SAM #W911SR27SPPFC

Army Seeks Mature Prophylactic Medical Countermeasure Platform Candidates

The U.S. Army is seeking information on mature platform technologies that could be developed into prophylactic medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats. - Opportunity and buyer: The notice describes the VAMP effort led by the Department of War’s Portfolio Management Executive for CBRN Defense, Joint Program Manager–CBRN Medical, Accelerated Defense Pharmaceuticals Product Office. - Candidate technologies: The government is interested in safe and effective prophylactic candidates for one or more CBRN threats, including approaches with clinical safety experience or strong preclinical immunogenicity, safety, and efficacy data. - Potential development work: Candidate development may include design and formulation, stage-appropriate cGMP manufacturing and lot release, stability testing, applicable animal toxicity and efficacy studies, FDA regulatory support, and human Phase I or II trials. Phase III trials are excluded. - Delivery and technical approaches: Traditional intramuscular injection and non-traditional routes, including transdermal or microneedle patches and intranasal formulations, may be considered. Immune-modulating approaches are also of interest. - Development expectations: Candidates should be advanced toward FDA licensure, with manufacturing, safety, efficacy, stability, and regulatory activities appropriate to their stage of development. FDA pre-IND/IND interactions and submissions, and IND maintenance, may be part of the work. - Timing and scope: The anticipated period of performance is up to four years from award; dates are to be negotiated. The notice does not identify a specific product, quantity, part number, vendor, or contract value. - Procurement status: This is an information-seeking opportunity, not an award announcement. No specific commercial OEM is named.

Description

The Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE CBRND), Medical - Accelerated Defense Pharmaceuticals program is formally requesting information from capable companies. The objective of the program is to progress the development of existing prophylactic MCMs manufactured on existing platform technologies that support clinical safety and/or possess strong preclinical immunogenicity, safety, and efficacy data.

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