The National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID) has approved three new concepts for potential biodefense funding: Advanced Development of Multiplex Diagnostic Platforms; Targeting Therapeutics Development to Relieve Bottlenecks in Translational Research; and Microbiology and Infectious Diseases Biological Resource Repository.
Concepts represent early planning stages for program announcements, request for applications, or solicitations. For each concept, a NIAID Council subcommittee examines its scientific merit, relative priority, appropriate budget, and funding mechanism. Council’s regular and ad hoc members approve, disapprove, or suggest modifications to each concept.
Concepts selected to be published as initiatives become part of NIAID’s budget plan, which is later incorporated into the President’s Budget proposal to Congress. Approved concepts become published in the NIH Guide and as funding opportunity announcements in Grants.gov.
While not all concepts become initiatives, they highlight NIAID’s research interests and are good topics for investigator-initiated applications:
Advanced Development of Multiplex Diagnostic Platforms BAA
This initiative will support the advancement of multiplex diagnostics, taking advantage of new FDA guidances that pave the way for developing a rapid multiplex platform capable of detecting both common infectious disease-causing pathogens and rare, low-prevalence NIAID Category A-C biodefense pathogens and toxins. Candidate multiplex diagnostic platform should have the capability to detect a minimum of five pathogens directly from a blood sample and have been designed for use in a primary healthcare setting such physicians’ offices, health clinics, emergency departments, and low resource settings.
The types of activities that may be supported under this initiative include:
- Reformulating and optimizing a multiplex diagnostic assay
- Finalizing instrument design
- cGMP manufacturing of the instrument and assay reagents
- Validating software
- Analytical specificity and sensitivity studies
- Clinical specificity and sensitivity studies
- Preparing and submitting FDA documents (510k or premarket)
Diagnostic tests to detect infectious disease-causing pathogens in additional clinical matrices may be proposed as appropriate for an offeror’s platform and may include saliva, sputum, urine, feces, and/or other types of clinical samples.
Targeting Therapeutics Development to Relieve Bottlenecks in Translational Research BAA
This initiative will support lead identification, optimization, and preclinical testing to enhance the pool of candidate small-molecule therapeutics available for future clinical development. The activities to be supported include medicinal chemistry, structure activity relationship (SAR), synthetic-route scouting towards process development, formulation development, and preclinical (non-GLP) toxicology and preclinical efficacy testing for biodefense and emerging infectious diseases.
Of particular interest are broad-spectrum antibacterials with emphasis on targeting antimicrobial resistant strains, as well as broad-spectrum antivirals and small molecule antitoxins.
Microbiology and Infectious Diseases Biological Resource Repository (MID-BRR) RFP
This initiative will provide support for a biological resource repository to include reference reagents for current DMID and NIAID high-priority pathogens (e.g., TB, malaria, influenza, antimicrobial resistance, biodefense) and other emerging diseases, with flexibility to respond to future priorities.
Specific activities include acquiring, authenticating, producing, preserving, storing, and distributing research and reference reagents to support the infectious diseases research community. The proposed repository will serve basic through applied researchers across the NIAID extramural portfolio, as well as investigators around the globe.
The objective of this effort is to provide access to high-quality, standardized strains and reagents to encourage and facilitate research on NIAID pathogens and agents, and ultimately advance the development of medical countermeasures.
Contacts for each concept area are listed on the NIAID announcement.
