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Vaccines and Related Biological Products Advisory Committee 154Th Meeting Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 154th Meeting November 8, 2018 FDA White Oak Campus – Great Room – Salon C Silver Spring, Maryland 20903 MEMBERS Chair David Greenberg, M.D. ***+ Kathryn Edwards, M.D. + Expertise: Industry Representative Expertise: Pediatric Infectious Diseases Term: 02/01/2016 – 01/31/2020 Term: 02/01/2015 – 01/31/2019 Associate Vice President Sarah H. Sell and Cornelius Vanderbilt Regional Medical Head, North America Chair in Pediatrics Sanofi Pasteur Division of Pediatric Infectious Diseases Swiftwater, PA 18370 Vanderbilt University School of Medicine Monroe Carell, Jr. Children’s Hospital at Vanderbilt Holly Janes, Ph.D. Nashville, TN 37232 Expertise: Biostatistics Term: 06/10/2016 – 01/31/2020 Hana El Sahly, M.D. Associate Member Expertise: Vaccines, Infectious Diseases Fred Hutchinson Cancer Research Center Term: 06/10/2016 – 01/31/2020 Vaccine and Infectious Disease Division Associate Professor Division of Public Health Sciences Department of Molecular Virology and Seattle, WA 98109 Microbiology Department of Medicine Michael Kurilla, M.D., Ph.D. + Section of Infectious Diseases Expertise: Infectious Diseases, Pathology Baylor College of Medicine Term: 01/31/2018 – 01/31/2021 Houston, TX 77030 Director, Division of Clinical Innovation National Center for Advancing Translation Leonard Friedland, M.D. Sciences Expertise: Alternate Industry Representative National Institutes of Health Term: 02/01/2016 – 01/31/2020 Bethesda, MD 20852 Vice President Scientific Affairs and Public Health, Vaccines GlaxoSmithKline Philadelphia, PA 19112 **Consumer Representative ***Industry Representative + Not Attending ^ Acting Chair Page 1 of 5 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 154th Meeting November 8, 2018 FDA White Oak Campus – Great Room – Salon C Silver Spring, Maryland 20903 MEMBERS (Cont’d) Myron Levine, M.D., D.T.P.H., F.A.A.P Arnold Monto, M.D. ^ Expertise: Infectious Diseases Expertise: Epidemiology & Infectious Term: 01/31/2018 – 01/31/2022 Diseases Grollman Distinguished Professor and Term: 02/01/2016 – 01/31/2020 Associate Dean for Global Health Thomas Francis Jr. Collegiate Professor Vaccinology and Infectious Diseases of Public Health Center for Vaccine Development Professor of Epidemiology University of Maryland School of Medicine Department of Epidemiology Baltimore, MD 21201 University of Michigan School of Public Health Ofer Levy, M.D., Ph.D. + Ann Arbor, MI 48109 Expertise: Infectious Diseases Term: 02/01/2015 – 01/31/2019 Paul Offit, M.D. Director Precision Vaccines Program Expertise: Infectious Diseases Staff Physician, Division of Infectious Term: 02/01/2018 – 01/31/2022 Diseases & Principal Investigator Professor of Pediatrics Boston Children’s Hospital & Division of Infectious Diseases Professor, Harvard Medical School Abramson Research Building Boston, MA 02115 The Children’s Hospital of Philadelphia Philadelphia, PA 19104 H. Cody Meissner, M.D. Expertise: Infectious Diseases Andrea Shane, M.D., M.P.H., M.Sc. Term: 01/31/2018 – 1/31/2022 Expertise: Pediatric & Infectious Diseases Professor of Pediatrics Term: 02/01/2018 – 01/31/2022 Tufts University School of Medicine Associate Professor of Pediatrics Director, Pediatric Infectious Disease Division of Pediatric Infectious Diseases Tufts Medical Center Emory University School of Medicine Boston, MA 02111 Atlanta, GA 30322 Page 2 of 5 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 154th Meeting November 8, 2018 FDA White Oak Campus – Great Room – Salon C Silver Spring, Maryland 20903 MEMBERS (Cont’d) Paul Spearman, M.D. + Sheldon Toubman, J.D. ** Expertise: Pediatric & Infectious Diseases Expertise: Law Term: 01/31/2018 – 01/31/2022 Term: 08/16/2017 – 01/31/2021 Director, Division of Infectious Diseases Staff Attorney Albert B. Sabin Chair in Pediatric New Haven Legal Assistance Association Infectious Diseases New Haven, CT 06510 Cincinnati Children’s Hospital Medical Center Melinda Wharton, M.D., M.P.H. Professor, Department of Pediatrics Expertise: Epidemiology, Vaccine Policy University of Cincinnati School and Safety Science of Medicine Term: 05/13/2016 – 01/31/2020 Cincinnati, OH 45229 Director, Immunization Services Division National Center for Immunization and Geeta K. Swamy, M.D. Respiratory Diseases Expertise: Infectious Diseases Centers for Disease Control and Prevention Term: 01/31/2018 – 01/31/2022 Atlanta, GA 30333 Senior Associate Dean Vice Chair for Research & Faculty Development Associate Professor, ObGyn Department of Obstetrics & Gynecology Division of Maternal-Fetal Medicine Duke University Durham, NC 27710 Page 3 of 5 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 154th Meeting November 8, 2018 FDA White Oak Campus – Great Room – Salon C Silver Spring, Maryland 20903 FDA PARTICIPANTS/SPEAKERS Carolyn Wilson, Ph.D. Marion Gruber, Ph.D. Associate Director for Research Director Center for Biologics Evaluation and Research Office of Vaccines Research and Review Food and Drug Administration Center for Biologics Evaluation and Research Silver Spring, MD 20993 Food and Drug Administration Silver Spring, MD 20993 Philip Krause, M.D. Konstantin Chumakov, Ph.D. Deputy Director Associate Director for Research Office of Vaccines Research and Review Office of Vaccines Research and Review Center for Biologics Evaluation and Research Center for Biologics Evaluation and Research Food and Drug Administration Food and Drug Administration Silver Spring, MD 20993 Silver Spring, MD 20993 Jerry P. Weir, Ph.D. Director, Division of Viral Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration Page 4 of 5 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 154th Meeting November 8, 2018 FDA White Oak Campus – Great Room – Salon C Silver Spring, Maryland 20903 FDA ADMINISTRATIVE STAFF DESIGNATED FEDERAL OFFICER ACTING COMMITTEE MANAGEMENT Serina A. Hunter-Thomas, M.S.A., R.N. SPECIALIST CAPT, U.S. Public Health Service Joanne Lipkind, M.S. Division of Scientific Advisors & Consultants Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Center for Biologics Evaluation & Research Food and Drug Administration Food and Drug Administration Silver Spring, MD 20903 Silver Spring, MD 20903 Phone: (240) 402-5771 Phone: (240) 402-8106 E-mail: [email protected] E-mail: [email protected] DIRECTOR Prabhakara Atreya, Ph.D. Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20903 Phone: (240) 402-8006 E-mail: [email protected] Page 5 of 5 .
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