BWH PHARMACOPEDIMIOLOGY AND PHARMAECONOMICS

FELLOWSHIP DIRECTORS

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AARON S. KESSELHEIM, MD, JD, MPH

Fellowship Site Director

Professor of Medicine, Harvard Medical School

Aaron S. Kesselheim, M.D, J.D, MPH, is a Professor of Medicine at HMS, leader of the Division of Pharmacoepidemiology and Pharmacoeconomics Program On Regulation, Therapeutics, And Law (www.PORTALresearch.org), and a general internist. He leads an interdisciplinary research center focusing on clinical, societal, and other factors that affect the value and evidence based use of prescription drugs and medical devices and how to optimize policies affecting those issues to improve patient health outcomes. He has testified before Congress on pharmaceutical policy, medical device regulation, generic drugs, and modernizing clinical trials, and is a member of the FDA Peripheral and Central Nervous System Advisory Committee. His work has been funded by the Arnold Ventures, Greenwall Faculty Scholar in Bioethics Program, the Commonwealth Fund, the Robert Wood Johnson Foundation, the FDA, and AHRQ, among others. In recognition of his dedication to mentorship, Dr. Kesselheim received HMS’s Young Mentor Award in 2015-2016. He recently developed a massive open online course called Prescription Drug Regulation, Cost, and Access: Current Controversies in Context disseminated via the HarvardX platform to over 80,000 participants world-wide. He is the editor-in-chief of the Journal of Law, Medicine, and Ethics and a member of the Perspectives advisory board for the New England Journal of Medicine. In the fall of 2020, he was elected to the National Academy of Medicine.

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BENJAMIN N. ROME, MD, MPH

Fellowship Site Director

instructor of Medicine, Harvard Medical School

Benjamin N. Rome, MD, MPH is general internist and health policy researcher at Harvard Medical School and a faculty member in the Division of Pharmacology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital. Within the Division, Dr. Rome works within the Program On Regulation, Therapeutics, And Law (PORTAL) to study the evaluation, regulation, cost, and use of prescription drugs in the United States. His research interests include how drug prices affect patient adherence and clinical outcomes, value-based drug pricing, and policies to make medications more affordable to patients. His work has been has published in the New England Journal of Medicine, JAMA, Health Affairs, and JAMA Internal Medicine. His research has also been featured in a Congressional report about rising prescription drug prices and he has testified in front of the US House of Representatives about evidence-based drug approval during the Covid-19 pandemic. Dr. Rome received his undergraduate degree in community health from Brown University, his medical degree from Harvard Medical School, and his Master of Public Health from the Harvard T.H. Chan School of Public Health while he was a general internal medicine fellow at PORTAL. He trained in internal medicine at Brigham and Women's Hospital and is a practicing primary care physician at the Phyllis Jen Center for Primary Care at Brigham and Women's Hospital.

FELLOWSHIP PROGRAM FACULTY

Jerry Avorn, M.D.

Professor of Medicine, Harvard Medical School

Chief Emeritus of the Division of Pharmacoepidemiology and Pharmacoeconomics

  • The scientific, policy, and social factors that shape physicians’ drug choices

  • Medication compliance by patients

  • The identification and prevention of adverse drug effects; programs to improve the appropriateness of prescribing and drug taking

  • Pharmaceutical cost-effectiveness analysis

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Niteesh K. Choudhry, M.D., Ph.D.
Professor of Medicine, Harvard Medical School

  • Impact of medication costs and drug benefit design on the use of and adherence to medications for common chronic conditions, such as coronary artery disease, hyperlipidemia and diabetes.

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Robert J. Glynn, Ph.D., Sc.D.
Professor of Medicine (in Biostatistics), Harvard Medical School
Associate Professor of Biostatistics, Harvard T.H. Chan School of Public Health

  • Design and analysis of studies of risk factors and treatments for chronic diseases

  • Designing, monitoring, and analyzing data from large-scale randomized trials, prospective cohort studies, and case-control studies

  • Accounting for missing data, analysis of clustered data, and approaches to identify and adjust for selection bias

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Krista F. Huybrechts, M.S., Ph.D.
Associate Professor of Medicine, Harvard Medical School

  • Assessment of adverse outcomes associated with psychotropic medication use in different populations and settings, including elderly nursing home patients and pregnant women.

  • Exploring how variation in medication prescribing at the level of the physician or institution can be used to improve confounding control in observational studies in the area of psychiatry.

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Seo Young Kim, M.D., M.S.C.E.
Associate Professor of Medicine, Harvard Medical School

  • Comparative safety and effectiveness of medications for the rheumatic diseases, health services/outcome research in rheumatology.

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Ameet Sarpatwari, Ph.D., J.D.
Assistant Professor in Medicine, Harvard Medical School

  • The effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes; with current focus on drug product selection laws, risk evaluation and mitigation strategies, and regulatory and patent exclusivities.

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Sebastian Schneeweiss, M.D., Sc.D.

Professor of Medicine and Epidemiology, Harvard Medical School

Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics

  • The comparative effectiveness and safety of biopharmaceuticals and analytic methods to improve the validity of epidemiologic studies using complex healthcare databases.

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Rishi Desai, MS, PhD

Assistant Professor of Medicine, Harvard Medical school

  • Epidemiology and pharmacoepidemiology of cardio-renal conditions including heart failure and end stage renal disease

  • Data science innovations to maximize the potential of electronic health records for medical product safety surveillance

  • Analytical methodology development to improve confounding adjustment in non-randomized studied of medication outcomes

 

William B. Feldman, MD, DPhil, MPH

Instructor of Medicine, Harvard Medical School

  • Drug pricing and pharmaceutical policy

  • Comparative effectiveness and safety of treatments for pulmonary disease

  • Patents and regulatory exclusivities, with a focus on drug-device combination products

 

Nancy Haff, MD, MPH

Instructor of Medicine, Harvard Medical School

  • Implementation of evidence-based practices for the prevention and treatment of cardiometabolic disease in primary care

  • Strategies to address clinical inertia in chronic disease management

  • Provider and patient health behavior change

 

Timothy Savage, MD, MPH, MSc

Instructor of Medicine, Harvard Medical School

  • Comparative safety and effectiveness of medications used in children

  • Comparative safety and effectiveness of antimicrobial medications use across the lifespan

  • Methods to improve the reliability of real-world evidence studies in pediatrics

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Julie Lauffenburger, PharmD, PhD

Assistant Professor of Medicine, Harvard Medical School

  • Evaluating medication use and adherence in chronic diseases and prescribing of high-risk medications for older adults

  • Using pragmatic trials to design and test strategies to optimize medication use and prescribing​

 

Shirley Wang, PhD, ScM

Associate Professor of Medicine, Harvard Medical School

  • Understanding when and how studies using clinical practice data can generate fit-for-purpose evidence to meet regulatory, HTA, payer needs

  • Developing tools and guidance to increase reproducibility and validity of comparative effectiveness and safety studies conducted with clinical practice data

  • Advancing methods for signal identification from clinical practice data (adverse events, drug repurposing)

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* Denotes faculty who have graduated from the Fellowship Program