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September 2023 Trans-Divisional Council-Approved Concepts

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.

Note: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year (FY) 2025 Concepts

Center of Excellence for Systems Modeling of Infection and Immunity Across Biological Scales

Request for Applications—proposed FY 2025 initiative

Contact: 
Office of Data Science and Emerging Technologies
datascience-foa@niaid.nih.gov

Objective: Computational modeling has emerged as an important scientific method in infectious, allergic, and immune-mediated disease (IID) research. Modeling is used to 1) elucidate biological mechanisms of infection and/or immunity, 2) optimize public health control measures in response to epidemic threats, and 3) forecast epidemic trajectories. Computational modeling is of great relevance to NIAID and complements basic, clinical, and translational research, especially as a method to better understand the biological mechanisms of infection and immunity.

Computational modeling is increasingly used for research in IID, including in the NIAID research portfolio. In recent years the proportion of computational modeling projects among investigator-initiated applications to NIAID has grown and a large proportion of the MIDAS (Models of Infectious Disease Agent Study) network, a large global modeling network, is supported by NIAID. Current IID modeling projects lack coordination and a scientific direction as most modeling projects and networks are working in relative isolation. Some parts of the modeling community are organized as small disease-specific modeling networks funded by the Gates Foundation, the U.S. CDC, GAVI, and others, such as the Malaria Modeling Consortium, the HIV Modeling Consortium, and the Vaccine Impact Modeling Consortium. The MIDAS network used to be a major NIH-supported driver of collaboration and coordination, supported by the National Institute of General Medical Sciences (NIGMS), but NIGMS has significantly scaled down set-aside funding for MIDAS in recent years.

There is a need and opportunity for NIAID to coordinate modelers funded by NIAID and others to advance modeling methods and collaboration. As a global leader in IID research, NIAID is uniquely positioned to provide guidance to the modeling community towards addressing the most pressing strategic IID research priorities.

This initiative will achieve multiple scientific objectives: 

  1. To develop and conduct innovative modeling research for NIAID priority biomedical questions.
  2. To coordinate and disseminate modeling research across projects funded by NIAID divisions.
  3. To foster a diverse community of new and existing investigators dedicated to IID modeling.
  4. To establish educational opportunities in modeling of IID for students and junior investigators.
  5. To develop new approaches to enable data and model sharing in a reproducible way aligned with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles and the NIAID Data Ecosystem.

The outcome of this initiative will be a diverse and collaborative network of independent researchers dedicated to computational modeling of IID, who use cutting edge modeling methods to address key NIAID strategic priorities. The network will also quickly mobilize modeling capabilities in the community to meet NIAID needs during epidemics or pandemics.

Description: This initiative will support the establishment of one U54 Center of Excellence (CoE) to advance systems modeling research across biological scales and to coordinate the community of IID modelers. The CoE will prioritize coordination of modelers who are already funded by NIAID grants and cooperative agreements but will not exclude collaborations with modelers supported by other funding agencies. To incentivize modeling applications that connect to the CoE, NIAID is also developing a notice of special interest (NOSI) for investigator-initiated applications on IID modeling to the parent R01 and R21 notices of funding opportunities (NOFOs).

The CoE will conduct research to advance modeling methods (research projects) and perform activities to coordinate the modeling community (coordinating cores). The research projects will advance computational methods for systems modeling across biological scales in areas related to immunology, and infectious, allergic, or immune-mediated diseases. The research projects will also develop “bridge models” to connect systems models at different biological scales, including:

  1. Models that bridge between molecular and organism-scale processes, such as bridging between molecular- and cellular-level mechanisms of infection, pathogenicity, and the immune response, and organism-level pathogen and immune dynamics.
  2. Models that bridge between organism and population-level processes, such as bridging between within-host dynamics of pathogen replication and the immune system and between-host transmission.

The research projects are encouraged to focus on infectious diseases within NIAID’s mission, as well as allergic or immune-mediated diseases and immunology. Inclusion of HIV as one of the pathogens and expertise in immunology is mandatory. Selected pathogens should represent multiple transmission routes. The exact set of pathogens and immune-mediated/allergic diseases besides HIV that the CoE will select will depend on the expertise of the principal investigators (PIs). The research projects should include mechanistic modeling of processes related to infection, the immune response against infection or vaccination, and/or allergic/immune-mediated diseases.

