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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Appendix F Speaker Biographies Christie M. Ballantyne, M.D., is director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center; chief of the Section of Atherosclerosis and Vascular Medicine, interim chief, Section of Cardiology, Department of Medicine, Baylor College of Medicine; director of the Maria and Alando J. Ballantyne, M.D., Atherosclerosis Laboratory; professor of medicine with a joint appointment in Pediatrics, Baylor College of Medicine; and codirector, Lipid Metabolism and Atherosclerosis Clinic, The Methodist Hospital, Houston, TX. He received his Doctor of Medicine from Baylor College of Medicine, and his postgraduate training included an internal medicine residency at The University of Texas Southwestern Medical School, a cardiology fellowship at Baylor College of Medicine, and an American Heart Association (AHA)/Bugher Foundation Fellowship at the Howard Hughes Medical Institute and Institute for Molecular Genetics at Baylor. Dr. Ballantyne is a Fellow of the American Association for the Advancement of Science, member of the American Society for Clinical Investigation, Fellow of the American College of Cardiology (ACC), and Fellow of the American College of Physicians. He previously served as governor of the Texas Chapter of the ACC and president of the Houston Chapter of the AHA. Dr. Ballantyne has been the recipient of numerous study grants, including an AHA Established Investigator Award and several National Institutes of Health (NIH) grants to study leukocyte–endothelial adhesion molecules and novel biomarkers for atherosclerosis. He has been a member of numerous steering committees for multicenter trials, including the Atherosclerosis
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Risk in Communities (ARIC) study, Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT), A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID), National Cholesterol Education Program Evaluation Project Utilizing Novel E-Technology II (NEPTUNE II), and Effect of Niacin ER/Lovastatin on Peak Walking Time and Claudication Onset Time in Patients with Intermittent Claudication (ICPOP). He has also participated as a member of several data and safety monitoring boards and is editorial director for www.lipidsonline.org. He has published extensively and has spoken nationally and internationally on lipids, atherosclerosis, and inflammation. Dr. Ballantyne’s research interests include the pathophysiology of atherosclerosis, with an emphasis on monocyte activation and adhesion. His clinical interests include preventive cardiology, lipids, metabolic syndrome, atherosclerosis, genetics, and coronary artery disease. Joseph Bonventre, M.D., Ph.D., received his M.D. and Ph.D. (Biophysics) from Harvard University. Dr. Bonventre is the Robert H. Ebert Professor of Medicine and Health Sciences and Technology at Harvard Medical School. He is director of the Renal Division at Brigham and Women’s Hospital. His research involves investigating the mechanisms of cellular and tissue injury and repair, particularly as applied to ischemic injury to the kidney. H. Bryan Brewer, Jr., M.D., is the director of Lipoprotein and Atherosclerosis Research at the Cardiovascular Research Institute at Washington Hospital Center in Washington, DC. He was formerly chief of the Molecular Disease Branch at the National Heart, Lung, and Blood Institute (NHLBI) of the NIH, a position he held from 1976 until 2005. Dr. Brewer’s research led to the elucidation of the first published sequences for the human plasma apolipoproteins, the initial determination of the metabolism of the plasma apolipoproteins in normal and hyperlipidemic individuals, as well as the identification of multiple gene defects leading to the genetic dyslipoproteinemias. More recently, he has pioneered the use of transgenic mice and rabbits, as well as recombinant adenovirus vectors to identify genes that modulate lipoprotein metabolism and the development of atherosclerosis. Dr. Brewer received his M.D. from Stanford University School of Medicine. After completing his internship and residency in Internal Medicine at Massachusetts General Hospital, he joined NHLBI. He served as a member of the Board of the National Cholesterol Education Program, which established treatment guidelines for patients with hyperlipidemia in the United States. As a recipient of the J.D. Lane Investigator Award from the U.S. Public Health Service,
