Appendix B

Participant Biographies

Jeffrey M. Drazen, M.D. (Workshop Chair), was born in Missouri. He attended Tufts University, with a major in physics, and Harvard Medical School, and served his medical internship at Peter Bent Brigham Hospital in Boston. Thereafter, he joined the Pulmonary Divisions of the Harvard hospitals. He served as Chief of Pulmonary Medicine at the Beth Israel Hospital, Chief of the combined Pulmonary Divisions of the Beth Israel and Brigham and Women’s Hospitals, and finally as the Chief of Pulmonary Medicine at Brigham and Women’s Hospital. Through his research, he defined the role of novel endogenous chemical agents in asthma. This led to four new licensed pharmaceuticals for asthma with over 5 million people on treatment worldwide. In 2000, he assumed the post of Editor-in-Chief of the New England Journal of Medicine. During his tenure, the Journal has published major papers advancing the science of medicine, including the first descriptions of SARS and papers modifying the treatment of cancer, heart disease and lung disease. The Journal, which has over a million readers every week, has the highest impact factor of any journal publishing original research.

Christopher Beardmore began his career in regulatory affairs, influenced by leading human subject and animal subject protection committees at large academic institutions. While at the University of Maryland at Baltimore and the University of California at Los Angeles (UCLA) he reviewed and improved human subject protection systems, served as an advisor to streamline research processes, drafted policy and procedure



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Appendix B Participant Biographies Jeffrey M. Drazen, M.D. (Workshop Chair), was born in Missouri. He attended Tufts University, with a major in physics, and Harvard Medical School, and served his medical internship at Peter Bent Brigham Hospital in Boston. Thereafter, he joined the Pulmonary Divisions of the Harvard hospitals. He served as Chief of Pulmonary Medicine at the Beth Israel Hospital, Chief of the combined Pulmonary Divisions of the Beth Israel and Brigham and Women’s Hospitals, and finally as the Chief of Pulmonary Medicine at Brigham and Women’s Hospital. Through his research, he defined the role of novel endogenous chemical agents in asthma. This led to four new licensed pharmaceuticals for asthma with over 5 million people on treatment worldwide. In 2000, he assumed the post of Editor-in-Chief of the New England Journal of Medicine. During his tenure, the Journal has pub- lished major papers advancing the science of medicine, including the first descriptions of SARS and papers modifying the treatment of cancer, heart disease and lung disease. The Journal, which has over a million readers every week, has the highest impact factor of any journal publishing original research. Christopher Beardmore began his career in regulatory affairs, influ- enced by leading human subject and animal subject protection commit - tees at large academic institutions. While at the University of Maryland at Baltimore and the University of California at Los Angeles (UCLA) he reviewed and improved human subject protection systems, served as an advisor to streamline research processes, drafted policy and procedure 97

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98 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE manuals and developed training and education programs to improve systems. This included work with IRB members regarding review respon- sibilities and dealing extensively in issues related to ethical and regulatory training regarding GCP. Also while at UCLA, he represented all regula- tory departments on an electronic research-networking database project designed to integrate regulatory affairs with budget and contract services. In September 2001, Mr. Beardmore relocated to Fort Detrick, Maryland, and worked with the U.S. Army Medical Research Institute of Infectious Disease to improve human subject activities. There he authored a position paper proposing innovative approaches to developing investigational biowarfare protective products. Over the years Mr. Beardmore has also consulted for numerous research hospitals, institutes, and IRBs including the West Los Angeles VA Medical Center, Friends Research Institute, and St. Johns Hospital/John Wayne Cancer Institute. All of these experiences led Mr. Beardmore to recognize a serious need to improve systems and permit ethical research to be conducted more efficiently. In 2004, he took on the role of Chief Operating Officer and Co-Founder of Premiere Oncol- ogy, a medical oncology research and treatment group operating in Santa Monica, California; San Diego, California; and Scottsdale, Arizona. Work - ing with this group of practices until 2008, Mr. Beardmore established and streamlined the efforts of physicians, sites, and ancillary service providers and matched them with appropriate studies and sponsors to rapidly become one of the largest private Phase I groups in the United States. Mr. Beardmore found his vision for a community network of oncologists needed to be expanded beyond a single entity and left to form Transla - tional Research Management (TRM) in 2009. TRM is dedicated to the creation of a community-focused clinical trial network, designed to bring innovative products to oncologists to potentially treat, ameliorate, or cure life-threatening or otherwise debilitating chronic disease. Currently TRM manages over 50 sites and is contracted with over 430 ancillary service providers who support those sites. Robert Califf, M.D., graduated from Duke University, summa cum laude and Phi Beta Kappa, in 1973 and from Duke University Medical School in 1978, where he was selected for Alpha Omega Alpha. He performed his internship and residency 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 Master of the American College of Cardiology (2006). He is currently Vice Chancellor for Clinical Research, Director of the Duke Translational Medicine Insti - tute (DTMI), and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. For 10 years he was the Founding Director of the Duke Clinical Research Insti-

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99 APPENDIX B tute (DCRI), the premier academic research organization in the world. He is the editor-in-chief of Elsevier’s American Heart Journal, the old- est cardiovascular specialty journal. He has been author or co-author of more than 800 peer-reviewed journal articles and a contributing editor for theheart.org, an online information resource for academic and practicing cardiologists. He was recently acknowledged as one of the 10 most cited authors in the field of medicine by the Institute for Scientific Information (ISI). Dr. Califf led the DCRI for many of the best-known clinical trials in cardiovascular disease. With an annual budget of over $100 million, the DCRI has more than 1,000 employees and collaborates extensively with government agencies, the medical-products industry, and academic partners around the globe in all therapeutic areas. In cooperation with his colleagues from the Duke Databank for Cardiovascular Disease, Dr. Califf has written extensively about the clinical and economic outcomes of chronic heart disease. He is considered an international leader in the fields of health outcomes, quality of care, and medical economics. Dr. Califf’s role as Director of the Duke Translational Medicine Institute, which is funded in part by an NIH CTSA, includes service as co-chairman of the Principal Investigators Steering Committee of the CTSA. Dr. Califf has served on the Cardiorenal Advisory Panel of the FDA and the Pharma- ceutical Roundtable of the IOM. He served on the IOM committees that recommended Medicare coverage of clinical trials as well as the removal of ephedra from the market and on the IOM’s Committee on Identify- ing and Preventing Medication Errors. He is currently a member of the IOM Forum on Drug Discovery, Development, and Translation and a subcommittee of the Science Board of FDA. He was the founding director of the coordinating center for the Centers for Education & Research on Therapeutics (CERTs), a public–private partnership among the Agency for Healthcare Research and Quality, FDA, academia, the medical-products industry, and consumer groups. This partnership focuses on research and education that will advance the best use of medical products. He is now the co-chairman of the CTTI, a public–private partnership focused on improving the clinical trials system. Doug Cropper, M.H.A., is President and CEO of Genesis Health System (GHS) based in the Quad Cities area of Iowa and Illinois. GHS is a not- for-profit system offering a full continuum of health care services to a 10-county area. With an A1 Bond rating, GHS reported total operating revenue of $558 million in fiscal year 2010 and employs over 5,000 people. GHS has been the recipient of numerous awards and recognitions, includ- ing Thomson Reuters 50 Top Heart Hospitals, Thomson Reuters Top 50 Health Systems, 2010 J.D. Powers and Associates Distinguished Hospital for Providing “An Outstanding Patient Experience,” a Top 100 IHS, 100

