Appendix C
Committee Member and Consultant Biographies

John R. Ball, M.D., J.D. (Chair), is the executive vice president of the American Society for Clinical Pathology. He is a graduate of Emory University, received a J.D. and an M.D. from Duke University, and was a Robert Wood Johnson Clinical Scholar at George Washington University. After a residency in Internal Medicine at Duke Medical Center, he held several health policy positions within the U.S. Department of Health and Human Services and was a senior policy analyst in the Office of Science and Technology Policy in the Executive Office of the President from 1978 to 1981. From 1986 to 1994, Dr. Ball was the executive vice president of the American College of Physicians, and from 1995 to 1999 he served as president and chief executive officer of the Pennsylvania Hospital. Dr. Ball was the senior vice president and practice director of The Lewin Group’s Health Care Organizations Practice in 2000. He is also a member of the American Clinical and Climatological Association and the Society of Medical Administrators.


Michelle A. Albert, M.D., M.P.H., is an assistant professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, where she is also an associate physician and the director of behavioral and neurocardiovascular cardiology. Dr. Albert is a board-certified internist and cardiologist, with joint appointments in the Division of Cardiovascular Diseases and the Division of Preventive Medicine, Brigham and Women’s Hospital. Dr. Albert earned her M.D. from the University of Rochester School of Medicine and Dentistry, and completed her Internal Medi-



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Appendix C Committee Member and Consultant Biographies John R. Ball, M.D., J.D. (Chair), is the executive vice president of the American Society for Clinical Pathology. He is a graduate of Emory Uni- versity, received a J.D. and an M.D. from Duke University, and was a Robert Wood Johnson Clinical Scholar at George Washington University. After a residency in Internal Medicine at Duke Medical Center, he held several health policy positions within the U.S. Department of Health and Human Services and was a senior policy analyst in the Office of Science and Technology Policy in the Executive Office of the President from 1978 to 1981. From 1986 to 1994, Dr. Ball was the executive vice president of the American College of Physicians, and from 1995 to 1999 he served as president and chief executive officer of the Pennsylvania Hospital. Dr. Ball was the senior vice president and practice director of The Lewin Group’s Health Care Organizations Practice in 2000. He is also a member of the American Clinical and Climatological Association and the Society of Medical Administrators. Michelle A. Albert, M.D., M.P.H., is an assistant professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, where she is also an associate physician and the director of behavioral and neu - rocardiovascular cardiology. Dr. Albert is a board-certified internist and cardiologist, with joint appointments in the Division of Cardiovascular Diseases and the Division of Preventive Medicine, Brigham and Women’s Hospital. Dr. Albert earned her M.D. from the University of Rochester School of Medicine and Dentistry, and completed her Internal Medi- 

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 EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS cine internship, residency, and chief residency at Columbia University Presbyterian Medical Center. She then completed a clinical and research fellowship in Cardiovascular Diseases at the Brigham and Women’s Hos - pital. Dr. Albert also completed a research fellowship in Cardiovascular Epidemiology at that hospital and, during that time, earned an M.P.H. with a concentration in Epidemiology from the Harvard School of Public Health. Dr. Albert devotes approximately 3 months of the year to clinical duties and 8 months to research activities. Specifically, she is an attending physician for the clinical cardiovascular services and cardiac intensive care units at Brigham and Women’s Hospital. In these roles, her clini- cal responsibilities include care for the most critically ill cardiovascular patients. Dr. Albert’s research interest concerns the molecular and genetic epidemiology of hemostasis, thrombosis, and inflammation. A central component of her work involves cardiovascular risk prediction using novel biochemical markers in large population-based cohorts. Specifically, Dr. Albert is involved in comparative cardiovascular risk assessment in different race/ethnic groups and international populations as well as work related to the role of chronic psychological stress on cardiovascular outcome. As the Principal Investigator (PI) of a Doris Duke Clinical Scien- tist Development Award, she piloted a blood collection project to evaluate novel biochemical markers and genetic polymorphisms of cardiovascular risk among geographically diverse Black women living in the United States. Funding from the Donald W. Reynolds Foundation as an Associ- ate Investigator also supports this work. Her research time encompasses developing clinical and epidemiologic cohorts, devising clinical hypoth - eses, performing data analyses, writing manuscripts, and presenting her findings at numerous venues. Dr. Albert also teaches Harvard Medical School students and resi- dents at the Veterans Administration (VA) Medical Center and Brigham and Women’s Hospital. Dr. Albert is actively involved in several profes- sional organizations, including the Association of Black Cardiologists, American Heart Association (AHA), and the American College of Cardi - ology (ACC). Fred Apple, Ph.D., is a professor in the Department of Laboratory Medi- cine and Pathology at the University of Minnesota–Twin Cities. He also serves as the medical director of Clinical Laboratories and the Clinical Chemistry and Toxicology Laboratories at Hennepin County Medical Center. In addition, he serves as the forensic toxicology consultant to the Hennepin County Medical Examiner’s Office. Dr. Apple instructs residents and Fellows during their Chemistry and Toxicology rotations, and directs the Ph.D. Clinical Chemistry Fellowship program. Dr. Apple’s

