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Project Title:
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Animal Models for Assessing Countermeasures to Bioterrorism Agents
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PIN:
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ILAR-K-08-02-A
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Major Unit:
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Division on Earth and Life Studies
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Sub Unit:
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Board on Life Sciences
Institute for Laboratory Animal Research
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RSO:
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Anestidou, Lida
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Subject/Focus Area:
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Project Scope
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A major component of the U.S. Department of Defense (DoD) efforts in biodefense is the Transformational Medical Technologies Initiative (TMTI), the goal of which is to protect warfighters from disease and biological warfare agents. Specifically, the rationale of the Initiative is to fully exploit advanced science and technology innovation in order to successfully counter future genetically engineered biological weapons and naturally emerging infectious diseases that can impact the warfighter.
Ethical constraints preclude the use of human participants in efficacy studies that could kill or permanently disable healthy human volunteers. In order to overcome this predicament, the U.S. Food and Drug Administration (FDA) instigated the Animal Rule (21 CFR Parts 314 and 601). It is expected that many TMTI-developed products would be submitted to FDA and subject to evaluation under the Animal Rule.
The National Academies will convene an ad hoc committee to examine the utility and relevance of animal models to TMTI-funded research and prepare a consensus report. Specifically, the committee's report will:
1. Evaluate how well the existing TMTI-employed or candidate animal models reflect the pathophysiology, clinical picture and treatment of human disease as related to the agents of interest.
2. Address 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 FDA's Animal Rule.
3. Evaluate alternatives to the use of animal models based on the premise of The Three Rs (i.e., refinement, reduction, and replacement of animal use; such venues would include but not be limited to in vitro work, computational modeling, new biotechnological tools, surrogate diseases, etc.) vis-à-vis the Animal Rule and FDA licensure. The evaluation will also consider the development of more humane models for infectious diseases research that do not incorporate death as an endpoint (i.e., humane endpoints).
The project is sponsored by the U.S. Department of Defense
The approximate start date for the project is March 27, 2009.
A report will be issued at the end of the project in approximately 20 months.
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Project Duration:
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20 months
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