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  1. Drug Safety and Risk Management Advisory Committee

Drug Safety and Risk Management Advisory Committee Roster

Applying for Membership on FDA Advisory Committees

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

Current Number of Vacancies = 0
Note, one or more vacancies may be in the nomination process or a final appointment may have been made.

Chairperson
Sonia Hernandez-Diaz, MD, MPH, DrPH
Expertise: Pharmacoepidemiology
Term: 6/1/2018 – 5/31/2022
Professor of Epidemiology
Department of Epidemiology
Harvard T.H. Chan School of Public Health
677 Huntington Avenue, Room 816
Boston, Massachusetts 02115

Designated Federal Officer
Philip A. Bautista, PharmD
Division of Advisory Committee and Consultant Management
Office of Executive Programs
Center for Drug and Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
(301) 796-9001 Fax: (301) 847-8533
E-mail: [email protected]

Karim Anton Calis, PharmD, MPH, FASHP, FCCP
Expertise: Medication Safety, Pharmacovigilance, Pharmacoepidemiology
Term: 6/1/2019 – 5/31/2023
Director of Clinical Research and Compliance
Office of the Clinical Director, Division of Intramural Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health
Hatfield Clinical Research Center, 10-CRC, Room 1-3130
10 Center Drive (MSC 1109)
Bethesda, Maryland 20892

Marie R. Griffin, MD, MPH
Expertise: Pharmacoepidemiology and Internal Medicine
Term: 6/1/2018 – 5/31/2022
Professor of Health Policy, Emerita
Department of Health Policy
Vanderbilt University
2525 West End Ave, Suite 1200
Nashville, Tennessee 37203

John B. Hertig, PharmD, MS, CPPS, FASHP
Expertise: Medication Safety
Term: 6/1/2021 – 5/31/2025
Associate Professor and Vice Chair
Department of Pharmacy Practice
Butler University College of Pharmacy and Health Sciences
4600 Sunset Avenue
Indianapolis, Indiana 46208

Collin A. Hovinga, PharmD, MS, FCCP
Expertise: Clinical Pharmacology, Pharmacovigilance, Pediatrics
Term: 6/1/2020 – 5/31/2024
Senior Vice President
Clinical and Scientific Development
The Institute for Advanced Clinical Trials (I-ACT) for Children
Clinical Associate Professor of Pharmacy
University of Texas at Austin, College of Pharmacy
2409 University Avenue
Austin, Texas 78712

Krista F. Huybrechts, MS, PhD
Expertise: Pharmacoepidemiology
Term: 6/1/2021 – 5/31/2025
Associate Professor of Medicine and Epidemiology
Harvard Medical School and Harvard T.H. Chan School of Public Health
Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine
Brigham & Women’s Hospital
1620 Tremont Street, Suite 3030
Boston, Massachusetts 02120

Martin Kulldorff, PhD
Expertise: Biostatistics
Term: 6/1/2018 – 5/31/2022
Professor of Medicine and Biostatistician
Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine
Harvard Medical School and Brigham & Women's Hospital
1620 Tremont Street, Suite 3030
Boston, Massachusetts 02120

Vincent Lo Re III, MD, MSCE
Expertise: Infectious Diseases and Pharmacoepidemiology
Term: 6/1/2021 – 5/31/2025
Associate Professor of Epidemiology and Medicine
Center for Clinical Epidemiology and Biostatistics
Center for Pharmacoepidemiology Research and Training
Perelman School of Medicine
University of Pennsylvania
836 Blockley Hall
423 Guardian Drive
Philadelphia, Pennsylvania 19104

Mara McAdams DeMarco, MS, PhD
Expertise: Pharmacoepidemiology
Term: 6/1/2021 – 5/31/2025
Associate Professor and Director of Clinical Outcomes Research
Department of Surgery
Johns Hopkins University School of Medicine
Department of Epidemiology
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe Street, Room W6033
Baltimore, Maryland 21205

**Reema J. Mehta, PharmD, MPH
Expertise: Industry Representative
Term: 11/1/2019 – 10/31/2023
Vice President
Head of Risk Assessment and Management
Center of Excellence
Pfizer, Inc.
100 Route 206
North Peapack, New Jersey 07977

Lewis S. Nelson, MD
Expertise: Medical Toxicology and Emergency Medicine
Term: 6/1/2020 – 5/31/2024
Professor and Chair
Department of Emergency Medicine
Chief, Division of Medical Toxicology
Rutgers New Jersey Medical School
185 South Orange Avenue
Newark, New Jersey 07103

*Suzanne B. Robotti
Expertise: Consumer Representative
Term: 2/21/2021 – 5/31/2024
President
MedShadow Foundation
Executive Director
DES Action USA
229 East 85th Street, Unit K
New York, New York 10028

* Consumer Representative
** Industry Representative, (non voting)

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