissioning, conducting and authoring evaluations of various health technologies in national Health Technology Assessment agencies and for Bayer Diagnostics in California. Dr. Marshall’s history of peer-reviewed research grant funding includes a number of cancer screening studies evaluating cost-effectiveness and patient preferences. Dr Marshall is a co-investigator on a recently submitted NCI Program Project Grant proposal on Personalized Medicine for Colorectal and Breast Cancer, a grant from the Blue Shield of California Foundation on the policy challenges for personalized medicine, and a grant from Genome Canada on Genome-Specific Approaches to Therapy in Childhood (GATC). Dr. Marshall has held leadership positions for health care professional organizations including the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Health Technology Assessment. Dr. Marshall has authored or co-authored more than 40 papers published in peer-reviewed journals as well as a number of book chapters, and other published technical reports. She has served on the Editorial Board for International Journal for Technology Assessment in Health Care since 1998, and is a referee for various health economic and health policy journals. kevin Schulman, M.D., is a professor of medicine in the Duke University School of Medicine, where he also serves as the director of the Center for Clinical and Genetic Economics and as an associate director of the Duke Clinical Research Institute. He holds a joint appointment as a professor of business administration in Duke University’s Fuqua School of Busi- ness, where he is the director of the Health Sector Management Program. Dr. Schulman also holds appointments in the Center for Health Services Research in Primary Care in the Durham VA Medical Center, the Duke Center for Clinical Health Policy Research, and the Trent Center for Bio- ethics, Humanities and History of Medicine. His research interests include economic evaluation in clinical research; health services research and policy, including access to care and the impact of reimbursement and regulatory policies on clinical practice; and medical decision making, especially in patients with life-threatening conditions. Steven Shak, M.D., is chief medical officer and co-founder of Genomic Health, Inc., a company pioneering the practical application of genomics to clinical practice. Genomic Health has used new molecular diagnostic

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 DIFFUSION AND USE OF GENOMIC INNOVATIONS technologies and rigorous clinical studies to develop the Oncotype DX™ breast cancer assay. From July 1996 to October 2000, he served in various roles in Medical Affairs at Genentech, Inc., most recently as senior director and staff clinical scientist. From November 1989 to July 1996, Dr. Shak served as a director of Discovery Research at Genentech, where he was responsible for Pulmonary Research, Immunology, and Pathology. He led the clinical team that gained approval for Herceptin®, a targeted biologic treatment for metastatic breast cancer. He also initiated the cancer clinical trials of the anti-angiogenesis agent, anti-VEGF (Avastin™). In addition, Dr. Shak discovered Pulmozyme®, a mucus-dissolving enzyme that is approved worldwide for the treatment of the genetic disease, Cystic Fibrosis. Prior to joining Genentech, he was an assistant professor of Medicine and Phar- macology at New York University School of Medicine. He holds a B.A. in Chemistry from Amherst College and an M.D. from New York University School of Medicine, and completed his post-doctoral training at University of California at San Francisco. Sean Tunis, M.D., M.Sc., is the founder and director of the Center for Medical Technology Policy in San Francisco, where he is working with health care decision makers and stakeholders to support the rapid evalua- tion and effective use of new medical technologies. He is also a principal at Rubix Health, which consults with early-stage life sciences companies on reimbursement strategy designed around developing reliable evidence of product value. Through September of 2005, Dr. Tunis was the director of the Office of Clinical Standards and Quality and chief medical officer at the Centers for Medicare and Medicaid Services (CMS). In this role, he had lead responsibility for clinical policy and quality for the Medicare and Medicaid programs, which provide health coverage to over 100 million U.S. citizens. Dr. Tunis supervised the development of national coverage policies, quality standards for Medicare and Medicaid providers; quality measurement and public reporting initiatives, and the Quality Improve- ment Organization program. As chief medical officer, Dr. Tunis served as the senior advisor to the CMS Administrator on clinical and scientific policy. He also co-chaired the CMS Council on Technology and Innovation. Dr. Tunis joined CMS in 2000 as the director of the Coverage and Analysis Group. Before joining CMS, Dr. Tunis was a senior research scientist with the Lewin Group, where his focus was on the design and implementation of prospective comparative effectiveness trials and clinical registries. Dr. Tunis also served as the director of the Health Program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate Committee on Labor and Human Resources, where he participated in policy development regarding pharmaceutical and device regulation. He received a B.S. degree in History of Science from Cornell University, and a

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 APPENDIX B medical degree and masters in Health Services Research from the Stanford University School of Medicine. Dr. Tunis did his residency training at UCLA and the University of Maryland in Emergency Medicine and Internal Medi- cine. He is board certified in Internal Medicine and holds adjunct faculty positions at Johns Hopkins and Stanford University School of Medicine.

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