B

Speaker Biosketches

Jesse A. Berlin, Sc.D., is vice president of epidemiology at Johnson &Johnson Pharmaceutical Research and Development. Before moving to Johnson & Johnson, Dr. Berlin spent 15 years as a faculty member of the University of Pennsylvania in the Center for Clinical Epidemiology and Biostatistics. He is a fellow of the American Statistical Association. Dr. Berlin has served on the Institute of Medicine Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides and on the committee for the first biennial update. He has authored or coauthored over 230 publications in a wide variety of clinical and methodological areas, including papers on the study of meta-analytic methods as applied to randomized trials and epidemiology. He serves on the Scientific Advisory Committee to the Observational Medical Outcomes Partnership, a public–private partnership aimed at understanding methods for assessing drug safety in large, administrative databases. Dr. Berlin received his Sc.D. in Biostatistics from the Harvard School of Public Health.

Jeffery D. Blaustein, Ph.D., is editor-in-chief of Endocrinology and president of the Society for Behavioral Neuroendocrinology. A professor at the University of Massachusetts Amherst, Dr. Blaustein founded the Center for Neuroendocrine Studies and is director of the Neuroscience and Behavior Program. He was a charter member of the Society for Women’s Health Research Interdisciplinary Studies in Sex-differences Network on Sex, Gender, Drugs and the Brain. He is on the editorial boards of Journal of Neuroendocrinology and Frontiers in Neuroendocrinology. Dr. Blaustein has been working in behavioral neuroendocrinology for almost four decades. His major research interests



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B Speaker Biosketches Jesse A. Berlin, Sc.D., is vice president of epidemiology at Johnson & Johnson Pharmaceutical Research and Development. Before moving to Johnson & Johnson, Dr. Berlin spent 15 years as a faculty member of the University of Pennsylvania in the Center for Clinical Epidemiology and Biostatistics. He is a fellow of the American Statistical Association. Dr. Berlin has served on the Institute of Medicine Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides and on the committee for the first biennial update. He has authored or coauthored over 230 publications in a wide variety of clinical and methodological areas, including papers on the study of meta-analytic methods as applied to randomized trials and epidemiology. He serves on the Scientific Advisory Committee to the Observational Medical Outcomes Part- nership, a public–private partnership aimed at understanding methods for assessing drug safety in large, administrative databases. Dr. Berlin received his Sc.D. in Biostatistics from the Harvard School of Public Health. Jeffery D. Blaustein, Ph.D., is editor-in-chief of Endocrinology and president of the Society for Behavioral Neuroendocrinology. A professor at the University of Massachusetts Amherst, Dr. Blaustein founded the Center for Neuroendocrine Studies and is director of the Neuroscience and Behavior Program. He was a charter member of the Society for Women’s Health Research Interdisciplinary Studies in Sex-differences Network on Sex, Gender, Drugs and the Brain. He is on the editorial boards of Journal of Neuroendocrinology and Frontiers in Neuroendocrinology. Dr. Blaustein has been working in behavioral neuroendocrinology for almost four decades. His major research interests 49

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50 SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH are in the cellular processes underlying steroid hormone effects on behavior and reproductive physiology and the mechanisms by which stress and other environmental factors influence steroid hormone action in the brain. Although he has used female sexual behavior as a model for many years, he has more recently branched out into animal models of disorders of mental health. He has published over 140 articles, and his research has been funded by the National Institutes of Health and the National Science Foundation for over 30 years. Dr. Blaustein received his Ph.D. from the University of Massachusetts in 1977 and completed a postdoctoral program at Rutgers University from 1977 to 1979. Larry Cahill, Ph.D., is a professor of neurobiology and behavior at the University of California, Irvine (UCI). He received his bachelor’s degree from Northwestern University and his Ph.D. from UCI. He did postdoctoral work both at the Technical University in Darmstadt, Germany, and at UCI. He has investigated brain mechanisms of emotional memory in both animal and human subjects for over 30 years, the last 10 of which drew him into studies of sex influences on brain function, a topic that he now considers his most important field of research. He has twice been voted his school’s Outstanding Professor by the students, a fact he considers to be the finest formal honor of his career. Carolyn M. Clancy, M.D., was appointed director of the Agency for Healthcare Research and Quality (AHRQ) on February 5, 2003, and reappointed on October 9, 2009. Before her appointment, Dr. Clancy was director of AHRQ’s Center for Outcomes and Effectiveness Research. Dr. Clancy, a general internist and health-services researcher, is a graduate of Boston College and the University of Massachusetts Medical School. After clinical training in internal medicine, Dr. Clancy was a Henry J. Kaiser Family Foundation Fellow at the University of Pennsylvania. Before joining AHRQ in 1990, she was an assistant professor in the Department of Internal Medicine of the Medical College of Virginia. Dr. Clancy holds an academic appointment at the George Washington University School of Medicine (clinical associate professor in the Department of Medicine) and serves as senior associate editor of Health Services Research. She serves on multiple editorial boards, including those of Annals of Internal Medicine, Annals of Family Medicine, the American Journal of Medical Quality, and Medical Care Research and Review. Dr. Clancy is a member of the Institute of Medicine and was elected a Master of the American College of

