The DoD’s Joint Project Manger for Medical Countermeasures Systems (JPM MCS) is seeking sources to perform non-clinical safety and efficacy studies for medical countermeasures (MCM) against biothreats.
The requirement is to support product development through FDA approval as well as the development, qualification, validation of supporting assays to characterize MCM responses and support animal model efforts. The MCS mission also includes comprehensive assessment and developmental testing of detection and diagnostic systems.
Many of the target threat agents for the MCS mission require development under the FDA’s Animal Rule as human efficacy testing is not possible, either due to low incidence of occurrence and/or efficacy could never be verified using clinical studies.
The primary objective of this RFI is to gather information that will assist in determining a suitable contract solution that efficiently, effectively, and economically provides and maintains a high standard for CBRN medical countermeasure advanced development, manufacture, and production to meet DoD’s objectives.
Respondents are requested to submit capability statements and indicate if their level of interest is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm.
Further details are available via Solicitation Number: W911QY-15-S-NON-CLINICAL. The response deadline is Mar. 5, 2015.