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INTRODUCTION

JOHN R. LA MONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH

The Institute of Medicine (IOM) of the National Academies of Science held a symposium, in memory of Dr. John R. La Montagne on April 4-5, 2005, to discuss the current state of the art of research on pandemic influenza and to identify gaps in research. The symposium serves as a first step of discussion towards a combined and coordinated research effort among Department of Health and Human Services agencies, other governmental agencies, international partners and the private sector. The statement of task that guided the Symposium agenda included these specific questions:

  1. What is the current state of the science on pandemic influenza research?

  2. What are the pressing unmet scientific questions and technical issues?

  3. What administrative, logistic or legal impediments exist that block progress towards the development of interventions to respond to pandemic influenza?

  4. How can collaboration among Global Health Security Action Group nations be strengthened to address unmet scientific questions and technical issues related to research on pandemic influenza?

  5. What do experts believe are the most important next steps to take to advance research on pandemic influenza?

The Symposium was funded by the Department of Health and Human Services, Office of Public Health Emergency Preparedness, the Vaccine Program Office, and the National Institute of Allergy and Infectious Disease, National Institutes of Health.

Dr. Harvey Fineberg, President of the Institute of Medicine moderated the workshop, which included plenary presentations from leading experts. Following the plenary sessions, symposium participants engaged in working group discussions on a number of topics.


Day 1

1.

Influenza Virulence and Antigenic Change

2.

Controlling Animal Influenza and Decreasing Animal-to-Human Transmission

3.

Influenza Diagnostics for Surveillance

4.

Treatments and Immunotherapies – Antivirals and Non-Specific Approaches



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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings 1 INTRODUCTION JOHN R. LA MONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH The Institute of Medicine (IOM) of the National Academies of Science held a symposium, in memory of Dr. John R. La Montagne on April 4-5, 2005, to discuss the current state of the art of research on pandemic influenza and to identify gaps in research. The symposium serves as a first step of discussion towards a combined and coordinated research effort among Department of Health and Human Services agencies, other governmental agencies, international partners and the private sector. The statement of task that guided the Symposium agenda included these specific questions: What is the current state of the science on pandemic influenza research? What are the pressing unmet scientific questions and technical issues? What administrative, logistic or legal impediments exist that block progress towards the development of interventions to respond to pandemic influenza? How can collaboration among Global Health Security Action Group nations be strengthened to address unmet scientific questions and technical issues related to research on pandemic influenza? What do experts believe are the most important next steps to take to advance research on pandemic influenza? The Symposium was funded by the Department of Health and Human Services, Office of Public Health Emergency Preparedness, the Vaccine Program Office, and the National Institute of Allergy and Infectious Disease, National Institutes of Health. Dr. Harvey Fineberg, President of the Institute of Medicine moderated the workshop, which included plenary presentations from leading experts. Following the plenary sessions, symposium participants engaged in working group discussions on a number of topics. Day 1 1. Influenza Virulence and Antigenic Change 2. Controlling Animal Influenza and Decreasing Animal-to-Human Transmission 3. Influenza Diagnostics for Surveillance 4. Treatments and Immunotherapies – Antivirals and Non-Specific Approaches

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings Day 2 1. Immunology, Assay Standardization, and Correlates of Protection 2. Pandemic Vaccines – Assessment, Development and Production Strategies 3. Strategies to Contain Outbreaks and Prevent Spread 4. Virus Transmission: Understanding and Predicting Pandemic Risk Each working group was directed to: identify research needs broadly in the topic area; select the highest priority activities that should be accomplished in the immediate term (1-2 years), short term (5 years), long-term (10 years); and provide input on approaches and potential timelines to address those priority needs. An expanded list of specific questions for each workgroup was also provided. A chairperson, topic briefer, and rapporteur, were assigned to each working group to facilitate the discussion. The working group briefer provided an overview of the state-of-the art (what is known) and the gaps (what is not known) in the working group area to frame the discussion. The rapporteur synthesized the discussion and provided an oral presentation of the working group’s research priorities to the plenary. The Proceedings of the John La Montagne Memorial Symposium on Pandemic Influenza Research Gaps represents a slightly edited transcript of the plenary presentations, rapporteur presentations, plenary discussion and presentation slides. It is not an official report of the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, or the National Research Council (the “National Academies”). Opinions and statements included in the transcript are solely those of the individual persons or participants at the workshop, and are not necessarily adopted or endorsed or verified as accurate by the National Academies. Appendix A contains short biographies of plenary speakers and Appendix B provides a list of the individuals who attended the symposium. The Symposium agenda follows.