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APPENDIX B 51 Physicians in 2004. In 2009, she was awarded the William B. Graham Prize for Health Services Research. Dr. Clancy’s major research interests include improving health care quality and patient safety and reducing disparities in care associated with patients’ race, ethnicity, gender, income, and education. As director of AHRQ, she launched the first annual report to Congress on health care disparities and health care quality. Janine A. Clayton, M.D., is the deputy director of the Office of Research on Women’s Health (ORWH) in the Office of the Director of the National Institutes of Health (NIH). Before joining ORWH, she was the deputy clinical director of the National Eye Institute (NEI). She is a board-certified ophthalmologist, and her research interests include immune-mediated diseases of the cornea and conjunctiva, women’s eye health, and the standardization of outcome measures of diseases of the anterior segment. Dr. Clayton has been an attending physician and clinical investigator in cornea and uveitis at NEI since 1996, conducting research on inflammatory diseases of the anterior segment and providing medical and surgical uveitis fellowship training. Her clinical research has included randomized controlled trials of novel therapies for immune- mediated ocular diseases and studies of the development of digital imaging techniques for the anterior segment. Dr. Clayton has served on several committees at the NIH Clinical Center and currently serves on the Food and Drug Administration Advisory Panel for Ophthalmic Devices, the board of directors of Women in Ophthalmology, the executive committee of the Women’s Eye Health.Org, the medical and scientific advisory board of Tissue Banks International, and the editorial boards of The Ocular Surface and Oral Diseases. Dr. Clayton received her undergraduate degree with honors from the Johns Hopkins University and her M.D. from Howard University College of Medicine. She completed a residency in ophthalmology at the Medical College of Virginia and fellowship training in cornea and external disease at the Wilmer Eye Institute of Johns Hopkins Hospital and in uveitis and ocular immunology at NEI. Gregory D. Curfman, M.D., is the executive editor of the New England Journal of Medicine (NEJM). In his leadership position at NEJM, he is responsible for setting journal editorial policies and for articles dealing with cardiovascular disease and health policy. Dr. Curfman has edited many articles on clinical trials. He developed and directs the Perspective section of NEJM, which addresses issues at the interface of medicine and

