Centers for Precision Disease Modeling (U54) (Clinical Trials Not Allowed)

This funding opportunity, issued by the National Institutes of Health (NIH) and specifically through the Office of Research Infrastructure Programs (ORIP), aims to support the development and advancement of Centers for Precision Disease Modeling through U54 Cooperative Agreements. These Centers will focus on integrating advancements in personalized medicine with the latest techniques in animal genomics and genetic manipulation, thus creating precision animal models that enhance the predictive value of preclinical studies. The Centers are expected to develop mechanisms for the scientific community to nominate specific human genomic variants for testing in animal models, validate the resulting genetic modifications, and conduct comprehensive functional analyses. Additionally, the Centers will work on creating and distributing animal models as resources for the wider biomedical community, thereby playing a significant role in bridging research from model organisms to human clinical applications. The overarching goal of this funding initiative is to support research that contributes to precision disease modeling, facilitating a pipeline that ranges from preclinical scientific discovery to developing potential interventions. This program aligns with earlier efforts under previous initiatives, aiming to further refine methods that help translate genetic and omic data into meaningful human health applications. Each Center must manage a variety of research activities that can be adapted to different disease conditions, avoiding projects that target only a single disease or research category. Importantly, the initiative emphasizes cross-disease applicability, ensuring that the work conducted is relevant to multiple NIH Institutes and Centers. Any applications focused predominantly on the interests of one specific NIH Institute will be ineligible. Applicants are invited to request funding of up to $1,250,000 in direct costs per year, with a project duration not exceeding five years. ORIP intends to fund up to three awards, depending on the availability of NIH appropriations and the quality of the submitted proposals. The Centers must maintain a set of required sections, including Coordination, Preclinical/Co-Clinical, Bioinformatics, Resource and Service, and Disease Modeling units, each of which contributes to the functional operation of the Center. These components will ensure a systematic approach to precision disease modeling, from collecting and processing patient data to generating and characterizing animal models. The Centers are also expected to provide services to the biomedical community and manage program income generated through these services. Eligible applicants include a wide range of higher education institutions, both public and private, as well as nonprofits, for-profit organizations, local governments, and specific tribal and community-based organizations. Foreign entities are not eligible, nor are foreign components of U.S.-based organizations. Applicants must complete several registrations, including with the System for Award Management (SAM), eRA Commons, and Grants.gov, before applying. The due date for new and renewal applications is December 15, 2024, with the earliest possible start date for funded projects in August 2025. Applications must strictly adhere to the multi-component instructions specified in the application guide, and applicants should use the NIH ASSIST system or an institutional system-to-system solution for submission. The project components include an overall section, along with specific sections for coordination, preclinical and co-clinical work, bioinformatics, services, and disease modeling, with each section having defined page limits. The Centers will also be guided by a Steering Committee comprising both internal and NIH representatives to manage project selection and oversight. An external advisory board will be established to provide additional guidance and evaluate the Centers' progress. The Centers are expected to generate valuable resources for the scientific community, including precision animal models and data, accessible through publicly available repositories. They will also develop co-clinical programs, enabling studies in animal models that run parallel to human clinical trials, and are required to provide broad access to these models for use in diagnostics, therapeutics, and preventive medicine strategies. The research objectives include improving disease modeling techniques, developing new phenotyping ontologies, validating biomarkers, and supporting the development of individualized therapies. The focus is on large-scale projects that involve high-throughput technologies to evaluate genomic data, ultimately aiming to support innovative therapeutic developments and reduce the attrition of drug candidates in clinical trials.