Appendix F
Agendas of Stakeholder Meetings Held by the Committee on Review of Priorities in the National Vaccine Plan (July 2008-June 2009)

FIRST NATIONAL STAKEHOLDER MEETING VACCINE SUPPLY AND USE

Thursday, July 24, 2008

University of Chicago Gleacher Center, Room 300

Chicago, Illinois

8:15 – 8:30 am

Welcome and Committee Introductions

Claire V. Broome

Institute of Medicine (IOM) Committee Chair

8:30 – 9:45 am

Childhood immunization schedule

Melinda Wharton

Deputy Director

National Center for Immunizations and Respiratory Diseases (NCIRD)

Centers for Disease Control and Prevention (CDC)



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Appendix F Agendas of Stakeholder Meetings Held by the Committee on Review of Priorities in the National Vaccine Plan (July 2008-June 2009) FIRST NATIONAL STAKEHOLDER MEETING VACCINE SUPPLY AND USE Thursday, July 24, 2008 University of Chicago Gleacher Center, Room 300 Chicago, Illinois Welcome and Committee Introductions 8:15 – 8:30 am Claire V. Broome Institute of Medicine (IOM) Committee Chair Childhood immunization schedule 8:30 – 9:45 am Melinda Wharton Deputy Director National Center for Immunizations and Respiratory Diseases (NCIRD) Centers for Disease Control and Preention (CDC) 

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN Alternative venues for immunization (adolescent and adult) Gina Mootrey Associate Director for Adult Immunization Immunization Serices Diision National Center for Immunization and Respiratory Diseases Coordinating Center for Infectious Diseases Centers for Disease Control and Preention Incentives and requirements (across the lifespan) Lance Rodewald Director Immunization Serices Diision National Center for Immunization and Respiratory Diseases Coordinating Center for Infectious Diseases Centers for Disease Control and Preention Surveillance and monitoring Anne Schuchat RADM, U.S. Public Health Serice (PHS) Director, National Center for Immunization and Respiratory Diseases Centers for Disease Control and Preention Committee questions 9:45 – 10:00 am Panel: Surveillance and information systems 10:00 – 10:45 am Mike Garcia Vice President and Chief Operations Officer Scientific Technologies Corporation Christine Hahn Idaho State Epidemiologist Department of Health and Welfare Discussant: Emily Peterson Coordinator, Immunization Information Systems Minnesota Department of Health Committee questions and discussion 10:45 – 11:15 am

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 APPENDIX F Achieving better use of vaccines 11:15 – 11:45 am Gregory A. Poland Director Vaccine Research Group Mayo Clinic Committee questions and discussion 11:45 am – 12:00 pm 12:00 – 1:00 pm Lunch Panel: Access to immunization services 1:00 – 2:00 pm Jeffrey Duchin Chief, Communicable Disease Control Epidemiology and Immunization Section Public Health—Seattle & King County Mitchel Rothholtz Chief of Staff American Pharmacists Association Carl Toren Medical Director Chicago Family Health Center Discussants: Lyle J. Fagnan Director, Oregon Rural Practice-Based Research Network Associate Professor of Family Medicine Oregon Health and Science Uniersity Representatie, American Academy of Family Practice Cheryl A. Peterson Senior Policy Fellow Department of Nursing Practice and Policy American Nurses Association Committee questions and discussion 2:00 – 2:30 pm

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0 PRIORITIES FOR THE NATIONAL VACCINE PLAN Vaccine finance: Overview of stakeholder input 2:30 – 3:10 pm and NVAC working group draft white paper Walter Orenstein National Vaccine Adisory Committee (NVAC) Vaccine Finance Working Group Associate Director, Emory Vaccine Center Director, Emory Program for Vaccine Policy and Deelopment Emory Uniersity Discussants: Ann Clemency Kohler Executie Director National Association of State Medicaid Directors Alan Rosenberg Vice President Wellpoint, Inc. Representatie, America’s Health Insurance Plans Committee questions and discussion 3:10 – 3:30 pm 3:30 – 3:45 pm Break Panel: Provider knowledge and practice 3:45 – 4:15 pm George Isham Chief Health Officer Health Partners Allison Kempe Professor of Pediatrics Director, Primary Care Research Fellowship Director, Children’s Outcomes Research Program Uniersity of Colorado at Dener Health Sciences Center Julie Morita Medical Director Immunization Program Chicago Department of Public Health

