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Appendix B Speaker and Moderator Biographies Scott D. Ramsey, M.D., Ph.D. (Chair), is a Full Member in the Cancer Prevention Program, Division of Public Health Science at the Fred Hutchin- son Cancer Research Center. He directs the Cancer Technology Assessment Group, a multidisciplinary team devoted to clinical and economic evalua- tions of new and existing cancer prevention, screening, and treatment tech- nologies. In addition, Dr. Ramsey is a Professor in the School of Medicine, School of Pharmacy, and the Institute for Public Health Genetics at the University of Washington. He is a member of the Institute of Medicineâs National Cancer Policy Forum. Dr. Ramseyâs research focuses on economic evaluations in cancer. He has published widely on patterns of care, costs, and cost-effectiveness of treatments for lung, colorectal, and prostate cancer. His current studiesâfunded by the National Cancer Institute, National Human Genome Research Institute, Centers for Disease Control and Pre- vention, and several pharmaceutical manufacturersâinclude projects to develop a genetic screening policy model for colorectal cancer, a multicenter study of decision making for men with newly diagnosed prostate cancer, and studies of cancer screening, incidence, treatment, and outcomes for Native Americans diagnosed with cancer. Along with investigators at the University of Washington, Dr. Ramsey codirects an NCI-funded training program in biobehavioral and cancer outcomes research. Peter Bach, M.D., MAPP, is a member of the Health Outcomes Research Group in the Department of Epidemiology and Biostatistics, and a pul- 129
130 assessing and improving value in cancer care monary and critical care physician in the Department of Medicine at Memorial Sloan-Kettering Cancer Center. His main research interests are in assessing and improving the quality of cancer care. His work has focused particularly on improving the quality of care for African American patients in Medicare, including cancer care. His work has shown that low quality of care contributes to excess mortality for African Americans with lung cancer, and that limited access to high-quality primary care physicians may reduce quality of care more generally for African Americans. He also studies the link between cigarette smoking, lung cancer, and early detection, and has developed statistical models that can be used to predict the probability that someone will develop lung cancer based on their age and smoking history. These models were recently used to demonstrate that CT screening for lung cancer may not benefit patients: people who are screened appear to die of lung cancer at the same rate as if they had not been screened, despite CT screening detecting many early lung cancers and leading to many diagnostic tests, invasive procedures, and surgeries. Dr. Bach is also engaged in health care policy work. In 2005 and 2006 he served as Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services (CMS) in Washington, DC, where he oversaw the agencyâs cancer initiatives, evidence development work through conditional coverage, and data policy. In that role, he was a liaison to other health agencies, including the FDA, NIH, and AHRQ. He currently serves as a member of the Institute of Medicineâs National Cancer Policy Forum. He is the recipient of the Boyer award for clinical research, was the previous incumbent of the Frederick Adler faculty chair, and has been the recipient of grants from the National Cancer Insti- tute, the National Institute of Aging, and the American Lung Association. Dr. Bach is a graduate of Harvard College, the University of Minnesota Medical School, and the University of Chicago School for Public Policy. He conducted his medical residency and subspecialty fellowship at the Johns Hopkins Hospital in Baltimore, Maryland. During the 1994 Rwandan civil war, he provided medical care to refugees in Goma, Zaire. Anthony Back, M.D., is Professor of Medicine at the University of Washington in Seattle. He is Director of the Cancer Communication and Palliative Care Programs at the Seattle Cancer Care Alliance and the Fred Hutchinson Cancer Research Center. He is a board-certified medical oncol- ogist whose primary research interests are physicianâpatient communica- tion and palliative care, and he practices gastrointestinal oncology. Dr. Back was a Faculty Scholar on the Project on Death in America and is a member
Appendix B 131 of the ASCO Communication Task Force. He is the Principal Investigator for the Oncotalk Teach, communication skills training program for Medical Oncology fellows (R25 CA 119019), and is an investigator on other NIH- funded observational studies of physicianâpatient communication about hope and information (R01 PI J.R. Curtis) and prognosis in hematologic malignancies (R01 P.I. Stephanie Lee). Diane S. Blum, M.S.W., is Executive Director of CancerCare, Inc., a national nonprofit organization that provides free professional support ser- vices including counseling, education, financial assistance and practical help to people with cancer and their loved ones. Ms. Blum joined CancerCare in 1984 as Director of Social Service, and became Executive Director in 1990. Previously, Ms. Blum served as a social work supervisor at Memorial Sloan-Kettering Cancer Center and the Dana Farber Cancer Institute. Ms. Blumâs areas of expertise include the psychosocial needs of cancer patients and their families, costs of cancer treatments and care, women and breast cancer, cancer survivorship, and nonprofit management. Cofounder of the National Alliance of Breast Cancer Organizations, Ms. Blum is also a founder of National Breast Cancer Awareness Month and serves as ÂEditor- in-Chief ofÂ cancer.net, the ASCO website for patients and the public. She is also a member of the editorial boards of five other oncology-related publications. Additionally, she has served on committees of the Institute of Medicine, ASCO, and the National Association of Social Work, among others. Most recently, Ms. Blum was one of 15 members of an expert panel that recommended psychosocial services be included as standard care for all cancer patients. She currently serves