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 APPENDIX C main research interest is the molecular mechanisms that control protein expression in ischemic, necrotic heart, and skeletal muscle. He is also involved in directing and participating in national multicenter clinical trial studies involving biochemical markers of myocardial injury. In addi- tion, Dr. Apple consults with diagnostic, medical instrument, and phar- maceutical industries in the areas of forensic toxicology, clinical toxicol - ogy, and chemistry through his limited liability company. Dr. Apple has been actively involved in National Institutes of Health (NIH), VA, and industry-sponsored research studies involving the appli- cation of cardiac, vascular, inflammatory, and ischemic biomarkers for the detection of myocardial cell damage and reperfusion injury identified as either ischemic or inflammatory. He also has an interest in risk stratifica- tion and outcomes research. In addition, he has led investigations in sports medicine that concern the biochemistry of exercise. Dr. Apple is also an active participant in studies addressing forensic/postmortem analysis of drugs and alcohol in tissues, blood, and vitreous humor. Other endeavors involve ethanol pharmacokinetics and substance testing. Additionally, Dr. Apple has participated in a number of professional societies, such as the Academy of Clinical Laboratory Physicians and Scientists, National Committee for Clinical Laboratory Standards, American Association for Clinical Chemistry, and American Board of Clinical Chemistry. Robert M. Califf, M.D., is currently vice chancellor for Clinical Research, director of the Duke Translational Medicine Institute (DTMI), and pro- fessor of medicine in the Division of Cardiology at the Duke University Medical Center. Dr. Califf’s role as director of the DTMI, which is funded in part by an NIH Clinical and Translational Science Award (CTSA), includes service as cochair of the Principal Investigators Steering Com - mittee of the CTSA. He is also the cochair of the Clinical Trials Transfor- mation Initiative, a public–private partnership focused on improving the clinical trials system. Dr. Califf graduated from Duke University, summa cum laude and Phi Beta Kappa, and from Duke University Medical School, where he was selected for Alpha Omega Alpha. He performed his internship and residency at the University of California–San Francisco and his fellow - ship in Cardiology at Duke University. He is board certified in Internal Medicine and Cardiology and is a master of the ACC. For 10 years, Dr. Califf was the founding director of the highly esteemed Duke Clinical Research Institute (DCRI). Dr. Califf led the DCRI in 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 col- laborates extensively with government agencies, the medical products industry, and academic partners around the globe in all therapeutic areas.

