Team - H4P

Research Faculty

Krista Huybrechts, MS, PhD

Krista F. Huybrechts, MS, PhD is an Associate Professor of Medicine at Harvard Medical School and an epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital. She also holds an appointment as adjunct Assistant Professor of Epidemiology at Boston University School of Public Health. 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. She currently serves on the Board of Directors of the International Society of Pharmacoepidemiology and Therapeutic Risk Management, and is a member of FDA’s Drug Safety and Risk Management Advisory Committee.

Sonia Hernandez Diaz, MD, DrPH

Sonia Hernández-Díaz, MD, DrPH is a Professor of Epidemiology at the Harvard T.H. Chan School of Public Health, where she serves as Director of the Pharmacoepidemiology & Real World Evidence (RWE) Program. Her research focuses on examining drug safety during pregnancy. She has experience with case-control surveillance studies, pregnancy registries, and pregnancy cohorts nested within healthcare utilization data. Examples of her work include inquiries of the teratogenic effects of antiepileptic drugs, antidepressants, antipsychotics, antiretrovirals, opioids, and vaccines in pregnancy. Another group of research activities concerns the application of innovative methodologic concepts to increase the efficiency and the validity of observational studies. In recent projects her team has emulated hypothetical target trials to evaluate infertility treatments, COVID-19 vaccines, and antidiabetic drugs. Dr. Hernández-Díaz has served as chair for the Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration, as member of the NICHD Pregnancy & Neonatology (PN) Study Section, and as member of the Teratogenic Information Services (TERIS) Advisory Board. She was elected President of the Society for Perinatal and Pediatric Epidemiology in 2014 and President of the International Society for Pharmacoepidemiology in 2015.

Brian T. Bateman, MD, MSc

Brian T. Bateman, MD, MSc is Professor and Chair of the Department of Anesthesiology, Perioperative, and Pain Medicine at Stanford University School of Medicine. His research interests focus on pharmacoepidemiology in pregnancy and the epidemiology of pregnancy-related complications. He has particular interest in the use of opioids during pregnancy and its consequences, the safety of cardiovascular medications in pregnancy, predictors of severe maternal morbidity and mortality, and medication safety in the perioperative period. He is on the editorial board of Anesthesiology and is an editor of the upcoming edition of Chestnut’s Obstetric Anesthesia: Principles and Practices. He is a voting member of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. He has served as a technical consultant to the Joint Commission, expert reviewer for the Agency for Healthcare Research and Quality, on study sections at the NIH and PCORI, and grant review boards for funding agencies from several other countries. He serves on the Board of Directors for the Society for Obstetric Anesthesia and Perinatology.

Loreen Straub, MD, MS

Loreen Straub, MD, MS is an Instructor of Medicine at Harvard Medical School and Investigator in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. Her research centers on the utilization, comparative safety and effectiveness of medications in pregnant and pediatric populations, with a particular focus on psychotropic substances. She also has a special interest in the advancement of methods to improve the utilization of large population-based healthcare databases for epidemiologic research.

Shirley Wang, PhD, ScM

Shirley Wang PhD, ScM is an Associate Professor at Brigham and Women’s Hospital, Harvard Medical School. Her research is focused on 1) developing innovative, non-traditional analytic methods to understand the safety and effectiveness of medication use in routine clinical care as well as 2) facilitating appropriate use of complex methods for analyzing large observational healthcare data. She is currently PI on multiple NIH R01s and is also funded by FDA. Her methods work has received several awards from international societies.

Dr. Wang leads the Meta-Research in Pharmacoepidemiology program, with recent projects aimed at improving the transparency, reproducibility and robustness of evidence from healthcare databases (www.repeatinitiative.org) and informing when and how real-world evidence studies can draw causal conclusions to inform regulatory or other healthcare decision-making (www.rctduplicate.org), through a series of large scale emulation projects offering insights into what types of clinical questions can be answered with real-world data and which methods are the most robust.

Dr. Wang co-led the 1st and 2nd joint task forces for the International Society of Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) focused on real-world evidence for healthcare decision-making. She is a former Board member of ISPE and currently serves as an elected member of the Patient Centered Outcomes Research Institute (PCORI) Methods Committee and Lead Epidemiologist for the FDA’s Sentinel Innovation Center

Yanmin Zhu, MS, PhD

Yanmin Zhu, MS, PhD is an Assistant Professor of Medicine at Harvard Medical School and Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Her current research focuses on the utilization and outcomes of commonly used prescription medications in pregnant women and their offspring. She also has a special interest in linking large existing databases to obtain rich information across multiple data sources and establishing advanced methods to generate evidence on medication use during pregnancy for clinical practice.

Timothy Savage, MD, MPH, MSc

Timothy Savage, MD, MPH, MSc is an Associate Epidemiology in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital, Instructor of Medicine at Harvard Medical School, and a pediatric infectious diseases attending physician and Associate Hospital Epidemiology at Boston Children's Hospital.