Excerpt

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.

Contents

• The National Academies
• Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents
• Board on Life Sciences
• Institute for Laboratory Animal Research Council
• Preface
• Summary
  • CHARGE TO THE AUTHORING COMMITTEE
  • PRINCIPAL FINDINGS AND RECOMMENDATIONS
• 1. Introduction
  • STATEMENT OF TASK
  • COMMITTEE PROCESS
  • ANIMAL RULE
  • BIOLOGICAL WEAPONS CONVENTION
  • KEY ISSUES EXAMINED
• 2. Selection or Development of an Animal Model
  • PATHOGENESIS
  • HOST-PATHOGEN INTERACTIONS
  • PULMONARY ANATOMY AND PHYSIOLOGY
• 3. Generation and Characterization of Aerosolized Agents
  • PRINCIPLES FOR GENERATION OF AEROSOL
  • CHARACTERIZATION OF AEROSOL
• 4. Dosimetry Considerations
  • DOSE METRICS
• 5. Experimental Design
  • DELIVERY OF DOSE
  • EXPERIMENTAL DESIGN AND SELECTION OF DOSE
• 6. Resource Issues
  • PERSONNEL NEEDS AND TRAINING
  • INFRASTRUCTURAL ISSUES
  • AGENCY CONSIDERATIONS
• About the Authors
• Glossary
• References
• Appendix A

This study was supported by the Department of Health and Human Services, National Institutes of Health through Contract No. N01-OD-4-2139 Task Order 152. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. The content of this publication does not necessarily reflect the views or policies of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government.

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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.