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

88 Pages·2006·0.75 MB·English

by  Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents

Committee on Animal Models for Testing Interventions
Against Aerosolized Bioterrorism Agents
Board on Life Sciences
Institute for Laboratory Animal Research

Division on Earth and Life Studies

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COMMITTEE ON ANIMAL MODELS
FOR TESTING INTERVENTIONS AGAINST
AEROSOLIZED BIOTERRORISM AGENTS

Charles H. Hobbs (Chair), Lovelace Respiratory Research Institute,
Albuquerque, New Mexico
David C. Dorman, CIIT Center for Health Research, Research Triangle Park,
North Carolina
Diane E. Griffin, Johns Hopkins University, Baltimore, Maryland
Jack R. Harkema, Michigan State University, East Lansing, Michigan
Beth L. Laube, Johns Hopkins University, Baltimore, Maryland
David E. Lenz, U.S. Army Medical Research Institute of Chemical Defense,
Aberdeen Proving Ground, Maryland
Stephen S. Morse, Columbia University, New York, New York
Robert F. Phalen, University of California, Irvine, California

Staff

Jennifer Obernier, Study Director
Kerry Brenner, Study Director (through August 2005)
Joe Larsen, Postdoctoral Fellow
Seth Strongin, Senior Program Assistant
Anne Jurkowski, Senior Program Assistant
Karen Imhof, Administrative Assistant
John Horigan, Christine Mirzayan Science and Technology Policy Graduate
Fellow

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BOARD ON LIFE SCIENCES

Corey S. Goodman (Chair), Renovis, Inc., South San Francisco, California
Ann M. Arvin, Stanford University School of Medicine, Stanford, California
Jeffrey Bennetzen, University of Georgia, Athens, Georgia
Ruth Berkelman, Emory University, Atlanta, Georgia
Deborah Blum, University of Wisconsin, Madison, Wisconsin
R. Alta Charo, University of Wisconsin, Madison, Wisconsin
Dennis Choi, Merck Research Laboratories, West Point, Pennsylvania
Jeffrey L. Dangl, University of North Carolina, Chapel Hill, North Carolina
Paul R. Ehrlich, Stanford University, Stanford, California
James M. Gentile, Research Corporation, Tucson, Arizona
Jo Handelsman, University of Wisconsin, Madison, Wisconsin
Ed Harlow, Harvard Medical School, Boston, Massachusetts
David Hillis, University of Texas, Austin, Texas
Kenneth Keller, University of Minnesota, Minneapolis, Minnesota
Randall Murch, Virginia Polytechnic Institute and State University,
Alexandria, Virginia
Gregory A. Petsko, Brandeis University, Waltham, Massachusetts
Stuart L. Pimm, Duke University, Durham, North Carolina
James Tiedje, Michigan State University, East Lansing, Michigan
Keith Yamamoto, University of California, San Francisco, California

Staff

Fran Sharples, Director
Denise Grosshans, Financial Associate

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INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL

Stephen W. Barthold (Chair), University of California, Center for Comparative
Medicine, Davis, California
William C. Campbell, Drew University, Madison, New Jersey
Jeffrey I. Everitt, GlaxoSmithKline Research and Development, Comparative
Medicine and Investigator Support, Research Triangle Park, North Carolina
Michael F. Festing, Leicestershire, United Kingdom
James G. Fox, Massachusetts Institute of Technology, Division of Comparative
Medicine, Cambridge, Massachusetts
Estelle B. Gauda, Johns Hopkins University School of Medicine, Johns
Hopkins Hospital, Baltimore, Maryland
Janet Gonder Garber, Pinehurst, North Carolina
Coenraad F.M. Hendriksen, Netherlands Vaccine Institute, Bilthoven, The
Netherlands
Jon H. Kaas, Vanderbilt University, Nashville, Tennessee
Jay R. Kaplan, Wake Forest University School of Medicine, Department of
Pathology, Winston-Salem, North Carolina
Joseph W. Kemnitz, University of Wisconsin, Primate Research Center,
Madison, Wisconsin
Leticia V. Medina, Abbott Laboratories, Abbott Park, Illinois
Abigail L. Smith, University of Pennsylvania, University Laboratory Animal
Resources, Philadelphia, Pennsylvania
Stephen A. Smith, Virginia Polytechnic Institute and State University,
Department of Biomedical Sciences and Pathobiology, Blacksburg, Virginia
Peter Theran, Massachusetts Society for the Prevention of Cruelty to Animals,
Angell Animal Medical Center, Boston, Massachusetts

Staff

Joanne Zurlo, Director
Kathleen Beil, Administrative Assistant

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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.
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