Appendix B

Speaker Biographical Sketches

Robert C. Bast, Jr., M.D., is vice president for translational research at the University of Texas MD Anderson Cancer Center. His office facilitates translation of new strategies, drugs, and devices from the laboratory to the clinic, as well as the movement of human material and data from the clinic to the laboratory. Dr. Bast’s group coordinates programs to train physician-scientists and clinician-investigators, facilitate development of multi-investigator grants, provide instrumental shared resources, to develop faculty inventions, and enhance collaborations with pharmaceutical companies.

Dr. Bast received his B.A. cum laude from Wesleyan University and his M.D. magna cum laude from Harvard Medical School. After completing a medical internship at Johns Hopkins Hospital, he served as a research associate at the National Cancer Institute (NCI). Returning to Boston, Dr. Bast completed a medical residency at the Peter Bent Brigham Hospital and a fellowship in medical oncology at the Dana-Farber Cancer Institute. He joined the faculty at Harvard as an assistant professor and was subsequently appointed associate professor at the Dana-Farber Cancer Institute. Dr. Bast was recruited to the Duke University Medical Center in 1984 as professor of medicine, microbiology, and immunology to codirect the Division of Hematology-Oncology and to serve as clinical director of the cancer center. In 1987, he became the director of the Duke Comprehensive Cancer Center, and, in 1992, he was named Wellcome Clinical Professor of Medicine in honor of R. Wayne Rundles. In July 1994, Dr. Bast was recruited to head the Division of Medicine at MD Anderson Cancer Center and to fill the Harry Carothers Wiess Chair for Cancer Research. In 2000,



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Appendix B Speaker Biographical Sketches Robert C. Bast, Jr., M.D., is vice president for translational research at the University of Texas MD Anderson Cancer Center. His office facili- tates translation of new strategies, drugs, and devices from the labora- tory to the clinic, as well as the movement of human material and data from the clinic to the laboratory. Dr. Bast’s group coordinates programs to train physician-scientists and clinician-investigators, facilitate develop- ment of multi-investigator grants, provide instrumental shared resources, to develop faculty inventions, and enhance collaborations with pharmaceutical companies. Dr. Bast received his B.A. cum laude from Wesleyan University and his M.D. magna cum laude from Harvard Medical School. After completing a medical internship at Johns Hopkins Hospital, he served as a research associate at the National Cancer Institute (NCI). Returning to Boston, Dr. Bast completed a medical residency at the Peter Bent Brigham Hospital and a fellowship in medical oncology at the Dana-Farber Cancer Institute. He joined the faculty at Harvard as an assistant professor and was subse- quently appointed associate professor at the Dana-Farber Cancer Institute. Dr. Bast was recruited to the Duke University Medical Center in 1984 as professor of medicine, microbiology, and immunology to codirect the Division of Hematology-Oncology and to serve as clinical director of the cancer center. In 1987, he became the director of the Duke Comprehensive Cancer Center, and, in 1992, he was named Wellcome Clinical Professor of Medicine in honor of R. Wayne Rundles. In July 1994, Dr. Bast was recruited to head the Division of Medicine at MD Anderson Cancer Center and to fill the Harry Carothers Wiess Chair for Cancer Research. In 2000, 81

