- Country: USA
- Summary: Pre Solicitation - Antibiotic for Treatment of Bacterial Pneumonia or Bloodstream Infections
- UST Ref No: 121732241
- Deadline: 11 Jul 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 75A50125R00005
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- Description:
- Description
BARDA seeks to identify qualified vendors capable of advancing the development of antibiotics for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and bloodstream infections (BSI), as well as post-exposure prophylaxis (PEP) and/or treatment of biothreat pathogens. In direct support of BARDA-s preparedness and response posture, the antibiotics will be positioned for potential procurement. Capable vendors must furnish all necessary services, qualified professional, technical and administrative personnel, materials, equipment, and facilities to perform the required tasks. The target product description and mandatory source requirements are antibiotic programs that 1) already have or expect to hold their end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by May 1, 2025, with an intended indication for the treatment of HABP/VABP; 2) or already have or expect to hold their end-of-Phase 2 meeting with the FDA by May 1, 2025, with an intended indication for the treatment of BSI; 3) or already have or expect to hold their end-of-Phase 2 meeting with the FDA by May 1, 2025, with an intended indication for the treatment of HABP/VABP or BSI that could also be developed for a biothreat indication; 4) or antibiotics that are approved for HABP/VABP and/or BSI that have sufficient data to warrant development for a biothreat indication.
This project is for investing in late-stage development, procurement, and stockpiling of antibiotics to treat HABP/VABP and/or BSI caused by drug-resistant bacterial and/or biothreat pathogens, and actively seeks vendors with existing domestic manufacturing capabilities or at minimum a timeline and summarized approach to onshore drug substance manufacturing and fill/finish of drug product. The total period of performance will be no more than 120 months; the period of performance for the Base and Option periods may overlap; the duration of each period will be dep... - Documents:
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CLICK HERE TO LOGINPre Solicitation - Antibiotic for Treatment of Bacterial Pneumonia or Bloodstream Infections - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, a Government sector organization in USA, has announced a new tender for Pre Solicitation - Antibiotic for Treatment of Bacterial Pneumonia or Bloodstream Infections. This tender is published on USARFP under UST Ref No: 121732241 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-07-11.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