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Dr. Brewer also received the Heinrich Wieland Prize from the Federal Republic of Germany; the Public Health Service Commendation, Meritorious Service, and Distinguished Service Medals from the NIH; the George Lyman Duff Memorial Commendation Award Lecture; and the Robert I. Levy Award. Dr. Brewer has published more than 450 original manuscripts and 75 reviews and book chapters on the subjects of genetic dyslipoproteinemias, lipoprotein metabolism, and atherosclerosis. He has served on the boards of several prestigious journals and is currently on the editorial board of the Journal of Biological Chemistry. James de Lemos, M.D., is the director of the Coronary Care Unit at Parkland Memorial Hospital and the director of the Cardiology Fellowship at the University of Texas Southwestern Medical School in Dallas, Texas. He is an associate professor of medicine and holds the J. Fred Schoelkopf Endowed Chair in Cardiology. He is an active investigator in the Donald W. Reynolds Cardiovascular Research Center at University of Texas Southwestern, and remains closely affiliated with the Thrombolysis in Myocardial Ischemia research group. His primary research interest is risk assessment and management of acute and chronic coronary artery disease. His other research interests include electrocardiography as a means of assessing the coronary microcirculation after thrombolysis or percutaneous coronary intervention, and the use of novel biomarkers for prognostic assessment among patients with coronary artery disease. He has worked extensively with novel biomarkers such as B-type natriuretic peptide, Monocyte Chemoattractant protein-1, and soluble CD40 ligand. He was recently the lead author of the Z phase of the A to Z trial, an international trial investigating different cholesterol-lowering strategies in patients with acute coronary syndromes. He graduated from Harvard Medical School and completed an Internal Medicine Residency at the University of Texas Southwestern Medical Center, where he also served as chief medical resident. He completed a Fellowship in Cardiovascular Medicine at Brigham and Women’s Hospital, and served on the faculty of Brigham and Women’s Hospital and Harvard Medical School before moving to University of Texas Southwestern Medical School. He has served on multiple committees of the AHA and ACC and is on the editorial board of the American Journal of Cardiology and the American Heart Journal. He has authored or coauthored over 150 manuscripts or book chapters and won several teaching awards. David Dilts, Ph.D., M.B.A., is director of Clinical Research for the Knight Cancer Institute and professor of Healthcare Management at the Oregon Health & Science University. Currently, he is on leave as a joint professor of Management and Engineering Management in the Owen Graduate
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease School of Management and the Vanderbilt University School of Engineering. He is director of Engineering Management Program and is codirector of the Center for Management Research in Healthcare. This center, funded in part by the National Cancer Institute (NCI), WebMD, and others, has as its primary mission the exchange of knowledge between management and health care to dramatically impact the practice of medicine. One research stream, funded by the NCI, is to apply management principles to significantly reduce the time and steps required to open oncology clinical trials. This research has completed in-depth examinations of four NCI-designated Comprehensive Cancer Centers, two major oncology cooperative groups, the NCI Cancer Therapy Evaluation Program, and the NCI Centralized Institutional Review Board. His work has been published in more than 160 articles, conference papers, presentations, book chapters, books, and monographs. This research has been supported by grants totaling nearly $10 million in the past decade. Philip Greenland, M.D., is director of the Northwestern University Clinical and Translational Sciences Institute and Principal Investigator of Northwestern University’s NIH-funded Clinical and Translational Science Award. He holds the Harry W. Dingman Professorship (Endowed Chair) in Preventive Medicine and was chair of the Department of Preventive Medicine at Northwestern University from 1991 to 2005. In 2005, he was appointed senior associate dean for Clinical and Translational Research at Northwestern’s Feinberg School of Medicine. Dr. Greenland holds a B.A. from Williams College in Massachusetts and an M.D. from the University of Rochester School of Medicine and Dentistry. Following postgraduate education in Internal Medicine and Cardiology, Dr. Greenland was an assistant and associate professor in the Departments of Medicine, Preventive and Community Medicine, and Psychiatry at the University of Rochester from 1980 to 1991. In 1989–1990, Dr. Greenland was visiting professor of Cardiology at the Henry Neufeld Cardiovascular Institute at Tel-Hashomer Hospital, Tel-Aviv University, Israel. In 1999–2000, he served as visiting professor in the Department of Preventive Medicine at the Brigham and Women’s Hospital, Harvard Medical School, Boston. From 2004–08, Dr. Greenland was editor of the Archives of Internal Medicine. He has also served on the editorial boards of Journal of the American Medical Association (JAMA), American Journal of Epidemiology, and Journal of Cardiovascular and Pulmonary Rehabilitation. He is a current member of the scientific advisory board of Science—Translational Medicine. Dr. Greenland’s research work is notable in three primary areas. He and his colleagues have demonstrated the substantial role of traditional cardiovascular risk factors in long-term cardiovascular risk assessment. His JAMA paper in 2003 has been recognized as an “ISI Classic,” a highly