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 APPENDIX F Discussants: Lyle J. Fagnan Director, Oregon Rural Practice-Based Research Network Associate Professor of Family Medicine Oregon Health and Science Uniersity Representatie, American Academy of Family Practice Wayne Hachey Director, Preentie Medicine and Sureillance Office of the Assistant Secretary of Defense (Health Affairs) Force Health Protection and Readiness Department of Defense Committee questions and discussion 4:15 – 4:45 pm Panel: Vaccine supply 4:45 – 5:45 pm Norman W. Baylor Office of Vaccines Research and Reiew Center for Biologics Ealuation and Research (CBER) Food and Drug Administration (FDA) Laurel Wood Manager Immunization Program Alaska Department of Health and Social Serices Chair Association of Immunization Managers Discussants: Marguerite D. Baxter Vice President and Head, Global Public Affairs Noartis Vaccines and Diagnostics, Inc. Isabelle Claxton Director Public Policy and Adocacy GSK Vaccines

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN John D. Grabenstein Senior Director, Adult Vaccine Medical Affairs Merck Vaccines & Infectious Diseases Gregory S. Wallace Chief, Vaccine Supply & Assurance Branch Immunization Serices Diision National Center for Immunization & Respiratory Diseases Centers for Disease Control and Preention Committee questions and discussion 5:45 – 6:15 pm Public comment 6:15 – 6:30 pm SECOND NATIONAL STAKEHOLDER MEETING DEVELOPMENT OF NEW AND IMPROVED VACCINES Monday, December 1, 2008 Huntington Room, Arnold and Mabel Beckman Center 100 Academy Drive Irvine, California Please note: Panelist titles and affiliations are provided at the end of the agenda. (*) denotes panelists who will give a formal presentation (†) denotes panelists who contributed to the draft National Vaccine Plan Welcome and Committee Introductions 8:30 am Claire V. Broome Institute of Medicine (IOM) Committee Chair Panel 1: Encouraging scientific innovation (new 8:45 – 10:15 am vaccines, better vaccines) Moderator: Milagritos Tapia (IOM committee member)

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 APPENDIX F Panelists: Philip Dormitzer (Noartis) Kathryn Edwards (Vanderbilt Uniersity) Emil Gotschlich (Rockefeller Uniersity) Harry Greenberg (Stanford Uniersity) Diane Griffin (Johns Hopkins Uniersity) Ed Mocarski* (MedImmune) Barbara Mulach† (National Institutes of Health [NIH]/National Institute of Allergy and Infectious Diseases [NIAID]) Stanley Plotkin* (Sanofi) Robin Robinson† (HHS/BARDA) Rebecca Sheets† (NIH/NIAID) (ia ideo) Justin Wright (BD Medical-Pharmaceutical Systems) 10:15 – 10:30 am Break Panel 1 continued 10:30 – 11:15 am Panel 2: Financing vaccine research and 11:15 am – 12:30 pm development Moderator: Claire V. Broome (IOM Committee Chair) Panelists: Harry B. Greenberg (Stanford Uniersity) Karl D. Handelsman (CMEA Ventures) Daid C. Kaslow (Merck) Leighton Read* (Alloy Ventures) Jeffrey Ulmer (Noartis) 12:30 – 1:30 pm Lunch Panel 3: Addressing public needs and priorities 1:30 – 3:00 pm Moderator: Edgar Marcuse (IOM committee member) Panelists: Philip R. Dormitzer (Noartis) Kathryn Edwards (Vanderbilt Uniersity) Daid C. Kaslow (Merck) Edward Mocarski (MedImmune)