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100 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Most Wired Hospitals and Health Systems, Nursing Magnet designation, and the Consumer Choice Award from National Research Corporation. Mr. Cropper has more than 30 years of health care experience, starting out as a surgical orderly at St. Mark’s Hospital in Salt Lake City, Utah. Prior to Genesis, he was Executive Vice President of Inova Health System and Administrator of the Inova Fairfax Hospital Campus in Falls Church, Vir- ginia. Previous to his 5-year tenure at Inova, he served as Administrator of St. John’s and St. Joseph’s Hospitals and Vice President of HealthEast in St. Paul, Minnesota. Mr. Cropper graduated magna cum laude with a B.S. in history from the University of Utah (1984) and received a master’s in Healthcare Administration from the University of Minnesota in 1988. James H. Doroshow, M.D., FACP, has been the Director of the Division of Cancer Treatment and Diagnosis (DCTD), NCI, NIH, since 2004. He fosters collaboration with other NCI divisions and offices, as well as extra- mural scientists and clinicians, patient advocates, and professional cancer organizations. He leads the DCTD professional staff, who represent a wide array of scientific specialties, to integrate their insights and skills into a crossdisciplinary, scientifically driven, cooperative research endeavor to discover and develop better diagnostic and therapeutic interventions for cancer. Dr. Doroshow also oversees his own active laboratory program focusing on two lines of research: discovering the mechanisms that drive the anthracycline antibiotic cell death program and understanding the role of oxidative signals in the development and treatment of colon cancer. From 1983 to 2004, Dr. Doroshow was the Associate Director for Clinical Research at the City of Hope’s (COH) Comprehensive Cancer Center in Duarte, California; the Chairman of the COH Department of Medical Oncology and Therapeutics Research; and the Leader of the COH Cancer Center’s Clinical and Experimental Therapeutics Program. Through these roles, he oversaw solid tumor therapeutic research, supervised a staff of 75 involved in investigating novel targeted agents and other therapies, and directed a program of clinical research that supported more than 150 concurrently active clinical trials. While at COH, he founded an early ther- apeutics consortium of three NCI-designated cancer centers in California funded by both NCI’s Phase I and II support grants. He was also the principal investigator for COH’s membership in the Southwest Oncology Group (SWOG) and founding Chair of the SWOG Early Therapeutics Committee. From the time he received his first research grant in 1980, Dr. Doroshow was funded continuously by NCI and NIH until moving to NCI in 2004. He is the author of more than 300 full-length publications in the areas of the molecular and clinical pharmacology of the anthracycline antibiotics, the role of oxidant stress in signal transduction, and novel

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101 APPENDIX B therapeutic approaches to breast, gastrointestinal, lung, and gynecologic cancer. Dr. Doroshow is a senior editor of Clinical Cancer Research. He is a member of the editorial boards of the International Journal of Oncology, Technology in Cancer Research and Treatment, and Oncology. He is also an associate editor for the widely used Manual of Clinical Oncology published by the International Union Against Cancer. Dr. Doroshow served from 1995 to 2001 as a member of the Subspecialty Board on Medical Oncology of the American Board of Internal Medicine, from 1999 to 2000 as Chair of NCI’s Scientific Review Group-A Cancer Centers, and from 1990 to 1992 as Chair of the NIH Experimental Therapeutics II Study Section. He is currently a member of the FDA Oncologic Drugs Advisory Committee. Dr. Doroshow received his bachelor’s degree, magna cum laude, from Harvard College in 1969 and his medical degree, Alpha Omega Alpha, from Harvard Medical School in 1973. After completing an internship and residency at Massachusetts General Hospital in Boston, he spent 3 years (1975-1978) at NCI as a clinical associate. He is board certified in internal medicine and medical oncology. Prior to joining COH in 1981, he held the position of Assistant Professor of Medicine in the Division of Medical Oncology at the University of Southern California School of Medicine in Los Angeles. Paul R. Eisenberg, M.D., M.P.H., FACP, is the Senior Vice President of Global Regulatory Affairs and Safety at Amgen, effective February 2008. He was promoted after serving as Vice President of Global Regula - tory Affairs and Safety since January 2007, and Vice President of Global Safety since December 2005. Prior to joining Amgen, Dr. Eisenberg was the Vice President of Lilly Global Product Safety. At Lilly he also led Clinical Development teams in Cardiovascular, Critical Care, and Inflam- mation Therapeutic Areas as Vice President–Internal Medicine and in discovery as Executive Director of Cardiovascular Research and Clinical Investigation. Dr. Eisenberg received his M.D. from New York Medical College and M.P.H. in Tropical Medicine from Tulane University School of Public Health. He was a Professor of Medicine at Washington Univer- sity in St. Louis where his academic career, over 18 years, was focused on basic and clinical research in cardiovascular disease and thrombosis. This work led to over 100 publications in peer-reviewed journals and books. He has been involved in the discovery and development of numerous new molecular entities (NMEs) in both his academic and industry career. Dr. Eisenberg has led the development and registration of multiple NMEs in cardiovascular and critical care. In addition, he has extensive experi - ence in global safety and risk management programs for drug develop- ment programs and postmarketing in multiple therapeutic classes.

