Opportunity Information: Apply for PAR 20 085
The Pilot Centers for Precision Disease Modeling (U54) funding opportunity (PAR-20-085) is a National Institutes of Health cooperative agreement designed to launch a small number of collaborative centers that can connect human precision medicine findings directly to advanced animal modeling. The central idea is to tighten the link between what is being discovered in patients (especially specific genomic variants) and what can be tested and understood in preclinical systems, using modern animal genomics, gene editing, and related technologies such as the creation of interspecies somatic hybrids. By building an integrated, repeatable workflow across these areas, the program aims to improve how well preclinical studies predict human disease biology and treatment response.
A key deliverable expected from each Center is a practical, community-facing process for bringing human genomic variation into an animal model testing pipeline. In other words, the broader research community should be able to nominate unique human variants, and the Center should be able to evaluate those variants in a cost-effective, high-throughput way. The FOA emphasizes more than just creating edited animals: once gene editing is confirmed to be correct, the Centers are expected to set up robust assays and phenotyping strategies to perform comprehensive functional studies. This means moving from "we made the variant" to "we can measure what it does," including whether and how it causes disease-relevant changes, and doing so in a way that supports systematic interpretation across projects.
Another major mission is resource creation and distribution. These Centers are not meant to be closed efforts that only generate data for the proposing team. