Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
The objective of this NOFO is to support a program of multi-project translational research Centers focused on advancing potential MCM candidates (therapeutics, immunotherapeutics, vaccines, vaccine technologies, and in vitro diagnostics) for known or emerging AMR bacteria and fungi beyond discovery through preclinical development.NIAID encourages Centers focused on development of MCMs that are effective against a variety of pathogens and toxins, technologies that can be widely applied to improve classes of products, and platforms that can reduce the time and cost of creating new products. For this NOFO, "preclinical development" is defined as all activities including hit-to-lead candidate identification through Investigational New Drug (IND) application enabling.
Each Center will be organized around a specific major objective, theme or program goal, that addresses development of MCMs for AMR bacteria and/or fungi. NIAID anticipates considerable variety among Center themes and objectives, which can range for example, from the development of countermeasures targeting a specific resistant pathogen or group of resistant pathogens, to the development of new technologies or platforms that target a wide array of these pathogens selected from the list below. Because FDA authorization of MCMs identified through these programs should be a long-term goal, each Center should consider and address anticipated regulatory barriers for the targeted countermeasure or technology, particularly for new classes of MCMs for which there are no precedents for FDA approval. Consistent with these goals, a Product Development Strategy, which should include Milestones and Product Development Plans, must be included in the Overall component of each application, with the exception of those focusing upon early translational studies in fungal pathogens.
Examples of translational Center themes could include, but are not limited to, the following areas:
- Evaluate single or multiple targets and MCM modalities (i.e., diagnostics, therapeutics and/or vaccines) to address a specific AMR pathogen;
- Develop new approaches for a known pathogen target (e.g., gyrase, cell wall, transcription/translation) to include broad-spectrum therapeutics with extended activity against more than one AMR pathogen;
- Develop potentiators that restore susceptibility to known therapeutic classes;
- Develop a monoclonal antibody (mAb), phage, or other technology approach to counter pathogen resistance;
- Use systems immunology and reverse vaccinology to design antigens/immunogens to be used in the development of vaccines, immunotherapeutics or diagnostics;
- Develop faster, direct-from-specimen pathogen identification (ID) tests to mitigate risk of progression to sepsis onset;
- Develop faster phenotypic antibacterial susceptibility test (AST) characterization for better antibiotic stewardship.
Application budgets are not expected to exceed $5 million in direct costs per year and should reflect the actual needs of the proposed project.
April 29, 2024
Candace Kerr, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6257
Email: candace.kerr@nih.gov