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease cited paper in clinical medicine, for its key role in addressing the long-held myth that only 50 percent of patients with cardiovascular disease have traditional risk factors present. Other papers by Greenland and colleagues have demonstrated the long-lasting and overwhelming effect of traditional cardiovascular risk factors for long-term risk prediction. Greenland’s research was also among the first to show that cardiovascular risks after myocardial infarction are different in women and men. His 1991 paper, cited more than 300 times, inaugurated the field of research on heart disease outcomes in women. He is also regarded as a leader in the selective use of cardiovascular imaging, especially coronary calcium measurement by cardiac computed tomography, in global cardiovascular risk assessment. His 2004 JAMA paper on this topic has been recognized as the leading paper in this area, cited more than 200 times. He has chaired or cochaired multiple guidelines panels dealing with risk assessment in cardiovascular disease. Dr. Greenland is a member of the NHLBI Board of External Experts and a member of the NHLBI Monitoring Board for the Framingham Heart Study. He previously served on the NIH Study Section on Cardiovascular and Sleep Epidemiology. He currently chairs the ACC–AHA Guidelines Panel on Assessment of Cardiovascular Risk in the Asymptomatic Individual, and he is a member of the NHLBI Cardiovascular Prevention Guidelines Panel. Dr. Greenland has served as a reviewer of several Institute of Medicine reports, most recently the report on medical effects of the Gulf War. James T. Mayne, Ph.D., DABT, has more than 20 years of pharmaceutical industry experience, including scientific and managerial leadership roles in Drug Safety and Regulatory Affairs for Pfizer, Inc. Currently, he is the senior director of Regulatory Strategy and Policy for Pfizer’s Global Research & Development. In addition to contributions at the project and portfolio levels, he was instrumental in the development and implementation of genomics, proteomics, and metabonomics investigative and biomarker capabilities at Pfizer. More recently Dr. Mayne has worked both internal and external to Pfizer on regulatory strategy and regulatory policy issues, including biomarker development and qualification, drug-induced liver injury, and biotherapeutics development. He has published over 25 original research and review articles on topics related to biomarkers, drug safety, and drug development, and holds of three U.S. and international patents. Dr. Mayne received his Ph.D. and postgraduate training in Comparative Toxicology at Cornell University. He is a past guest lecturer in Safety Risk Assessment and Risk Management at Northeastern University and Yale University, and is currently on the faculty of the Harvard–Massachusetts Institute of Technology Clinical Investigator Training Program, where he provides practical insight into safety assess-
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease ment and drug development strategies in pharmaceutical research and development. Professional activities include membership in the Drug Information Association, Society of Toxicology, and New York Academy of Sciences, and certification by the American Board of Toxicology. Rebecca Miksad, M.D., M.P.H., is engaged in health services and outcomes research as an attending gastrointestinal oncologist at Beth Israel Deaconess Medical Center (BIDMC) and as a senior scientist at the Institute for Technology Assessment at Massachusetts General Hospital. Her research has been supported by a Young Investigator Award from the American Society of Clinical Oncology. Her current and past research support includes the Timely Special Opportunity Award from the Dana-Farber Cancer Institute, the NIH Loan Repayment Program, and the Clinical Research Feasibility Fund Award from BIDMC. Recent awards include the Lee Lusted Prize for outstanding research from the Society for Medical Decision Making and the Clinical Research Award from the Eastern Cooperative Oncology Group. Dr. Miksad received her B.A. in economics from Harvard University, an M.D. with honors in research from Cornell University, and an M.P.H. from Harvard University. She completed her internal medicine residency at New York-Presbyterian Hospital and her Hematology/Oncology fellowship at BIDMC. She completed the NCI-funded post-doctoral fellowship in the Dana-Farber/Harvard Cancer Center Program in Cancer Outcomes Research Training (PCORT). Dr. Miksad’s