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

Solicitation description

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...

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