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82 GENOME-BASED DIAGNOSTICS Dr. Bast was appointed vice president for translational research. In 2004, he became the Harry Carothers Wiess Distinguished University Professor for Cancer Research. Overall, Dr. Bast has published more than 600 articles and chapters and has edited the textbook Cancer Medicine. He has been recognized by the Institute for Scientific Information as one of the most frequently cited scientists in his field (top 0.5 percent). He continues to care for patients with breast and ovarian cancer and has been listed in the Best Doctors of America and in America’s Top Physicians. Al B. Benson III, M.D., FACP, FASCO, is a professor of medicine in the Division of Hematology/Oncology at Northwestern University’s Feinberg School of Medicine in Chicago, Illinois. He is also the associate director for clinical investigations at the Robert H. Lurie Comprehensive Cancer Center, an NCI-designated Comprehensive Cancer Center, at Northwestern Univer- sity. In addition, he is an attending physician at Northwestern Memorial Hospital, a staff physician at Jesse Brown Veterans Affairs Medical Center, and a consultant to the Rehabilitation Institute of Chicago. Dr. Benson earned his medical degree at the State University of New York at Buffalo after which he completed an internal medicine residency at the University of Wisconsin Hospitals in Madison, Wisconsin. He was an assistant professor of medicine at the University of Illinois and co-medical director for the National Public Health Service in Champaign, Illinois. He then served as a clinical oncology and research fellow at the University of Wisconsin Clinical Cancer Center, where he received an American Cancer Society Fellowship Award. Dr. Benson is active on numerous professional committees, often serv- ing as an officer. He is a recipient of the American Society of Clinical Oncology (ASCO) Statesman Award (Fellow of ASCO) and has served on a number of committees. He has been a member of the Task Force on Quality of Cancer Care, the co-chair of ASCO’s Colorectal Cancer Guidelines Sub- committee, the Stage II Colon Cancer Guidelines Panel, and the Guidelines Panel for Use of Radiofrequency Ablation for Colorectal Cancer Hepatic Metastases. He also is the chair of both the Eastern Cooperative Oncology Group Gastrointestinal and Data Monitoring Committees and a member of the National Cancer Institute Gastrointestinal Steering Committee. In addi- tion, he is a past president of the Illinois Medical Oncology Society, past president of the Association of Community Cancer Centers (ACCC), and an executive committee member and immediate past chair of the board of directors of the National Comprehensive Cancer Network (NCCN). He is the chair of both the NCCN Hepatobiliary Guidelines Panel and a member of the Colon, Rectal and Anal Panel and a member of the Pancreatic Can- cer and Neuroendocrine Panels. He is a past president of the International Society of GI Oncology. Dr. Benson is a member of the Scientific Board of

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APPENDIX B 83 Directors of the Patient Advocate Foundation, the National Patient Advo- cate Foundation, and Friends of Cancer Research. Dr. Benson is on the editorial board of the ASCO Connection, Ameri- can Health and Drug Benefits, Personalized Medicine in Oncology, Jour- nal of Comparative Effectiveness Research, and Gastrointestinal Cancer Research, among other publications. His most recent national awards include the NCCN Rodger J. Winn Award and the ACCC Outstanding Achievement in Clinical Research Award. Deborah E. Collyar has been a leader in cancer patient advocacy since 1991, utilizing her extensive business expertise to bridge gaps between sci- ence, medical providers, and patients. Her advocacy spans many diseases and in-depth programs with many academic and private institutions, non- profits, government agencies, companies, and patients. Ms. Collyar founded the Patient Advocates in Research international network after successfully developing research patient advocacy throughout cancer centers and coop- erative groups. Ms. Collyar has chaired the Cancer and Leukemia Group B Committee on Advocacy, Research Communication, Ethics, and Dispari- ties and served on many NCI, American Association for Cancer Research, and ASCO committees. Currently, she serves on the NCI’s Investigational Drug Steering Committee, Experimental Therapeutics program, and the Cancer Immunotherapy Network. She also works with the Clinical and Translational Science Awards Sentinel Network to help researchers learn about community needs. Patricia Deverka, M.D., M.S., M.B.E., is a senior research director at the Center for Medical Technology Policy (CMTP). Her current research respon- sibilities, including the Center for Comparative Effectiveness Research in Cancer Genomics and the CER Institute, reflect her broad expertise in comparative-effectiveness research and genomics and personalized medi- cine. Before joining CMTP, Dr. Deverka was on the faculty at the Institute for Pharmacogenomics and Individualized Therapy at the University of North Carolina at Chapel Hill, where her research focused on issues such as coverage and reimbursement and improving the evidence base for pharma- cogenomic tests. Earlier in her career, she worked as an outcomes researcher in the pharmaceutical industry and was vice president of scientific affairs at Medco Health Solutions, where she led several pharmacogenomic-related initiatives. Dr. Deverka has a medical degree from the University of Pitts- burgh and is board certified in general preventive medicine and public health. She also obtained a master’s degree in bioethics from the University of Pennsylvania and completed a fellowship at Duke University’s Institute for Genome Sciences and Policy.