on ASCOâs Cost of Care Task Force, examining the financial impact of cancer treatments on patients and their families. Ms. Blumâs awards include the Lifetime Achievement Award from the Board of Sponsors of National Breast Cancer Awareness Month, the Special Recognition Award from the National Coalition for Cancer Sur- vivorship, the Republic Bank Breast Cancer Research Foundation Award, and the Special Recognition Award of the American Society of Clinical Oncology. Ms. Blum has written and lectured extensively about the psy- chosocial needs of cancer patients and their families. Her research has been published in a variety of medical journals including theÂ American Journal of Hospice and Palliative Care, Journal of Oncology, Journal of Psychosocial Oncology, Journal of Pain and Symptom Management, Annals of Internal Medicine, and Oncology Nursing News, among others. Ms. Blum received a bachelorâs degree from the University of Rochester and a masterâs degree
132 assessing and improving value in cancer care from the School of Social Welfare at the State University of New York at Buffalo. Dan W. Brock, Ph.D., is the Frances Glessner Lee Professor of Medical Ethics in the Department of Social Medicine, the Director of the Division of Medical Ethics at the Harvard Medical School, and the Director of the Harvard University Program in Ethics and Health. Prior to his arrival at Harvard, Professor Brock was Senior Scientist and a member of the Depart- ment of Clinical Bioethics at the National Institutes of Health. Until July 2002, he was Charles C. Tillinghast, Jr., University Professor, Professor of Philosophy and Biomedical Ethics, and Director of the Center for Biomedi- cal Ethics at Brown University where he had a joint appointment in the Phi- losophy Department (of which he was Chair from 1980 to 1986) and in the Medical School. He served as Staff Philosopher on the Presidentâs Commis- sion for the Study of Ethical Problems in Medicine in 1981â1982, and in 1993 was a member of the Ethics Working Group of the Clinton Task Force on National Health Reform. He has been a consultant in biomedical ethics and health policy to numerous national and international bodies, including the Office of Technology Assessment of the U.S. Congress, the Institute of Medicine, the National Bioethics Advisory Commission, and the World Health Organization. He is a Fellow and former member of the Board of Directors of the Hastings Center, and was a Fellow in the Ethics and Profes- sionsâ Program and in the Division of Medical Ethics at Harvard University in 1991â1992. He was President of the American Association of Bioethics in 1995â1996, and was a founding Board Member of the American Soci- ety for Bioethics and Humanities. He is the author of over 150 articles in bioethics and in moral and political philosophy, which have appeared in books and refereed scholarly journals, including theÂ New EnÂgland Journal of Medicine,Â JAMA,Â Science,Â Hastings Center Report,Â Philosophy and Public Affairs, andÂ Ethics. He is the author of Deciding for Others: The Ethics of Surrogate Decision Making, 1989, (with Allen E. Buchanan);Â Life and Death: Philosophical Essays in Biomedical Ethics, 1993; and From Chance to Choice: Genetics and JusticeÂ (with Allen Buchanan, Norman Daniels, and Daniel Wikler), 2000, all published by Cambridge University Press. He is currently an editorial board member of 12 professional journals in ethics, bioethics, and health policy, and has lectured widely at national and international conferences, professional societies, universities, and health care institutions. Current research focuses on ethical issues in health resource prioritization,
Appendix B 133 with a special focus on cost-effectiveness analysis, and on genetic selection for enhancement and to prevent disability. Michael Chernew, Ph.D., is a professor in the Department of Health Care Policy at Harvard Medical School. One major area of his research focuses on assessing the impact of managed care on the health care marketplace, with an emphasis on examining the impact of managed care on health care cost growth and on the use of medical technology. Other research has examined determinants of patient choice of hospital and the impact of health plan performance measures on employee and employer selection of health plans. Dr. Chernew is a member of the Commonwealth Foundationâs Commission on a High-Performance Health Care System. In 2000 and 2004, he served on technical advisory panels for the Center for Medicare and Medicaid Services that reviewed the assumptions used by the Medicare actuaries to assess the financial status of the Medicare trust funds. On the panels, Dr. Chernew focused on the methodology used to project trends in long-term health care cost growth. In 1998, he was awarded the John D. Thompson Prize for Young Investigators by the Association of University Programs in Public Health. In 1999, he received the Alice S. Hersh Young Investigator Award from the Association of Health Services Research. Both of these awards recognize overall contributions to the field of health services research. Dr. Chernew is a research associate of the National Bureau of Eco- nomic Research and is on the editorial boards ofÂ Health AffairsÂ andÂ Medical Care Research and Review. He is also coeditor of theÂ American Journal of Managed CareÂ and senior associate editor ofÂ Health Services Research. Dr. Chernew received an A.B. from the University of Pennsylvania College of Arts and Sciences, a B.S. from the University of Pennsylvania Wharton School (economics), and a Ph.D. in economics from Stanford Univer- sity, where his training focused on areas of applied microeconomics and econometrics. Steven B. Cohen, Ph.D., is Director, Center for Financing, Access, and Cost Trends at the Agency for Healthcare Research and Quality (AHRQ). Dr. Cohen directs a staff of approximately 50 highly trained and skilled economists, statisticians, social scientists, clinicians and support staff con- ducting intramural and supporting extramural research on behalf of AHRQ. He also directs activities necessary to conduct and support a wide range of studies related to the cost and financing of personal health care services.