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102 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Lynn M. Etheredge is an independent consultant on health care and social policy issues and heads the Rapid Learning Project at George Washington University. His career started at the White House Office of Management and Budget (OMB), where he was OMB’s principal analyst for Medicare and Medicaid and led its staff work on national health insurance proposals. Mr. Etheredge headed OMB’s professional health staff in the Carter and Reagan administrations. Later, he was a co-author of the Jackson Hole Group’s proposals for health care reform. In 2007, he proposed the concept of the “rapid-learning health system” and is collaborating widely in devel- oping this approach. Mr. Etheredge’s recent publications include “Creat- ing a High-Performance System for Comparative Effectiveness Research” and “Medicare’s Future: Cancer Care.” He serves on the editorial board of Health Affairs. He is author of more than 85 publications and is a graduate of Swarthmore College. Gary L. Filerman, Ph.D., is President of the Atlas Health Foundation, an organization that addresses rural veteran’s health services access issues and quality of care in corrections. He is adjunct professorial lecturer at the George Washington University School of Public Health and Health Ser- vices. He is also advisor to Joint Commission International, focusing on global health standards and relationships with international organizations and is an Open Society Institute faculty mentor. He formerly served at professor and chairman of the Department of Health Systems Administra- tion at Georgetown University. Prior to joining Georgetown in 2000 he was for 2 years professor and interim chairman of the Department of Health Services and Policy at the George Washington University. Dr. Filerman joined the Georgetown faculty after a long career as the global leader in the development of management capacity and competency for health ser- vices. For 28 years he headed the Association of University Programs in Health Administration, a consortium of university, institute, and ministry programs in 30 countries. With the support of the W.K. Kellogg Founda- tion, Pew Trusts, the Robert Wood Johnson Foundation, the Common- wealth Fund, the World Health Organization (WHO), the U.S. Agency for International Development (USAID), and multinational corporations, his efforts focused upon the assessment of health system management needs, the design of university programs, and faculty and curriculum development and evaluation. He later served as vice president for inter- national development of Planned Parenthood Federation of America, associate director of the Pew Commission on the Future of the Health Professions, senior health advisor at the Academy for Educational Devel- opment, consultant to the World Bank private health sector initiative, workforce leader for the World Bank Romania health sector reform, and headed planning for the 1997 Tashkent conference on NIS medical edu-

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103 APPENDIX B cation reform. He has served as a consultant to ministries of health, uni - versities, and health systems in 38 countries. Dr. Filerman has published widely on health care management development. He earned master’s degrees in Latin American government and health services administra - tion and his Ph.D. in health services from the University of Minnesota. He has been honored by the University of Leuven, the University of Puerto Rico, The Ohio State University, the University of Chicago, and with the Distinguished Contribution Award of the Regents of the University of Minnesota. He serves on several boards, including Volunteers of America. The endowed Filerman Prize is the highest recognition of leadership and scholarship in health systems administration education. Louis Fiore, M.D., M.P.H., was born in Brooklyn, New York, and attended the State University of New York in Stony Brook (chemistry) and Upstate Medical Center in Syracuse (M.D.). He completed his residency and fel- lowships in hematology and oncology at the Boston VA and obtained an M.P.H. from the Harvard School of Public Health. Dr. Fiore has been an intramural researcher within the VA for 20 years. He was the Principal Investigator of the CHAMP Trial, a secondary prevention study of AMI that enrolled 5,000 subjects to either aspirin alone or in combination with warfarin. In 1996 he founded the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), an epidemiology center within the VA Cooperative Studies Program. In 2002 the Center was expanded to include a clinical trials coordinating center. Since 2009 he has focused on bringing medical informatics expertise to the Program. His current interest lies in applying the disciplines of clinical trials, epi - demiology, and informatics to integrate research into clinical care. To this end he has established the Point of Care Clinical Trials program in the VA. Sherine E. Gabriel, M.D., M.Sc., is Professor of Medicine (Rheumatology) and Professor of Epidemiology, and the William J. and Charles H. Mayo Endowed Professor. She is currently Co-Principal Investigator and Direc- tor of Education, Center for Clinical and Translational Sciences, and Medi- cal Director for Strategic Alliances and Business Development at Mayo Clinic. She is a Past President of the American College of Rheumatol- ogy. Dr. Gabriel’s research, which is largely NIH-funded, has resulted in more than 350 peer-reviewed scientific publications addressing the risks, costs, determinants, and outcomes of the rheumatic diseases. She has received numerous research awards in recognition of these contribu- tions. On January 21, 2011, Dr. Gabriel was appointed by the U.S. Gen- eral Accountability Office to the Methodology Committee of PCORI and, soon after, was appointed as its first chair. PCORI was created by the U.S. Patient Protection and Affordable Care Act of 2010 as a nonprofit, non-

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104 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE governmental organization to help patients, clinicians, purchasers, policy makers, and others make better-informed health decisions by carrying out research that provides high-quality, relevant evidence about interventions and strategies to prevent, diagnose, treat, and monitor health conditions. Dr. Gabriel earned a Doctor of Medicine degree, with distinction, from the University of Saskatchewan, Canada, completed internal medicine resi - dency and rheumatology fellowship at Mayo Graduate School of Medi - cine and a master of science in clinical epidemiology from McMaster University. She is certified by the American Board of Internal Medicine in internal medicine and in rheumatology. Elaine K. Gallin, Ph.D., is currently a partner at QE Philanthropic Advi- sors, a consulting firm established in 2010 that serves nonprofits special - izing in biomedical research, science and math education, and interna - tional health. From 1999 through February 2010, Dr. Gallin served as the Doris Duke Charitable Foundation’s (DDCF’s) first Program Director for Medical Research. In that capacity, she led the creation and management of a portfolio of grant programs that committed more than $185 million to supporting clinical research. Dr. Gallin also designed and led DDCF’s $65 million African Health Initiative. Launched in September 2007, this initiative supports large-scale health services delivery projects designed to provide integrated primary health care linked to rigorous operations and implementation research in several sub-Saharan African communities. Before joining DDCF, Dr. Gallin spent two decades working for the U.S. government, first as a research physiologist and then as research adminis- trator where she last served as the Deputy Director of the Office of Inter- national Health Programs in the U.S. Department of Energy overseeing health research programs in countries of the former Soviet Union. During this period, she also spent a sabbatical year working in the Science Com- mittee of the U.S. House of Representatives as a Congressional Science Fellow. Dr. Gallin has participated in numerous professional committees and review panels, including several for IOM and NIH. She was a found- ing member and the first Vice Chair of the Health Research Alliance (an alliance of not-for-profit, nongovernmental research funders). Dr. Gallin is currently a member of the Sickle Cell Disease Advisory Committee at the National Heart Lung and Blood Institute, the Forum on Drug Discovery, Development, and Translation at IOM, the Scientific Advisory Board for the Avon Foundation, and the President’s Council of Cornell Women. Dr. Gallin received her B.S. from Cornell University and her Ph.D. from the City University of New York, and completed postdoctoral fellowships in physiology at Johns Hopkins University Medical School and Columbia University Medical School.

