Vaccines and Related Biological Products Committee July 28, 2017 Final Roster
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Vaccines and Related Biological Products Committee July 28, 2017 Final Roster
Vaccines and Related Biological Products Committee July 28, 2017 Final, Roster
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FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING #147 July 28, 2017 FDA White Oak � Great Room B/C Silver Spring, Maryland 20903 MEMBERS CHAIR Edwards, Kathryn, M.D. Expertise: Pediatric Infectious Diseases Term: 02/01/2015-01/31/2019 Sarah H. Sell and Cornelius Vanderbilt Chair in Pediatrics Division of Pediatric Infectious Diseases Vanderbilt University School of Medicine Monroe Carell, Jr. Children's Hospital at Vanderbilt 1161 21st Avenue South D-7227 MCN Nashville, TN 37232 Englund, Janet M.D. Expertise: Pediatrics and Infectious Dis. Term: 02/01/2014-01/31/2018 Professor Department of Pediatrics University of Washington Director, Pediatric Transplant Infectious Diseases Seattle Children's Hospital 4800 Sand Point Way, N.E., #MA7.234 Seattle, WA 98105 Greenberg, David, M.D.***+ Expertise: Industry Representative Term: 02/01/2016-01/31/2020 Associate Vice President Regional Medical Head North America Sanofi Pasteur One Discovery Drive Swiftwater, PA 18370 Janes, Holly, Ph.D.+ Term: 06/10/2016-01/31/2020 Expertise: Biostatistics Associate Member Fred Hutchinson Cancer Research Center Vaccine and Infectious Disease Division Division of Public Health Sciences 1100 Fairview Avenue North, M2-C200 P.O. Box 19024 Seattle, WA 98109 El Sahly, Hana, M.D.+ Term: 06/10/2016-01/31/2020 Expertise: Vaccines, Infectious Diseases Associate Professor Department of Molecular Virology and Microbiology Department of Medicine Section of Infectious Diseases Baylor College of Medicine One Baylor Plaza Rm 225D, BCM-MS280 Houston, TX 77030 + Not Attending **Consumer Representative (Vacant position) ***Industry Representative ++Acting Consumer Representative ^Acting Industry Representative Page 1 of 6 FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING #147 July 28, 2017 FDA White Oak � Great Room B/C Silver Spring, Maryland 20903 MEMBERS (CONTINUED) Kotloff, Karen, M.D. Expertise: Pediatrics and Infectious Dis. Term: 02/01/2014-01/31/2018 Professor of Pediatrics and Medicine Head, Division of Infectious Disease and Tropical Pediatrics Associate Director for Clinical Research Center for Vaccine Development University of Maryland School of Medicine 685 W. Baltimore Street HSF 1, Rm 480 Baltimore, MD 21201 Levy, Ofer, M.D., Ph.D. Expertise: Infectious Diseases Term: 02/01/2015-01/31/2019 Staff Physician, Division of Infectious Diseases & Principal Investigator Boston Children's Hospital Faculty Member, Human Biology & Translational Medicine and Associate Professor, Harvard Medical School 300 Longwood Avenue Boston, MA 02115 Lynfield, Ruth, M.D. Expertise: Epidemiology and Pediatrics Term: 04/30/2014-01/31/2018 Medical Director Minnesota Department of Health 625 Robert Street North PO Box 64975 St. Paul, MN 55164 Long, Sarah, M.D.+ Expertise: Pediatrics and Infectious Dis. Term: 02/01/2014-01/31/2018 Professor of Pediatrics Drexel University College of Medicine Chief, Section of Infectious Diseases St. Christopher's Hospital for Children Erie Avenue at Front Street Philadelphia, PA 19134 McInnes, Pamela, D.D.S., MSc. (Dent). Expertise: Translational and Clinical Resea Term: 05/13/2016�01/31/2019 Deputy Director National Center for Advancing Translational Sciences (NCATS) National Institutes of Health (NIH) 6701 Democracy Blvd., Suite 904 Bethesda, MD 20892 Moore, Patrick, M.D.+ Expertise: Epidemiology & Micro. Term: 02/01/2014-01/31/2018 American Cancer Society Professor Distinguished Professor, Microbiology and Molecular Genetics University of Pittsburgh Cancer Institute Hillman Cancer Research Pavilion, Suite 1.8 5117 Centre Avenue Pittsburgh, PA 15213 Page 2 of 6 FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING #147 July 28, 2017 FDA White Oak � Great Room B/C Silver Spring, Maryland 20903 Monto, Arnold, M.D. Expertise: Epidemiology & Infectious Diseases Term: 02/01/2016-1/31/2020 Thomas Francis Jr. Collegiate Professor of Public Health Professor of Epidemiology University of Michigan School of Public Health Department of Epidemiology