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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
JOHN R. LA MONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH
Meeting Proceedings
Board on Population Health and Public Health Practice
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
THE NATIONAL ACADEMIES PRESS
500 Fifth Street, NW. Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
This study was supported by Contract No. N01-OD-4-2139, Task Order No. 159 between the National Academy of Sciences and the National Institutes of Health. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
Additional copies of this report are available from the
National Academies Press,
500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); http://www.nap.edu.
For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu.
Copyright 2005 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museum in Berlin.
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
Goethe
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
Adviser to the Nation to Improve Health
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.
www.national-academies.org
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
PLANNING GROUP ON THE JOHN R. LA MONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH
RICHARD B. JOHNSTON, M.D., Professor of Pediatrics,
Department of Pediatrics, University of Colorado School of Medicine, Denver, CO
ANN ARVIN, M.D., Lucile Packard Professor of Pediatrics and Microbiology & Immunology,
Stanford University, Stanford, CA
CAROL CARDONA, D.V.M., PH.D., Veterinary Medicine Extension,
University of California, Davis, Davis, CA
PETER PALESE, PH.D., Professor & Chair,
Department of Microbiology, Mount Sinai School of Medicine, New York, NY
STAFF
ROSE MARIE MARTINEZ, Sc.D., Director,
Board on Population Health and Public Health Practice
ALICE WEZI MUNTHALI, M.P.H.
HOPE HARE, M.F.A., Administrative Assistant Consultant
SANDRA HACKMAN, Copy Editor
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
JOHN R. LAMONTAGNE
1943-2004
This symposium is dedicated to the memory and legacy of John R. LaMontagne, Deputy Director of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.
As a quiet but tireless champion, he helped to spearhead some of the most important recent global efforts to fight infectious diseases and to improve the health of children and adults everywhere. For nearly 30 years, John’s thoughtful demeanor and even-handed approach led the way in tackling some of nature’s greatest challenges to humankind. His influence has been incalculable on both national and international programs related to the development of vaccines for pertussis, rotavirus, AIDS, influenza, and malaria; new drugs for tuberculosis; and, more recently, biodefense research. In all of his work, John brought the human and public health dimensions to the efforts of laboratory research. He served the nation and the world immeasurably well, and we are better for it.
For the leadership, wise counsel, humor, and friendship that he shared with us and so many others, we are deeply grateful.
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
Contents
1
INTRODUCTION
1
John R. La Montagne Memorial Symposium on Pandemic Influenza Research
1
Day 1- April 4, 2005
3
Day 2-April 5, 2005
4
Meeting Opening Remarks
5
Meeting Opening Remarks
5
Dr. Harvey Fineberg, President, Institute of Medicine
5
2
PLENARY SPEAKERS, DAY 1
7
Opening Remarks
7
The Honorable Michael Leavitt, Secretary of the Department of Health and Human Services
7
Meeting Objectives
10
Dr. Bruce Gellin, Director, National Vaccine Program Office
10
Current Status of Avian Influenza and Pandemic Threat
12
Dr. Julie Louise Gerberding, Director, Centers for Disease Control and Prevention
12
Plenary Presentation Slides-Dr. Julie Louise Gerberding
16
Meeting the Challenge of Pandemic Vaccine Preparedness: An FDA Perspective
19
Dr. Jesse Goodman, Director, Center for Biologics Evaluation and Review U.S. Food and Drug Administration
19
Plenary Presentation Slides-Dr. Jesse Goodman
25
Global Pandemic Preparedness Research Efforts
29
Dr. Klaus Stöhr, Project Leader, Global Influenza Programme, World Health Organization
29
Plenary Presentation Slides-Dr. Klaus Stöhr
35
The Role of NIH Research in Pandemic Influenza Preparedness
40