134 assessing and improving value in cancer care Studies include analyses of health care use and expenditures by individuals and families for personal health care services, the sources of payment for health care, the availability and cost of health insurance, and health status, outcomes, and satisfaction. Dr. Cohen also leads AHRQâs administration of surveys and development of large primary data sets, including the Medi- cal Expenditure Panel Survey (MEPS), to support health care policy and behavioral research and analyses. Dr. Cohen has authored over 100 journal articles and publications in the areas of biostatistics, survey research meth- odology, estimation, survey design, and health services research. He has also served as an Associate Professor in the Department of Health Policy and Management at the Johns Hopkins University and the Department of Health Services Administration at the George Washington University. He received his Ph.D. and M.S. in Biostatistics from the University of North Carolina and his B.A. in Mathematics and History, CUNY. He is also a Fellow of the American Statistical Association. Patricia M. Danzon, Ph.D., is the Celia Moh Professor at the Wharton School, University of Pennsylvania, where she is a Professor and former Chair of the Health Care Management Department, and Professor of Insurance and Risk Management. She is also Chair of the Health Care Management Department. Professor Danzon received a B.A. First Class, in Politics, Philosophy and Economics, from Oxford University, England, and a Ph.D. in Economics from the University of Chicago. Dr. Danzonâs previous positions include Associate Professor at Duke University, Research Economist at the Rand Corporation, and Visiting Professor at the Univer- sity of Chicago. Professor Danzon is an internationally recognized expert in the fields of health care, pharmaceuticals, insurance, and liability systems. She is a member of the Institute of Medicine and of the National Academy of Social Insurance. She is also a Research Associate of the National Bureau of Eco- nomic Research. Board memberships include the Board of the International Health Economics Association. She has served as a consultant on interna- tional health care issues to the World Bank, the European Commission Working Group on Pharmaceuticals, the New Zealand Treasury, the Asian Development Bank, and U.S. Agency for International Development. In the United States her consulting experience includes work for the American Medical Association, the American Hospital Association, the Insurance Services Office, the Institute for Civil Justice, the Alliance of American Insurers, and the Pharmaceutical Manufacturersâ Association. Professor
Appendix B 135 Danzon is an Associate Editor of the Journal of Health Economics and the International Journal of Health Care Finance and Economics. She was previ- ously an Associate Editor of the American Economic Review, the Journal of Risk and Insurance, and the Journal of Biolaw and Business. She has published widely in scholarly journals on a broad range of subjects related to medical care, pharmaceuticals, insurance, and the economics of law. Michael Drummond, B.Sc., M.Com., D.Phil., is Professor of Health Economics and former Director of the Centre for Health Economics at the University of York. His particular field of interest is in the economic evalu- ation of health care treatments and programs. He has undertaken evalua- tions in a wide range of medical fields including care of the elderly, neonatal intensive care, immunization programs, services for people with AIDS, eye health care, and pharmaceuticals. He is the author of two major textbooks and more than 500 scientific papers, has acted as a consultant to the World Health Organization and was Project Leader of a European Union Project on the Methodology of Economic Appraisal of Health Technology. He has been President of the International Society of Technology Assessment in Health Care, and the International Society for Pharmacoeconomics and Outcomes Research. He is currently a member of the Guidelines Review Panels of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, and is a Principal Consultant for i3Innovus. Robert L. Erwin cofounded the not-for-profit Marti Nelson Cancer Foun- dation in 1994 with his late wife, Marti Nelson, M.D. This advocacy organi- zation, based in Davis, California, provides free assistance to patients seeking help with clinical trial enrollment or other access to experimental therapies. The organization operates through a network of unpaid, ad hoc volunteers, including scientists, physicians, and people with other relevant expertise. The Foundationâs website, www.CancerActionNow.org has become a resource for individuals looking for additional information on a variety of cancer-related topics. During the past few years, the Foundation has broad- ened its services to include provision of technical information and analysis to other advocacy organizations, and has increased its work on complex or controversial policy issues in drug development, approval, and reimburse- ment that affect groups of patients as well as individuals. Mr. Erwin is also a member of the board of directors of C3: The Colorectal Cancer Coalition (Alexandria, Virginia), and the NorthBay Healthcare Foundation (Fairfield, California). Mr. Erwin serves as a member of the Data and Safety Monitor-
136 assessing and improving value in cancer care ing Board for the Cancer and Leukemia Group B. He is a member of the Research Committee of the American Society of Clinical Oncology, and a member of the National Cancer Policy Forum. He served as member of the California Breast Cancer Research Council from 1996 to 1999 and was its Chairman from 1997 to 1999. Mr. Erwin is President of iBioPharma, Inc. (Newark, Delaware), a public biotechnology company developing vaccines for the prevention and treatment of infectious diseases. He is also chairman of Novici Biotech, LLC (Vacaville, California). From 2003 until 2007 he was managing director of Bio-Strategic Directors, LLC, a life science-industry consulting firm focused on intellectual property and strategy. He was chief executive officer of Large Scale Biology Corporation from 1992 to 2003 and served as its chairman until 2006. He was chairman of Icon Genetics AG from 1999 until its acquisition by a subsidiary of Bayer AG in 2006. Mr. Erwin is