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0 EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS Dr. Califf occasionally provides advice to industry on specific projects pertaining to biomarkers. Additionally, Dr. Califf was the founding director of the coordinating center for the Centers for Education & Research on Therapeutics, a pub - lic–private partnership among the Agency for Healthcare Research and Quality, the Food and Drug Administration (FDA), academia, the medi - cal products industry, and consumer groups. This partnership focuses on research and education that will advance the best use of medical products. Dr. Califf is the editor-in-chief of Elsevier’s American Heart Journal, the oldest cardiovascular specialty journal. He has been author or coauthor of more than 900 peer-reviewed journal articles and a contributing editor for theheart.org, an online information resource for academic and practicing cardiologists. 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. He was recently acknowledged as one of the 10 most cited authors in the field of medicine by the Institute for Scientific Information. Dr. Califf has served on the Cardiorenal Advisory Panel of the FDA and the Pharmaceutical Roundtable of the Institute of Medicine (IOM). He served on the IOM committees that recommended Medicare cover- age of clinical trials as well as the removal of ephedra from the market and on the IOM’s Committee on Identifying 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 the FDA. Victor g. De gruttola, Sc.D., is professor and chair of the Department of Biostatistics at the Harvard School of Public Health. Dr. De Gruttola received an M.S. in Bioengineering from Harvard University. He com- pleted his M.S. in Epidemiology and his Doctorate of Science in Biosta - tistics at the Harvard School of Public Health. Dr. De Gruttola’s research activities concern developments of statistical methods required for an appropriate public health response to the AIDS epidemic. His work has been instrumental in outlining the transmission of HIV, natural history of infection with HIV, and clinical research on AIDS therapies. His work involves not only development and application of statistical methodology for analysis of data from clinical research studies and public health surveillance systems, but also medical issues surrounding HIV infection and concerns of communities most affected by the epidemic. His research goals have included forecasting future AIDS incidence, devel-

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 APPENDIX C oping strategies for clinical research on HIV infection, and evaluating the public health impact of antiviral treatment. A major focus of this research has been on the development and consequences of resistance to antiretroviral drugs. Dr. De Gruttola has also been engaged in statistical issues such as the degree to which the treatment response of HIV-related biomarkers constitute adequate evidence for clinical efficacy. Because of the lack of standard methods to assess the value of data obtained from various biological markers for predicting drug efficacy, he is interested in developing methods to understand and interpret these data. He has also worked on projections of AIDS incidence using data from the New York City Health Department. A special focus of this work was estimation of the risk that children of HIV-infected mothers would develop AIDS in the first 10 years of life using data combined from a variety of sources. Dr. De Gruttola’s current interest is in the development of methods for evaluat - ing the plausibility of achieving control of HIV in specific settings using available interventions, and evaluating the community-level impact of pilot studies of combinations of such interventions. David L. DeMets, Ph.D., is a well-known biomedical researcher and med- ical educator at the University of Wisconsin–Madison. He is a professor of Statistics and Biostatistics and chair of the Department of Biostatistics and Medical Informatics. Dr. DeMets received his Master’s and Doctoral Degrees in Biostatistics from the University of Minnesota. He then com - pleted a postdoctoral appointment within NIH, followed by 10 years at the National Heart, Lung, and Blood Institute (NHLBI), where he eventually assumed the role of chief of the Biostatistics Research Branch. Dr. DeMets developed an interest in the use of statistical methods to design, moni - tor, and analyze clinical trials. A focus of his work has been in sequential design with specific application to data interim monitoring of accumulat - ing data in an ongoing clinical trial. Dr. DeMets is a Fellow of the Interna - tional Statistics Institute, the American Statistical Association, the Society for Clinical Trials, the American College of Medical Informatics, and The American Association for the Advancement of Science. He has served on the Board of Directors for the American Statistical Association and Society for Controlled Clinical Trials. He also served terms as president of the Society for Clinical Trials and the Eastern North American Region of the Biometric Society. He has coauthored or coedited four books, titled Fundamentals of Clinical Trials, Data Monitoring Committees in Clinical Trials, and Data Monitoring in Clinical Trials: A Case Studies Approach. Dr. DeMets serves on data safety monitoring boards for industry clinical trials. Robert gerszten, M.D., is a senior associate in the Broad Institute of Harvard and the Massachusetts Institute of Technology (MIT) and asso-