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52 SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH society. He has an interest in health law, has provided congressional testimony on health issues, and has written numerous editorials for NEJM. Dr. Curfman attended Princeton University and Harvard Medical School and is board-certified in internal medicine and cardiovascular medicine. Frank Davidoff, M.D., MACP, is executive editor for the Boston-based Institute for Healthcare Improvement and a contributing writer for JAMA. He has also served on the faculty of Harvard Medical School and the University of Connecticut Medical School before becoming senior vice president for education of the American College of Physicians. He previously served as editor of Annals of Internal Medicine from 1995 to 2001. Dr. Davidoff has served on the Non-Prescription Drug Advisory Committee of the Food and Drug Administration, as vice-chair of the board of Physicians for Human Rights, as chair of the Journal Oversight Committee for JAMA, and as a member of the editorial boards of Quality and Safety in Healthcare, the Journal of General Internal Medicine, and the Canadian Medical Association Journal. Dr. Davidoff received his M.D. from Columbia University in 1959 and completed his residency training in internal medicine and endocrinology at the Massachusetts General Hospital in Boston. He has been the principal investigator of research grants from the National Institutes of Health, the National Fund for Medical Education, the Commonwealth Fund, the Pew Charitable Trust, and the American College of Physicians–American Society of Internal Medicine Foundation. Denise L. Faustman, M.D., Ph.D., is an associate professor of medicine at Harvard Medical School and director of the Immunobiology Laboratories at the Massachusetts General Hospital. Dr. Faustman’s research accomplishments include the first scientific description of modifying the antigens on donor tissues to change their foreignness, which is now being used in clinical trials. Currently Dr. Faustman works on strategies aimed at halting the established autoimmune disease process, such as that for type I diabetes, and the regeneration of the destroyed organs that form the basis of those autoimmune diseases. She is a member of the American Association for the Advancement of Science and has served as a member of many committees of the Institute of Medicine. Dr. Faustman earned her M.D. and Ph.D. from Washington University School of Medicine in 1982 and 1985, respectively. She completed her internship, residency, and fellowships in internal medicine

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APPENDIX B 53 and endocrinology at the Massachusetts General Hospital. She started as an independent investigator at Harvard Medical School in 1987. Robert M. Golub, M.D., is deputy editor of JAMA and associate professor of medicine at the Northwestern University Feinberg School of Medicine. His academic appointments are in the Division of General Internal Medicine and the Department of Preventive Medicine. Dr. Golub’s research is in medical decision-making, including decision analysis, cost-effectiveness analysis, psychology of decision-making, and assessing patient preferences, and he has served on the board of trustees of the Society for Medical Decision Making. He served as chair of the Northwestern University Medical School curriculum committee and developed the curriculum on medical decision-making (which includes critical appraisal of the medical literature), serving as course director since 1992; for this curricular work, he received the Society of General Internal Medicine National Clinician–Educator Award for Teaching Innovation. Dr. Golub received his undergraduate degree from Princeton University and his M.D. from Columbia University College of Physicians and Surgeons. He completed his internship and residency at Northwestern University School of Medicine Northwestern Memorial Hospital. Katrina L. Kelner, Ph.D. is the editor of Science’s new journal Science Translational Medicine. She started at Science as a manuscript editor for research papers in neuroscience over 20 years ago. Since then, she has held several other positions at Science: editor of Biology Perspectives, deputy editor for Commentary, and deputy editor for Life Sciences, overseeing the editorial staff who handle research papers in the life sciences. Dr. Kelner’s interests revolve around application of basic- science advances and tools to clinical problems. She has spoken on numerous panels and at meetings on current advances in biology, the peer-review process, data-sharing, and conflict of interest in scholarly publishing. Dr. Kelner earned her undergraduate degree in biology at Reed College in 1975 and her Ph.D. in cell biology and neuroscience in 1981 at Baylor College of Medicine. Barnett S. Kramer, M.D., M.P.H., is editor-in-chief of the Journal of the National Cancer Institute. He serves as chairman of the Physician Data Query (PDQ) Editorial Board on Screening and Prevention and is a member of the PDQ Treatment Editorial Board. Dr. Kramer has served on the Cancer Prevention Committee of the American Society of Clinical