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN Stanley A. Plotkin* (Sanofi) Robin Robinson† (HHS/BARDA) 3:00 – 3:15 pm Break Panel 4: Regulatory and other issues in 3:15 – 4:30 pm developing and licensing novel processes, new technologies, etc. Moderator: Arthur Reingold (IOM committee member) Panelists: Karl D. Handelsman (CMEA Ventures) Daid C. Kaslow (Merck) Karen Midthun (FDA/CBER) Leighton Read (Alloy Ventures) Rebecca Sheets† (NIH/NIAID) (ia ideo) Jeffrey Ulmer (Noartis) Closing dialogue 4:30 – 5:30 pm Moderator: Claire V. Broome (IOM committee chair) Question to all stakeholders at the meeting: What criteria would you use to determine what objecties should receie the greatest leel of attention in the National Vaccine Plan? Final obserations about the day’s discussions All panelists and audience members 5:30 pm Adjourn PANELIST TITLES AND AFFILIATIONS Philip Dormitzer Senior Director and Senior Project Leader (viral vaccine research) Novartis Vaccines and Diagnostics Kathryn Edwards Sarah Sell Professor of Pediatrics Director, Division of Pediatric Clinical Research Vanderbilt University School of Medicine

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 APPENDIX F Emil Gotschlich R. Gwin Follis-Chevron Professor Laboratory of Bacterial Pathogenesis and Immunology Rockefeller University Harry B. Greenberg Senior Associate Dean for Research and Training Stanford University School of Medicine Professor of Medicine (Gastroenterology & Hepatology) Microbiology and Immunology, and Staff Physician VA Palo Alto Health Care System Diane Griffin Professor Alfred and Jill Sommer Professor and Chair in Molecular Microbiology and Immunology Johns Hopkins Bloomberg School of Public Health Karl D. Handelsman Managing Director CMEA Ventures David C. Kaslow Vice President, Infectious Diseases and Vaccines Franchise Merck Research Laboratories Karen Midthun Deputy Director, Center for Biologics Evaluation and Research Food and Drug Administration Edward S. Mocarski, Jr.* Distinguished Fellow, MedImmune Vaccines MedImmune, AstraZeneca Professor Emeritus Stanford University Robert W. Woodruff Professor in the Department of Microbiology and Immunology Emory Vaccine Center, Emory University Barbara Mulach† Director, Office of Scientific Coordination and Program Operations Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases National Institutes of Health

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN Stanley Plotkin* Executive Advisor to CEO, Sanofi Pasteur Emeritus Professor of Pediatrics, University of Pennsylvania Leighton Read* General Partner Alloy Ventures Robin Robinson† Director, Biomedical Advanced Research Development Authority U.S. Department of Health and Human Services CAPT Rebecca Sheets† Vaccine Scientific and Regulatory Specialist National Institute of Allergy and Infectious Diseases National Institutes of Health Jeffrey Ulmer Global Head, External Research Novartis Vaccines and Diagnostics Justin Wright Manager, Bio-Analytical Sciences BD Medical-Pharmaceutical Systems THIRD NATIONAL STAKEHOLDER MEETING INFORMED VACCINE DECISION MAKING Monday, February 2, 2009 Keck Center of the National Academies 500 Fifth Street, N.W. Washington, DC Please note: Panelist titles and affiliations are provided at the end of the agenda. (*) denotes panelists who will provide brief introductory comments at the beginning of a panel (†) denotes panelists who contributed to the draft National Vaccine Plan

