The Department of the Army is seeking proposals for New Approach Methodologies (NAMs) to reduce reliance on traditional animal models, de-risk Medical Countermeasure (MCM) development against CBRN threats, and shorten MCM development timelines. The proposal should address one or more of the four topic areas: Immunogenicity and Toxicology Testing, Aerosol exposure/MCM Efficacy in Lung, Testbed Capabilities, and Pharmacokinetic Prediction Applications. The proposal should include a whitepaper, up to 5 pages, and two supporting documents, with a total of 15 pages. The proposal should describe the model system, test or capability, its workings, and how it is intended to reproduce key features of CBRN threat exposure, biological responses, efficacy, and toxicology.
Some key points to consider:
• The proposal should specify which topic area(s) the technology addresses.
• The proposal should describe the model system, test or capability, its workings, and how it is intended to reproduce key features of CBRN threat exposure, biological responses, efficacy, and toxicology.
• The proposal should indicate whether the test or capability is intended for use in a research and development setting or for use in a regulated environment or to support regulatory requirements.
• The proposal should provide information on the technology itself, such as required critical reagents, sustainability of supplies, shelf life, throughput, readouts, reproducibility, extent of qualification or validation, etc.