Regulatory Science

Working Group Members

Co-Chairs

  • Christopher P. Austin, M.D.
    Director
    National Center for Advancing Translational Sciences (NCATS)

  • Story C. Landis, Ph.D.
    Director
    National Institute of Neurological Disorders and Stroke (NINDS)

Working Group Coordinators

  • Kathy L. Kopnisky, Ph.D.
    Office of Biotechnology Activities
    Office of Science Policy
    Office of the Director
    National Institutes of Health (NIH)

  • Vicki Seyfert-Margolis, Ph.D.
    Advisor to the Chief Scientist
    Food and Drug Administration (FDA)

  • Danilo Tagle, Ph.D.
    Associate Director for Special Initiatives
    National Center for Advancing Translational Sciences (NCATS)

Members

  • Guillermo Arreaza-Rubin
    Program Director
    Clinical Immunology of Diabetes
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • John Timothy Baldwin, Ph.D.
    Deputy Chief
    Advanced Technologies and Surgery Branch
    Division of Cardiovascular Diseases,
    National Heart, Lung, and Blood Institute (NHLBI)

  • David Balshaw, Ph.D.
    Program Director
    Center for Risk and Integrated Sciences
    Division of Extramural Research and Training
    National Institute of Environmental Health Sciences (NIEHS)

  • Dana Bryant, MPH
    Program Analyst
    National Center for Advancing Translational Sciences (NCATS)

  • Greg Campbell, Ph.D.
    Director
    Division of Biostatistics, Center for Devices and Radiological Health
    Food and Drug Administration (FDA)

  • Christine Colvis, Ph.D.
    Program Director
    National Center for Advancing Translational Sciences (NCATS)

  • Robin Conwit, M.D.
    Medical Officer
    Office of Clinical Research
    National Institute of Neurological Diseases and Stroke (NINDS)

  • Bonnie B. Dunn, Ph.D.
    Scientific Review Officer
    National Center for Advancing Translational Sciences (NCATS)

  • Suzanne Fitzpatrick, Ph.D.
    Senior Science Policy Analyst
    Office of the Commissioner
    Food and Drug Administration (FDA)

  • Thomas Flammang, Ph.D.
    Associate Director
    National Center for Toxicological Research
    Food and Drug Administration (FDA)

  • Ronald N. Germain, M.D., Ph.D.
    NIH Distinguished Investigator
    Chief, Laboratory of Systems Biology
    Chief, Lymphocyte Biology Section
    Associate Director, Trans-NIH Center for Human Immunology (CHI)
    National Institute of Allergy and Infectious Diseases (NIAID)

  • David Jacobson-Kram, Ph.D.
    Associate Director
    Office of New Drugs
    Center for Drug Evaluation and Research
    Food and Drug Administration (FDA)

  • Scott Janis, Ph.D.
    Program Director
    Office of Clinical Research
    National Institute of Neurological Diseases and Stroke (NINDS)

  • Lyric Jorgenson, Ph.D.
    Office of Science Policy Analysis
    Office of the Director
    National Institutes of Health (NIH)

  • Holli Hamilton, M.D., M.P.H.
    Senior Medical Officer
    Division of Extramural Research
    National Institute of Dental and Craniofacial Research (NIDCR)

  • Lori Henderson, Ph.D.
    Program Director
    Division of Discovery Science and Technology
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)

  • Rosemarie Hunziker, Ph.D.
    Program Director
    Division of Discovery Science and Technology
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)

  • Jennie Larkin, Ph.D.
    Program Director
    National Heart, Lung, and Blood Institute (NHLBI)

  • Albert Lee, Ph.D.
    Program Director, Advanced Technologies and Surgery Branch
    Division of Cardiovascular Diseases
    National Heart, Lung, and Blood Institute (NHLBI)

  • Sara Lin, Ph.D.
    Program Director
    Lung Biology and Disease Branch
    National Heart, Lung, and Blood Institute (NHLBI)

  • Nadya Lumelsky, Ph.D.
    Director
    Tissue Engineering and Dental and Craniofacial Regenerative Medicine Research Program
    Integrative Biology and Infectious Disease Branch
    National Institute of Dental and Craniofacial Research (NIDCR)

  • Martha S. Lundberg, Ph.D.
    Program Director, Tissue Engineering
    Division of Cardiovascular Sciences
    National Heart, Lung, and Blood Institute (NHLBI)