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54 SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH Oncology and was the committee chair from 2006 to 2007. He has extensive experience in cancer-treatment studies, primary-prevention studies, and clinical screening trials of lung, ovarian, breast, and prostatic cancers. He is an investigator and on the steering committee for two large cancer screening trials sponsored by the National Cancer Institute: the Prostate, Lung, Colorectal, Ovarian Trial and the National Lung Screening Trial. He has a strong interest in weighing and reporting the strength of medical evidence and runs an annual Medicine in the Media Workshop to help working journalists to develop methods of reporting medical evidence. Dr. Kramer received his medical degree from the University of Maryland Medical School and completed his internship and residency in internal medicine at Barnes Hospital in St. Louis, MO. He completed a medical-oncology fellowship at the National Cancer Institute. He is board-certified in internal medicine and medical oncology and has received a master’s degree in public health from Johns Hopkins University Bloomberg School of Public Health. Christine Laine, M.D., M.P.H., FACP, is editor-in-chief of Annals of Internal Medicine. She is board-certified in internal medicine and remains active in patient care and teaching at Jefferson Medical College in the Division of Internal Medicine. Dr. Laine first joined Annals of Internal Medicine in 1995 as an associate editor and became a deputy editor in 1998 and senior deputy editor in 2008. In 2009, Dr. Laine became the editor and a senior vice president at the American College of Physicians. She is active in medical journalism and holds leadership positions in the International Committee of Medical Journal Editors, the Council of Science Editors, and the World Association of Medical Editors Ethics and Policy Committee. She has been instrumental in the development of editorial policy about such issues as authorship, conflicts of interest, and data-sharing in medical research. Dr. Laine graduated summa cum laude with a double major in biology and writing from Hamilton College in Clinton, NY. She received her medical degree from the State University of New York at Stony Brook and completed residency training in internal medicine at the New York Hospital (Cornell University) and a fellowship in general internal medicine and clinical epidemiology at Beth Israel Hospital (Harvard University). Dr. Laine earned her MPH with a concentration in quantitative methods and clinical epidemiology at Harvard University. Marianne J. Legato, M.D., FACP, is the founder and editor-in-chief of Gender Medicine, professor of clinical medicine at Columbia University

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APPENDIX B 55 College of Physicians and Surgeons, and adjunct professor of medicine at Johns Hopkins Medical School. Dr. Legato founded the Partnership for Gender-Specific Medicine at Columbia University in 1997 and is the editor of the first textbook on gender medicine, Principles of Gender- Specific Medicine. She spent her research career in cardiovascular research on the structure and function of the cardiac cell with the support of the American Heart Association and the National Institutes of Health. She has written numerous books for the lay public on women and cardiovascular disease and on gender-specific medicine. Dr. Legato received her medical degree from New York University School of Medicine in 1962. Judith H. Lichtman, M.P.H., M.Sc., Ph.D., is associate professor of epidemiology and public health at the Yale University School of Medicine. Dr. Lichtman’s research focuses on heart disease and stroke outcomes, using large administrative databases and observational studies, and on biologic, social, and environmental factors that influence the presentation and outcomes of young women with heart disease. Since her faculty appointment at Yale in 2001, Dr. Lichtman has been the prinicipal investigator in studies funded by the Centers for Disease Control and Prevention, the National Institute on Aging, the Agency for Healthcare Research and Quality, the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Neurological Disorders and Stroke (NINDS), and several private foundations. She is currently the principal investigator in two NINDS-funded projects that examine disease trends and outcomes for elderly stroke patients and co–principal investigator in an NHLBI-funded prospective observational study designed to examine the care and outcomes of young acute-myocardial- infarction patients (the VIRGO study). Dr. Lichtman has served on numerous national committees related to heart disease and stroke, including the American Heart Association (AHA) Patient Education System Task Force, the AHA Peer Review Evaluation Design Task Force, the AHA Stroke and Epidemiology Councils, and the AHA Quality of Care and Outcomes Research Expert Panel. She has been a member of the Program Committee for the AHA Conference on Cardiovascular Disease Epidemiology and Prevention and a cochair of two National AHA Writing Committees, and she is a member of the AHA Council on Epidemiology and Prevention Stroke Statistics Committee. She is also a member of the American Stroke Association Advisory Committee and the Quality Improvement Working group for

