RFI/SSN for Host Directed Therapeutics for the Prevention of Progression to ARDS RPP-26-12-PreventARDS_RFI_SSN

Objective The objective of this combined Request for Information (RFI) / Sources Sought Notice (SSN) is for BARDA program officials to better refine the requirements for host directed therapeutics for the prevention of progression to acute respiratory distress syndrome (ARDS) in support of BARDA s Influenza and Emerging Infectious Diseases Division (IEIDD). BARDA is considering establishing long-term partnerships with multiple contractors. The information requested from this RFI will serve as market research while also assisting with requirements development of this vital program. None of the information in this RFI is intended to suggest a particular approach or contract solution. Project Scope BARDA seeks Performer(s) to support the continuation of the ARDS Preparedness and Response Program. This project supports advancing the late-stage clinical development of host-directed therapeutics for the prevention of progression to ARDS in hospitalized patients with viral respiratory infection who require supplemental oxygen. The Proposal would include a?Phase 3 clinical development plan?including?dose selection?for a host-directed therapeutic product that has supportive Phase 2 data?demonstrating?efficacy in preventing worsening of severe disease in hospitalized patients with viral respiratory infection. A product that is in an ongoing Phase 3 trial is preferred.? **Please see Attachment B Draft RPP for detailed information. SAM.Gov Sources Sought Notice (SSN) This RFI also constitutes as a Sources Sought Notice. BARDA anticipates awards will be made to multiple contractors with the best solutions and capabilities. Mandatory Eligibility Criteria:?Proposed?host-directed therapeutic(s)?must?meet the following?minimum?criteria?to be considered for award:? Data?demonstrating?a?robust?therapeutic?mechanism of action?that?is?applicable?to the resolution of severe disease due to influenza infection.? Demonstrated preclinical and/or clinical efficacy against severe disease due to?viral respiratory?infection.? Relevance to viral respiratory infection, including influenza, through intended enrollment of?appropriate patients.? Rationale behind dose selection for?a?Phase?3?study.? Feedback and concurrence from FDA on the?study design of?a?proposed?or current?Phase 3?study.? Note: Failure to adequately document compliance of the above mandatory requirement will result in the elimination of the Offeror from further consideration. No further discussions will be held. BARDA encourages qualified contractors to respond so we can better understand the current state of the science. This SSN/RFI is issued for information and planning purposes only and does not constitute a solicitation. All information received in response to the SSN/RFI that is marked as proprietary will be handled accordingly by the Government. Responses to this SSN/RFI are not considered offers and cannot be accepted by BARDA to form a binding contract. Responders are solely responsible for all expenses associated with responding to this SSN/RFI. All information submitted in response to this SSN/RFI shall remain with the Government and will not be returned. *BARDA may compete the resulting RPP amongst eligible respondents of this RFI only. RFI Response Format: Interested parties are invited to submit responses to any of the questions in Attachment A as well as a technical capabilities statement. Responses to this RFI should explore the listed questions as well as similar issues to best support the successful advancement of this effort. Responses should consist of a cover page that provides administrative and contact information (contact name, title, email address, phone number) and organizational information of the responder (entity name, headquarters, mailing address). Respondents are also invited to review the draft RPP included as Attachment B and provide general feedback via track changes. Respondents are requested to provide: Responses to questions in Attachment A RFI Questions Technical Capabilities Statement General Feedback on Attachment B Draft RPP via track changes Respondents must clearly mark all copyrighted information, data, and materials with appropriate restrictive legends (e.g., confidential, privileged, proprietary, trade secret). To aid in protecting your information, please segregate proprietary information. DO NOT SUBMIT ANY CLASSIFIED INFORMATION. Responses to this RFI should explore the listed questions as well as similar issues to best support the successful advancement of this effort. Please submit responses by email to laura.saddison@hhs.gov no later than 3:00 pm EDT April 15, 2026. Responses: BARDA encourages qualified performers to respond so we can better understand the current state of the science. The full draft RPP is being provided to allow for advance planning purposes and to allow additional time for potential proposal development and/or partnering. Please note that non-federal employees performing advisory and assistance services will have access to any submission under this RFI. All non-federal employees are required to sign a non-disclosure agreement prior to accessing the RFI responses. Thank you for your participation in this RFI. Please contact laura.saddison@hhs.gov with any questions or concerns.