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National Research Council (US) Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents. Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents: Appropriate Use of Animal Models. Washington (DC): National Academies Press (US); 2006.

Cover of Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents

Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents: Appropriate Use of Animal Models.

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Preface

The terrible events of September 11, 2001, and the dissemination of Bacillus anthracis by mail in October 2001, markedly increased awareness of the possibility of bioterrorism attacks and of the need for new vaccines and therapeutics to protect U.S. citizens from them.

Following this, Congress markedly increased the funding for research for new vaccines and therapeutics to protect the United States from a bioterrorist attack. Such research had largely been conducted by the U.S. Army Medical Research Institute of Infectious Diseases at Ft. Detrick, Maryland. Much of this research is now being directed by the National Institute of Allergy and Infectious Disease of the National Institutes of Health.

An integral part of the development of new vaccines and therapeutics is obtaining the necessary approvals from the U.S. Food and Drug Administration both for their initial use in people and their eventual licensure for general use. The present accelerated pace of development, however, has led to several additional needs: standardization of methods for the generation and characterization of aerosols of bioterrorism agents for use in animal studies (necessary for licensure of vaccines and therapeutics), characterization of the threat to the population, and expansion of the number of laboratories conducting the research. The Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents was convened by the National Research Council to address these issues. It was tasked by its sponsor, the National Institute of Allergy and Infectious Disease, to prepare a short consensus report that articulates the difficulties of testing countermeasures to aerosolized bioterrorism agents and considers whether there are opportunities for improving current approaches to animal testing of countermeasures against aerosols by applying knowledge from other fields of science.

Thus, the Committee organized a workshop, titled “Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents,” which was held July 6th – 7th, 2005, in Washington, D.C. The Committee selected as participants scientists, from diverse disciplines, who made presentations that ultimately were integral to the development of this report.

As chairman, I thank the committee members for contributing their expertise and time to the committee, the workshop, and the report. And the entire committee thanks NRC staff members Kerry Brenner and Jennifer Obernier for their organizational skills and hard work in arranging the workshop and preparing the report. Thanks too to Seth Strongin for providing logistical support. The report would not have been possible without their assistance.

The report has been reviewed in draft form by individuals chosen for their diverse perspective and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The reviewers’ comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following people for their review of the report:

Lynn Andersen, Johns Hopkins University, Baltimore, Maryland

Chris Gennings, Virginia Commonwealth University, Richmond, Virginia

Michael T. Kleinman, University of California, Irvine, California

Roger O. McClellan, Toxicology and Human Health Risk Analysis, Albuquerque, New Mexico

Matthew S. Meselson, Harvard University, Boston, Massachusetts

Stanley Perlman, University of Iowa, Iowa City, Iowa

David Y. H. Pui, University of Minnesota, Minneapolis, Minnesota

Chad Roy, U.S. Army Medical Research Institute for Infectious Diseases, Fort Detrick, Maryland

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by:

Peter Ward, University of Michigan, Ann Arbor, Michigan

Peter Palese, Mount Sinai School of Medicine, New York, New York

Appointed by the NRC, these individuals were responsible for ensuring that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report, however, rests entirely with the authoring committee and the institution.

Charles H. Hobbs, Chair

Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents

Copyright © 2006, National Academy of Sciences.
Bookshelf ID: NBK20357
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