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Priorities for the National Vaccine Plan
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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Alternative venues for immunization (adolescent and adult)
Gina Mootrey
Associate Director for Adult Immunization
Immunization Services Division
National Center for Immunization and Respiratory Diseases
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
Incentives and requirements (across the lifespan)
Lance Rodewald
Director
Immunization Services Division
National Center for Immunization and Respiratory Diseases
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
Surveillance and monitoring
Anne Schuchat
RADM, U.S. Public Health Service (PHS)
Director, National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
9:45 – 10:00 am
Committee questions
10:00 – 10:45 am
Panel: Surveillance and information systems
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
10:45 – 11:15 am
Committee questions and discussion
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11:15 – 11:45 am
Achieving better use of vaccines
Gregory A. Poland
Director
Vaccine Research Group
Mayo Clinic
11:45 am – 12:00 pm
Committee questions and discussion
12:00 – 1:00 pm
Lunch
1:00 – 2:00 pm
Panel: Access to immunization services
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 University
Representative, American Academy of Family Practice
Cheryl A. Peterson
Senior Policy Fellow
Department of Nursing Practice and Policy
American Nurses Association
2:00 – 2:30 pm
Committee questions and discussion
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2:30 – 3:10 pm
Vaccine finance: Overview of stakeholder input and NVAC working group draft white paper
Walter Orenstein
National Vaccine Advisory Committee (NVAC)
Vaccine Finance Working Group
Associate Director, Emory Vaccine Center
Director, Emory Program for Vaccine Policy and Development
Emory University
Discussants:
Ann Clemency Kohler
Executive Director
National Association of State Medicaid Directors
Alan Rosenberg
Vice President
Wellpoint, Inc.
Representative, America’s Health Insurance Plans
3:10 – 3:30 pm
Committee questions and discussion
3:30 – 3:45 pm
Break
3:45 – 4:15 pm
Panel: Provider knowledge and practice
George Isham
Chief Health Officer
Health Partners
Allison Kempe
Professor of Pediatrics
Director, Primary Care Research Fellowship
Director, Children’s Outcomes Research Program
University of Colorado at Denver Health Sciences Center
Julie Morita
Medical Director
Immunization Program
Chicago Department of Public Health
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Discussants:
Lyle J. Fagnan
Director, Oregon Rural Practice-Based Research Network
Associate Professor of Family Medicine
Oregon Health and Science University
Representative, American Academy of Family Practice
Wayne Hachey
Director, Preventive Medicine and Surveillance
Office of the Assistant Secretary of Defense (Health Affairs) Force Health Protection and Readiness
Department of Defense
4:15 – 4:45 pm
Committee questions and discussion
4:45 – 5:45 pm
Panel: Vaccine supply
Norman W. Baylor
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration (FDA)
Laurel Wood
Manager
Immunization Program
Alaska Department of Health and Social Services
Chair
Association of Immunization Managers
Discussants:
Marguerite D. Baxter
Vice President and Head, Global Public Affairs Novartis Vaccines and Diagnostics, Inc.
Isabelle Claxton
Director
Public Policy and Advocacy
GSK Vaccines
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John D. Grabenstein
Senior Director, Adult Vaccine Medical Affairs
Merck Vaccines & Infectious Diseases
Gregory S. Wallace
Chief, Vaccine Supply & Assurance Branch
Immunization Services Division
National Center for Immunization & Respiratory Diseases
Centers for Disease Control and Prevention
5:45 – 6:15 pm
Committee questions and discussion
6:15 – 6:30 pm
Public comment
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
8:30 am
Welcome and Committee Introductions
Claire V. Broome
Institute of Medicine (IOM)
Committee Chair
8:45 – 10:15 am
Panel 1: Encouraging scientific innovation (new vaccines, better vaccines)
Moderator: Milagritos Tapia (IOM committee member)
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Panelists:
Philip Dormitzer (Novartis)
Kathryn Edwards (Vanderbilt University)
Emil Gotschlich (Rockefeller University)
Harry Greenberg (Stanford University)
Diane Griffin (Johns Hopkins University)
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) (via video)
Justin Wright (BD Medical-Pharmaceutical Systems)
10:15 – 10:30 am
Break
10:30 – 11:15 am
Panel 1 continued
11:15 am – 12:30 pm
Panel 2: Financing vaccine research and development
Moderator: Claire V. Broome (IOM Committee Chair)
Panelists:
Harry B. Greenberg (Stanford University)
Karl D. Handelsman (CMEA Ventures)
David C. Kaslow (Merck)
Leighton Read* (Alloy Ventures)
Jeffrey Ulmer (Novartis)
12:30 – 1:30 pm
Lunch
1:30 – 3:00 pm
Panel 3: Addressing public needs and priorities
Moderator: Edgar Marcuse (IOM committee member)
Panelists:
Philip R. Dormitzer (Novartis)
Kathryn Edwards (Vanderbilt University)
David C. Kaslow (Merck)
Edward Mocarski (MedImmune)
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Stanley A. Plotkin* (Sanofi)
Robin Robinson† (HHS/BARDA)
3:00 – 3:15 pm
Break
3:15 – 4:30 pm
Panel 4: Regulatory and other issues in developing and licensing novel processes, new technologies, etc.
Moderator: Arthur Reingold (IOM committee member)
Panelists:
Karl D. Handelsman (CMEA Ventures)
David C. Kaslow (Merck)
Karen Midthun (FDA/CBER)
Leighton Read (Alloy Ventures)
Rebecca Sheets† (NIH/NIAID) (via video)
Jeffrey Ulmer (Novartis)
4:30 – 5:30 pm
Closing dialogue
Moderator: Claire V. Broome (IOM committee chair)
Question to all stakeholders at the meeting: What criteria would you use to determine what objectives should receive the greatest level of attention in the National Vaccine Plan?
