Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.
NB: Council approval does not guarantee that a concept will become an initiative.
Table of Contents
Fiscal Year (FY) 2023 Concepts
- Diagnostics Preclinical Services Program
- Biological and Emerging Infections Research Resources Program (BEI-RRP)
- Preclinical Services for Biopharmaceutical Product Development
- Partnerships for Rapid Diagnostics and Phenotypic Antibacterial Susceptibility Testing for Bacteremia or Hospital Acquired Pneumonia
- Improved Drug Susceptibility Testing (DST) for Tuberculosis
- Biocontainment Laboratory Support for Pandemic Preparedness
Diagnostics Preclinical Services Program
Request for Proposals—proposed FY 2023 initiative
Contact:
Ebony Taylor
ebony.taylor@nih.gov
240-292-0668
Objective: To accelerate development of diagnostic technologies with gap-filling services, so that U.S. public health is better prepared for future biothreats and emerging infectious diseases.
Description: This initiative will support essential services that are often unavailable to start-up companies in early-stage product development, including: clinical specimen acquisition, especially for novel or rare emerging infectious diseases; clinical isolates, especially novel or antimicrobial resistant strains; assay services, such as recombinant protein or antibody reagent development to accelerate assay development; cell-line development and cell-based assays for assay modeling and surrogate testing; and product development processes (regulatory strategies, quality systems compliance) to support program maturity and reduce risk for securing advanced development funding (e.g., BARDA). This initiative will not support clinical studies as part of final validation of diagnostic product, but it will support animal model testing for biothreat agents as part of assay development.
Biological and Emerging Infections Research Resources Program (BEI-RRP)
For the published contract solicitation, check the December 23, 2021 announcement, The Biological and Emerging Infections Research Resources Program (BEI-RRP).
Preclinical Services for Biopharmaceutical Product Development
Request for Proposals—proposed FY 2023 initiative
Contact:
Jaqueta Tilghman
jaqueta.tilghman@nih.gov
301-761-7081
Objective: To advance and assist with the development of biopharmaceutical products intended to treat infectious diseases.
Description: This initiative seeks to maintain a valuable NIAID resource that provides a suite of product development services for biopharmaceutical products that are intended for treating infectious diseases. The biopharmaceutical products include therapeutic antibodies, cell lines, proteins, peptides, natural products, bacteriophages and nucleic acid-based materials (such as siRNA, oligonucleotides, genes, or plasmids), and live entities and their derivatives. These are products produced using live organisms or synthetic processes with some unique properties including: 1) multiple step synthesis and process scale-up, 2) complex quality control and bioanalytical analysis, and 3) high-risk, long-duration, and high-cost.
Through this initiative, NIAID will continue to provide the following support for biopharmaceutical products:
- Product development planning and evaluation
- Assay development and product characterization
- Process development and formulation
- cGMP manufacturing
- Regulatory support [e.g., chemistry, manufacturing, and controls (CMC) documentation]
While the overall suite of services is comprehensive, the intent is to provide gap-filling support on a case-by-case basis for biopharmaceutical product candidates. These services are intended to help investigators from academia and industry obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support clinical trials), fulfill regulatory requirements, and complete studies to support investigational new drug filing and product performance of early-phase clinical trials.
Partnerships for Rapid Diagnostics and Phenotypic Antibacterial Susceptibility Testing for Bacteremia or Hospital Acquired Pneumonia
Request for Applications—proposed FY 2023 initiative
Contact:
Alec Ritchie
aritchie@niaid.nih.gov
240-627-3356
Objective: To advance research focused on developing and/or producing medical diagnostics that permit rapid differential species identification, and corresponding phenotypic antibacterial susceptibility profiles for bacteremia or hospital acquired pneumonia.
Description: The purpose of this concept is to advance the development of diagnostics that permit rapid differential species identification, and corresponding phenotypic antibacterial susceptibility profiles. The primary goal of such diagnostics is to facilitate antibacterial stewardship, thereby reducing selective pressure and improving patient outcomes. The proposed diagnostic must be designed to differentially detect at least three pathogens in blood or samples analyzed for hospital- and/or ventilator-associated pneumonia.
The proposed diagnostic platforms and/or technologies must be supported by proof-of-concept data demonstrating feasibility.
Improved Drug Susceptibility Testing (DST) for Tuberculosis
Request for Applications—proposed FY 2023 initiative
Contact:
Karen Lacourciere
lacourcierek@niaid.nih.gov
240-627-3297
Objective: To support the development of new diagnostic technologies for tuberculosis (TB) drug susceptibility testing (DST), including point-of-care DST and companion diagnostics for new TB drugs.
Description: This concept would further the development of new diagnostic technologies for TB DST with an emphasis on rapid, point-of-care, low complexity assays. As new drugs move forward in the pipeline, there is a need for companion DST diagnostics for new drugs to ensure new drugs are used most effectively. Current phenotypic methods for determining drug resistance (DR) provide clinically relevant drug susceptibility information but have limitations. For example, the gold standard relies on culture, requires time for growth, and does not provide a result for many days. The program would solicit highly innovative DST assays, including phenotypic DST that may rely on a readout that does not require full growth as in traditional DST assays. Innovative technologies beyond nucleic acid amplification tests will be encouraged. This effort is anticipated to include exploratory work that would further improve our knowledge of genotypic and phenotypic correlates of clinical DR, which can be complex. Research that leverages the rapid advances in diagnostic technologies for COVID-19 applied to TB are also encouraged. Furthermore, this effort would be targeted to technology holders partnered with academic, clinical, and laboratory colleagues with TB diagnostic expertise.
Biocontainment Laboratory Support for Pandemic Preparedness
Request for Applications—proposed FY 2023 initiative
Contact:
Paula Bryant
paula.bryant@nih.gov
240-292-4130
Objective: To provide support for biocontainment laboratories [biosafety levels (BSL) 3 and 4] to develop and maintain resources and facilities necessary for preparedness against viruses with pandemic potential. These awards will support administrative and core facilities that supply consistent services and remove bottlenecks in antiviral research, as well as facility renovations.
Description: NIAID will provide support for biocontainment (BSL-3 and BSL-4) facilities and related core research services to further the goals of pandemic preparedness and the Antiviral Program for Pandemics, which aims to advance the development of antivirals against select pathogens with pandemic potential (http://www.niaid.nih.gov/research/antivirals). Applicant institutions will be expected to demonstrate expertise and research funding in RNA viruses with pandemic potential (Bunyavirales, Coronaviridae, Paramyxoviridae, Filoviridae, Togaviridae). Support may include the following, as needed:
- Administrative Core–provides management and oversight of facility, which may include the following: maintenance, lifecycle planning, staff training, and quality systems.
- Integrated Research Cores–provide specialized services essential to support biocontainment research activities, to include removing bottlenecks in advancing antivirals against viruses with pandemic potential. Core services such as the following may be envisioned: veterinary/animal, virology, imaging, pathology services, screening, insectary, and/or aerobiology.
- Facility Upgrades–include repair, renovation, and modernization to enhance functions and operations of existing facilities; equipment connected to building systems to modernize or improve efficiencies; and building automation systems.