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The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. In response to threats presented by emerging infectious diseases and bioterrorism, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established complementary research programs to facilitate development of medical countermeasures for certain pathogens and toxins.
This FOA solicits applications to continue the Centers of Excellence for Translational Research (CETR) program focused on the development of medical countermeasures and associated platforms/technologies targeting select NIAID Emerging Infectious Diseases/Pathogens. For the purposes of this FOA, "translational research" is defined as research and developmental activities focused on transforming basic science outcomes (knowledge, technologies, infrastructure, etc.) into new and innovative approaches for prevention, diagnosis, and treatment of disease. Emphasis will be placed on Centers that integrate current research knowledge and infrastructure with highly innovative and synergistic approaches to facilitate medical countermeasure development, and address related constraints, challenges or barriers to product development, licensure and usage. Priority will be given to Centers that address the greatest clinical need.
The objective of this FOA is to continue a program of multi-project translational research Centers focused on advancing discovery, preclinical development, production, licensure and/or use of new or improved countermeasures (therapeutics, immunotherapeutics, vaccines, vaccine technologies, and medical diagnostics) or related technologies specific to select NIAID Emerging Infectious Diseases/Pathogens. NIAID encourages Centers focused on development of medical countermeasures 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.
Each Center will be organized around a Center-selected theme (Center theme) that addresses development and/or use of a targeted countermeasure or technology. NIAID anticipates considerable variety among Center themes and objectives, which can range from the development of single or multiple countermeasures targeting a specific group of listed pathogens/toxins to the development of new technologies or platforms that target a wide array of pathogens/toxins. Translational activities are anticipated to range from very early discovery-based efforts to late-stage preclinical development with industrial participation. Additionally, each Center will consider and address anticipated regulatory barriers for the targeted countermeasure or technology, particularly for new classes of medical countermeasures for which there are no precedents for FDA approval.
Examples of translational Center themes include, but are not limited to, the following areas:
Note: For the purpose of this FOA, "preclinical" is defined as all activities beyond lead candidate identification or technology/platform/prototype development.
Note: For the purpose of this FOA, "broad-spectrum" is defined as a countermeasure which is effective against multiple infectious disease agents where one or more is a targeted select NIAID Emerging Infectious Diseases/Pathogen.
Note: Center themes supported by this program must target select NIAID Emerging Infectious Diseases/Pathogens (see below). Accordingly, all Center research and development activities must utilize the virulent form of a listed human pathogen under appropriate biosafety conditions, or a CDC-approved excluded strain that is an attenuated form of the human pathogen.
Note: While Clinical development strategies and/or clinical studies (e.g. sample collection, strain isolation, etc.) may be included within an overall project, clinical trials will not be supported. Utilization of human-derived material in pre-clinical studies is encouraged.
To be responsive to this FOA, applications must focus on translational activities towards development of one or more specific countermeasures or technologies described below.