Final observations 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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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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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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8:30 am
Welcome and Overview of the Agenda and the Day’s Proceedings
Committee Introductions
Claire V. Broome
Institute of Medicine (IOM)
Committee Chair
8:45 am
Panel 1: Who and what informs personal decision making about immunization?
Moderator: Edgar Marcuse, IOM committee member
Topics of discussion may include
Science, values, social norms, credibility of sources, ease of access, access to and comprehension of information, behavioral factors (e.g., risk aversion), opinions of formal or informal community leaders
Factors for and against using certain sources of information
Preferred sources and information needs of diverse populations (age, ethnicity, etc.)
Health care providers, their knowledge, and their role
Panelists:
Louis Z. Cooper (Columbia University)
Vicky Debold (National Vaccine Information Center [NVIC])
Julie Downs (Carnegie Mellon)
Lynda Flowers (AARP)
Samuel L. Katz (Duke University)
Julie Leask (University of Sydney)
Anita Manning (Freelance Journalist)
Mairi Breen Rothman (American College of Nurse-Midwives)
Kristine Sheedy† (CDC/NCIRD)
Questions and comments from the audience
10:30 am
Break
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Kenneth J. Rothman, RTI International Patricia Saddier, Merck
Brian Strom, University of Pennsylvania
Melinda Wharton, CDC/ISO
Questions and comments from the audience
12:30 pm
Lunch
1:30 pm
Update from the National Vaccine Advisory Committee Safety Working Group
Andy Pavia, NVAC working group chair
1:45 pm
Panel 3: Basic science (in vivo, in vitro, and 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
Adequacy of animal models for studying vaccine responses
Exploring the role of adjuvants in adverse reactions to vaccines
Gaps in understanding of immune system (immune response to vaccines, the immature immune system, etc.)
Participants:
George Curlin, NIH/NIAID
Kathy Edwards, Vanderbilt University
Charles Hackett, NIH/NIAID
Neal Halsey, Johns Hopkins University
Ruth Karron, Johns Hopkins University
Phillip Krause, FDA
Questions and comments from the audience
3:15 pm
Break
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3:30 pm
Panel 4: Policy issues related to vaccine safety and compensation for vaccine injuries
Moderator: Sara Rosenbaum, IOM committee member
Topics for discussion may include
Vaccine safety as conceived in the 1986 act that established the Vaccine Injury Compensation Program
Implications of recent decisions of the U.S. Court of Federal Claims
Participants:
Louis Z. Cooper, Columbia University
Barbara Loe Fisher, NVIC
Anthony Robbins, Tufts University
Jeff Sconyers, Seattle Children’s Hospital, outgoing chair ACCV
Tim Westmoreland, Georgetown University
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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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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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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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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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 development 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.
8:30 am
Welcome, Overview, and Committee Introductions
Claire V. Broome, IOM Committee Chair
8:45 am
Panel 1: Development of new vaccines and those 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
Role of non-Western vaccine companies as vaccine developers and suppliers for both developed and developing nations
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Discussants:
Norman Baylor, CBER/FDA (by phone)
Brent Burkholder, NCIRD/CDC
Thomas Cherian, World Health Organization (WHO)
Mark Feinberg, Merck
John Ferguson, Novartis Vaccines & Diagnostics
Orin Levine, Johns Hopkins University
Adel Mahmoud, Princeton University (by phone)
Margaret McCluskey, U.S. Agency for International Development (USAID)
Regina Rabinovich, Gates Foundation
Jerald Sadoff, Aeras Global TB Vaccine Foundation
Theodore Tsai, Novartis
Justin Wright, BD Medical-Pharmaceutical Systems
10:30 am
Break
10:45 am
Panel 2: Immunization program issues: Infrastructure, communication, impact of eradication or elimination
Moderator: Milagritos Tapia, IOM committee member
Topics of discussion may include
Quality and safety of administration, storage, inventory management, cold chain, other infrastructure issues
Impact of health systems “reform”
Are vaccines reaching those at highest risk of disease?
Innovative approaches to target high-risk or hard-to-reach groups
Implications of target populations with high proportion of HIV infected
Discussants:
Brent Burkholder, NCIRD/CDC
Thomas Cherian, WHO
Rod Hausser, BD Medical-Pharmaceutical Systems
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Orin Levine, Johns Hopkins University
Margaret McCluskey, USAID
Robert Steinglass, John Snow Inc.
Linda Venczel, Gates Foundation
12:30 pm
Lunch
1:30 pm
Panel 3: Surveillance of safety, effectiveness, coverage, disease
Moderator: Art Reingold, IOM committee member
Topics of discussion may include
Immunization program monitoring and evaluation
Coverage measurement versus disease impact
Challenges of safety monitoring (e.g., yellow fever vaccine in Africa)
Discussants:
Brent Burkholder, NCIRD/CDC
John Ferguson, Novartis Vaccines & Diagnostics
David 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
3:30 pm
Panel 4: Financing vaccine development and purchase
Moderator: David Paltiel, IOM committee member
Topics of discussion may include
Financing new vaccine development
Financing purchase of expensive new vaccines (e.g., pneumococcal conjugate, human papilloma virus)
Sustainable support for new vaccines by developing countries
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Experience with novel financing approaches—International Financing Facility for Immunization (IFFIm), Advance Market Commitment (AMC), Gates (pros and cons)
Prioritizing support for optimal use of existing vaccines versus development of new vaccines
Discussants:
Brent Burkholder, NCIRD/CDC
Orin Levine, Johns Hopkins University
Melinda F. Moree, Global Health Services
Regina Rabinovich, 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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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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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
