Animal Models for Assessing Countermeasures to Bioterrorism Agents

by National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research

The Transformational Medical Technologies (TMT) has been a unique component of the U.S. Department of Defense (DoD) medical biodefense efforts since 2006. Its mission is to advance countermeasure research and development in support of the broader goal of the DoD to protect warfighters from emerging infectious diseases and future genetically engineered biological weapons. The TMT, using advanced science and technology approaches, focused on the development of roadspectrum countermeasures that target common host and pathogen pathways or enhance the host's immune response. Many of these pathogens are lethal or cause such debilitating diseases in humans that it is ethically inappropriate to test the efficacy of these countermeasures in human volunteers. In lieu of human participants, these products may be tested in animals and approved for human use under the provisions of the Food and Drug Administration (FDA)'s 2002 Animal Rule. The reliance on animal models for the development and licensure of medical countermeasures against biothreats is challenging for a number of reasons. The ad hoc Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents prepared a consensus report that would address the challenges stemming from developing and testing medical countermeasures against biothreat agents in animal models. Animal Models for Assessing Countermeasures to Bioterrorism Agents evaluates how well the existing TMT-employed or candidate animal models reflect the pathophysiology, clinical picture, and treatment of human disease as related to the agents of interest. The report addresses the process and/or feasibility of developing new animal models for critical biodefense research, placing emphasis on the need for a robust and expeditious validation process in terms of the FDA's Animal Rule. The report also evaluates alternatives to the use of animal models based on the premise of the Three Rs.

152 pages, Paperback

First published December 9, 2011

About the author

The National Research Council (NRC) functions under the auspices of the National Academy of Sciences (NAS), the National Academy of Engineering (NAE), and the Institute of Medicine (IOM). The NAS, NAE, IOM, and NRC are part of a private, nonprofit institution that provides science, technology and health policy advice under a congressional charter signed by President Abraham Lincoln that was originally granted to the NAS in 1863. Under this charter, the NRC was established in 1916, the NAE in 1964, and the IOM in 1970. The four organizations are collectively referred to as the National Academies.

The mission of the NRC is to improve government decision making and public policy, increase public education and understanding, and promote the acquisition and dissemination of knowledge in matters involving science, engineering, technology, and health. The institution takes this charge seriously and works to inform policies and actions that have the power to improve the lives of people in the U.S. and around the world.

The NRC is committed to providing elected leaders, policy makers, and the public with expert advice based on sound scientific evidence. The NRC does not receive direct federal appropriations for its work. Individual projects are funded by federal agencies, foundations, other governmental and private sources, and the institution’s endowment. The work is made possible by 6,000 of the world’s top scientists, engineers, and other professionals who volunteer their time without compensation to serve on committees and participate in activities. The NRC is administered jointly by the NAS, NAE, and the IOM through the NRC Governing Board.

The core services involve collecting, analyzing, and sharing information and knowledge. The independence of the institution, combined with its unique ability to convene experts, allows it to be responsive to a host of requests.

The portfolio of activities includes:

* Consensus Studies: These comprehensive reports focus on major policy issues and provide recommendations for solving complex problems.
* Expert Meetings and Workshops: By convening symposia, workshops, meetings, and roundtables, the NRC connects professionals as well as the interested public and stimulates dialogue on diverse matters.
* Program and Research Management: At the request of state and federal agencies, the NRC manages and evaluates research programs, conducts program assessments, and reviews proposals.
* Fellowships: The NRC administers several postdoctoral fellowship programs.

Free Scientific Information: Publishing more than 200 reports and related publications each year, the institution is one of the largest providers of free scientific and technical information in the world. Most of it is now on the Web at www.nap.edu.