RFI/SSN for Host Directed Therapeutics for the Prevention of Progression to ARDS

Solicitation / RFP / RFQ

This Request for Project Proposals (RPP) from the Biomedical Advanced Research and Development Authority (BARDA) seeks proposals for the advanced clinical development of host-directed therapeutics to prevent the progression of Acute Respiratory Distress Syndrome (ARDS) in hospitalized patients with severe viral respiratory infections. The goal is to address a critical capability gap in treatments for this condition, which currently has no FDA-approved therapies.

• Development and implementation of a regulatory strategy and clinical development plan for FDA approval.

• Conduct of a Phase 3 clinical trial demonstrating efficacy in preventing ARDS progression.

• Awardees will serve as the regulatory product sponsor, responsible for all FDA submissions and maintenance of regulatory filings.

• Submission of all relevant regulatory and supporting documentation to the Government.

• Monthly and annual technical and financial reports, along with a detailed final clinical study report.

• Participation in regular progress meetings with the Government.

• Project Awards will be executed under the Rapid Response Partnership Vehicle (RRPV) Other Transaction Agreement (OTA).

• Period of Performance is estimated up to three (3) years, potentially extending beyond, for Phase 3 trials, FDA submissions, and product approval.

• Anticipated total USG funding is approximately $XM, with an anticipated X award(s).

• Cost sharing is encouraged, with the Government anticipating up to 30% cost-sharing.

• Proposals require a Technical Proposal, Cost Proposal, and Statement of Work/Milestone Payment Schedule.

• Key deadlines: Questions Due April 29, 2026; Proposals Due May 20, 2026.

• Proposals will be evaluated based on Technical Approach, Relevant Corporate and Capabilities Experience, Program Management Approach, and Cost/Price.

• Technical Approach is the most important non-cost factor.

• Offerors must be RRPV members at the time of proposal submission.

• Offerors must attest to their intent and ability to comply with ASPR Security Requirements.

• Proposals must be submitted through the RRPV BDR Portal.

• Specific templates and detailed instructions are provided in the attachments.

Request for Information (RFI) / Sources Sought Notice (SSN)

This RFI/SSN is issued by the Biomedical Advanced Research and Development Authority (BARDA) to gather market research and refine requirements for host-directed therapeutics aimed at preventing the progression to Acute Respiratory Distress Syndrome (ARDS) in hospitalized patients with viral respiratory infections requiring supplemental oxygen. BARDA is considering establishing long-term partnerships with multiple contractors.

BARDA seeks performers to support the continuation of the ARDS Preparedness and Response Program. This involves advancing the late-stage clinical development of host-directed therapeutics. Proposals should include a Phase 3 clinical development plan, including dose selection, for a product with supportive Phase 2 data demonstrating efficacy. A product already in an ongoing Phase 3 trial is preferred.

Proposed therapeutics must meet the following minimum criteria:

• Demonstrate a robust therapeutic mechanism of action applicable to severe influenza disease.

• Show demonstrated preclinical and/or clinical efficacy against severe disease from viral respiratory infections.

• Be relevant to viral respiratory infections (including influenza) through appropriate patient enrollment.

• Provide a rationale for dose selection for a Phase 3 study.

• Include feedback and concurrence from the FDA on the proposed or current Phase 3 study design.

• Response Due Date: 3:00 PM EDT on April 15, 2026.

• Submission Method: Email to laura.saddison@hhs.gov.

• Required Content:

  • Cover page with administrative and contact information.
  • Responses to questions in Attachment A (RFI Questions).
  • Technical Capabilities Statement.
  • General feedback on Attachment B (Draft RPP) via track changes.

• Proprietary information should be clearly marked and segregated. Do not submit classified information.

• This RFI/SSN is for information and planning purposes only and does not constitute a solicitation.

• BARDA may compete the resulting RPP amongst eligible respondents of this RFI only.

• Non-federal employees may access submissions after signing a non-disclosure agreement.

Form / Attachment / Pricing Sheet

This document, "Attachment A," contains vendor questions and comments related to the "RRPV PreventARDS RFI." It serves as a mechanism for potential bidders to provide feedback and seek clarification on a draft Request for Proposal (RFP).

• Technical Activities: Inquires about any missing technical activities in the draft RFP, considering the period of performance and specific technical solutions.
• Marketplace Competitiveness: Asks if the services are competitively offered in the common marketplace under standard commercial terms.
• Business Size: Seeks confirmation on whether the organization is an "Other than Small Business" under NAICS 541714.
• Response Time: Asks for the number of days required to provide a thorough response once the solicitation opens.
• Additional Feedback: Requests general feedback to assist with updates to the draft RFP, including operational efficiencies and pandemic response considerations.

This attachment provides insight into potential areas of focus and clarification for the upcoming solicitation. Bidders can use this to understand the types of questions being considered by the government and other potential offerors, and to anticipate areas that may require detailed responses or further clarification in their own proposals.