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 APPENDIX F Welcome and Overview of the Agenda and the 8:30 am Day’s Proceedings Committee Introductions Claire V. Broome Institute of Medicine (IOM) Committee Chair Panel 1: Who and what informs personal 8:45 am decision making about immunization? Moderator: Edgar Marcuse, IOM committee member Topics of discussion may include • cience, values, social norms, credibility S of sources, ease of access, access to and comprehension of information, behavioral factors (e.g., risk aversion), opinions of formal or informal community leaders • actors for and against using certain F sources of information • referred sources and information needs of P diverse populations (age, ethnicity, etc.) • ealth care providers, their knowledge, and H their role Panelists: Louis Z. Cooper (Columbia Uniersity) Vicky Debold (National Vaccine Information Center [NVIC]) Julie Downs (Carnegie Mellon) Lynda Flowers (AARP) Samuel L. Katz (Duke Uniersity) Julie Leask (Uniersity of Sydney) Anita Manning (Freelance Journalist) Mairi Breen Rothman (American College of Nurse-Midwies) Kristine Sheedy† (CDC/NCIRD) Questions and comments from the audience 10:30 am Break

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN Kenneth J. Rothman, RTI International Patricia Saddier, Merck Brian Strom, Uniersity of Pennsylania Melinda Wharton, CDC/ISO Questions and comments from the audience 12:30 pm Lunch Update from the National Vaccine Advisory 1:30 pm Committee Safety Working Group Andy Paia, NVAC working group chair Panel 3: Basic science (in vivo, in vitro, and 1:45 pm human clinical models) Moderator: Claire V. Broom, IOM Committee Chair Topics for discussion may include • Current research on host risk factors, gaps • Genetic contributions to immune response • dequacy of animal models for studying A vaccine responses • xploring the role of adjuvants in adverse E reactions to vaccines • aps in understanding of immune system G (immune response to vaccines, the immature immune system, etc.) Participants: George Curlin, NIH/NIAID Kathy Edwards, Vanderbilt Uniersity Charles Hackett, NIH/NIAID Neal Halsey, Johns Hopkins Uniersity Ruth Karron, Johns Hopkins Uniersity Phillip Krause, FDA Questions and comments from the audience 3:15 pm Break

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 APPENDIX F Panel 4: Policy issues related to vaccine safety 3:30 pm and compensation for vaccine injuries Moderator: Sara Rosenbaum, IOM committee member Topics for discussion may include • accine safety as conceived in the V 1986 act that established the Vaccine Injury Compensation Program • mplications of recent decisions of the U.S. I Court of Federal Claims Participants: Louis Z. Cooper, Columbia Uniersity Barbara Loe Fisher, NVIC Anthony Robbins, Tufts Uniersity Jeff Sconyers, Seattle Children’s Hospital, outgoing chair ACCV Tim Westmoreland, Georgetown Uniersity Questions and comments from the audience 5:15 pm Closing comments 5:30 pm Adjourn PANELIST TITLES AND AFFILIATIONS Robert Ball Chief, Vaccine Safety Branch Division of Epidemiology Food and Drug Administration George Curlin Medical Officer Office of the Director Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases National Institutes of Health

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN Louis Z. Cooper Professor Emeritus, Pediatrics College of Physicians and Surgeons Columbia University Adrian Dana Senior Director Clinical Risk Management and Safety Surveillance Merck Research Labs Vicky Debold Director of Patient Safety National Vaccine Information Center Kathryn Edwards Sarah Sell Professor of Pediatrics Director, Division of Pediatric Clinical Research Vanderbilt University School of Medicine Susan Ellenberg Professor of Biostatistics Associate Dean for Clinical Research University of Pennsylvania School of Medicine Barbara Loe Fisher President and Co-founder National Vaccine Information Center Charles Hackett Deputy Director Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases National Institutes of Health Neal Halsey Professor Department of International Health, Disease Prevention & Control Department of Pediatrics Johns Hopkins University