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105 APPENDIX B John I. Gallin, M.D., was appointed director of the NIH Clinical Center in 1994. The Clinical Center serves the clinical research needs of 17 NIH institutes and is the largest hospital in the world totally dedicated to clinical research. During his tenure, Dr. Gallin has overseen the design and construction of a new research hospital for the Clinical Center, the Mark O. Hatfield Clinical Research Center, which opened to patients in 2005; the establishment of a new curriculum for clinical research training now offered globally; and development of new information systems for biomedical translational and clinical research. While serving as Clinical Center director, Dr. Gallin has continued to be an active clinician and researcher. His primary research interest is in a rare hereditary immune disorder, chronic granulomatous disease (CGD). His laboratory described the genetic basis for several forms of CGD and has done pioneering research that has reduced life-threatening bacterial and fungal infections in CGD patients. A New York native, Dr. Gallin attended public school in New Rochelle, NY, graduated cum laude from Amherst College, and earned an M.D. degree at Cornell University Medical College. After a medical internship and residency at New York University’s Bellevue Hospital Medical Center, he received postdoctoral training in basic and clinical research in infectious diseases at NIH from 1971 to 1974. He then went back to the New York University-Bellevue Medical Center as senior chief medical resident from 1974 to 1975 before returning to NIH. In 1985, Dr. Gallin began a 9-year period as scientific director for intra - mural research activities at the NIAID. Dr. Gallin was the founding chief of Laboratory of Host Defenses, NIAID, served as chief of the laboratory for 12 years, and continues as chief of the lab’s clinical pathophysiology section. He has published more than 325 articles in scientific journals and has edited two textbooks: Inflammation, Basic Principles and Clinical Cor- relates (Lippincott, Williams, and Wilkins, 1999, now in its third edition) and Principles and Practices of Clinical Research (Academic Press, 2002, now in its second edition). Dr. Gallin is a member of the American Society for Clinical Investigation, the Association of American Physicians, and the IOM of the National Academy of Sciences, and he is a Master of the American College of Physicians. Annetine C. Gelijns, Ph.D., is the Co-Chair of the Department of Health Evidence & Policy at Mount Sinai School of Medicine, New York, New York. Dr. Gelijns also holds the positions Professor of Health Policy, and Co-Director of the International Center for Health Outcomes and Inno- vation Research (InCHOIR) at Mount Sinai School of Medicine. Before coming to Mount Sinai in 2008, she was Professor of Public Health and Surgical Sciences in the Department of Surgery, College of Physicians and Surgeons, and the Division of Health Policy and Management of

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106 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE the Mailman School of Public Health, Columbia University, New York City. She was also a Division Chief in the Department of Surgery. Prior to her position at Columbia, she directed the Program on Technologi- cal Innovation in Medicine at the IOM, National Academy of Sciences. From 1983 to 1987, she worked for the Steering Committee on Future Health Scenarios and for the Health Council, the Netherlands. Dr. Gelijns has been a consultant to various national and international organiza- tions, including WHO and the Organisation for Economic Co-operation and Development (OECD). Her research focuses on measurement of the long-term clinical outcomes and economic impact of clinical interven - tions, patient safety research, and the factors driving the development and diffusion of medical technology. She has special expertise in cardio- vascular disease, particularly in the design, coordination, and analysis of multicenter trials. She is the PI or Co-PI of several Data Coordinating Centers for NHLBI-sponsored trials, including CT Surgery Clinical Trials Network, the REMATCH trial, and several newer generations of LVAD trials. Dr. Gelijns has published, in such journals as the New England Journal of Medicine, the Journal of the American Medical Association, and Health Affairs, on the methodology and conduct of complex surgical and device trials, the assessment of quality of life and economic analysis of clinical procedures, and volume-outcome studies, as well as policy studies on technological change. Rebecca D. Jackson, M.D., is the Associate Dean for Clinical Research, Professor of Medicine and Director of the Center for Women’s Health at The Ohio State University. She also serves as the founding Director of the OSU Center for Clinical and Translational Science and the Prin - cipal investigator of OSU’s CTSA from NIH. Dr. Jackson received both her undergraduate and medical degree from The Ohio State University and her internship and residency training in internal medicine at Johns Hopkins Hospital. She returned to Ohio State in 1981 to complete her fel- lowship training in endocrinology and joined the faculty as an Assistant Professor of Endocrinology, Diabetes and Metabolism in 1983. Dr. Jackson has had a commitment to clinical and translational research throughout her academic career with a focus on examining and finding solutions to women’s health issues, particularly osteoporosis and chronic musculo - skeletal diseases associated with aging. Continuously federally funded since arriving at Ohio State, her individual and collaborative research efforts have resulted in peer-reviewed publications in the Journal of the American Medical Association, the New England Journal of Medicine, Annals of Internal Medicine, the Journal of Bone and Mineral Research, and other general medicine and subspecialty journals. She was lead author of the Women’s Health Initiative analyses that showed that calcium plus vita -

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107 APPENDIX B min D had a modest but nonsignificant effect on reducing hip fracture in postmenopausal women. Based upon its major scientific merit, this paper was selected for inclusion in the Annual Bibliography of Significant Advances in Dietary Supplements Research published by the Office of Dietary Supple- ments and NIH. Her recent efforts have focused on identifying genetic signatures and biomarkers for predicting risk for hip fracture, osteo- arthritis, and cardiovascular disease. Her ultimate goal is to leverage this information to further elucidate the pathophyisology of these common complex diseases as well as to improve screening, prevention, and treat - ment. Dr. Jackson has served in leadership roles in both professional and scientific organizations including vice chair of the WHI Steering Com - mittee from 2002 to 2010 and national co-chair of the CTSA Consortium in 2010 and she is currently a member of the Executive Committee of the NHLBI Exome Sequencing Project, the Executive Committee of the CTSA Consortium, the Board of Directors of the Clinical Research Forum, the NIH Advisory Board for Clinical Research, and secretary of the Society of Clinical and Translational Science. She has been the recipient of numerous awards and recognitions, including the NIH Physician Scientist Award and the Kellogg Foundation National Leadership Fellowship, and she is a member of Alpha Omega Alpha and a fellow of the American Associa - tion for the Advancement of Science. Dr. Jackson, who for more than a decade has been named one of “America’s Best Doctors” by U.S. News & World Report, is also a member of the Ohio Women’s Hall of Fame, has been recognized as a YWCA Woman of Achievement, and was named an American Medical Women’s Association Legend. Michael King Jolly, Pharm.D., is Senior Vice President of Quintiles Drug Development Innovation, where he leads drug development teams for partnered programs. Chief among his responsibilities are structuring and managing drug development collaborations with pharmaceutical com- panies. Dr. Jolly’s pharmaceutical career began at Burroughs Wellcome Co. (BW) in 1983. While at BW, he served as Project Leader for over five new molecular entities in cardiovascular medicine and Brand Leader for LANOXIN brand digoxin for heart failure. Dr. Jolly first joined Quintiles in 1995 and led a strategic business unit that provided oversight of more than 40 cardiovascular product development programs ranging from Pre- IND to Phase IV. In 2000, he took a position at King Pharmaceuticals as Executive Vice President, where he formed a multidisciplinary research and development organization using a “virtual development model” in which outsourced partners performed all operations work, directed by a small core of functional experts. In early 2007, Dr. Jolly returned to Quintiles, joining NovaQuest. Dr. Jolly also teaches at Duke University Medical School and the School of Pharmacy at the University of North

