RFP - 2-PAM Autoinjectors for Project Bioshield (PBS)

The Biomedical Advanced Research and Development Authority (BARDA) is seeking proposals for the development and procurement of 2-PAM autoinjectors for the treatment of organophosphate poisoning, including nerve agents, in adult and pediatric populations. The contract will include late-stage clinical development, regulatory approval, and procurement of 2-PAM autoinjectors for the Strategic National Stockpile's (SNS) CHEMPACK Program. The offeror will be required to demonstrate the ability to manufacture 2-PAM autoinjectors that meet FDA reliability standards and obtain FDA approval for the treatment of OP poisoning. The contract will have a base period of up to three years and a total contract period of up to eight years with the exercise of options. Some key aspects of the job include: • Developing and maintaining a risk mitigation plan • Providing a security plan for the manufacture, process, storage, and inventory of 2-PAM autoinjectors • Conducting clinical studies to support regulatory approval • Obtaining FDA concurrence on the regulatory evaluation and approval of 2-PAM autoinjectors • Packaging 2-PAM autoinjectors for ease of distribution and use during a declared emergency