Faculty

Sonia Hernández-Díaz’s area of interest is drug safety evaluation from non-randomized data, with a special emphasis on the design, conduct, and analysis of studies in pregnant women and their infants. She has experience developing and applying methods to case-control surveillance designs, case-only designs, and ad hoc pregnancy cohorts (registries).

More recently, in collaboration with colleagues at Brigham and Women’s Hospital, she identified a cohort of more than 2 million low income pregnant women ascertained in multiple large administrative databases from the Medicaid Analytic eXtract (MAX). The MAX, national Medicaid data available from the Centers of Medicare and Medicaid Services, provides a unique opportunity to examine important descriptive, etiologic and comparative safety questions in a national sample. She has implemented the same methods to identify cohorts of mothers linked to infants within Electronic Medical Records from the UK (THIN) and an US nationwide commercial claims insurance administrative database (Truven MarketScan Research Data). She has long-term collaborations with investigators in Norway, Sweden, Iceland, Denmark and Finland. Recent projects include the identification of nested exposed pregnancy cohorts within health care data pooled from the Scandinavian National Registers and US administrative claims databases. Examples of her work include inquiries of the comparative safety of antiretroviral therapy regimes, specific psychotropics, and specific anti-epileptic drugs for pregnant women and their offspring. Another group of research activities concerns the application of causal structural approaches to define confounding and selection biases to facilitate the identification, communication, and resolution of common analytical problems in non-randomized studies.

Hernandez-Diaz has published more than 200 articles in respected clinical and epidemiological journals. She is Past-President of the International Society for Pharmacoepidemiology and Past-President of the Society for Perinatal and Pediatric Epidemiology Research; and serves as a Special Government Employee for the FDA Drug Safety and Risk Management Advisory Committee, as a Member of the NICHD Pediatric and Obstetric Pharmacology Study Section, and as Member of the TERIS Advisory Board. Through her service to public health institutions she has contributed to the translation of research into policy and actionable recommendations for stakeholders.

Krista F. Huybrechts, MS, PhD, is a pharmacoepidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital where she co-directs the Harvard Program on Perinatal and Pediatric Pharmacoepidemiology (www.harvardpreg.org). Her research centers on the utilization, comparative safety and effectiveness of prescription medications in pregnant women and their offspring, and on studying the outcomes of medications for mental health disorders in vulnerable populations. She also has a special interest in research methodology and innovative research applications in relation to both these fields of study.

Together with colleagues at Brigham and Women’s Hospital and Harvard Chan, she developed large linked cohorts of publicly and privately insured pregnant women and their offspring, which form the basis for most of her work on medication safety in pregnancy.

Dr. Huybrechts holds an appointment as adjunct faculty at Boston University School of Public Health where she teaches Drug Epidemiology.  She currently serves on the Board of Directors of the International Society of Pharmacoepidemiology and is on the editorial board of Pharmacoepidemiology and Drug Safety.

Julie C. Lauffenburger, PharmD, PhD, is an Assistant Professor of Medicine at Harvard Medical School and an Associate Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Her research focuses on improving medication use, adherence, and healthcare delivery in patients with common chronic diseases, particularly through the development and evaluation of patient-oriented behavioral interventions. She has extensive experience using pragmatic trials, predictive analytics and observational study designs in large healthcare databases. Dr. Lauffenburger is a Principal Investigator of research projects funded by the National Institutes of Health and the National Institute for Health Care Management. She teaches Epidemiologic Methods in Health Services Research (EPI235) along with Dr. Darren Toh. She is also the Assistant Director of the Center for Healthcare Delivery Sciences and practicing pharmacist at Brigham and Women’s Hospital.

Dr. Schneeweiss is an internist and pharmacoepidemiologist whose research focuses on the comparative effectiveness and safety of biopharmaceuticals. He has developed analytic methods to improve the scientific validity of epidemiologic analyses using complex longitudinal healthcare databases for newly marketed medical products. The overarching theme of his research is applying advanced real-world data analytics for regulatory decision making transparently and in rapid cycles. His work is published in >350 articles. His work is funded by NIH, PCORI, Arnold Foundation, and the US Food and Drug Administration (FDA), where he is also a voting consultant.