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112 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE completed his Fellowship in Medical Oncology in 1991 at the Dana Farber Cancer Institute, and completed a postdoctoral fellowship in molecular oncology in 1994 at the Harvard Medical School/Howard Hughes Medi - cal Institute under the guidance of Dr. Philip Leder. Richard K. Murray, M.D., FACP, joined Merck & Co., Inc. in November 1994, where he was a founding member of the Regional Medical Director Program. Over the subsequent 17 years, he assumed increasing responsi- bility within U.S. Human Health Medical and Scientific Affairs, including head of U.S. Academic and Professional Affairs, and he was promoted to Vice President, External Medical and Scientific Affairs, in August of 2007. He became Head of the Global Center for Scientific Affairs in May 2010, including responsibility for the Merck Investigator-Initiated Studies Program. Dr. Murray, a native Washingtonian, graduated from Clark University (Worcester, Massachusetts) with an A.B. in psychology and an M.A. in chemistry. He graduated from Howard University College of Medicine (Washington, DC) and subsequently was an intern, medical resident, Chief Medical Resident, and Pulmonary and Critical Care Fel- low at the University of Pennsylvania in Philadelphia. Prior to joining Merck, Dr. Murray was assistant professor of medicine at the University of Pennsylvania, where he was an investigator in the area of reactive airways disease, smooth muscle function, and calcium signaling. He was also Co-Director of the Adult Asthma Program at the Hospital of the Uni- versity of Pennsylvania. Dr. Murray is board certified in internal medicine and pulmonary diseases. He is a Fellow of the American College of Physi- cians, a Fellow of the American College of Chest Physicians, and a Fellow of the College of Physicians of Philadelphia. He serves on the boards of directors for the Merck Childhood Asthma Network and the Southeast Pennsylvania Chapter of the American Heart Association. Dr. Murray has previously represented Merck at the IOM Clinical Research Roundtable and the Roundtable on Health Disparities. Richard Platt, M.D., M.Sc., is a professor and chair of the Department of Population Medicine at Harvard Medical School and Executive Director of the Harvard Pilgrim Health Care Institute. He is principal investigator of the AHRQ HMORN DEcIDE Center, a CDC Prevention Epicenter, and a CDC Center of Excellence in Public Health Informatics. He also leads the FDA’s Mini-Sentinel program and contracts with FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evalu - ation and Research (CBER) to conduct postmarketing studies of drugs’ and biologics’ safety and effectiveness. He chaired FDA’s Drug Safety and Risk Management Advisory Committee, is a member of the Association of American Medical Colleges’ Advisory Panel on Research, and the IOM

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113 APPENDIX B Roundtable on Value & Science-Driven Health Care. Dr. Platt was co-chair of the Board of Scientific Counselors of CDC’s Center for Infectious Dis - eases. Additionally, he has chaired the NIH study section Epidemiology and Disease Control 2, and the CDC Office of Health Care Partnerships steering committee. Ihor W. Rak, M.D., was born in New York City, graduated from The City College of New York, and earned his medical degree at the College of Physicians and Surgeons at Columbia University, New York City. He completed his internship, residency, and fellowship at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia. He has earned several medical board certifications (pediatrics, neurology, pediatric neurology, and clinical neurophysiology). After serving in the U.S. Air Force as Chief of Pediatric Neurology and Neurology Services in the U.S. Air Force Medical Corps, Wright-Patterson Air Force Base, Ohio, Dr. Rak was an assistant professor of neurology and research associate at the University of Virginia, Charlottesville, Virginia. Dr. Rak was Founder and Medical Director of the Epilepsy Center and Co-Director of the Sleep Disorders Center at Sacred Heart Hospital, Allentown, Pennsylvania. As Principal Investigator he continued his clinical research activities, contributing to many investigational antiepileptic drugs. Since joining AstraZeneca Global Clinical Research in 1996, he has provided medical and project team leadership for a number of clinical projects, including SEROQUEL. As Global Product Director for Emerging Neuroscience, he successfully led the global neurologic, psychiatric, and overactive bladder early development projects. In 2005 Dr. Rak was appointed Vice President, Global Clinical Development for the Neuroscience Therapy Area. In his current role, he oversees the development and delivery of the clinical contributions for both emerging products and established brands in the Global Neuroscience Therapy Area. Dr. Rak attended executive develop - ment programs at the University of Pennsylvania’s Wharton School of Business and R&D Executive Leadership Program at Harvard Business School. He has held numerous leadership roles, including President and Chairman of the Board of Trustees with the American Academy of Phar- maceutical Physicians (AAPP, now APPI, the Academy of Pharmaceutical Physicians and Investigators) and Vice President of Strategic Planning the National Alliance for the Mentally Ill (NAMI), Delaware Chapter. Jean L. Rouleau, M.D., is the Scientific Director of the Institute of Circu- latory and Respiratory Health of the Canadian Institutes of Health and Research (CIHR). Dr. Rouleau was Dean of the University of Montreal’s Faculty of Medicine from 2003 to 2010. He practices cardiology at the Montreal Heart Institute. He has also served as a member of the CIHR