The research projects should also include both determinants and risk factors related to IID and immunity, such as vaccination, antimicrobials, pathogen evolution and co-circulation, host genetics, climate factors, and vulnerable populations, among others.

The coordinating cores will include activities to administer the CoE, to share models, data, and software, and community building activities, such as an annual meeting, workshops, educational opportunities, and opportunity funds:

  1. Model and data sharing: Develop approaches for data and model sharing that go beyond current practices of code repositories or catalogues, and leverages executable workflow technology, the FAIR guiding principles, and the NIAID Data Ecosystem.
  2. Educational opportunities: Organize workshops and other educational opportunities for students and junior researchers from computational and biomedical sciences, especially those from underrepresented groups, interested in advancing their modeling expertise.
  3. Opportunity fund: Develop an opportunity fund to stimulate new modeling research in strategic areas that complement the CoE IID research program and to support NIAID research needs during emerging epidemic threats.
  4. Foster the modeling community: Develop activities that include, but are not limited to, an annual meeting, seminars, and an online presence.
  5. Administration: Possess the capability and resources to efficiently manage all its research and coordinating activities.

The CoE should be prepared to rapidly pivot research and coordinating activities to respond to NIAID and community needs during epidemics or pandemics.

The CoE will be led by multiple PIs, likely across multiple institutions, to cover the required range of research and coordinating expertise. The CoE will be led by a U.S.-based institution since most NIAID-funded modelers are based in the United States. Foreign components will be allowed since much of NIAID-relevant modeling occurs outside of the United States.

U.S.-Brazil Collaborative Biomedical Research - Phase 2

Request for Applications—proposed FY 2025 initiative

Contact: 
Lucy Ruderman
lucy.ruderman@nih.gov
301-761-7896

Objectives:

  • To increase U.S. scientists’ access to infectious disease and immunology research opportunities in Brazil and support U.S. scientists’ funding for collaborative research projects.
  • To foster, expand, and strengthen U.S.-Brazil basic, clinical, and translational research collaboration.

Description: This initiative will support U.S. investigators working with Brazilian colleagues in collaborative research projects. An overall program of cooperation with Brazil, which will include this initiative, may also include separately supported workshops, training, and other jointly developed activities. The focus will be on immunology and infectious diseases, including HIV/AIDS and its comorbidities [additional areas of focus may be added by other participating NIH institutes and centers (ICs) including the National Cancer Institute, National Human Genome Research Institute, National Institute on Aging, National Institute of Child Health and Human Development, National Institute of Environmental Health Sciences, National Institute of Neurological Disorders and Stroke, National Institute of Mental Health, Office of AIDS Research, and other ICs]. Areas of priority interest to NIAID are determined by U.S. scientists and are likely to include HIV/AIDS, malaria, bacterial infections including tuberculosis, sexually transmitted infections, influenza, pandemic preparedness, neglected tropical diseases, parasitic diseases, antimicrobial resistance, arboviral infections, and adjuvant discovery and the role of immune responses in pathogenesis. Following standard NIH review and award practices, NIAID and the other participating ICs will fund U.S. co-investigators; the Brazil Ministry of Health (MS) and Ministry of Science, Technology, Innovation, and Communication (MCTI) will fund the Brazilian co-investigators through the National Council for Scientific and Technological Development (CNPq) in each joint research project application.

U.S.-South Africa Program for Collaborative Biomedical Research - Phase 3 (Infectious Diseases)

Request for Applications—proposed FY 2025 initiative

Contacts: 
Peter Gerstenberger
peter.gerstenberger@nih.gov
240-747-7157

Holly Curtis
holly.curtis@nih.gov
301-761-5666

Objectives:

  • To increase U.S. scientists’ access to infectious disease and immunology research opportunities in South Africa and support U.S. scientists’ funding for collaborative research projects.
  • To foster, expand, and strengthen U.S.-South Africa basic, clinical, and translational research collaboration.

Description: This initiative will support U.S. investigators working with South African colleagues in collaborative research projects focused on infectious disease and immunology research [non-HIV/AIDS]. An overall program of cooperation with South Africa, which will include this initiative, may also include separately supported workshops, training, and other jointly developed activities. The focus will be on immunology and infectious diseases, not including HIV/AIDS and sexually transmitted infections [additional areas of focus may be added by other participating NIH institutes and centers (ICs)]. Areas of priority interest to NIAID are determined by U.S. scientists and are likely to include malaria, tuberculosis, influenza, pandemic preparedness, parasitic diseases, antimicrobial resistance, arboviral infections, other viral diseases with pandemic potential, and adjuvant discovery and the role of immune responses in pathogenesis. Following standard NIH review and award practices, NIAID and the other participating ICs will fund U.S. co-investigators; the South Africa Medical Research Council will provide the funding for the South African co-investigators.