an inventor on several issued and pending patents. He has B.S. and M.S. degrees in zoology and genetics from Louisiana State University. Lou Garrison, Ph.D., is Professor and Associate Director in the Pharma- ceutical Outcomes Research and Policy Program, Department of Pharmacy, at the University of Washington in Seattle. His recent research focuses on designing and conducting economic and outcomes research evaluations of pharmaceutical, biotechnology, and diagnostic products, and on policy issues related to pricing and reimbursement, regulatory risk-benefit analysis, and pharmacogenetics. Prior to joining UW in 2004, Dr. Garrison was Vice President of Health Economics and Strategic Pricing in Roche Pharma- ceuticals for 5 years, working and living in Basel, Switzerland, for the final 2Â½ years. In 12 years at Roche, he eventually directed a department of over 20 staff members charged with developing and implementing economic and quality-of-life strategies to support global pricing, reimbursement, and market access. Before joining the pharmaceutical industry in 1992, Dr. Garrison was Director of the Project HOPE Center for Health Affairs in Maryland, where he conducted numerous domestic and international health policy projects, including health system reform studies and training in Poland and Jamaica. Dr. Garrison has been a member of ISPOR since 1995, and has served in many capacities, including co-chair of the Real World Data Task Force, participant in leadership retreats, and workgroup leader on the Drug Cost Task Force. He has also served as a member of the ISPOR Institutional Council, PhRMAâs Health Outcomes Committee, and the IFPMAâs Health Economics Advisory Group. Most recently, he has been an advisor to ISPORâs Latin American expansion. Dr. Garrison
Appendix B 137 earned his Ph.D. in economics at Stanford University in 1981. Over his 28-year career, he has made numerous presentations at professional meet- ings, and provided pharmacoeconomic training both for those within the pharmaceutical industry and outside, including groups as diverse as payors in South Africa and Brazil. He has authored or coauthored over 75 publica- tions and reports. Jeffrey C. Lerner, Ph.D., has served since 2001 as President and Chief Executive Officer of ECRI Institute. Prior to this, he held the position of Vice President for Strategic Planning for 17 years. He played the key role in setting the course for ECRI Instituteâs transition fromÂ its origins as a medi- cal device evaluation laboratory to a broader health research organization that assesses clinical procedures and drug therapies in addition to medical devices. He has conceived of, secured funding for, and implemented numerous programs in technology assessment. For example, he was the first Center Director of ECRI Instituteâs Evidence-based Practice Center (EPC) under the Agency for Healthcare Research and Quality (AHRQ), and Coordina- tor of the Technical Expert Panel of the National Guideline Clearinghouse (a project sponsored by AHRQ in cooperation with the American Medical Association and the American Association of Health Plans). He also served as a member of the Medicare Coverage Advisory Committee (MCAC) until 2003 and is currently on the Advisory Board of the U.S. Cochrane Collaboration Center. Dr. Lerner maintains a special interest in assistive technology for the disabled and has served as principal investigator on projects for the U.S. Department of Transportation and the Easter Seals Society. He was the first Director of ECRI Instituteâs Center for Health- care Environmental Management, which offers programs worldwide. He developed ECRI Instituteâs annual technology assessment educational conference. In 1992, the Society for Strategic Healthcare Planning and Management of the Hospital Association of Pennsylvania selected him for the Dorinson Award. Dr. LernerÂ was a member of the Technical Board of the Milbank Memorial Fund in New York and a member of the United States Pharmacopeial Convention in Rockville, Maryland. He served as Chair forÂ 7 of his 22 years on the Board of Governors of the Philadelphia Health Care Academy, a program for high school students living in poverty areas. He is also on the Executive Board of the Greater Philadelphia Life Sciences Congress; a former President of the Board of the Health Strategy Network, a society of healthcare planners and managers; and an associate
138 assessing and improving value in cancer care editor of theÂ Journal of Ambulatory Care Management. He is an Adjunct Senior Fellow of the Leonard Davis Institute of Health Economics of the University of Pennsylvania. Over the past 27 years, Dr. Lerner made major presentations to gov- ernment agencies and professional organizations worldwide and has writ- ten articles, editorials, and book chapters, such as âThe National Patient Library: Evidence-based Information for Consumers,â which appeared in the winter 1998 issue of theÂ International Journal of Technology Assessment in Health Care. Dr. Lerner authored theÂ Journal of Legal MedicineâsÂ book review essay of âRescuing Science from Politics, Regulation, and the Distor- tion of Scientific Research,â edited by Wendy Wagner and Rena Steinzor. Dr. Lerner received his M.A., M.Phil., and Ph.D. from Columbia Univer- sity, where he was awarded three University Presidentâs Fellowships and other honors. His B.A. is from Antioch College, and his business training is from the Wharton School. He also studied abroad at St. Andrewâs Uni- versity, Scotland. Mary McCabe, R.N., M.A., is Director of the Cancer Survivorship Pro- gram at the Memorial Sloan-Kettering Cancer Center, where she is respon- sible for developing and implementing centerwide comprehensive programs for adult cancer survivors. She is also a faculty member in the Division of Medical Ethics at the Cornell Weill Medical College. A graduate of T Â rinity College, Emory University, and Catholic University, Mary McCabe held several positions at the National Cancer Institute before joining the Memorial Sloan-Kettering Cancer Center, including Assistant Director of the Division of Cancer Treatment and Diagnosis, Director of the Office of Clinical Research Promotion, and faculty member of the Department of Bioethics at the National Institutes of Health (NIH). Mary McCabe has served as a member of numerous committees, including Co-Chair of the Clinical Research Networks Working Group at the National Institute of Health, Chair of the Clinical Trials Integration Committee at the National Cancer Institute (NCI), the Scientific Advisory Board, and the Lance Armstrong Foundation, and is a faculty member of the NCI Adolescent and Young Adult Oncology Progress Review Group. She is a member of the Oncology Nursing Society, American Society of Clinical Oncology, American Nurses Association, Women in Cancer Research, and American Society for Bioethics and Humanities. Mary McCabe has published numer- ous peer-reviewed articles, serves on the editorial boards for Seminars in Oncology Nursing, Oncology, and Oncology News International, and is editor
Appendix B 139 of Oncology for Nurses. She has received numerous awards, including the American Cancer Society Merit Award, Oncology Nursing Society Leader- ship Award, NIH Outstanding Performance Award, NIH Directorâs Award, and the Outstanding Alumnae Award, Emory University. Harold L. Moses, M.D., graduated from Berea College in 1958 and then obtained an M.D. degree from Vanderbilt University School of Medicine in 1962. After residency training in pathology at Vanderbilt and postdoctoral research training at the National Institutes of Health, he spent 5 years as a faculty member in pathology at Vanderbilt and 12 years at the Mayo Clinic in Rochester, Minnesota, the last 6 of which were as Chair of the Depart- ment of Cell Biology. He returned to Vanderbilt 20 years ago as Professor and Chair of the Department of Cell Biology in the School of Medicine. Fifteen years ago he became the Founding Director of the Vanderbilt C Â ancer Center with a concurrent appointment as the B.F. Byrd, Jr., Profes- sor of Clinical Oncology. He resigned as Chair of the Department of Cell Biology in 1998 to devote more time to the Cancer Center, now named the E. ÂBronson Ingram Cancer Center. At the end of 2004, he became ÂDirector Emeritus of the Vanderbilt-Ingram Cancer Center and the Hortense B. Ingram Professor of Medical Oncology. Dr. Moses is well known for his work on the transforming growth factor-Î² family of growth regulatory peptides and has received a number of awards for his research. He has served as president of the American Association for Cancer Research, chair of the NIH Chemical Pathology Study Section, is a member of the Integration Panel for the U.S. Army Breast Cancer Program, is Co-Chair of the Breast Cancer Progress Review Group for the National Cancer Institute and Chair of the National Cancer Institute Cancer Centers review panel. He is cur- rently Past President of the American Association of Cancer Institutes, and a member of the Institute of Medicine of the National Academies. He chairs the National Cancer Policy Forum of the Institute of Medicine. Peter J. Neumann, Sc.D., is Director of the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, and Professor of Medicine at Tufts University School of Medicine. Prior to joining Tufts, he was on the faculty of the Harvard School of Public Health for 10 years, most recently as Asso- ciate Professor of Policy and Decision Sciences. His research focuses on the role of cost-effectiveness analysis and risk-benefit trade-offs in health care decision making. He has conducted numerous economic evaluations of
140 assessing and improving value in cancer care medical technologies, including evaluations of treatments for Alzheimerâs disease. He also directs a project to develop a comprehensive registry of cost-effectiveness analyses in health care. Dr. Neumann has contributed to the literature on the use of willingness to pay and quality-adjusted life- years (QALYs) in valuing health benefits. His other research has focused on the Food and Drug Administrationâs regulation of health economic information, and the role of clinical and economic evidence in informing public- and private-sector health care decisions, including those made by the Medicare program. He is the author or co-author of over 100 papers in the medical literature, and the author of Using Cost-Effectiveness Analysis to Improve Health Care (Oxford University Press, 2005). He is a contribut- ing editor of Health Affairs and member of the editorial board of Value in Health. Dr. Neumann has served as President of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and as a trustee of the Society for Medical Decision Making. He has also held various policy positions in Washington, DC, including Special Assistant to the Adminis- trator at the Health Care Financing Administration. He received his doctor- ate in health policy and management from Harvard University. Lee N. Newcomer, M.D., M.H.A., is the Senior Vice President, Oncology for UnitedHealthcare. His unit is responsible for improving the quality and affordability of care for the 111,000 cancer patients covered by United- Healthcare. Prior to rejoining United Health Group (UHG), Dr. Newcomer was a founding executive of Vivius, a consumer-directed venture that allowed consumers to create their own personalized health plans. From 1991 to 2000, Dr. Newcomer held a number of positions at UHG, including Chief Medical Officer. His work there emphasized the development of performance mea- sures and incentives to improve clinical care. Prior to joining UHG, he was Medical Director for CIGNA Health Care of Kansas City. Dr. Newcomer is a board-certified medical oncologist; he practiced medical oncology for 9 years in Tulsa, Oklahoma, and Minneapolis (Park Nicollet Clinic). He is currently the Chairman of Park Nicollet Health Services, an integrated system of over 650 physicians and a 400-bed hospital. The group is nationally recognized for its leadership in quality, safety, and lean processes. Dr. Newcomer earned a B.A. degree in biology from Nebraska Wes- leyan University, an M.D. degree from the University of Nebraska Col- lege of Medicine, and an M.S. degree in health administration from the University of Wisconsin at Madison. He completed his internship and residency in internal medicine from the University of Nebraska Hospital,
Appendix B 141 and fellowships in medical oncology and administrative medicine from the Yale University School of Medicine and the University of Wisconsin at Madison, respectively. Greg Rossi, Ph.D., Senior Director Health Economics and Outcomes Research at Genentech Inc., received his doctorate in Molecular Biology and Protein Chemistry from the University College London (UCL) in 1993. Since then he has worked in the biotechnology industry, predominantly in the clinical development of supportive care and antineoplastic therapies in the oncology and hematology therapeutic areas. Between 1996 and 2007 Dr. Rossi was at Amgen, Inc. From 1996 to 2005 he was involved in the development and registration of a number of oncology supportive care therapies including responsibility for the design and conduct of a number of phase II, P3, and postlicensing clinical trials. In these clinical development roles he was responsible for directly interacting with the EMEA, the FDA, and other regulatory agencies. He has also been responsible for interac- tion with CMS and private payors in the United States, as well as review and input into EU health technology assessments submissions. Between 2005 and 2007 Dr. Rossi was therapeutic area head, Global Marketing, responsible for co-leading the development and commercialization strategy of Amgenâs late-stage therapeutic oncology pipeline of seven molecules in phase II and III clinical development. In this role he was responsible for overseeing the development of evidence strategies designed to meet the requirements for EU and U.S. registration, coverage, and reimbursement. Currently Dr. Rossi leads the Health Economics and Outcomes Research group at Genentech with responsibilities in Oncology, Immunology, and Tissue Growth and Repair therapy areas as well as providing development support for product pricing and patient access initiatives. Dr. Rossi is author over 25 clinical research manuscripts and numerous abstracts. Daniel J. Sargent, Ph.D., Professor of Biostatistics and Oncology at the Mayo Clinic, is the Group Statistician for the North Central Cancer Treat- ment Group and the director of Cancer Center Statistics at the Mayo Clinic Comprehensive Cancer Center. In this capacity he oversees a group of ap- proximately 50 statisticians at the Mayo Clinic; the accomplishments of this group have been repeatedly cited as outstanding by external peer review. He received his B.S., M.S., and Ph.D. from the University of Minnesota, and has been at Mayo Clinic since graduating in 1996. He is a member of the U.S. Gastrointestinal Cancer Steering Committee, and co-chaired the
142 assessing and improving value in cancer care Gastrointestinal Committee for the NCI Common Data Elements Project. Dr. Sargent co-chaired a joint NCI-EORTC committee on methodology for tumor marker studies, was a member of the FDA panel on endpoints for colon cancer clinical trials, and currently sits on the NCI Clinical Trials Advisory Committee, which oversees all cancer clinical trials in the United States. He has extensive peer-review activities as a member and chair of a NCI Study section (Subcommittee Hâthe first statistician in history to chair that study section), membership on several NCI Special Empha- sis Panels, and ad hoc reviewing for funding agencies around the world. Dr. Sargent is a chair or member of over 30 data safety and monitoring committees, including chairing the committee for the NCI-funded Ameri- can College of Radiology Imaging Network. Dr. Sargent has published papers on innovative designs for phase I, II, and III clinical trials as well as advances in survival analysis, meta-analysis, surrogate endpoints, and designs for validating tumor biomarkers. He is the founder and leader of the Adjuvant Colon Cancer Endpoints (ACCENT) collaborative group, which has assembled the worldâs largest database of individual patient data from adjuvant colon cancer trials (> 33,000 patients). He has authored over 150 peer-reviewed manuscripts, book chapters, editorials, and letters, including first-author publications in the New England Journal of Medicine, Journal of the National Cancer Institute, Journal of Clinical Oncology, Cancer, Controlled Clinical Trials, Biometrics, Statistics in Medicine, and Seminars in Oncology. Deborah Schrag, M.D., M.P.H., is a health services researcher focusing on the study of cancer care delivery in the Department of Medical Oncology at the Dana-Farber Cancer Institute. Dr. Schrag describes the patterns and outcomes of cancer treatment in order to determine how well treatments with efficacy established in the clinical trial setting are translated into practice in nonresearch settings. This involves strategic use of observational and found data sources and application of statistical techniques to evaluate the impact of treatment interventions in nonexperimental settings. Recent work has focused on technology diffusion and efforts to determine what determines how rapidly new treatments are adopted and the factors that drive utilization. Dr. Schragâs current project seeks to evaluate the quality of care delivered to indigent patients with cancer who are insured by the State Medicaid programs in New York and California. By using Medicaid enrollment and claims histories linked to other data sources including hospital discharge abstracts and tumor registry data, the goal is to prioritize
Appendix B 143 areas for improving care delivery to the poor. Ultimately, the goal is to inform design of sustainable systems architecture for ongoing surveillance of the quality of cancer care. An alternate theme of her research involves improving the cancer care experience for patients by enhancing data col- lection, information systems, documentation standards, and ultimately clinicianâpatient communication. She pursues these research areas through a series of collaborative projects and works with health services research- ers, biostatisticians, epidemiologists, clinical trialists, decision scientists, and economists. Dr. Schrag works with a variety of public and private organizations such as state health departments, AHRQ, ASCO, NCCN, CALGB, and ABIM to develop strategies to evaluate and improve the qual- ity of cancer care. Although most of the research questions she is interested in are relevant across the spectrum of malignant disease, as a practicing gastrointestinal oncologist, Dr. Schrag has greatest expertise in GI tumors and has focused to greatest extent on studying these themes with respect to colorectal cancer. Thomas J. Smith, M.D., is the Massey Endowed Professor of Palliative Care Research and Esteemed Professor of Medicine at the Virginia Com- monwealth UniversityâMassey Cancer Center in Richmond. He shares leadership of the Thomas Palliative Care Program with Patrick Coyne, R.N., M.S.N., and codirects the Cancer Control and Prevention Program of Massey with Cathy Bradley, Ph.D. His interests are access to care and improvements in the quality of care. With colleagues Bruce Hillner and Chris Desch (deceased) the group has published articles in the New England Journal of Medicine, JAMA, JNCI, and the Journal of Clinical Oncology on cost-effectiveness and rational allocation of resources, the quality of cancer care and ways to improve it, and new models of care. Colleague Bruce Hillner and he did the background reports for the Institute of Medicine/ National Research Council 1999 report Ensuring Quality Cancer Care, and subsequently published the evidence for less-than-optimal cancer care and ways to improve it in the Journal of Clinical Oncology. Dr. Smith recently chaired the Health Economics Service Policy and Ethics (HESPE) program to choose a center for Canada to develop optimal pan-Canadian cancer prevention, detection, treatment, and control strategies. Dr. Smith received the national Humanism in Medicine Award in 2000, and in 2000 and 2006 was voted the Distinguished Clinician on the VCU-MCV faculty. In June 2008 he received the ASCO Statesman award for continued service in creating national practice guidelines. He is the medical director of the
144 assessing and improving value in cancer care Thomas Palliative Care Unit that opened May 2000, now designated as the national Palliative Care Leadership Center for Cancer by the Robert Wood Johnson Foundation Center to Advance Palliative Care. In July 2005 it won the American Hospital Association Circle of Life award for being the best palliative care program in the country, in 2006 was voted best university program by the International Association for Hospice and Palliative Care, and in 2007 won the LifeNet Award for Service in organ transplantation. In 2008 the VCUâs Rural Cancer Outreach Program won the Hematology/ Oncology News International HOPE award for leadership in small clinical programs and the HOPE award for clinical excellence for integration of palliative care into regular cancer care. Dr. Smith has an active practice in medical oncology and palliative/hospice medicine, concentrating on new treatments for breast cancer and symptom control. Current grant fund- ing includes G08 LM009525-01 (PI Smith) Truthful Information about Prognosis and Options for People with Advanced Cancer to make truthful information available over the Internet; R01CA116227-02 (Meier; Smith, site PI) Palliative Care for Hospitalized Cancer Patients, and the Virginia Initiative for Palliative Care. Ellen L. Stovall, President and CEO of National Coalition for Cancer Survivorship, is a 37-year survivor of three bouts with cancer and has been advocating for more than 30 years to improve cancer care in America. Ms. Stovall is a member of the Institute of Medicine of the National Acad- emiesâ National Cancer Policy Forum, established in May 2005 to succeed the National Cancer Policy Board (NCPB). The Forum allows government, industry, academic, and survivor advocacy representatives to meet and privately discuss public policy issues that arise in the prevention, control, diagnosis, and treatment of cancer.Â Prior to the establishment of the Forum, Stovall was vice-chair of the National Cancer Policy Board Committee on Cancer Survivorship. In that capacity, she co-edited the Institute of Medicineâs report From Cancer Patient to Cancer Survivor: Lost in Transition, which addressed the issues adult cancer survivors face. Ms. Stovall serves as vice-chair of the Robert Wood Johnson Foundationâs National Advisory Committee to Promote Excellence in Care at the End of Life, and she is the vice-chair of the Foundationâs National Advisory Committee for Pursu- ing Perfection: Raising the Bar for Health Care Performance. Ms. Stovall currently serves on the Boards of Directors of the National Committee for Quality Assurance (NCQA) and the Leapfrog Group, and she participates on a steering committee of the National Quality Forum (NQF) to estab-
Appendix B 145 lish consensus around cancer care quality measures. She also sits on several advisory panels, working groups, and committees of the National Cancer Institute, American Association for Cancer Research, and the American Society of Clinical Oncology. In 1997, Ms. Stovall founded and served as president of THE MARCH .â.â. Coming Together to Conquer Cancer. Through her leadership, this national public awareness campaign focused both national and regional media attention on the issues of cancer research and quality cancer care for all Americans. Recognizing a need for the voice of cancer survivors to be heard during the national debate over health care reform, the Cancer Leadership Council (CLC) was convened in 1993 under her direction. Ms. Stovall also served a 6-year term on the National Cancer Instituteâs National Cancer Advisory Board (NCAB), an appointment she received in 1992 from President Clinton. Today, Ms. Stovall is frequently called upon to work with administration and congressional staff on a variety of cancer-related policy issues, most notably access to quality cancer care. Sean Tunis, M.D., M.Sc., is the Founder and Director of the Center for Medical Technology Policy in San Francisco, where he works with health care decision makers, experts, and stakeholders to improve the value of clini- cal research on new and existing medical technologies. He consults with a range of domestic and international health care organizations on issues of comparative effectiveness, evidence-based medicine, clinical research, and technology policy. Through September 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 poli- cies, quality standards for Medicare and Medicaid providers, quality mea- surement and public reporting initiatives, and the Quality Improvement 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 Technology Assessment 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 advi-
146 assessing and improving value in cancer care sor 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 Biology and History of Science from the Cornell University School of Agriculture, and a 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 Medicine. He is board certified in Internal Medicine and holds adjunct faculty positions at Johns Hopkins and Stanford University Schools of Medicine. Peter A. Ubel, M.D., is Professor of Medicine and Professor of Psychology at the University of Michigan, a primary care physician at the Ann Arbor Veterans Affairs Medical Center, Associate Director of the Michigan Robert Wood Johnson Clinical Scholars Program, and Director of the Center for Behavioral and Decision Sciences in Medicine at the University of Michi- gan. His research explores controversial issues about the role of values and preferences in health care decision making, from decisions at the bedside to policy decisions. He uses the tools of decision psychology and behavioral economics to explore such topics as informed consent, shared decision mak- ing, and health care rationing. Dr. Ubel has won many research awards, including a Presidential Early Career Award for Scientists and Engineers from President Clinton in 2000. In 2008, Dr. Ubel was awarded the role of Robert Wood Johnson Foundation Health Policy Investigator and became a member of the World Economic Forum. He is author of Pricing Life: Why It Is Time for Health Care Rationing (MIT Press, 2000), Youâre Stronger Than You Think: Tapping the Secrets of Emotionally Resilient People (McGraw- Hill, 2006), and Free Market Madness: Why Human Nature is at Odds with Economicsâand Why It Matters (Harvard Business Press, 2009). Neil S. Wenger, M.D., M.P.H., is Professor of Medicine in the Division of General Internal Medicine at UCLA and a consulting researcher at RAND. He is director of the UCLA Healthcare Ethics Center and is chair of the Ethics Committee at the UCLA Medical Center. He also is director of the NRSA Primary Care Research Fellowship in the UCLA Division of General Internal Medicine and Health Services Research. Dr. Wenger is an active general internist and carries out research in the empirical study of clinical ethics, care of and decision making for the older patient, and quality of health care. He directs the Assessing Care of the Vulnerable Elders project, which has developed a quality-of-care assessment system for vulnerable
Appendix B 147 older persons and interventions to improve care for this group. Other areas of interest include medication adherence, teaching clinical ethics, and mea- suring the quality of end-of-life care. Janet Woodcock, M.D., is the Director of the Center for Drug Evalua- tion and Research. She previously held various positions within the Office of the Commissioner, FDA, as Deputy Commissioner and Chief Medical Officer, she shared responsibility and collaborated with the Commissioner in planning, organizing, directing, staffing, coordinating, controlling, and evaluating the agencyâs scientific and medical regulatory activities in order to achieve the mission of FDA. She also served as the Deputy Commis- sioner for Operations and Chief Operating Officer, FDA, where she was responsible for overseeing agency operations and crosscutting regulatory and scientific processes at the FDA. Dr. Woodcock has close interactions with diverse constituencies, including the clinical and scientific com- munities, members of Congress and the administration, national media, patient and consumer advocacy groups, the international drug regulatory community, the regulated industry, and representatives of federal and state agencies. She frequently appears in or is quoted by the national media and has testified repeatedly before Congress. Dr. Woodcock has led many cross-agency initiatives while at the FDA. She introduced the concept of pharmaceutical risk management in 2000 as a new approach to drug safety. She has led the Pharmaceutical Quality for the 21st Century Initiative since 2002. This effort to modernize pharmaceutical manufacturing and its regulation through the application of modern science and quality man- agement techniques has been highly successful in meeting its objectives. She has spearheaded an initiative on pharmacogenomics that has led to unprecedented agencyâindustry interactions on pharmacogenomics use in drug development. Over the last 2 years, she has been leading the FDAâs Critical Path Initiative, which is designed to improve the scientific basis for medical product development. Dr. Woodcock was director of the Center for Drug Evaluation and Research from 1994 to 2005. During this period, review times for new and generic drugs were cut in half, while the stan- dards for quality, safety, and effectiveness were improved. Dr. Woodcock also oversaw initiatives to automate submission and review of applications and adverse event reports. Now nearing completion, these initiatives will allow the center to make much more drug information publicly available. Under Dr. Woodcockâs leadership, CDERâs regulatory decision making was made more open and transparent to the public. Changes included
148 assessing and improving value in cancer care publishing CDERâs regulatory procedures and policies, developing over 100 technical âguidancesâ that describe regulatory standards, providing an unprecedented degree of participation of consumer and patient repre- sentatives in FDA processes, and creating an extensive center website that includes drug reviews and consumer information. Prior to joining CDER, Dr. Woodcock was director of the Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research (CBER). There she oversaw approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis. She also served as Acting Deputy Director of CBER for several years. Dr. Woodcock has earned numerous FDA awards including six Commissionerâs Special Citations. She also received a Presi- dential Rank Meritorious Executive Award, the Nathan Davis Award from the American Medical Association (1999), the Roger W. Jones Award for Executive Leadership from American University (2000), the Public Health Leadership Award (2004) from the National Organization for Rare Disor- ders (NORD), the VIDA Award from the National Alliance for Hispanic Health (2005), the Leadership Award in Personalized Medicine from the Personalized Medicine Coalition, three HHS Secretaryâs Distinguished Service Awards, and the HHS Asian-Pacific Network achievement award (2001). Dr. Woodcock received her M.D. from Northwestern University Medical School in 1977. She received her undergraduate degree from Buck- nell University. She has held teaching appointments at Pennsylvania State University and the University of California at San Francisco.