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

Background
The Biomedical Advanced Research and Development Authority (BARDA) is seeking proposals for the late-stage clinical development and regulatory approval of 2-PAM autoinjectors, a drug/device combination product intended to treat organophosphate (OP) poisoning, including nerve agents, in both adult and pediatric populations.

This initiative is part of Project Bioshield, aimed at enhancing national preparedness against biological threats. The contract also includes the procurement of these autoinjectors for the Strategic National Stockpile (SNS) and CHEMPACK Program.

Work Details
The contractor will be responsible for:
1. Program Management: Overseeing project execution and ensuring compliance with regulatory requirements.
2. Development/Finalization of Adult Device: Achieving reliability requirements (99.999%) and conducting human factors studies for both adult and pediatric devices.
3. Manufacturing Validation Lots: Producing lots that meet consistency and stability standards.
4. Regulatory Activities: Supporting Emergency Use Authorization (EUA) and/or FDA approval processes for the 2-PAM autoinjectors.
5. Procurement: Supplying up to 2 million autoinjectors to the SNS/CHEMPACK Program over the contract period, with an initial base period of performance expected to last 36 months.
6. Post-Marketing Commitments: Ensuring compliance with any post-marketing studies or commitments required by the FDA following approval.

Period of Performance
The geographic location(s) the contract will be performed (if provided)

Place of Performance
The work will primarily be performed in facilities compliant with current Good Manufacturing Practices (cGMP), as well as locations designated by BARDA for delivery of products.

Bidder Requirements
Bidders must demonstrate capabilities in manufacturing FDA-approved medical products, possess necessary security clearances, provide a comprehensive security plan, and ensure key personnel qualifications are met.

Additionally, bidders should have experience in late-stage product development and regulatory submissions related to medical countermeasures.