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 APPENDIX F Sean Hennessy Senior Scholar, Epidemiology Center for Clinical Epidemiology and Biostatistics Assistant Professor of Epidemiology, University of Pennsylvania School of Medicine Assistant Professor of Pharmacology, Department of Pharmacology Director of Ambulatory Drug Use and Effects, University of Pennsylvania Medical Center Florence Houn Vice President, Regulatory Affairs Celgene Corporation John Iskander Associate Director for Immunization Safety Centers for Disease Control and Prevention Ruth Karron Director, Center for Immunization Research Director, Johns Hopkins Vaccine Initiative Johns Hopkins University Samuel L. Katz Wilburt C. Davison Professor Emeritus of Pediatrics Duke University Phillip Krause Laboratory Chief Lead Research Investigator Center for Biologics Evaluation and Research Food and Drug Administration Tracy Lieu Professor Director of Faculty Development Director, Center for Child Health Care Studies Department of Ambulatory Care and Prevention Harvard Pilgrim Health Care and Harvard Medical School

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN Andy Pavia Professor, Division of Infectious Diseases University of Utah School of Medicine Chair, Vaccine Safety Working Group, National Vaccine Advisory Committee Anthony Robbins Professor Department of Public Health and Family Medicine Tufts University Lanie Friedman Ross Carolyn and Matthew Bucksbaum Professor of Clinical Ethics Professor, Departments of Pediatrics, Medicine, and Surgery Associate Director, MacLean Center for Clinical Medical Ethics University of Chicago Kenneth J. Rothman Distinguished Fellow in Epidemiology Vice President, Epidemiology Research RTI International Patricia Saddier Senior Director, Epidemiology Department Merck Research Laboratories Jeff Sconyers Senior Vice President and General Counsel Seattle Children’s Hospital Chair, Advisory Commission on Childhood Vaccines Brian Strom George S. Pepper Professor of Public Health and Preventive Medicine Departments of Biostatistics and Epidemiology University of Pennsylvania Thomas M. Vernon Consultant with Sanofi Pasteur Former VP, Merck Vaccine Division Former Executive Director, Colorado Department of Health

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 APPENDIX F Tim Westmoreland Visiting Professor of Law Georgetown University Melinda Wharton Deputy Director National Center for Immunizations and Respiratory Diseases Centers for Disease Control and Prevention Some federal agencies contributed to the deelopment of the draft strategic National Vaccine Plan FIFTH NATIONAL STAKEHOLDER MEETING VACCINES AND GLOBAL HEALH Thursday, June 4, 2009 The Seattle Public Library 1000 Fourth Avenue Seattle, Washington Please note: Complete participant affiliations are provided at the end of the agenda. Welcome, Overview, and Committee 8:30 am Introductions Claire V. Broome, IOM Committee Chair Panel 1: Development of new vaccines and those 8:45 am needed for global use Moderator: Claire Broome, IOM Committee Chair Topics of discussion may include • Setting priorities • Scientific challenges • Regulatory issues • Implementation issues • Advocacy or policy communication issues • ole of non-Western vaccine companies as R vaccine developers and suppliers for both developed and developing nations

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0 PRIORITIES FOR THE NATIONAL VACCINE PLAN Discussants: Norman Baylor, CBER/FDA (by phone) Brent Burkholder, NCIRD/CDC Thomas Cherian, World Health Organization (WHO) Mark Feinberg, Merck John Ferguson, Noartis Vaccines & Diagnostics Orin Leine, Johns Hopkins Uniersity Adel Mahmoud, Princeton Uniersity (by phone) Margaret McCluskey, U.S. Agency for International Deelopment (USAID) Regina Rabinoich, Gates Foundation Jerald Sadoff, Aeras Global TB Vaccine Foundation Theodore Tsai, Noartis Justin Wright, BD Medical-Pharmaceutical Systems 10:30 am Break Panel 2: Immunization program issues: 10:45 am Infrastructure, communication, impact of eradication or elimination Moderator: Milagritos Tapia, IOM committee member Topics of discussion may include • uality and safety of administration, Q storage, inventory management, cold chain, other infrastructure issues • Impact of health systems “reform” • re vaccines reaching those at highest risk A of disease? • nnovative approaches to target high-risk or I hard-to-reach groups • mplications of target populations with I high proportion of HIV infected Discussants: Brent Burkholder, NCIRD/CDC Thomas Cherian, WHO Rod Hausser, BD Medical-Pharmaceutical Systems