research goals are to improve oncology treatment decision making through better characterization of cancer patient outcomes, improved accuracy of clinical endpoints, assessment of the economic implications of cancer therapy and application of decision analysis tools. Arthur Schatzkin, M.D., M.P.H., Dr.P.H., received his B.A. from Yale University, his M.D. from the State University of New York Downstate College of Medicine, and an M.P.H. and Dr.P.H. from Columbia University School of Public Health. He completed residency training in Internal Medicine at Montefiore Hospital in the Bronx, NY. and Preventive Medicine at Mount Sinai Medical Center in Manhattan.. In 1984 he joined the National Cancer Institute, where he is currently chief of the Nutritional Epidemiology Branch, Division of Cancer Epidemiology and Genetics. Dr. Schatzkin’s research in recent years has focused on prospective cohort studies of diet and cancer, with an emphasis on improving exposure assessment methods for investigating long-standing, but as yet unresolved, hypotheses (e.g., dietary fat versus breast cancer, fiber and fruits and vegetables versus colorectal cancer). He is a Principal Investigator for the NIH–AARP Diet and Health Study, a prospective cohort study of
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease diet and cancer among more than a half million U.S. men and women; the Polyp Prevention Trial, an intervention study of the effect of a low-fat, high-fiber, fruit- and vegetable-enriched diet on colorectal adenoma recurrence, and the Observing Protein and Energy Nutrition (OPEN) study, a biomarker-based investigation of the measurement error structure of dietary assessment instruments. He is currently exploring Internet- and metabolomics-based approaches to assessing nutrition–cancer relations in large prospective studies. Robert Temple, M.D., is director of the Office of Medical Policy of the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) and is also acting director of the Office of Drug Evaluation I (ODE-I). He has served in this capacity since the office’s establishment in 1995. Dr. Temple received his M.D. from the New York University School of Medicine in 1967. In 1972 he joined CDER as a review medical officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of director of the Division of Cardio-Renal Drug Products. In his current position, Dr. Temple oversees ODE-1, which is responsible for the regulation of cardio-renal, neuro-pharmacologic, and psychopharmacologic drug products. He also oversees The Office of Medical Policy, which is responsible for regulation of promotion through the Division of Drug Marketing, Advertising, and Communication and for assessing the quality of clinical trials. Dr. Temple has a long-standing interest in the design and conduct of clinical trials and has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose–response, and trials using “enrichment” designs. Aliza Thompson, M.D., M.S., is a medical officer in the Division of Cardiovascular and Renal Products of the FDA. She received her M.D. from Johns Hopkins University and completed her Internal Medicine and Nephrology training at Columbia University/New York-Presbyterian Hospital. She holds an M.S. in Biostatistics/Patient Oriented Research Track from the Columbia University Mailman School of Public Health. Marc K. Walton, M.D., Ph.D., is currently associate director in the Office of Translational Science at the FDA’s CDER. Dr. Walton received his graduate degrees from the University of Chicago. Later, he completed a medical internship at Rush University/Presbyterian Medical Center in Chicago, followed by a neurology residency at University of Rochester. Following residency he moved to the National Institute of Neurological Disorders and Stroke, NIH, as a Senior Staff Fellow engaging in research on the development of neurotransmitter responses in the embryonic spi-
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease nal cord. In 1993, Dr. Walton joined the Center for Biologics Evaluation and Research (CBER) at the FDA as a medical officer. His work initially focused on clinical trials of investigational biological products (proteins, monoclonal antibodies, cellular therapies, and gene transfer therapies) as potential neurotherapeutic agents. He added the clinical areas of pulmonary, cardiovascular, endocrine, and hematologic disorders to his oversight when appointed to branch chief. Dr. Walton became the division director during the transfer of the biological protein product regulatory oversight from CBER to CDER, which broadened his areas of clinical oversight to all non-oncology uses of biological proteins. A subsequent move to the Office of Policy in the Office of the Commissioner gave him involvement in a broader range of agency-wide issues. He has now moved to the Office of Translational Science in CDER, where he is involved in fostering science and policies to support new approaches to therapeutic development.