Therapeutics for infections caused by Gram-negative pathogens:

The scope is restricted to direct-acting small-molecule therapeutics (or small molecules that can be used in combination with an existing drug that can restore the potency of that drug to clinically useful levels in an in vitro MIC assay by inhibition of a specific resistance mechanism). Molecules with properties that can deliver an oral or IV/oral option are preferred. In all cases, activity against both susceptible and multidrug-resistant organisms on the WHO and CDC bacterial threat lists is essential. See Target Product Profile.

Prevention of invasive diseases:

Novel approaches to prevention of invasive disease caused by Staphylococcus aureus or Escherichia coli are sought. The funding call is for preventative agents only. Prophylactic use of therapeutics is not considered preventative. An important parameter, therefore, is the duration of protection, which should be: (i) significant in the context of the disease; and (ii) rationalized (i.e., the active agent is present in sufficient quantities for this duration).

Given the history of challenges in drug development in this arena, modalities other than vaccines are preferred; however, if a vaccine is proposed, a novel aspect (e.g. adjuvant strategy or vaccine composition) that makes a compelling case must be underscored. See the following Target Product Profiles:

• E. coli vaccine
• E. coli monoclonal antibodies
• E. coli other
• S. aureus vaccine
• S. aureus monoclonal antibodies
• S. aureus other

Diagnostics for neonatal sepsis:

Consistent with our “Aligned by Design” strategy, we seek diagnostics to support the growing portfolio of potential maternal vaccines to prevent neonatal sepsis. Products focused on rapid triage, bacterial identification and/or antibiotic susceptibility testing are sought. Time-to-result and cost-of-goods are key criteria, and small-sample volumes are critical for this patient population. Pathogen ID and AST Products must focus on priority pathogens, including Klebsiella pneumoniae, Escherichia coli, Staphylococcus aureus and Acinetobacter baumannii. See the following Target Product Profiles:

• Rapid triage
• Pathogen ID
• Antibiotic Susceptibility/Resistance Testing

See also Health System Levels for Diagnostics.

Proof-of-concept for alternative sample types for diagnosing lower-respiratory-tract infections:

Consistent with our “Aligned by Design” strategy, we seek diagnostics to support the many therapeutic projects focused on lower-respiratory-tract infections (LRTI). Owing to the challenges with BAL samples, as a first step, projects that can demonstrate proof-of-concept data with alternative sample types are sought.