Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed)

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.