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114 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Governing Council from 2005 to 2010. A respected cardiologist and world- famous researcher, Dr. Rouleau previously taught at the University of Toronto and served as Director of the Cardiac Program and the Cardiol- ogy departments at Toronto’s University Health Network (UHN) and at Mount Sinai Hospital from 1999 to 2003. With experience in many university hospitals, Dr. Rouleau possesses a vast understanding of the worlds of teaching, research, and care settings. He earned his M.D. degree from the University of Ottawa and completed his clinical training at McGill University followed by postdoctoral research in San Francisco. Dr. Rouleau has published over 355 scientific articles in journals such as the American Journal of Medicine, the American Journal of Cardiology, the Canadian Medical Association Journal, Lancet, and the New England Journal of Medicine. He has been awarded the Canadian Centennial Medal, the Exceptional Merit Award given by the Fonds de la Recherche en Santé du Québec (FRSQ), the Canadian Henry Friesen Award, and the Canadian Cardiovascular Society’s Career Research Achievement Award. Arthur H. Rubenstein, M.B.B.Ch., is Professor, Department of Medicine, Division of Endocrinology at the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania. Previously, Dr. Ruben - stein was the Executive Vice President of the University of Pennsylvania for the Health System and Dean of the Raymond and Ruth Perelman School of Medicine from September 2001 to July 2011. Together, these entities make up Penn Medicine, a $3.6 billion enterprise dedicated to the related missions of medical education, biomedical research, and excel - lence in patient care. Founded in 1765, Penn’s Perelman School of Medi- cine received over $397.4 million in NIH research funds in fiscal year 2010. With 1,823 full-time faculty and nearly 3,000 students, trainees, residents, and fellows, the school is recognized worldwide for its superior educa- tion and training of the next generation of physician-scientists and lead- ers of academic medicine. The University of Pennsylvania Health System (UPHS) includes its flagship hospital, the Hospital of the University of Pennsylvania (HUP); Pennsylvania Hospital, the nation’s first hospital; Penn Presbyterian Medical Center; and Penn Medicine at Rittenhouse. In addition, it encompasses a primary care provider network, a faculty practice plan, home care, hospice, and nursing home and three multispe- cialty satellite facilities. Before joining Penn, Dr. Rubenstein served for four years as Dean of Mount Sinai School of Medicine and Gustave L. Levy Distinguished Professor. Earlier, he was the Lowell T. Coggeshall Distinguished Service Professor of Medical Sciences and Chairman of the Department of Medicine at the University of Chicago Pritzker School of Medicine. Dr. Rubenstein is an internationally prominent endocrinologist recognized for clinical expertise and groundbreaking research in dia-

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115 APPENDIX B betes. Well known for his inspired teaching, Dr. Rubenstein has served in numerous professional leadership positions during his career. These include President of the Association of Professors of Medicine, President of the Association of American Physicians, President of the Central Soci - ety for Clinical Research, Chairman of the American Board of Internal Medicine, Chairman of the Board of the Association of Academic Health Centers, and Chair of the National Diabetes Advisory Board. He has been a member of a study section and of the Advisory Council of the National Institute of Diabetes and Digestive and Kidney Diseases. Author of more than 350 publications, Dr. Rubenstein has held editorial advisory posi - tions with several respected journals, including service on the editorial boards of the Annals of Internal Medicine, the Journal of Diabetes and Its Complications, Medicine, and Clinical Trials Advisor. He was also a con- sulting editor to the Journal of Clinical Investigation. Dr. Rubenstein is the recipient of many awards and prizes, including the highest honor from the Association of Professors of Medicine, the Robert H. Williams Distin- guished Chair of Medicine Award. Among his other honors are the John Phillips Memorial Award from the American College of Physicians; the Banting Medal from the American Diabetes Association; and the David Rumbough Scientific Award from the Juvenile Diabetes Association. In 2009, Dr. Rubenstein was awarded the prestigious Abraham Flexner Award for Distinguished Service to Medical Education from the Associa - tion of American Medical Colleges. Born in South Africa, Dr. Rubenstein received his medical degree from the University of the Witwatersrand in Johannesburg. In 2001, he was honored by his alma mater when an honor- ary degree, Doctor of Science in Medicine, was conferred upon him. He is a Fellow of the College of Medicine of South Africa and of the Royal College of Physicians of London; a Master of the American College of Physicians; American Academy of Arts and Sciences; and a member of the IOM of the National Academy of Sciences. Richard A. Rudick, M.D., Professor of Medicine, Cleveland Clinic Lerner College of Medicine Hazel Prior Hostetler Chair of Neurology, Cleveland Clinic Director, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Vice Chairman, Research and Development in the Neurological Institute, Cleveland Clinic. Dr. Rudick graduated from Case Western Reserve University School of Medicine in 1975. Following internship and residency in medicine at the University of Connecticut, Dr. Rudick trained in neurology at the University of Rochester. During a postdoctoral research fellowship in the Center for Brain Research at the University of Rochester, studies focused on neurologic consequences of immune complex disease in animal systems and immunologic abnormali- ties in multiple sclerosis (MS) patients. Dr. Rudick’s subsequent studies

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116 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE on cerebrospinal fluid in MS were supported by an NIH clinical investi- gator career development award. In 1987, Dr. Rudick became Director of the Mellen Center. He has played key roles in several MS clinical trials, including pivotal registration trials of IFNb-1a (Avonex) and natalizumab (Tysabri) for relapsing remitting MS. He continues studies on immuno- logic changes in MS patients, has led development of new clinical and imaging measures for MS trials, and maintains a consultative clinical practice at the Mellen Center. Dr. Rudick has maintained continuous com- petitive grant funding from NIH and National Multiple Sclerosis Society for over 25 years. In addition to being Director of the Mellen Center, Dr. Rudick is Vice Chairman of Research and Development in the Neuro - logical Institute and Co–Principal Investigator of a citywide Clinical and Translational Science Collaborative. Kevin A. Schulman, M.D., M.B.A., is a professor of medicine and the Gregory Mario and Jeremy Mario Professor of Business Administration at Duke University. He is an associate director of the Duke Clinical Research Institute at the Duke University School of Medicine. At Duke’s Fuqua School of Business, he serves as director of the Health Sector Manage - ment Program, the Master of Management in Clinical Informatics, and the Center for the Study of Health Management. His other university affiliations include the Trent Center for Bioethics, Humanities and His - tory of Medicine; the Duke Translational Research Institute Pilot Project Advisory Committee; and the Duke Global Health Institute. Dr. Schulman is a distinguished researcher who has received more than $34 million in research grants. His research interests include health services research and policy, including access to care and the impact of reimbursement and regulatory policies on clinical practice; health economics and economic evaluation in clinical research; and medical decision making, especially in patients with life-threatening conditions. He regularly teaches courses in biotechnology, health policy, and health IT strategy. Dr. Schulman has published more than 350 papers and book chapters; his peer-reviewed articles have appeared in the New England Journal of Medicine, the Journal of the American Medical Association, and Annals of Internal Medicine. He is a member of the editorial/advisory boards of the American Journal of Medicine, the American Heart Journal, Health Services Research, and Value in Health. A recipient of numerous awards, Dr. Schulman is a fellow of the American College of Physicians and an elected member of the American Society for Clinical Investigation. He has served as session chair and panelist at dozens of medical and health care conferences. Dr. Schulman has also served on numerous grant review committees for the NIH, the Robert Wood Johnson Foundation, and other bodies. He is a member of the advisory board for the Centre for Healthcare Policy and Management