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56 SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH the AHA Get With the Guidelines Program. Dr. Lichtman received her Ph.D. in epidemiology from Yale University. Martha Nolan, J.D., is vice president of public policy for the Society for Women’s Health Research. She is responsible for the development and implementation of the society’s government-relations and public-policy programs. She also provides advice and counsel to the society president on public-policy goals and strategies. Dr. Nolan joined the society staff in September 2003 and has over 17 years of experience in working for the health-insurance industry. Her most recent experience was as assistant vice president for federal affairs at MetLife. Before joining MetLife, she was counsel for state affairs for United Health Group, where she oversaw lobbying, coordinated advocacy, and managed state legislative and regulatory issues for over half the country. She has also worked for CIGNA and the Health Insurance Association of America. A lawyer by profession, Dr. Nolan earned her J.D. at Suffolk University Law School. She received a bachelor’s degree in American history from Harvard University. Ameeta Parekh, Ph.D., is the director of research and development in the Office of Women’s Health (OWH) of the Food and Drug Administration (FDA). She leads the science program in OWH through collaborations and partnerships with other scientists in the FDA centers and with external leaders advancing women’s health. As the OWH R&D director, Dr. Parekh represents FDA and OWH in national and international organizations and meetings to advance the scientific understanding of sex differences and provides FDA regulatory updates on the participation of women in clinical trials and the regulations, policies, and review practices around this topic. Dr. Parekh’s background is in clinical pharmacology, pharmacokinetics, pharmacodynamics, and biopharmaceutics, and she has extensive regulatory experience at FDA, where she has worked for 25 years. Before joining OWH, she was a clinical-pharmacology lead in drug development with the Center for Drug Evaluation and Research in cardiovascular, gastrointestinal, reproductive, and urologic drugs. She is the FDA regulatory expert scientist for food effects and bioavailability of drugs. She has published extensively in peer-reviewed journals and book chapters and presented widely on women's health, drug development, clinical pharmacology, subgroup populations in drug development, and the drug-approval process.

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APPENDIX B 57 Rae Silver, Ph.D., is Helene L. and Mark N. Kaplan Professor of Natural and Physical Sciences and holds joint appointments in arts and sciences at Barnard College, Columbia University, and the Department of Pathology and Cell Biology of the Columbia University Medical Center. Dr Silver’s laboratory engages in two lines of research focusing on understanding neuroimmune system interactions and the brain clock. She created the undergraduate program in quantitative reasoning at Bernard College and, with colleagues, published studies of mathematical learning. She initiated the undergraduate major in neuroscience and served as its first program director. She also served as director of the graduate program in psychology at Columbia University. Dr Silver is a fellow of the American Academy of Arts and Sciences, American Association of Arts and Sciences. She has participated extensively in scientific and educational activities, including serving as cochair of the National Aeronautics and Space Administration’s Research Maxi- mization and Prioritization Committee, and as chair of the autonomic and limbic system theme of the Society for Neuroscience Program Committee. As senior adviser at the National Science Foundation, she worked with staff in all the scientific directorates to create a series of workshops to examine opportunities for the next decade in making advances in neuroscience through the joint efforts of biologists, chemists, educators, mathematicians, physicists, psychologists, and statisticians. She is a member of the Institute of Medicine Forum on Neuroscience and Nervous System Disorders. Dr. Silver received her Ph.D. in bio- psychology from Rutgers University. John B. Wong, M.D., is the chief of the Division of Clinical Decision Making, Informatics and Telemedicine in the Department of Medicine of Tufts Medical Center and the Clinical and Translational Science Institute of the Tufts University School of Medicine. He is a fellow of the American College of Physicians, a past president of the Society for Medical Decision Making, the statistical editor in decision and cost- effectiveness analysis for Annals of Internal Medicine at the American College of Physicians, and a consulting research member of the Tufts Evidence-Based Practice Center funded by the Agency for Healthcare Research and Quality (AHRQ). Besides serving on study sections for AHRQ and the National Institutes of Health, Dr. Wong has been a member of guideline committees for the American Association for the Study of Liver Disease Practice, the European League Against Rheumatism, OMERACT (Outcome Measures in Rheumatology), and the American College of Chest Physicians Antithrombotic Therapy. He

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58 SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH is the course director for evidence-based medicine at the Tufts University School of Medicine, the fellowship codirector for the National Library of Medicine–sponsored fellowship training program in medical informatics at Tufts Medical Center, and the medical informatics concentration leader for the Clinical Research Graduate Program of the Tufts University Sackler School of Biomedical Sciences. Dr. Wong’s research focuses on the application of decision analysis to medical issues to help patients, physicians, and policy-makers to choose among alternative tests, treatments, and policies and thereby to promote rational evidence- based efficient and effective patient-centered care that reflects individualized risk assessment and patient preferences. Dr Wong received his M.D. from the University of Chicago and had postgraduate training in internal medicine at Tufts Medical Center, including a National Library of Medicine–sponsored medical informatics fellowship in clinical decision-making.