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84 GENOME-BASED DIAGNOSTICS Noel Doheny joined Epigenomics in May 2011 as chief executive officer (CEO) of the U.S. subsidiary Epigenomics, Inc. He has more than 30 years of experience in the field of diagnostics, with more than 20 years in senior management. Prior to joining Epigenomics, Mr. Doheny held positions as CEO of OpGen; senior vice president for the Molecular Diagnostics Divi- sion of Affymetrix, Inc.; vice president of Pre-Analytical Solutions and as a member of the executive committee at QIAGEN; and president and CEO of BioStar, Inc. He has built several operating teams from the ground up, including the commercial teams to launch novel products at companies such as Ciba Corning, Biostar, and OpGen. Mr. Doheny obtained degrees in biology and chemistry from West Virginia University and attended George- town University for postgraduate studies in biochemistry prior to moving into industry. Lloyd K. Everson, M.D., completed his medical education at Harvard Uni- versity in 1969. He has recently served as vice-chairman and member of the board of directors of U.S. Oncology, Inc. In 1993, Dr. Everson became a member of the board of directors, president, and chief operating officer of American Oncology Resources, Inc., which was the predecessor organiza- tion of U.S. Oncology, Inc. In 2009, Dr. Everson formed the Life Beyond Cancer Foundation, for which he serves as chairman of the board. Dr. Everson has served in numerous leadership roles in medical educa- tion through his career, including the practice of oncology and hematology, cancer research, and academic and administrative medicine. His postgradu- ate education included clinical and research positions at Cornell Medical Center and New York Hospital, Memorial Sloan-Kettering Cancer Center, and the National Cancer Institute. Dr. Everson is a member of the board of directors of the Intercultural Cancer Council and a member of the board of directors of C-Change. He also serves as a member of the Sigma Alpha Epsilon Foundation board of directors and is a member of the board of directors of Interfaith of the Woodlands, Texas. He has served in leader- ship positions in several national organizations, including the NCI Board of Scientific Counselors and the NCI National Cancer Advisory Board. Dr. Everson has also served as president of the Association of Community Cancer Centers, medical director of the Indiana Regional Cancer Center, associate chairman of the Eastern Cooperative Oncology Group, and mem- ber of the CEO Roundtable on Cancer. Dr. Everson is the recipient of many honors and awards, including the University of North Dakota Sioux Award for Outstanding Alumni and the Houston Lifetime Outstanding Achievement Award. Andrew N. Freedman, Ph.D., is the chief of the Epidemiology and Genom- ics Research Program’s (EGRP’s) Clinical and Translational Epidemiology

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APPENDIX B 85 Branch. He oversees EGRP’s research portfolio and initiatives that focus on factors that influence cancer progression, recurrence, new primary cancers, survival and other treatment outcomes, and factors associated with cancer development among individuals with underlying diseases and conditions. In 1997, Dr. Freedman joined the National Cancer Institute’s Division of Cancer Control and Population Sciences (DCCPS) as a molecular epide- miologist in the Applied Research Program’s Risk Factor Monitoring and Methods Branch. He developed and supported a program of research in cancer risk prediction, genetic susceptibility testing, pharmacoepidemiol- ogy, and pharmacogenomics and managed research contracts, interagency and cooperative agreements, and a grant portfolio pertaining to these research areas. Dr. Freedman also directed multidisciplinary molecular, clinical, and translational epidemiology studies within the HMO Cancer Research Network; Department of Veterans Affairs medical system; NCI’s Surveillance, Epidemiology, and End Results Program; and the National Institutes of Health (NIH)-AARP Diet and Health Study. He is internation- ally recognized for his work in molecular cancer epidemiology and cancer risk prediction. In the areas of pharmacoepidemiology and pharmacogenomics, Dr. Freedman has developed research collaborations with several NIH institutes and centers and other agencies within the U.S. Department of Health and Human Services (HHS). He is chair of the Trans-NCI Pharmacoepidemi- ology and Pharmacogenomics Working Group and represents the NCI in the Trans-NIH Pharmacogenomics Working Group and the Institute of Medicine (IOM) Roundtable on Translating Genomic-Based Research for Health. Before joining the DCCPS, Dr. Freedman was a postdoctoral research fellow in the Genetic Epidemiology Branch of NCI’s Division of Cancer Epidemiology and Genetics. Elaine Jeter, M.D., is the Palmetto GBA Part B medical director for juris- diction 1 (J1) where she is currently working to implement the Molecular Diagnostic Services Program. She is a graduate of the Medical University of South Carolina (MUSC) and is board certified in clinical and anatomic pathology and in blood banking/transfusion medicine. Dr. Jeter received her undergraduate degree from the State University of New York and her mas- ter’s from the University of South Carolina. She was an academic physician at MUSC for 10 years and in private pathology practice in Columbia, South Carolina, for a number of years. Dr. Jeter joined Palmetto GBA in 2005. Gabriela Lavezzari, Ph.D., M.B.A., is director of development at Express Scripts–Medco, where she works toward proving the clinical utility and cost-effectiveness of a broad range of health care innovation products. Before joining Medco, Dr. Lavezzari was the laboratory director for