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117 APPENDIX B at the China Europe International Business School. In 2010–2011, he was a mentor for the Commonwealth Fund’s Harkness Fellowships in Health Care Policy and Practice. He is a voting member of the Medicare Evi- dence Development and Coverage Advisory Committee. Dr. Schulman received his M.D. from the New York University School of Medicine and his M.B.A., with a concentration in health care management, from the Wharton School of the University of Pennsylvania. He completed a residency in internal medicine at the Hospital of the University of Penn - sylvania and is board certified in internal medicine. Heather M. Snyder, Ph.D., assists with oversight of the Alzheimer’s Association International Research Grant Program, the world’s largest nonprofit initiative to advance Alzheimer’s research. Since 1982, the Association has committed $292 million to more than 2,000 best-of-field investigators worldwide. In addition to assisting with smooth review of proposals and distribution of awards to successful applicants, Dr. Snyder assumes primary responsibility for metrics and qualitative assessments to enhance the program’s effectiveness and impact, and for communi- cating program results to a wide range of audiences. After earning an undergraduate degree in biology and religious studies at the University of Virginia, Dr. Snyder moved on to graduate and postgraduate studies in Chicago, completing her Ph.D. at Loyola University Chicago Stritch School of Medicine and a postdoctoral fellowship at Children’s Memorial Research Center of Northwestern University. Scott J. Steele, Ph.D., M.A., serves as the Director of Research Alliances at the University of Rochester. In this role he fosters strategic research partnerships between the University’s research community and indus - try, government agencies and laboratories, and other academic institu - tions. He is actively involved with the University of Rochester Clinical and Translational Science Institute, serving as the Director of the Public– Private–Partnerships Key Function. Additionally, he holds an adjunct appointment in the Department of Community and Preventive Medi- cine. Prior to joining the University of Rochester, Dr. Steele served in the White House Office of Science and Technology Policy (OSTP), initially as a policy analyst and later designated as the Executive Director of the President’s Council of Advisors on Science and Technology (PCAST). Dr. Steele coordinated PCAST studies addressing issues in personalized med- icine, nanotechnology, energy technologies, and approaches to enhance university–private sector research partnerships. Previously, Dr. Steele served as a senior policy specialist and intelligence analyst at the Federal Bureau of Investigation (FBI), within the FBI’s Weapons of Mass Destruc- tion program. Dr. Steele received his B.S. with honors in biology from

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118 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Union College in Schenectady, New York. Following this, he performed research at the General Electric Center for Research and Development and was a fellow at NIH in Bethesda, Maryland. Dr. Steele completed his M.A. and Ph.D. in molecular biology at Princeton University. Janet Tobias is a technology/media executive specializing in health care, and an Emmy Award–winning director/producer/writer. Ms. Tobias started her career at CBS’ 60 Minutes as Diane Sawyer’s associate pro- ducer. At 60 Minutes she distinguished herself working on a wide range of domestic and international stories including a portrait of the Yakuza, the Japanese organized crime syndicate, and investigations into the lack of regulation in infertility treatment and the abuse of boys in a Guatemalan orphanage. Ms. Tobias moved with Ms. Sawyer to ABC News to launch Prime Time Live. At ABC she produced and directed both domestic and international stories ranging from a case study of organ donation to a portrait of the Kuwaiti royal family after the first Gulf War. After a short stint away from the networks to write a feature film screenplay, Ms. Tobias returned to NBC and moved into management at Dateline NBC. As a national producer at Dateline NBC, she supervised pieces on medical ethics and the home health care industry. She also continued to produce and direct her own stories, ranging from a historical look back at Soviet misinformation campaigns to an investigation into oil development in the Ecuadoran rainforest. Ms. Tobias left NBC News to become an Execu - tive Producer at VNI (which became New York Times Television). There she supervised the production of a foreign news show and reporting on a variety of foreign stories including an award-winning piece on rape as a war crime in Rwanda that appeared on Nightline. Ms. Tobias then returned to ABC News to head up editorial activities at its newly created Law and Justice Unit where she reported, directed, and supervised legal and criminal justice stories for all ABC news programs: Nightline, 20/20, World News Tonight, and Good Morning America. In 1998 Ms. Tobias began working as an executive with PBS, where she developed and produced programming not only for PBS but also joint projects with ABC and Discovery. She continued her directing and writing career, winning two American Bar Association silver gavels for a 4-hour Frontline/Nightline project on the juvenile justice system in California. In 2001, she launched Life 360, a weekly PBS series hosted by Michel Martin that combined doc- umentary pieces with dramatic and comic monologues. Life 360 launched just after 9/11 to laudatory reviews and won an Emmy in its first season. It was also one of two programs picked to pilot interactive television at PBS. In 2001, Ms. Tobias founded her own television/film production company, Sierra/Tango Productions. Sierra/Tango has produced over a dozen documentaries on social issues ranging from medical ethics to the

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119 APPENDIX B life of teenagers in America. Currently, Ms. Tobias is directing a film for worldwide theatrical release, and television broadcast, on the longest ever recorded uninterrupted survival underground in a cave. In addition to her National Emmy and American Bar Association awards, other awards include two Cine Golden Eagles, the George Foster Peabody Award, two Casey medals for meritorious journalism, a National Headliner Award, a Sigma Delta Chi Award, and honorable mention Robert F. Kennedy Journalism and Overseas Press Awards. Ms. Tobias is a member of the Writers Guild of America. In 2002, Ms. Tobias moved into the technology world full time when she joined Sawyer Media Systems, a Sequoia Capital backed creator of video technology for the web. Ms. Tobias was a member of the executive committee at Sawyer Media Systems, where she super- vised the web design and video teams. Cisco Systems bought the video portal Sawyer developed and incorporated it into their technical offerings. In 2004, Ms. Tobias was one of the founding partners of Ikana Media, now Ikana Health. In 2009, Ms. Tobias became the CEO of Ikana Health, which focuses on the mobile web, social media, and video as it relates to health care information and outcomes. Clients include AARP, Babycenter. com, Johnson & Johnson, St. Luke’s Roosevelt Hospital, Mount Sinai School of Medicine, Cisco Systems, Time Inc., and WGBH. A graduate of Yale University, Ms. Tobias served from January to September 2009 as a senior fellow at the University of British Columbia, Sauder School of Business Centre for Sustainability and Social Innovation. In 2009, she was appointed to the Forum on Drug Discovery, Development, and Trans- lation of the IOM, National Academy of Sciences. In 2010, Ms. Tobias became an adjunct assistant professor of Medicine in the Department of Health Evidence and Policy at Mount Sinai School of Medicine. Neil J. Weissman, M.D., FACC, is President of MedStar Health Research Institute, Professor of Medicine at Georgetown University School of Medi- cine, and he directs the Cardiovascular Core Laboratories at Washington Hospital Center in Washington, DC. Dr. Weissman’s research interests include valvular heart disease, left ventricular remodeling, and intra- vascular imaging. His ultrasound core laboratory has served as a site for over 150 multicenter trials, including multiple studies on pharmacologic effects of valvular and ventricular function, prosthetic valve assessments, and intracoronary therapies. Additionally, Dr. Weissman has served as principal investigator (PI) for numerous national and international multi- center trials; he recently was the national PI on a series of cardiac safety studies with over 8,000 participants. Dr. Weissman has published hun- dreds of abstracts and original reports in such well-regarded journals as the New England Journal of Medicine, the Journal of the American Medical Association, Annals of Internal Medicine, the American Journal of Cardiology,