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 EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS ciate professor of medicine in the Harvard Medical School. He is a PI in the Massachusetts General Hospital (MGH) Center for Immunology and Inflammatory Diseases and in the MGH Cardiovascular Research Center. Dr. Gerszten earned his M.D. Johns Hopkins University and com - pleted his residency at the University of Pennsylvania Hospital. He is board certified in Cardiovascular Disease by the American Board of Inter- nal Medicine. After completion of clinical training in Internal Medicine, Dr. Gerszten was a Postdoctoral Research Fellow in the laboratory of Dr. Shaun Coughlin in the Cardiovascular Research Institute at the University of California–San Francisco. Dr. Gerszten’s major focus in the Coughlin laboratory was the structure and function of the human thrombin recep- tor. Thereafter, he performed cardiac research with Dr. Anthony Rosen- zweig to study the molecular mechanisms of leukocyte recruitment as it relates to human inflammatory diseases, with an emphasis on cardiovas- cular diseases. Dr. Gerszten’s research focuses on the use of unbiased proteomic technologies to identify novel signals in inflammation and wound healing in cardiovascular biology. His overall goal is to identify new metabolites and proteins that mark disease activity, shed insight into disease progres - sion, and ultimately provide targets for therapeutic intervention. His research incorporates basic molecular and cell biology, chemistry and mass spectrometry, and bioinformatics, all with a foundation in clinical medicine. As a member of the Harvard–Partners Proteomics Steering Committee and the leader of a metabolomics effort at the Broad Insti- tute of MIT and Harvard, Dr. Gerszten uses emerging proteomics and metabolomics technologies to help identify novel signals derived from leukocytes, endothelial cells, or the myocardium. In ongoing translational studies, Dr. Gerszten’s lab applies these same methodologies directly to samples from well-phenotyped human cohorts to identify candidate bio - markers, which will undergo investigation to determine their functional roles. Dr. Gerszten holds pending patent applications resulting from his biomarker research. William R. Harlan, Jr., M.D., FACP, FACPM, FAAFP, FAHA, received his M.D. magna cum laude from the Medical College of Virginia and trained in Internal Medicine at Duke University and subsequently had training in Cardiology and Biochemistry at that institution. He has been a professor of medicine at Duke University, University of Alabama, Birmingham, and The University of Michigan. At these last two universities, he was also an Associate Dean within these schools of medicine. In 1987, Dr. Harlan became director of the Division of Epidemiology and Clinical Applica- tions at the NHLBI. In this position, he was responsible for the portfolio

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 APPENDIX C development and oversight of observational and interventional clinical research studies supported by the Institute. In 1991, Dr. Harlan was named associate director for Disease Prevention for NIH and charged with the development of the Women’s Health Initiative, a large multidimensional set of clinical trials and observational studies. He was also responsible for the development of the National Center for Complementary and Alterna- tive Medicine and the Office of Dietary Supplements at NIH and served as interim director of each. Dr. Harlan retired from the government in 2001 and has served as a consultant and senior advisor to the Division of Services and Intervention Research at the National Institute of Mental Health and the Office of Dietary Supplements. He has recently served as a senior consultant with the National Library of Medicine on clinical trials registration and a database of results that are part of ClinicalTrials.gov. Allan S. Jaffe, M.D., is a professor of medicine in the Cardiovascular Diseases Division with a joint appointment in the Department of Labo - ratory Medicine and Pathology at the Mayo Clinic College of Medicine. He is chair of the Division of Clinical Core Laboratory Services, which involves most of the clinical chemistry operations at the Mayo Clinic. He received his M.D. from the University of Maryland in Baltimore. He was a house officer in Internal Medicine and a Cardiology Fellow at Wash - ington University, and remained on the faculty there from 1978 to 1995. At Washington University, he was instrumental in the clinical develop - ment of the cardiac troponin I assays. When he left to become the chief of cardiology and associate chief of medicine at the State University of New York at Syracuse, where he was a full professor with an interna- tional academic reputation in the fields of acute ischemic heart disease, depression, heart disease, advanced cardiac life support, and biomarkers of cardiac injury. He was in Syracuse from 1995 to 1999, when he left to continue his academic career at the Mayo Clinic. He continues to be internationally known for his work in the areas mentioned above. He was cochair of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) trial and chair of the Biochemistry Panel of the European Society of Cardiology and ACC task force for the redefinition of myocardial infarction. Dr. Jaffe was also instrumental in composing the National Academy of Clinical Bio - chemistry and International Federation of Clinical Chemistry Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: Analytical Issues for Biomarkers of Heart Failure. He is on seven editorial boards, including Journal of the American Col- lege of Cardiology, American Journal of Cardiology, Clinical Chemistry, Clinical Proteomics, Psychosomatic Medicine, Cardiology Today, and Cardiovascular Therapeutics, and he recently rotated off the Circulation Board.

