Ketamine non-clinical intramascular

The Defense Health Agency is seeking a Contract Research Organization (CRO) to conduct non-clinical safety studies on intramuscular ketamine for battlefield pain management through a Request for Information (RFI). The project, managed by the United States Army Medical Research Acquisition Activity (USAMRAA), requires a GLP-compliant CRO capable of performing comprehensive investigational new drug (IND) enabling studies across multiple animal models including rats, mice, rabbits, mini-pigs, and ferrets. Key testing requirements include Median Lethal Dose 50%, Maximum Tolerated Dose, and repeat dosing protocols. Interested parties must submit a detailed capabilities statement electronically to Peter Mitchell by 1600 Eastern on June 13, 2025. Evaluation criteria will focus on GLP certification, controlled substance handling experience, FDA IND submission capabilities, and quality management plans.

The pre-solicitation notice indicates no specific set-aside designation for this opportunity, and the NAICS category is Pharmaceutical Preparation Manufacturing (325412). While no specific award value is mentioned, the project is associated with the Program Executive Office Operational Medical Systems (OPMED) Warfighter Protection and Acute Care Project Management Office (WPAC PMO) located at Fort Detrick, MD. The RFI explicitly states that this is an information-gathering exercise with no guarantee of future solicitation or contract award, and respondents are responsible for all submission expenses. The research will involve testing two ketamine compounds across multiple animal species to assess potential applications in battlefield pain management. Potential contractors should note that this is a preliminary information request designed to gauge industry capabilities and interest in a potential future procurement.