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings JOHN R. LAMONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH April 4-5, 2005 INSTITUTE OF MEDICINE Day 1- April 4, 2005 8:30 8:45 Welcome and Introduction Dr. Harvey Fineberg President, Institute of Medicine 8:45 9:00 Welcome Honorable Michael O. Leavitt Secretary, U.S. Department of Health and Human Services 9:00 9:15 Meeting Objectives Dr. Bruce Gellin Director, National Vaccine Program Office 9:15 9:45 Current Status of Avian Influenza and Pandemic Threat Dr. Julie Gerberding Director, Centers for Disease Control and Prevention 9:45 10:15 Meeting the Challenge of Pandemic Vaccine Preparedness: An FDA Perspective Dr. Jesse Goodman Director, Center for Biologics Evaluation and Review U.S. Food and Drug Administration 10:15 10:45 Global Pandemic Preparedness Research Efforts Dr. Klaus Stohr Global Influenza Programme, World Health Organization 10:45 11:00 Discussion Dr. Harvey Fineberg 11:00 11:30 The Role of NIH Research in Pandemic Influenza Preparedness Dr. Anthony Fauci Director, National Institute of Allergy and Infectious Disease, National Institutes of Health 11:30 3:30 Concurrent break-out groups 1-4 (with working lunch)       Group 1 (NAS Room 150): Influenza Virulence and Antigenic Change     Group 2 (NAS Board Room): Controlling Animal Influenza and Decreasing Animal-to-Human Transmission     Group 3 (NAS Lecture Room): Influenza Diagnostics for Surveillance     Group 4 (NAS Members Room): Treatments and Immunotherapies – Antivirals and Non-Specific Approaches 3:30 5:30 Working group 1,2,3,4 reports to the plenary Dr. Harvey Fineberg 6:00 9:00 Reception in the Great Hall  

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings JOHN R. LAMONTAGNE MEMORIAL SYMPOSIUM ON PANDEMIC INFLUENZA RESEARCH April 4-5, 2005 INSTITUTE OF MEDICINE Day 2-April 5, 2005 8:30 9:00 Modeling and Pandemic Preparedness Professor Neil Ferguson Professor of Mathematical Biology School of Medicine Imperial College of London 9:00 9:30 Clinical trials of potential pandemic vaccines-key issues Dr. John Treanor Associate Professor of Medicine, and of Microbiology and Immunology University of Rochester Medical Center 9:30 10:00 Research Issues in Animal Surveillance Dr. Robert Webster Professor and Chair, Department of Infectious Diseases, St. Jude’s Children’s Research Hospital 10:00 10:15 Break   10:15 2:30 Concurrent break-out groups 5-8 with working lunch       Group 5 (NAS Board Room): Immunology, Assay Standardization, and Correlates of Protection     Group 6 (NAS Room 150): Pandemic Vaccines – Assessment, Development and Production Strategies     Group 7 (NAS Members Room): Strategies to Contain Outbreaks and Prevent Spread     Group 8 (NAS Lecture Room): Virus Transmission: Understanding and Predicting Pandemic Risk 2:30 4:30 Working group 5,6,7,8 reports to the plenary Dr. Harvey Fineberg 4:30 6:00 Preparation for Pandemic Influenza: Filling the Gaps in Knowledge and Understanding Dr. Harvey Fineberg

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John R. La Montagne Memorial Symposium on Pandemic Influenza Research: Meeting Proceedings MEETING OPENING REMARKS Dr. Harvey Fineberg, President, Institute of Medicine Good morning and thank you for joining me for this Pandemic Influenza Research Symposium dedicated to the memory and legacy of John R. LaMontagne. John was a giant in infectious disease and vaccine research. He made extraordinary contributions to the development of swine flu vaccine, the whooping cough vaccine and vaccines against childhood diarrheas and pneumonia. He was a dedicated public servant and mentor to many. In all of his work, John brought the human and public health dimensions to the efforts of his research. He served the nation and the world immeasurably well, and we are better for it. I know for many of you, the memory of John and his quiet but tireless efforts to fight infectious diseases and to improve the health of people everywhere has brought you here to give of your time and intellectual efforts to advance his work. As you know, fighting influenza was one of John’s passions. He recognized influenza as a constant challenge to the health of our nation and the world and that the possibility of a pandemic outbreak related to new influenza strains, to which there is little immunity in the population, is as an ever-present threat. It is that threat that brings us here today to take stalk of where we are and where we need to be in order to be better prepared to respond when that threat becomes a reality. Over the next two days you will discuss in the working groups the current state of the art of research on pandemic influenza and identify gaps in research on influenza virology, immunology, diagnostics, antiviral drugs, surveillance/transmission, vaccines and their production, and strategies to contain outbreaks and prevent spread. We are seeking in the workshops to develop and refine everyone’s best thinking on the most glaring research gaps for each topic and develop ideas for how to progress in closing those gaps in the short and long term. While we will not adopt any formal recommendations, we intend for each participant from the public or private sector to emerge with a clearer idea of the constructive roles they can play in influenza research and preparedness. The success of this Symposium will rely upon candid, open discussions among the range of experts present. In this spirit, I would like to note that we are joined by a few members of the press who have continually followed the ongoing topic of pandemic flu preparations. Because we wish to encourage free and unfettered discussions throughout the symposium, we have stipulated that all remarks made during the plenary sessions and individual working groups must be considered on background only and not for quotation or attribution. Of course, any individual participant who wishes to engage in one-on-one interviews with reporters on the record may do so. It is now my pleasure to introduce the Honorable Michael O. Leavitt Secretary of the Department of Health and Human Services.

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