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 EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS Ronald M. krauss, M.D., is senior scientist and director of Atherosclerosis Research at Children’s Hospital Oakland Research Institute, adjunct pro- fessor in the Department of Medicine at the University of California, San Francisco and in the Department of Nutritional Sciences at the University of California, Berkeley, and guest senior scientist in the Department of Genome Sciences of Lawrence Berkeley National Laboratory. He received his undergraduate and medical degrees from Harvard University with honors and served his internship and residency on the Harvard Medical Service of Boston City Hospital. He then joined the staff of the National Heart, Lung, and Blood Institute in Bethesda, Maryland, first as clinical associate and then as senior investigator in the Molecular Disease Branch. Dr. Krauss is board-certified in internal medicine, endocrinology and metabolism, and is a member of the American Society for Clinical Inves - tigation, a Fellow of the American Society of Nutrition and the American Heart Association (AHA), and a Distinguished Fellow of the International Atherosclerosis Society. He a member of the U.S. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, founder and past chair of the AHA Council on Nutrition, Physical Activity, and Metabolism, and a National Spokesperson for the AHA. Dr. Krauss has also served on both the Com - mittee on Dietary Recommended Intakes for Macronutrients and the Committee on Biomarkers in Chronic Disease of the Institute of Medicine of the National Academy of Sciences. He has received numerous awards including the AHA Scientific Councils Distinguished Achievement Award and the Centrum Center For Nutrition Science Award of the American Society for Nutrition, and he is listed in Who’s Who in America and the World. Dr. Krauss is on the editorial boards of a number of journals, and is associate editor of Obesity. Dr. Krauss has published nearly 400 research articles and reviews on genetic, dietary, and drug effects on plasma lipo - proteins and coronary artery disease. In recent years Dr. Krauss’ work has focused on interactions of genes with dietary and drug treatments that affect metabolic phenotypes and cardiovascular disease risk. Harlan M. krumholz, M.D., S.M., is the Harold H. Hines, Jr., Professor of Medicine and Epidemiology and Public Health at Yale University School of Medicine, where he is director of the Robert Wood Johnson Clinical Scholars Program. He is also the director of the Yale–New Haven Hospital Center for Outcomes Research and Evaluation. He received his M.D. from Harvard Medical School and a Master of Science degree in Health Policy and Management at the Harvard School of Public Health. He trained in Internal Medicine at the University of California–San Francisco and in Cardiology at Beth Israel in Boston.

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 APPENDIX C Dr. Krumholz’s research is focused on determining optimal clinical strategies and identifying opportunities for improvement in the preven - tion, treatment, and outcome of cardiovascular disease, with an emphasis on underrepresented populations. Using methods of clinical epidemiol - ogy and health services research, he has sought to illuminate the balance of risks, benefits, and costs of specific clinical approaches. The research efforts are intended to provide critical information to improve the quality of health care, monitor changes over time, and guide decisions about the allocation of scarce resources. Dr. Krumholz is currently leading initiatives through the Centers for Medicare & Medicaid Services to develop national mortality measures for public reporting of hospital performance. In an effort to investigate ways that hospitals can improve outcomes through decreasing door-to-balloon times, he initiated and chairs the steering committee of D2B: An Alliance for Quality, an international campaign launched by the ACC to imple - ment key evidence-based strategies to achieve guideline-recommended door-to-balloon time. He also serves as PI on two multicenter projects sponsored by the NHLBI: (1) the VIRGO study, an investigation of issues surrounding the care and outcomes of young women with acute myocar- dial infarction; and (2) a study examining the effect of a telemonitoring strategy on the outcomes of patients with heart failure. Dr. Krumholz is a member of the Association of American Physicians, the American Society for Clinical Investigation, and the IOM. He is also the author of the book The Expert Guide to Beating Heart Disease. Maria Lopes-Virella, M.D., Ph.D., is a professor in the Department of Medicine and the Division of Endocrinology, Diabetes, and Medical Genetics at the Medical University of South Carolina (MUSC). Dr. Lopes- Virella serves as a staff physician, director of the Nutrition Support Team, and chief of the Clinical Chemistry Section of Laboratory Services at the Ralph H. Johnson VA Medical Center at MUSC. Additionally, she has a joint appointment in the Department of Immunology & Microbiology and in the Department of Pathology and Laboratory Medicine, College of Medicine. Dr. Lopes-Virella also has appointments in the Oral and Com- munity Health Sciences Division, Department of Stomatology, College of Dental Medicine at MUSC and in the Department of Bioengineering at Clemson University. She received her M.D. and doctorate degree in medicine/biochemistry from the University of Lisbon, Portugal. Thereaf - ter, she completed Internal Medicine and Clinical Pathology residencies at University Hospital in Lisbon and two fellowships (Endocrinology and Pathology) at MUSC. Her research interests are modified LDLs as biomarkers for the pro- gression of type 1 diabetes, quantity of iron stores as indicators of acute

