Sonia Hernández-Díaz,M.D., Dr.P.H. a physician and pharmacoepidemiologist, she is the Director of the Pharmacoepidemiology & CER Program and Associate Professor of Epidemiology at the Harvard School of Public Health. Her area of interest is drug safety evaluation from non-randomized data, with a special emphasis in the analysis of the safety of drugs during pregnancy. Dr. Hernández-Díaz has considerable experience in the design, conduct, and analysis of data relating to the safety of drugs during pregnancy. She has collaborated in studies using Medicaid, GPRD, THIN and other large healthcare research databases, in addition to case control studies and pregnancy registries. Her work has been published in the leading clinical and epidemiologic journals over the last decade. Dr. Hernández-Díaz has served as a member of the board of directors of the International Society for Pharmacoepidemiology and as a Special Government Employee and Voting member for the Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration. She has participated in writing safety guidelines for several drugs and has received several awards and distinctions for her work on drug safety and on methodology for non-randomized studies.
Two examples of her work include inquiries of the safety of folic acid antagonists use during the first trimester in relation to various birth defects. Recent work includes her ongoing assessment of comparative effectiveness and safety of antiepileptic drugs during pregnancy in relation to the risk of convulsions in the mother and birth defects in the fetus; ongoing evaluation of the comparative safety of different antiretroviral therapy regimes during pregnancy; and assessment of the risks and benefits of specific antidepressants for pregnant women and their offspring. Another group of research activities concerns the application of innovative methodologic concepts, including the use of causal structural approaches to define confounding and selection biases that might facilitate the identification, communication, and resolution of common analytical problems in non-randomized studies. Together with other faculty members, she has studied the impact of these biases and has developed approaches to increase the efficiency and the validity of observational research.
Sebastian Schneeweiss, MD, ScD, is Associate Professor of Medicine and Epidemiology at Harvard Medical School and Vice Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital. He is Principal Investigator of the DEcIDE Research Center on Comparative Effectiveness Research funded by AHRQ and PI of the Harvard-Brigham Drug Safety Research Center funded by FDA. His research focuses on the comparative effectiveness and safety of biopharmaceuticals and analytic methods to improve the validity of epidemiologic studies using complex healthcare databases. Dr. Schneeweiss is President of the International Society for Pharmacoepidemiology and is Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology. He is voting consultant on the FDA Drug Safety and Risk Management Advisory Committee and member of multiple scientific advisory boards.
Alexander Walker, MD, DrPH. Adjunct Professor of Epidemiology, HSPH. Dr. Walker’s research involves studies of drug utilization and the intended and unintended effects of pharmaceuticals and medical procedures in non-randomized studies in routine care populations. Almost of his work is done in collaboration with doctoral students in the pharmacoepidemiology program. Recently completed studies include an evaluation of the determinants of discontinuation of lipid lowering therapy in two HMOs. Patients’ persistence on therapy was much poorer than had been suggested by clinical trial results. Earlier work on medical devices included an examination of the risks, benefits, and costs of an implanted occlusive device as an alternative to surgical closure of patent ductus arteriosus. The occluder proved to be more costly, less effective, and more burdened with unwanted outcomes than surgery. Current studies include exploration of health events in large insurance and HMO data bases using neural networks and other pattern-recognition schemes. A common theme of much of the current work of Dr. Walker and his colleagues is the use of very large data bases derived from HMOs, insurance schemes, and governmental health authorities. Ongoing methodologic research is aimed at the efficient and accurate use of these resources. Dr. Walker served as chair of the Harvard School of Public Health’s Department of Epidemiology from 1996 to 2002 and now actively participates in the Pharmacoepidemiology Program by advising students and teaching the School’s popular Pharmacoepidemiology course, which has been the core of the Program since its foundation. He has mentored over 50 doctoral students during his career.
Soko Setoguchi, MD, MPH, DrPH, is Assistant Professor of Medicine at Harvard Medical School and Harvard School of Public Health and the Director of Safety and Outcome Research in Cardiology and an Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Dr. Setoguchi is an epidemiologist and physician trained in general medicine and cardiology, and is interested in comparative and clinical effectiveness/safety of cardiovascular medications or cardiovascular safety of commonly prescribed medications. She is also interested in large-database methods for comparative effectiveness/safety research and conducted various comparative effectiveness/safety studies. In addition to comparative effectiveness/safety studies, Dr. Setoguchi has been conducting health service and outcome research in patients with cardiovascular diseases such as coronary artery disease and heart failure. Dr. Setoguchi is also interested in improving validity of claims data research by linking claims data with other data sources such as registries for cancer, and cardiovascular disease and clinical birth records.
K. Arnold Chan, MD, ScD joined the Harvard School of Public Health faculty in 1998 and was the Program’s director until 2005, when he assumed the role of adjunct professor and joined i3 Drug Safety. Dr. Chan graduated from the Harvard Pharmacoepidemiology Program in 1992; after working as an epidemiologist in the pharmaceutical industry in Ciba-Geigy, he worked in Asia for several years in academia and provided consultation to governments on drug regulations. He also consulted frequently for the Asian branches of multi-national pharmaceutical companies. Since returning to Harvard, he has served as thesis advisor for a number of graduate students and has been teaching a course on information management in epidemiology, with a focus on the large linked health care databases. Dr. Chan’s research has mostly involved in the HMO Research Network Centers for Education and Research on Therapeutics (CERTs). Dr. Chan has served on the board of directors of the International Society for Pharmacoepidemiology (ISPE) and became an ISPE Fellow in 2003.
John D. Seeger, PharmD, DrPH is a pharmacoepidemiologist and chief scientist at Ingenix/i3 Drug Safety where he has conducted dozens of studies that have addressed regulatory drug safety issues across a wide range of drugs and disease conditions. Most of this work has involved the use of health insurance claims databases as platforms for pharmacoepidemiology, so Dr. Seeger’s methodologic expertise focuses on research issues encountered in such settings. He has worked extensively with propensity scores and related methods that seek to mitigate confounding by collapsing covariates, and he is a co-instructor in courses on propensity scores and pharmacoepidemiology at Harvard School of Public Health. He has authored or co-authored dozens of articles in the peer-reviewed medical literature.