BARDA Antibiotic for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia or Bloodstream Infections Caused by Drug-Resistant Bacteria or Biothreat Pathogens

Background
The Center for the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is focused on protecting the civilian population from health threats, including those posed by drug-resistant bacteria.

This Sources Sought Notice aims to gather information on antibiotics in development for treating hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and bloodstream infections (BSI), particularly those caused by drug-resistant bacteria and biothreat pathogens.

Work Details
BARDA is seeking information on antibiotic programs that meet the following criteria:

1) Programs that have or expect to hold their end-of-Phase 2 meeting with the FDA by May 1, 2025, for HABP/VABP treatment.

2) Programs for BSI treatment with similar FDA meeting timelines.

3) Programs that could also be developed for biothreat indications.

4) Approved antibiotics for HABP/VABP or BSI that have sufficient data for biothreat indication development.

Respondents should provide detailed information including: an overview of the antibiotic candidate, targeted pathogens, clinical indications, commercial formulation, FDA correspondences, intellectual property status, proposed timelines for submissions, nonclinical study overviews (including efficacy data), clinical development status across all phases (including trial designs and safety data), manufacturing plans (including registration status and stability testing), procurement strategies for USG-owned products, and a commercialization plan.