Room M5146, SPH II 1415 Washington Heights Ann Arbor, MI 48109-2029 Wharton, Melinda, M.D., M.P.H. Expertise: Epidemiology, Vaccine Policy and Safety Science Term: 05/13/2016�01/31/2020 Director, Immunization Services Division National Center for Immunization and Respiratory Diseases Center for Disease Control and Prevention 1600 Clifton Road NE, Mailstop A19 Atlanta, GA 30333 Sawyer, Mark, M.D. Expertise: Pediatrics and Infectious Dis. Term: 02/01/2014-01/31/2018 Professor of Clinical Pediatrics University of California, San Diego 3020 Children's Way San Diego, CA 92123 TEMPORARY VOTING MEMBERS Bennink, Jack, Ph.D. Chief, Viral Immunology Section National Institute of Allergy and Infectious Diseases National Institutes of Health Building 50, Room 5511 MSC 8001, 50 South Drive Bethesda, MD 20892 Griffin, Marie R., M.D., MPH Professor, Health Policy and Medicine Director, Vanderbilt MPH Program Vanderbilt University Medical Center Village at Vanderbilt, Suite 200 1500 21st Avenue S. Nashville, TN 37212 Hoofnagle, Jay H., M.D. Director, Liver Disease Research Branch Division of Digestive Diseases and Nutrition NIDDK, NIH 6707 Democracy Blvd., Room 6005 Bethesda, MD 20852 Lee, Mei-Ling Ting, Ph.D. Professor, Department of Epidemiology and Biostatistics Director, Biostatistics and Risk Assessment Center EPIB Room 2234R, SPH Building #255 4200 Valley Drive University of Maryland College Park, MD 20732 Page 3 of 6 FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING #147 July 28, 2017 FDA White Oak � Great Room B/C Silver Spring, Maryland 20903 TEMPORARY VOTING MEMBERS (cont.) Nolte, Hendrik, M.D., Ph.D.^ Senior Vice President Research and Development ALK, Inc. 135 Route 202/206 Bedminster, NJ 07921 Portnoy, Jay M., M.D.++ Director, Division of Allergy, Asthma and Immunology Children's Mercy Hospital 2401 Gillham Road Kansas City, MO 64108 Packer, Milton, M.D. Distinguished Scholar in Cardiovascular Science Baylor Heart and Vascular Institute Baylor University Medical Center 621 N. Hall Street Dallas, TX 75226 Ward, John W., M.D. Director, Division of Viral Hepatitis National Center for HIV/AIDS, Viral Hepatitis STD and TB Prevention Centers for Disease Control and Prevention 1600 Clifton Road NE Atlanta, GA 30333 SPONSOR SPEAKERS PRESENTATION Janssen, Robert, M.D. CMO, VP of Clinical Development Dynavax Technologies Corporation Schaffner, William, M.D. Professor of Preventive Medicine and Infectious Diseases Vanderbilt University School of Medicine McGuire, Darren, M.D. Professor of Medicine University of Texas Southwestern Medical Center Plotkin, Stanley, M.D. Emeritus Professor University of Pennsylvania and Member, Board of Directors Dynavax Technologies Corporation Poland, Gregory, M.D. Professor of Medicine Mayo Clinic Page 4 of 6 FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING #147 July 28, 2017 FDA White Oak � Great Room B/C Silver Spring, Maryland 20903 FDA SPEAKERS/PARTICIPANTS Gruber, Marion, Ph.D. Director Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 Weir, Jerry, Ph.D. Director, Division of Viral Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 Major, Marian, Ph.D. Division of Viral Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 Worobec, Alexandra, M.D. Division of Viral Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 Everett, Darcie, M.D., Ph.D. Division of Viral Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 Scott, John, Ph.D. Acting Director Division of Biostatistics Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 Page 5 of 6 FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING #147 July 28, 2017 FDA White Oak � Great Room B/C Silver Spring, Maryland 20903 FDA ADMINISTRATIVE STAFF DESIGNATED FEDERAL OFFICER CAPT Hunter-Thomas, Serina Vaccines and Related Biological Products Advisory Committee Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food & Drug Administration 10903 New Hampshire Avenue Building 71 Silver Spring, MD 20903 Phone: (240) 402-5771 Email: serina.hunterthomas@fda.hhs.gov COMMITTEE MANAGEMENT SPECIALIST Harvey, Rosanna Vaccines and Related Biological Products Advisory Committee Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food & Drug Administration 10903 New Hampshire Avenue Building 71 Silver Spring, MD 20903 Phone: (240) 402-8072 Email: rosanna.harvey@fda.hhs.gov Page 6 of 6