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 EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS coronary heart disease, and the role of matrix metalloproteinases in acute coronary heart disease. Ongoing research includes a recently completed NIH/NHLBI-funded study, “Markers and Mechanisms of Macrovascular Disease in Diabetes Mellitus,” in which she studied the role of immune responses to modified lipoproteins and of inflammation in the develop - ment of micro- and macrovascular complications in large cohorts of type 1 and type 2 diabetes; a VA Merit Review-funded research project on “Lipoprotein Metabolism and Cell-Lipoprotein Interactions in Diabetes Mellitus”; and a Juvenile Diabetes Foundation International-funded grant to study biomarkers and mechanisms of nephropathy in type 1 diabetes. Dr. Lopes-Virella is a Fellow of the AHA, American College of Nutri- tion, American College of Pathology, and Council of Nutrition, Physical Activity, and Metabolism, AHA as well as the Council on Arteriosclerosis, Thrombosis, and Vascular Biology, AHA. She serves on the boards of the National Lipid Association and American Board of Clinical Lipidology. Dr. Lopes-Virella is or has been a distinguished member of a number of professional organizations, including the Southern Society for Clini- cal Investigation, Endocrine Society, American Diabetes Association, and American Federation of Medical Research. She is the recipient of numer- ous awards, including a Special Emphasis Research Career Award from the NHLBI and the National Institute of Arthritis Metabolism and Diges - tive Diseases and a VA Clinical Investigator Award. In 2006, she received the Vision 7 Henry Middleton Award for Excellence in Research. She was the recipient of the Edwin Berman Lectureship Award from the Ameri - can Diabetes Association, John A. Colwell Award for Outstanding Con - tributions to Diabetes Research from the South Carolina Affiliate of the American Diabetes Association, and the Mary Jane Kugel Award from the Juvenile Diabetes Foundation International. Dr. Lopes-Virella has served on editorial boards and peer reviews for several journals and recently became an associate editor for the Journal of Clinical Lipidology. Roberta B. Ness, M.D., M.P.H., is the dean of the University of Texas School of Public Health, M. David Low Chair in Public Health, and co-PI of the Center for Clinical and Translational Science at the University of Texas–Houston. Dr. Ness received her M.D. from Cornell University and her M.P.H., with a concentration in Epidemiology, from Columbia Univer- sity. She completed her Internal Medicine internship and residency at Bel- levue Hospital in New York City. While completing her master’s program, she participated in the NIH Training Fellowship. Her research interests are in reproductive biology and women’s health. Dr. Ness has received acclaim from her colleagues concerning her research that examined the disease origins of pelvic inflammatory disease, preeclampsia, and ovarian cancer. Throughout her career, she investigated biological markers specific