  • Subhas Malghan, Ph.D.
    Deputy Director
    Office of Science Engineering Laboratories
    Center for Devices and Radiological Health
    Food and Drug Administration (FDA)

  • Brenton McCright, Ph.D.
    Research Biologist
    Center for Biologics Evaluation Research
    Food and Drug Administration (FDA)

  • Matthew McMahon, Ph.D.
    Senior Advisor for Translational Research
    Office of the Director
    National Eye Institute (NEI)

  • Richard T. Okita, Ph.D.
    Program Director
    Division of Pharmacology, Physiology, and Biological Chemistry
    National Institute of General Medical Sciences (NIGMS)

  • Robert T. O'Neill, Ph.D.
    Director
    Office of Biostatistics
    Center for Drug Evaluation and Research
    Food and Drug Administration (FDA)

  • Thomas Palker, Ph.D.
    Program Officer
    Division of Allergy, Immunology, and Transplantation
    National Institute of Allergy and Infectious Diseases (NIAID)

  • Carlos Pena, Ph.D.
    Senior Science Policy Advisor
    Office of the Commissioner
    Food and Drug Administration (FDA)

  • Mary Ellen Perry, Ph.D.
    Program Leader
    Office of Strategic Coordination
    Division of Program Coordination, Planning, and Strategic Initiatives
    Office of the Director
    National Institutes of Health (NIH)

  • J. Thomas Peterson, Ph.D.
    Chief
    Bioengineering Sciences and Technologies
    Center for Scientific Review (CSR)

  • Estelle Russek-Cohen, Ph.D.
    Supervisory Math Statistician
    Center for Biologics Evaluation Research
    Food and Drug Administration (FDA)

  • Jonathan Sackner-Bernstein, M.D.
    Associate Director
    Center for Devices and Radiological Health
    Food and Drug Administration (FDA)

  • Grace Shen, Ph.D.
    Group Leader
    Corneal Diseases and Ocular Immunology, Inflammation, & Infection
    National Eye Institute (NEI)

  • Douglas M. Sheeley, Sc.D.
    Deputy Director
    Division of Biomedical Technology
    National Center for Research Resources (NCRR)

  • William Slikker, Jr., Ph.D.
    Director
    National Center for Toxicological Research
    Food and Drug Administration (FDA)

  • Robert Star, M.D.
    Director
    Division of Kidney, Urologic, and Hematologic Diseases
    National Institute on Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Margaret Sutherland, Ph.D.
    Program Director
    Neurodegeneration Cluster
    National Institute of Neurological Diseases and Stroke (NINDS)

  • Robert Temple, M.D.
    Deputy Director of Clinical Science,
    Center for Drug Evaluation and Research
    Food and Drug Administration (FDA)

  • James V. Tricoli, Ph.D.
    Program Director
    Diagnostic Biomarkers and Technology Branch
    Cancer Diagnosis Program
    Division of Cancer Treatment and Diagnosis
    National Cancer Institute (NCI)

  • Hung Tseng, Ph.D.
    Health Scientist Administrator
    Division of Skin and Rheumatic Diseases
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  • Lois A. Tully, Ph.D.
    Program Director
    Division of Extramural Activities
    National Institute of Nursing Research (NINR)

  • Fei Wang, Ph.D.
    Health Scientist Administrator
    Division of Musculoskeletal Diseases
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  • Celia Witten, M.D., Ph.D.
    Director
    Office of Cellular Tissue & Gene Therapies
    Center for Biologics Evaluation Research
    Food and Drug Administration (FDA)

  • Jerome Wujek, Ph.D.
    Research Resources Officer
    National Eye Institute (NEI)

  • Anne Zajicek, M.D., Pharm.D.
    Acting Chief
    Obstetric & Pediatric Pharmacology Branch
    National Institute of Child Health and Human Development (NICHD)

  • Bram Zuckerman, M.D.
    Director
    Division of Cardiovascular Devices
    Center for Devices and Radiological Health
    Food and Drug Administration (FDA)

  • Steve Zullo, Ph.D.
    Program Director
    Division of Discovery Science and Technology
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)



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Division of Program Coordination, Planning, and Strategic Initiatives  •  National Institutes of Health  •  Bethesda, Maryland 20892