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 APPENDIX F Orin Leine, Johns Hopkins Uniersity Margaret McCluskey, USAID Robert Steinglass, John Snow Inc. Linda Venczel, Gates Foundation 12:30 pm Lunch Panel 3: Surveillance of safety, effectiveness, 1:30 pm coverage, disease Moderator: Art Reingold, IOM committee member Topics of discussion may include • mmunization program monitoring and I evaluation • overage measurement versus disease C impact • hallenges of safety monitoring (e.g., C yellow fever vaccine in Africa) Discussants: Brent Burkholder, NCIRD/CDC John Ferguson, Noartis Vaccines & Diagnostics Daid Fleming, Director & Health Officer, WA Kathy Neuzil, Program for Appropriate Technology in Health (PATH) Robert Steinglass, John Snow Inc. Linda Venczel, Gates Foundation 3:15 pm Break Panel 4: Financing vaccine development and 3:30 pm purchase Moderator: Daid Paltiel, IOM committee member Topics of discussion may include • Financing new vaccine development • inancing purchase of expensive new F vaccines (e.g., pneumococcal conjugate, human papilloma virus) • ustainable support for new vaccines by S developing countries

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN • xperience with novel financing E approaches—International Financing Facility for Immunization (IFFIm), Advance Market Commitment (AMC), Gates (pros and cons) • rioritizing support for optimal use of P existing vaccines versus development of new vaccines Discussants: Brent Burkholder, NCIRD/CDC Orin Leine, Johns Hopkins Uniersity Melinda F. Moree, Global Health Serices Regina Rabinoich, Gates Foundation Jerald Sadoff, Aeras Global TB Vaccine Foundation 5:30 pm Adjourn PANELIST TITLES AND AFFILIATIONS Jon Kim Andrus Professor, Department of Global Health Director, Global Health MPH Program George Washington University Norman Baylor Director, Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration Brent Burkholder Director, Global Immunization Division National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Thomas Cherian Coordinator Expanded Programme on Immunization Department of Immunization, Vaccines and Biologicals World Health Organization

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 APPENDIX F Mark Feinberg Vice President, Medical Affairs and Policy Merck Vaccines and Infectious Diseases Merck & Co., Inc. John Ferguson Vice President and Global Head Pharmacovigilance & Medical Safety Novartis Vaccines & Diagnostics David Fleming Director and Health Officer Department of Public Health Seattle/King County Rod Hausser Director Business Development and Operations BD Medical-Pharmaceutical Systems Orin Levine Executive Director, PneumoADIP Associate Professor, International Health Johns Hopkins University Adel Mahmoud Woodrow Wilson School of Public and International Affairs Department of Molecular Biology Princeton University Margaret McCluskey Senior Technical Advisor, HIV Vaccines GH/Office of HIV & AIDS U.S. Agency for International Development Melinda F. Moree Vice President, Global Health Services Kathy Neuzil Director, Influenza Vaccine Project Clinical Director, Rotavirus Vaccine Program PATH

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN Regina Rabinovich Director, Infectious Diseases Development Global Health Program The Bill & Melinda Gates Foundation Jerald Sadoff President and Chief Executive Officer Aeras Global TB Vaccine Foundation Robert Steinglass Technical Director, IMMUNIZATIONBasics Project John Snow Inc. Theodore Tsai Senior Vice President, Scientific Affairs Novartis Linda Venczel Vaccine-Preventable Diseases Integrated Health Systems Development The Bill & Melinda Gates Foundation Justin Wright Manager, Bio-Analytical Sciences BD Medical-Pharmaceutical Systems