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120 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE the American Heart Journal, and the Journal of the American College of Cardi- ology. He also has written several review articles and book chapters and wrote a textbook on cardiac imaging. Dr. Weissman received his medical degree from Cornell University Medical College in New York City. He then completed his internship, residency, and chief residency in internal medicine at the New York Hospital in New York City. He followed his residency training with a clinical and research fellowship in cardiology and a fellowship in cardiac ultrasound at Massachusetts General Hospital in Boston, Massachusetts. Prior to moving to the Washington Hospi- tal Center, he was the director of the clinical echo lab at Georgetown University. Dr. Weissman is internationally recognized as an expert in car- diac ultrasound and served on several national organizations, including Chair of the Guidelines and Standards, Board of Directors and Executive Committee of the American Society of Echocardiography, Chair of the Program Committee for Imaging for the American College of Cardiology, and Chair of the Scientific Sessions for the American Society of Echo- cardiography. Dr. Weissman is often an invited expert on FDA Advisory Committee and NIH commissions. Alastair J. J. Wood, M.D., was Professor of Medicine and Pharmacol- ogy, Assistant Vice Chancellor and Associate Dean at Vanderbilt Medical School before being appointed Emeritus Professor of Medicine and Emeri- tus Professor of Pharmacology in 2006. His current academic appoint - ments are Professor of Medicine and Professor of Pharmacology at Weill Cornell Medical College, New York. He is a Partner at Symphony Capital LLC, a New York–based Private Equity Company. Dr. Wood is a mem- ber of the National Academy of Sciences IOM, the American Associa- tion of Physicians (AAP), the American Society for Clinical Investigation (ASCI), Honorary Fellow, American Gynecological and Obstetrical Soci - ety (AGOS), and Fellow of the American College of Physicians. Dr. Wood served on the New England Journal of Medicine Editorial Board and was the NEJM Drug Therapy Editor for many years. He authored the chap- ter in Harrison’s Principles of Internal Medicine on Adverse Drug Reactions from the 9th through the 15th edition. He was the chairman of the FDA’s Nonprescription Drugs Advisory Committee until 2006, and chaired the 2005 FDA Advisory Committee on Cox-2 inhibitors. He previously served as a member of the Cardiovascular and Renal Advisory Committee of FDA and the FDA’s Nonprescription Drugs Advisory Committee. His research interests have been focused on understanding the mechanisms for interindividual variability in drug response and toxicity. His research has resulted in over 300 articles, reviews, and editorials.

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121 APPENDIX B Janet Woodcock, M.D., is the Director of the Center for Drug Evaluation and Research (CDER) at FDA. She also served as CDER Director from 1994 to 2005. Dr. Woodcock has held various positions within the Office of the Commissioner, FDA, from October 2003 to April 1, 2008. Prior to her 2008 reappointment to CDER, she served as Deputy Commissioner for Operations and Chief Operating Officer, where she was responsible for overseeing agency operations and crosscutting regulatory and scientific processes. She previously served in other positions at FDA, including Director, Office of Therapeutics Research and Review, and Acting Deputy Director, Center for Biologics Evaluation and Research. Dr. Woodcock received her M.D. from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California, San Francisco. She joined FDA in 1986. Clyde W. Yancy, M.D., M.Sc., FACC, FAHA, MACP, is the newly appointed Chief of Cardiology at Northwestern University, Feinberg School of Medicine, and Associate Director of the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital. He holds the Magerstadt Endowed Professor of Medicine Chair. Formerly he was the Medical Director, Baylor Heart and Vascular Institute at Baylor University Medi- cal Center in Dallas, Texas, and Chief of Cardiothoracic Transplantation at Baylor University Medical Center, Dallas, Texas. He is board certified in internal medicine with a subspecialty in cardiovascular disease. He is a Fellow of the American College of Cardiology, a Fellow of the American Heart Association (AHA), and a Master of the American College of Physi- cians. He is also a member of the International Society of Heart and Lung Transplantation (ISHLT), the American Society of Hypertension (ASH), the Heart Failure Society of America (HFSA), and the Association of Black Cardiologists (ABC). He has previously served on the Executive Council of the HFSA, is past chair of the Education Committee of the HFSA, and past chair the Council of Clinical Cardiology’s Heart Failure and Trans- plantation Sub-Committee of the AHA. Dr. Yancy has served two terms on the national Board of Directors for the AHA and was recognized as the AHA National Physician of the Year in 2003. He sits on the ACC/AHA Guideline Writing Committee for chronic heart failure and is a member of the ACC Guideline Taskforce which oversees all ACC/AHA guidelines. In 2009–2010, he served as President of the American Heart Association. Peter Paul Yu, M.D., is in clinical practice at the Palo Alto Medical Foun- dation (PAMF), a multispecialty medical group serving the San Francisco Bay area. Dr. Yu is Director of Cancer Research at PAMF and gradu-

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122 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE ated from the combined undergraduate and medical school program in medicine at Brown University. His residency was at St. Luke’s-Roosevelt Medical Center in New York City, where he was Chief Resident. After a fellowship at Mount Sinai Medical Center, Dr. Yu completed a post- doctoral fellowship at Memorial Sloan-Kettering Cancer Center in the laboratory of Dr. John Mendelsohn. He is board certified in both medical oncology and hematology. He has served as President of the Association of Northern California Oncologists, Chief of Medicine at El Camino Hos - pital in Mountain View, member of the Board of Directors of Pathways Homecare and Hospice, and is a member of the Audit Committee of the Cancer and Leukemia Group B (CALGB). He is currently a member of the board of directors of the American Society of Clinical Oncology (ASCO) and Chair of the ASCO HIT Work Group. Past ASCO activities have included Chair of the Clinical Practice Committee; member of the Cancer Research, Information Technology, Grant Selection, Audit and Nominating Committees; Chair of the Best of ASCO San Francisco 2005; Chair ASCO EHR Symposium 2009; Annual Meeting Educational Session Chair 2007, 2009, and 2010; and faculty of the Clinical Trials for the Com - munity Oncology Team Workshop 2005. Dr. Yu has served as co-chair of the Commission for Certification of Health Information Technology (CCHIT) Oncology work group, co-chair of the AMA-RAND Clinical Decision Support Oncology work group under contract to the Office of the National Coordinator for Health Information Technology, and co-chair of the ASCO-NCI CORE project, and has participated in several IOM health information technology workshops.