Autoinjector Platform RFI .png

This is a Request for Information (RFI) for planning purposes regarding the development of a formulation-agnostic autoinjector platform.

The Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense's (CPE CBRND) Joint Program Manager for CBRN Medical (JPM) seeks information on approaches to develop or leverage an existing modular autoinjector platform capable of delivering single or dual drug formulations in various chamber configurations. Specific drugs of interest include Atropine (2-1 mg/0.7 mL and PAM 660 mg/2 mL combination in a single autoinjector), Atropine (2 mg/0.7 mL), Midazolam (10 mg/0.7 mL), and Naloxone (10 mg/0.4 mL). The Government requires the autoinjector(s) to be operationally suitable, commercially viable beyond military applications, and capable of rapidly incorporating new medical countermeasures while minimizing design and production changes. CPE CBRND also seeks the option to leverage the autoinjector platform to deliver other chemical or biological agent exposure medical countermeasures. Respondents must submit their most current research and designs, and those with prior industry participation or submissions must update and resubmit their information. As part of the market research process, the Government may contact respondents for follow-up discussions. Required white papers must address Company Overview & Experience (FDA-compliant medical device program execution), Technical Solution (autoinjector prototype design specifications), and Regulatory Pathway (FDA approval/clearance strategy). No response deadline or award information is provided in this RFI excerpt.