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 APPENDIX C to reproductive dysfunction. Dr. Ness published papers concerning the use of fetal fibronectin to predict ectopic and intrauterine pregnancies, endometriosis markers, and ovarian cancer biological markers. Since her formal training, she has lent her expertise to a number of organizations; she is current president of the American College of Epidemiology. She was a core member of the Early Markers of Adult Disease Workgroup and Study Assembly and codirector for the Symposium on Ovarian Cancer and High-Risk Women: Implications for Prevention, Screening, and Early Detection. She currently gives lectures concerning markers and molecular epidemiology. Jennifer Van Eyk, Ph.D., is a professor of medicine in the Division of Cardiology and crossappointed to Biological Chemistry and Biomedical Engineering at Johns Hopkins University. She earned her doctoral degree from the University of Alberta. Her research combines physiology and proteomics to provide an in-depth analysis of the molecular basis for a variety of cardiac diseases ranging from myocardial ischemia to heart fail - ure. In addition, her group develops serum/plasma biomarkers in which de novo discovery is coupled with validation. Dr. Van Eyk holds patents resulting from her biomarker research. Dr. Van Eyk has been a Canadian Heart and Stroke Foundation Scholar (1996–2001) and Heart and Stroke Career Investigator (received in 2001), in addition to receiving a Canadian Institutes of Health Research Investigator Award prior to being recruited to Johns Hopkins. Dr. Van Eyk is a Fellow of the AHA, current chair of the Genomics and Translational Science Council for the AHA, a member of the senior editorial board of Proteomics: Clinical Application, and on the editorial board of the Journal of Physiology. She was a guest editor for a series on proteomics in a number of journals and has coedited two books in this area: Proteomic and Genomic Analysis of Cardiovascular Disease and Clinical Proteomics: From Diagnosis to Therapy. John A. Wagner, M.D., Ph.D., is vice president of Clinical Pharmacology and Acting Modeling and Simulation Integrator in Strategically Integrated Modeling and Simulation at Merck & Co. Dr. Wagner is also an adjunct assistant professor in the Division of Clinical Pharmacology within the Department of Medicine at Jefferson Medical College at Thomas Jefferson University. He is a visiting clinical scientist within the Harvard–MIT Divi- sion of Health Sciences and Technology in the Center for Experimental Pharmacology and Therapeutics. He received his M.D. from Stanford University School of Medicine and his Ph.D. from Johns Hopkins Univer- sity School of Medicine. His postgraduate training is in Internal Medicine and Molecular and Clinical Pharmacology. He is chair of the Pharma-

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 EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS ceutical Research and Manufacturers of America Clinical Pharmacology Technical Group, chair of the adiponectin workgroup for the Biomarkers Consortium, and member of the board of directors for the American Society for Clinical Pharmacology and Therapeutics. His publications are in the areas of biomarkers and surrogate endpoints, experimental medi - cine, pharmacokinetics, pharmacodynamics, and drug–drug interactions across a variety of therapeutic disciplines. Dr. Wagner was coauthor on an influential perspective in Nature Reviews Drug Discovery, entitled “A cost- effectiveness approach to the qualification and acceptance of biomarkers” and a paper in Clinical Pharmacology and Therapeutics on “Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.” Elizabeth A. yetley, Ph.D., who served as the consultant to the commit- tee, is a retired government scientist. Her career spans more than 28 years of government service, including 24 years at the FDA, culminating with her appointment as lead scientist for nutrition. From 2004 until her retire- ment, she was a senior nutrition research scientist with the NIH Office of Dietary Supplements. Her leadership activities in the field of nutrition public health policy have had a considerable impact. She has been respon- sible for nutrition labeling (particularly for the development of the health claims paradigm), national food fortification programs, use of national nutrition monitoring and surveillance systems to support nutrition and food safety health policies, infant formula and medical food reviews and regulatory oversight, dietary supplement regulation, and the use of nutri - ent-related reference values in public health policy formulation. She has received more than 75 honors, commendations, and letters of recognition for her service and has served as a scientific representative for the gov - ernment to more than 50 associations, panels, and committees. She has authored or coauthored approximately 100 scientific and peer-reviewed publications. Dr. Yetley received her Ph.D. in nutrition, with a minor in biochemistry and physiology, from Iowa State University.