Dr. Anthony S. Fauci, Director, National Institute of Allergy and Infectious Disease, National Institutes of Health
40
Plenary Presentation Slides-Dr. Anthony S. Fauci
45
3
MORNING PLENARY DISCUSSION, DAY 1 (APRIL 4, 2004)
53
Moderator: Dr. Harvey Fineberg
53
4
WORKING GROUPS, DAY 1
59
Working Group 1 Influenza Virulence and Antigenic Change
59
Report to Plenary
59
Rapporteur—Dr. Robert Lamb
59
Working Group 1 Presentation Slides: Influenza Virulence and Antigenic Change-Dr. Lamb, Rapporteur
63
Working Group 1 Briefing Slides: Influenza Virulence and Antigenic Change-Dr. Palese, Briefer
65
Working Group 2 Controlling Animal Influenza and Decreasing Animal-to-Human Transmission
69
Report to Plenary Rapporteur: Dr. Bruce Innis
69
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
Working Group 2 Briefing Slides: Controlling animal Influenza and Decreasing Animal-to-Human Transmission-Dr. Swayne, Briefer
73
Working Group 3 Influenza Diagnostics for Surveillance
80
Report to Plenary Rapporteur-Dr. Alan Hay
80
Working Group 3 Briefing Slides: Challenges and Strategies for Detection and Characterization of Influenza Viruses: Surveillance and Diagnosis-Dr. Cox, Briefer
83
Working Group 4 Antivirals and Non-Specific Approaches, Treatments and Immunotherapies
88
Report to Plenary Rapporteur: Dr. Charles Hackett
88
Working Group 4 Presentation Slides: Antivirals and Non-Specific Approaches, Treatments and Immunotherapies-Dr. Hackett, Rapporteur
91
Working Group 4 Briefing Slides: Antivirals and Non-Specific Approaches, Treatments and Immunotherapies-Dr. Hayden, Briefer
93
5
AFTERNOON DISCUSSION: REACTION TO RAPPORTEURS, DAY 1
99
6
PLENARY SPEAKERS, DAY 2
103
Modeling and Pandemic Preparedness,
103
Professor Neil Ferguson, Professor of Mathematical Biology, Faculty of Medicine, Imperial College of London
103
Clinical Trials of Potential Pandemic Vaccines: Key Issues
110
Dr. John Treanor, Associate Professor of Medicine and Microbiology and Immunology, University of Rochester Medical Center
110
Plenary Presentation Slides-Dr. John Treanor
117
Research Issues in Animal Surveillance
124
Dr. Robert Webster, Professor and Chair, Department of Infectious Diseases, St. Jude’s Children’s Research Hospital
124
Plenary Presentation Slides-Dr. Webster
128
7
MORNING PLENARY DISCUSSION, DAY 2 (APRIL 5, 2005)
133
Moderator: Dr. Harvey Fineberg
133
8
WORKING GROUPS, DAY 2
137
WORKING GROUP 5: Immunology, Assay Standardization, and Correlates of Protection
137
Rapporteur Report—Dr. Ann Arvin
137
Working Group 5 Presentation Slides: Immunology, Assay Standardization, and Correlates of Protection-Ann Arvin, Rapporteur
140
Working Group 5 Briefing Slides: Immunology, Assay Standardization, and Correlates of Protection-Dr. Brian Murphy, Briefer
141
WORKING GROUP 6: Pandemic Vaccines—Assessment, Development and Production Strategies
142
Rapporteur Report-Dr. Regina Rabinovich
142
Working Group 6 Presentation: Pandemic Vaccines-Assessment, Development and Production Strategies, Dr. Rabinovitch, Rapporteur
145
TABLE 1 Research Priorities for Vaccine Assessment, Development, and Production
146
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
Working Group 6 Briefing Slides: Pandemic Vaccines-Assessment, Development and Production Strategies-Dr. Harry Greenberg, Briefer
149
WORKING GROUP 7: Strategies to Contain Outbreaks and Prevent Spread
150
Rapporteur Report—Dr. Nicole Lurie
150
Working Group 7 Presentation Slides: Strategies to Contain Outbreaks and Prevent Spread-Dr. Nicole Lurie, Rapporteur
153
Working Group 7 Briefing Slides: Strategies to Contain Outbreaks and Prevent Spread-Dr. Neil Ferguson, Briefer
154
Viral Transmission: Understanding and Predicting Pandemic Risk
158
Working Group 8
158
Rapporteur Report—Dr. Peter Palese
158
Working Group 8 Presentation Slides: Viral Transmission: Understanding and Predicting Pandemic Risk-Dr. Peter Palese, Rapporteur
161
Working Group 8 Briefing Slides: Viral Transmission: Understanding and Predicting Pandemic Risk-Dr. Daniel Perez, Briefer
162
9
PREPARATION FOR PANDEMIC INFLUENZA: FILLING THE GAPS IN KNOWLEDGE AND UNDERSTANDING
165
A
SPEAKER BIOGRAPHIES
179
B
PANDEMIC FLU WORKSHOP PARTICIPANTS
183
CONTENTS OF CD
203
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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings
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