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86 GENOME-BASED DIAGNOSTICS Theranostics Health, a biotech company in Rockville, Maryland, focused on the discovery of new cancer theranostics biomarkers. There she man- aged the laboratory services and led the research and development efforts for biomarker discovery. Prior to that position, Dr. Lavezzari was a senior laboratory specialist with the AIDS Clinical Trials Group (ACTG) at Social and Scientific Systems. There she facilitated technical management and operations of ACTG lab structure domestically and internationally. Dr. Lavezzari received her Ph.D. in biology at the University of Milano, Italy, followed by her postdoctoral work at the National Institute of Neu- rological Disorders and Stroke. She also received her M.B.A. at the New York Institute of Technology. Debra Leonard, M.D., Ph.D., received her M.D. and Ph.D. from the New York University School of Medicine and is currently professor and vice- chair for laboratory medicine in the Department of Pathology and Labo- ratory Medicine as well as director of the clinical laboratories for New York–Presbyterian Hospital’s Cornell campus (NYPH–WCMC). She is also director of the Pathology Residency Training Program at NYPH–WCMC. Dr. Leonard was previously director of molecular pathology at the Uni- versity of Pennsylvania School of Medicine and is a nationally recognized expert in molecular pathology. She has served on several national commit- tees that develop policy for the use of genetic and genomic technologies and information, including most recently the Secretary’s Advisory Committee on Genetics, Health and Society that advises the Secretary of HHS. Dr. Leonard is editor of two molecular pathology textbooks and has spoken widely on various molecular pathology test services, the future of molecular pathology, and the impact of gene patents on molecular pathology practice. Dr. Leonard is interested in the use of genomic technologies in the practice of medicine to improve patient outcomes. Gary H. Lyman, M.D., M.P.H., FASCO, FRCP (Edinburgh), is professor of medicine and director of comparative effectiveness and outcomes research– oncology at Duke University and the Duke Cancer Institute. Dr. Lyman is also a senior fellow at the Duke Center for Clinical Health Policy Research. Dr. Lyman received his undergraduate and medical degrees from the State University of New York in Buffalo and completed internal medicine resi- dency at the University of North Carolina at Chapel Hill. He subsequently completed a clinical hematology/oncology fellowship at the Roswell Park Memorial Institute and a postdoctoral fellowship in biostatistics at the Harvard School of Public Health and the Dana Farber Cancer Center. Dr. Lyman previously served as professor of medicine, director of medical oncology and chief of medicine at the H. Lee Moffitt Cancer Center and Research Institute. During this period he served as professor of medicine

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APPENDIX B 87 and professor of epidemiology and biostatistics as well as associate chair- man of the Department of Medicine at the University of South Florida. Prior to relocating to Duke University in 2007, Dr. Lyman held positions as Thomas Ordway Professor of Medicine and cancer center director at the Albany Medical College and subsequently professor of medicine, associate cancer center director, and director of health services and outcomes research at the University of Rochester and Strong Memorial Hospital. Dr. Lyman is active in ASCO, serving as chair-elect of the ASCO Clini- cal Practice Guideline Committee after having chaired the Methodology Subcommittee for several years. Dr. Lyman also chairs several ASCO guide- line panels and is a member of the ASCO Biomarkers Guideline Working Group, the Comparative Effectiveness Research Task Force, and the Cost of Care Task Force. In 2010, Dr. Lyman received the prestigious ASCO States- man Award and was recently elected to the ASCO board of directors. Dr. Lyman is an advisor to the U.S. Food and Drug Administration (FDA) and the Oncology Drug Advisory Committee. He is editor-in-chief of Cancer Investigation and the peer review editor for ASCO’s Journal of Oncology Practice and serves on the editorial board of the Journal of Clinical Oncol- ogy and several other subspecialty journals. In addition to serving as a fellow of ASCO, Dr. Lyman is a fellow of the Royal College of Physicians (Edinburgh), the American College of Physicians, the American College of Preventive Medicine, and the American College of Clinical Pharmacol- ogy. His research interests include personalized cancer supportive care, comparative effectiveness studies of targeted therapies and biomarkers, mathematical and statistical prognostic and predictive models, advanced methods of evidence synthesis in support of clinical practice guidelines and population studies of patterns of cancer treatment, and the impact of health disparities on the quality of cancer care. Elizabeth Mansfield, Ph.D., is the director of the personalized medicine staff in the Office of In Vitro Diagnostic and Radiological Health (OIR) in the Center for Devices and Radiological Health, FDA, where she is developing a program to address companion and novel diagnostic devices. She was pre- viously a senior policy analyst in OIR, managing policy and scientific issues. From 2004 to 2006, Dr. Mansfield served as the director of regulatory affairs at Affymetrix, Inc. She previously served in other positions at FDA, including scientific reviewer and genetics expert. Dr. Mansfield received her Ph.D. from Johns Hopkins University and completed further postdoctoral training at NCI and the National Institute for Arthritis, Musculoskeletal, and Skin Diseases. Robert McCormack, Ph.D., is currently head of technology innovation and strategy for Veridex, LLC. He was formerly the director of technol-

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88 GENOME-BASED DIAGNOSTICS ogy assessment for Ortho-Clinical Diagnostics, focusing on novel cellular and molecular cancer technology. In 2005, he assumed the role of vice president of scientific and medical affairs at Veridex, LLC, a Johnson & Johnson start-up dedicated to the development and commercialization of novel cancer diagnostic tests. His group successfully conducted clinical tri- als to launch the first molecular test for assessing axillary nodal status in women diagnosed with breast cancer. Prior to this position, in 2001 he was appointed general manager of the cellular diagnostics group at Veridex. The cellular diagnostics group successfully launched their first product in 2004 for the detection and enumeration of circulating tumor cells in patients with metastatic breast cancer. He joined Johnson & Johnson in 1998 as vice president of clinical affairs for Ortho-Clinical Diagnostics. Under his direction, Ortho-Clinical Diagnostics became the first diagnostics com- pany to gain FDA approval for hepatitis assay testing on random access automation for clinical laboratories. In 1995, he joined Sanofi Diagnostics Pasteur as director of clinical and regulatory affairs and worldwide group leader for cancer diagnostics. Dr. McCormack spent his early career in genetic, molecular, and cellular research at the University of Minnesota, 3M, and Hybritech. He transitioned to clinical and regulatory affairs at Hybritech and was part of the team that successfully gained FDA approval for prostate-specific antigen in the early detection of prostate cancer. Dr. McCormack received his B.S. degree in medical technology from the Uni- versity of Wisconsin, River Falls, and his M.S. and Ph.D. degrees from the University of Minnesota in hematology and immunology, respectively. Lisa M. McShane, Ph.D., is a senior mathematical statistician in the Bio- metric Research Branch in the Division of Cancer Treatment and Diagnosis at the NCI. She earned her Ph.D. in statistics from Cornell University. Since 1996, Dr. McShane has worked closely with the NCI Cancer Diagnosis Program and Cancer Therapy Evaluation Program on statistical matters relating to the development and use of tumor markers for prognosis, pre- diction, and disease monitoring. She is a member of the NCI Program for the Assessment of Clinical Cancer Tests Strategy Group. Dr. McShane’s statistical interests and publications have covered a diverse set of topics, including statistical methods for the analysis of high- dimensional genomic data, multiple comparisons methods, surrogate end points, measurement error adjustment methods, laboratory quality control and assay reproducibility assessment, and spatial statistics. She has also been statistical coauthor on many biomedical papers covering such topics as genomic studies in breast, colon, and lung cancer; colorectal epithelial cell proliferation; serum markers in prostate cancer; molecular characterization of ovarian tumors; Parkinson’s disease; motor control disorders; stroke;

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APPENDIX B 89 and Creutzfeldt-Jakob disease. She is a co-author of the book Design and Analysis of DNA Microarray Investigations. Dr. McShane is a frequent speaker at national and international statis- tics meetings and oncology meetings. She has presented numerous statistical lectures, didactic lectures, and discussions on the design and analysis of biomarker studies, including gene expression microarray studies. In 2008, Dr. McShane was awarded a prestigious NIH Director’s Award in recogni- tion of her work on trial designs to assess predictive biomarkers for their utility in therapeutic decision making for patients with cancer. Lee N. Newcomer, M.D., M.H.A., is senior vice president at United Healthcare (UHC), with strategic responsibility for oncology, genetics, and women’s health. Prior to rejoining UHC in 2006, 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 UHC, including chief medical offi- cer. His work there emphasized the development of performance measures and incentives to improve clinical care. Prior to initially joining UHC, 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, Min- nesota (Park Nicollet Clinic). He is the former chairman of Park Nicollet Health Services, an integrated system of more than 700 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 from Nebraska Wesleyan Univer- sity, an M.D. degree from the University of Nebraska College of Medicine, and an M.H.A. from the University of Wisconsin–Madison. He completed his internship and residency in internal medicine at the University of Nebraska Medical Center and a fellowship in medical oncology at the Yale University School of Medicine. Kathryn A. Phillips, Ph.D., is professor of health economics and health services research at the University of California, San Francisco (UCSF), and founder/director of the UCSF Center for Translational and Policy Research on Personalized Medicine. She has appointments in the UCSF Department of Clinical Pharmacy, the UCSF Institute for Health Policy Studies, and the UCSF Comprehensive Cancer Center. Dr. Phillips holds degrees from the University of California, Berkeley, Harvard University, and the University of Texas at Austin and previously spent 8 years working for the federal government. Dr. Phillips’s research focuses on using quantitative tools to examine policy issues on how health care is organized, delivered, and financed in

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90 GENOME-BASED DIAGNOSTICS the United States. Her emphasis is on translation of new technologies and personalized medicine and its impact on clinical care, health economics, and health policy. She has published more than 100 peer-reviewed articles in such leading journals as Journal of the American Medical Association, New England Journal of Medicine, and Health Affairs. She also serves on the editorial board for 6 journals and has led or participated in approxi- mately 50 funded research grants, with continuous funding from NIH as a principal investigator since 1993. Dr. Phillips has served as an adviser to many organizations, including the IOM, the President’s Council of Advisors on Science and Technology, Genome Canada, FDA, the Australia Pharmaceutical Benefits Committee, and the Medicare Services Advisory Committee, and regularly speaks to national and international groups. Dr. Phillips also consults with a number of biotech start-ups and venture capital firms and serves on the Novartis Molecular Diagnostics Advisory Board. Margaret Piper, Ph.D., M.P.H., is the director of genomics resources at the Blue Cross Blue Shield Association Technology Evaluation Center (TEC), an Agency for Healthcare Research and Quality (AHRQ)-funded Evidence- based Practice Center (EPC). She has been with TEC since 1994, joining the staff full-time in 1999. Her experience at TEC has focused on systematic reviews of medical technology, including topics in autoimmunity and trans- plantation, oncology, laboratory medicine, and genomics/genetic testing. Dr. Piper has written more than 30 TEC systematic reviews and reports and has co-written 4 AHRQ-EPC reports. Among other outreach activities, Dr. Piper has served on CMS’s Medicare Evidence Development and Coverage Advisory Committee and on a work group for the Institute for Quality in Laboratory Medicine, and she currently serves on the working group for the Centers for Disease Control and Prevention (CDC)-funded Evaluation of Genomic Applications in Practice and Prevention (EGAPP) project. Her roles with the EGAPP working group include establishing methods and processes for evidence-based evaluation of genetic tests; prioritizing and selecting topics for review; participating in technical expert panels for commissioned evidence reviews; and developing conclusions or recom- mendations on the basis of the evidence. In addition to these activities, Dr. Piper has given presentations on evidence-based evaluation of genetic tests at meetings organized by the IOM, AHRQ, and the NCI. Prior experience includes more than 13 years of managing a variety of clinical diagnostic laboratory departments in both academic hospital and commercial clinical laboratory settings, designing and evaluating new laboratory diagnostics for the biomedical industry, consulting with physicians, publishing, and volunteer teaching for professional organizations in laboratory medicine. In 2000, Dr. Piper received a Distinguished Service Award from the Ameri-

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APPENDIX B 91 can Society of Clinical Pathologists Commission on Continuing Education. Following a mid-career NCI fellowship in cancer prevention and control, which included obtaining an M.P.H. in epidemiology, Dr. Piper gained experience in cancer epidemiology at the NCI and subsequently at the CDC, with a focus on cancer genetics. Dr. Piper has a B.S. in molecular biology (University of Wisconsin–Madison), a Ph.D. in immunology (Duke Univer- sity), and an M.P.H. in epidemiology (Emory University). Greg Rossi, Ph.D., is the vice president of payer and real-world evidence for AstraZeneca UK. His responsibilities include overseeing coverage and reimbursement submissions and real-world evidence (outcomes) studies and ensuring that development programs address evidence requirements of global payers. He received his doctorate in molecular biology and pro- tein chemistry from University College London in 1993. Since then he has worked in the biotechnology/pharmaceutical industry. Between 1996 and 2007, Dr. Rossi was at Amgen, Inc., where he held a number of roles in regulatory affairs, clinical development, and global product strategy. He was involved in the clinical development and registra- tion of a number of products, with responsibilities including negotiations with global reimbursement authorities and U.S. payers. Between 2005 and 2007, Dr. Rossi was responsible for coleading the development and commercialization strategies of Amgen’s therapeutic oncology pipeline in Phase II and III clinical development. In 2007, Dr. Rossi joined Genentech Inc./Roche Pharmaceuticals, where he was responsible for outcomes research, health economics, and global pricing. These responsibilities included providing input into the design of Phase II, III, and IV studies, conducting observational research stud- ies, developing global pricing policies, and generating health technology/ reimbursement dossiers for coverage and reimbursement submissions. Dr. Rossi is the author of more than 25 clinical research manuscripts and numerous abstracts. Howard I. Scher, M.D., is the first incumbent of the D. Wayne Calloway Chair in urologic oncology and chief of the Genitourinary Oncology Ser- vice at the Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan-Kettering Cancer Center (MSKCC). One of the foremost genitourinary medical oncologists in the country, he also serves as princi- pal investigator of the NIH Specialized Program of Research Excellence in prostate cancer at MSKCC, the Department of Defense Prostate Cancer Research Program (PCRP), and the Prostate Cancer Foundation–funded Prostate Cancer Clinical Trials Consortium, a 13-center research collabora- tive funded by the PCRP and the Prostate Cancer Foundation. Dr. Scher’s work is focused on three critical areas: developing treatments that target

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92 GENOME-BASED DIAGNOSTICS specific signaling pathways that contribute to prostate cancer growth, devel- oping noninvasive methods to determine whether these agents are working, and improving the way drugs and biomarkers are evaluated in the clinic. In addition, as professor of medicine at the Joan and Sanford Weill Medical College of Cornell University, Dr. Scher has mentored a new generation of physician-scientists who are already making important con- tributions to the field of prostate cancer research. He is the recipient of the Donald S. Coffey–Prostate Cancer Foundation Physician-Scientist Award and the Distinguished Alumnus Award. Dr. Scher also serves on numerous national scientific advisory boards and is a reviewer for many journals, including New England Journal of Medicine, Lancet, Lancet Oncology, Cancer Cell, Nature, and Journal of Clinical Oncology. He has written extensively and has published more than 400 peer-reviewed articles in scientific journals. Richard L. Schilsky, M.D., is professor of medicine and chief, Section of Hematology/Oncology in the Department of Medicine, Biological Sciences Division, at the University of Chicago. He earned his M.D. at the University of Chicago Pritzker School of Medicine in 1975. Following a residency in internal medicine at the University of Texas Southwestern Medical Center and Parkland Memorial Hospital, he received training in medical oncology and clinical pharmacology at the National Cancer Institute from 1977 to 1981. He then served as assistant professor of medicine at the University of Missouri–Columbia School of Medicine from 1981 to 1984 and then returned to the University of Chicago. Dr. Schilsky previously served as director of the University of Chicago Cancer Research Center (1991–1999) and as associate dean for clinical research (1999–2007). From 1995 to 2010, Dr. Schilsky served as chairman of the Cancer and Leukemia Group B, an NCI-sponsored national cancer clinical trials group. He is presently a member of the board of directors of the Alliance for Clinical Trials in Oncology and of CTNet, the statewide clinical trials network of Texas. An international expert in gastrointestinal malignancies and cancer pharmacology, Dr. Schilsky has served on a number of peer review and advisory committees for the NCI and previously served as chair of the Oncologic Drugs Advisory Committee for FDA. Dr. Schilsky is past chair of the NCI Board of Scientific Advisors and has served as a member of the Clinical and Translational Research Advisory Committee. Dr. Schilsky also served as a member of the board of directors of the American Soci- ety of Clinical Oncology and as ASCO president from 2008 to 2009. He is presently a member of the board of directors of the Conquer Cancer Foundation.

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APPENDIX B 93 He is also a member of the external advisory committees of several comprehensive cancer centers, including the Roswell Park Cancer Center, the MD Anderson Cancer Center, the Huntsman Cancer Institute, the Simmons Cancer Center at the University of Texas–Southwestern, the Tisch Cancer Institute at Mount Sinai Hospital, and the UCSF Helen Diller Fam- ily Comprehensive Cancer Center. Dr. Schilsky is an associate editor of Clinical Cancer Research, Semi- nars in Oncology, and the Journal of the National Cancer Institute; senior associate editor of Molecular Oncology; and a member of the editorial boards of Cancer Prevention Research, Cancer Investigation, Annals of Surgical Oncology, Journal of Cancer Research and Clinical Oncology, and several other journals. He has published more than 285 articles and book chapters in the medical literature and is the editor of 4 books. Sean Tunis, M.D., M.Sc., is the president and chief executive officer of the Center for Medical Technology Policy (CMTP) in Baltimore, Maryland. CMTP’s main objective is to improve the quality, relevance, and efficiency of clinical research by providing a neutral forum for collaboration among experts, stakeholders, and decision makers. Dr. Tunis was a member of the IOM Committee on Initial National Priorities for Comparative Effective- ness Research. He advises a wide range of domestic and international public and private health care organizations on issues of comparative effective- ness, evidence-based medicine, clinical research, reimbursement, and health technology policy. Through September of 2005, Dr. Tunis was the chief medical officer at CMS, where he had lead responsibility for clinical policy for the Medicare and Medicaid programs. Previously he 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, where he worked on pharmaceuti- cal and device policy issues. Dr. Tunis trained at the University of California, Los Angeles, and the University of Maryland in internal medicine and emergency medicine. He holds adjunct faculty positions at the Center for Health Policy at Stanford University, the Department of Internal Medicine at the Johns Hopkins University School of Medicine, and the Department of Surgery at UCSF.

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