Request for Information – Prophylactic Platform for Medical Countermeasures

The Department of Defense, through the Portfolio Management Executive for Chemical, Biological, Radiological and Nuclear Defense (PME CBRND) and the Accelerated Defense Pharmaceuticals (ADP) program, is issuing a Request for Information (RFI) under solicitation W911SR27SPPFC. The objective is to identify capable companies that can advance the development of prophylactic medical countermeasures (MCMs) using existing platform technologies. The program focuses on progressing these countermeasures through Phase I or Phase II clinical trials, with a goal of enabling interim fielding via Expanded Access Protocols or pre-Emergency Use Authorization. The anticipated period of performance is up to four years, with work primarily conducted at the contractor's facilities. Interested respondents must provide a comprehensive capability description, including technical approach, regulatory status with the FDA, cGMP manufacturing capabilities, and a development roadmap with rough order of magnitude cost estimates. Evaluation criteria for future selections will emphasize manufacturing process capability, product safety and efficacy, past FDA experience, and the plug-and-play nature of the platform across various pathogens. Submissions must be delivered as a single searchable PDF, featuring a specific cover page and a core capability description not exceeding four pages. All non-clinical and clinical data must be SEND and CDISC compliant, and manufacturing must adhere to cGMP standards to support an Investigational New Drug application through a Biologics License Application.