Dr. Schneeweiss is co-lead of the Methods Core of the FDA’s Sentinel program. He was President of the International Society for Pharmacoepidemiology, inaugural member of the PCORI Methods Committee and is Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology.

At Harvard Chan Dr. Schneeweiss teaches courses on Database Analytics for Pharmacoepidemiology (EPI286) and on Effectiveness Research in Longitudinal Healthcare Databases (EPI253). He received his medical training at the Ludwig-Maximilians University of Munich and his doctoral degree in pharmacoepidemiology from Harvard.

John D. Seeger, PharmD, MPH, DrPH, FISPE, a pharmacoepidemiologist and Chief Scientific Officer for Epidemiology at Optum who has conducted dozens of studies addressing 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, and Dr. Seeger’s methodologic expertise focuses on research issues encountered in such settings. He has worked extensively with propensity scores that seek to mitigate confounding by collapsing covariates, and he teaches several courses on propensity scores in pharmacoepidemiology. Throughout this work, Dr. Seeger has remained keenly aware of the limitations of research using administrative data and has supplemented the platform of insurance claims with additional data where appropriate, including laboratory test results, surveys, medical record reviews, and more recently has expanded into work involving electronic health record data.

Dr. Seeger is an Adjunct Assistant Professor of Epidemiology at the Harvard T.H. Chan School of Public Health. He has been active within the International Society of Pharmacoepidemiology (ISPE) and is a Past President and Fellow of the Society.

Darren Toh, ScD, is a pharmacoepidemiologist with an interest in the comparative safety and effectiveness research of medical products. His research has been focused on 1) assessing the risks and benefits of medical products using electronic data collected as part of routine healthcare delivery, and 2) developing and applying privacy-protecting analytic methods to conduct multi-center studies in distributed data networks. Darren is Director of Scientific Programs of the Therapeutics Research and Infectious Disease Epidemiology (TIDE) group.

He is also Director of Applied Surveillance at the Operations Center of the FDA-funded Sentinel System, a congressionally mandated national medical product safety surveillance system. He is Principal Investigator of projects funded by the National Institutes of Health, the Patient-Centered Outcomes Research Institute, and the Food and Drug Administration. Darren received his doctoral degree in Epidemiology from the Harvard School of Public Health

Alexander M. Walker, MD, DrPH is Adjunct Professor of Epidemiology at Harvard School of Public Health, where he was formerly a professor and Chair of the Department of Epidemiology.  His research encompasses the safety of drugs, devices, vaccines, and medical procedures. Current studies include post-marketing safety studies for recently approved drugs, natural history of disease studies to provide context for Phase III clinical trials, studies of the impact of drug labeling and warnings on prescribing behavior, and determinants of drug uptake and discontinuation. Additional areas of research and expertise include health effects of chemicals used in the workplace and statistical methods in epidemiology. Dr. Walker received an MD degree from Harvard Medical School in 1974, and a doctorate of Public Health in Epidemiology from the Harvard School of Public Health in 1981. Dr. Walker is associate editor of Pharmacoepidemiology and Drug Safety and is on the Board of Directors of the International Society for Pharmacoepidemiology, which he also served as President in 1995-1996. He was a statistical consultant for the New England Journal of Medicine from 1992 through 1996 and a Contributing Editor of The Lancet from 1999 through 2001. From 2000 through 2007, he served as Senior Vice President for Epidemiology at Ingenix. Dr. Walker has written or contributed to over 250 peer-reviewed articles in drug safety, epidemiology and occupational health, and is the author of a book of essays, Observation and Inference: An Introduction to the Methods of Epidemiology. Dr. Walker served as chair of the Harvard School of Public Health’s Department of Epidemiology from 1996 to 2002 and has mentored over 50 doctoral students during his career.