The Biomedical Advanced Research and Development Authority (BARDA) has released a Request for Project Proposals (RPP) under the Rapid Response Partnership Vehicle (RRPV) for developing small molecule therapeutics aimed at COVID-19 Pre-exposure Prophylaxis (PrEP). This initiative enhances national health security by advancing medical countermeasures against SARS-CoV-2 and future health threats.
BARDA’s call for proposals targets the development of next-generation COVID-19 therapeutics that provide pre-exposure prophylaxis (PrEP) and treatment solutions for new SARS-CoV-2 variants. The goal is to close existing capability gaps and improve preparedness for future pandemics.
Proposal Requirements
Applicants are required to submit both a Technical Proposal and a Cost Proposal. Key elements to include are:
- Technical Approach: Detailed description of the proposed solution, including mechanism of action, in vitro activity against specified variants, and development plan leading to clinical trials and regulatory approval.
- Manufacturing Plan: Strategies for scaling up production under current Good Manufacturing Practices (cGMP).
- Regulatory Strategy: Planned pathway to navigate regulatory requirements for an eventual FDA approval.
Evaluation Criteria
Proposals will be evaluated based on several critical capabilities required for the project. These include innovative drug design, comprehensive plans for both preclinical and clinical development, and the ability to scale production from the laboratory to commercial scale. A thorough understanding of FDA regulations is essential, as is a robust project management framework with a team experienced in drug development, clinical trials, regulatory affairs, and commercialization. These factors are crucial for the project’s success.
This RPP represents a critical opportunity for the biomedical community to contribute to a robust response against COVID-19 and future threats. By participating, developers have the chance to not only advance their technologies but also play a key role in global health security. BARDA’s initiative through the RRPV underscores a commitment to innovative partnerships and rapid development pathways, setting the stage for transformative impacts in the field of infectious diseases.
If your company has considered applying for BARDA funding, your federal funding journey starts here.
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