U.S.-South Africa Program for Collaborative Biomedical Research - Phase 3 (HIV/AIDS and STIs)

Request for Applications—proposed FY 2025 initiative

Contacts: 
Peter Gerstenberger
peter.gerstenberger@nih.gov
240-747-7157

Holly Curtis
holly.curtis@nih.gov
301-761-5666

Objectives:

  • To increase U.S. scientists’ access to HIV/AIDS and related research opportunities in South Africa and support U.S. scientists’ funding for collaborative research projects.
  • To foster, expand, and strengthen U.S.-South Africa basic, clinical, and translational research collaboration.

Description: This initiative will support U.S. investigators working with South African colleagues in collaborative research projects focused on HIV/AIDS and associated areas of research as well as sexually transmitted infections (STIs). An overall program of cooperation with South Africa, which will include this initiative, may also include separately supported workshops, training, and other jointly developed activities. The focus will be on HIV/AIDS, associated comorbidities, STIs, and other associated areas of research [additional areas of focus may be added by other participating NIH institutes and centers (ICs)]. Areas of priority interest to NIAID are determined by U.S. scientists and are likely to include prevention, treatment and care, cure, comorbidities, co-infections, STIs, cancer, behavior, and HIV risk. Following standard NIH review and award practices, NIAID and the other participating ICs will fund U.S. co-investigators; the South Africa Medical Research Council will provide the funding for the South African co-investigators.

NIAID Clinical Trial Implementation Cooperative Agreement

Program Announcement with Special Receipt, Referral, and/or Review Considerations—proposed FY 2025 initiative

Contacts: 

Division of AIDS
Martin Gutierrez
mgutierrez@niaid.nih.gov
240-292-4844

Division of Allergy, Immunology, and Transplantation
Ellen Goldmuntz
egoldmuntz@niaid.nih.gov
240-627-3502

Division of Microbiology and Infectious Diseases
NIAID_DMID_IICT@niaid.nih.gov

Objective: Although clinical research infrastructure is crucial to furthering the Institute’s research, NIAID recognizes that additional models of clinical research may be important to advancing its research mission; therefore, NIAID has established the investigator-initiated clinical trial program for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial infrastructure.

Description: This program consists of support for the NIAID Clinical Trial Implementation (U01) Cooperative Agreement. This renewal is designed to support investigator-initiated clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves nonroutine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Each NIAID Clinical Trial Implementation award will support a single clinical trial that may include more than one intervention. This program will not support more than one clinical trial. A single platform trial that allows for simultaneous comparison of multiple intervention groups against a single control group or a trial that includes more than one sequential stage would be permitted. For additional information about NIAID's investigator-initiated clinical trial program, refer to https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trial-resources.

NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement

Program Announcement with Special Receipt, Referral, and/or Review Considerations—proposed FY 2025 initiative

Contact: 
Natalia Kruchinin
kruchininn@mail.nih.gov
240-669-2919

Objective: Although clinical research infrastructure is crucial to furthering the Institute’s research, NIAID recognizes that additional models of clinical research may be important to advancing its research mission; therefore, NIAID has established the investigator-initiated clinical trial program for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial infrastructure.

Description: This program consists of support for the NIAID Small Business Innovation Research (SBIR) Phase II Clinical Trial Implementation Cooperative Agreement (U44) grant. This renewal is designed to support clinical trials that are implemented by small business organizations. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves nonroutine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies will be encouraged and may be proposed under this program. Each NIAID Clinical Trial Implementation award will support a single clinical trial. All research and development activities associated with awards made under this NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) notice of funding opportunity must be performed within the United States (the United States is defined as the 50 States, the territories and possessions of the United States, the Commonwealth of Puerto Rico, the Federated States of Micronesia, the Republic of Palau, the Republic of the Marshall Islands, and the District of Columbia). For more information, please refer to Investigator-Initiated Clinical Trials Questions and Answers at https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trials-faqs.
 

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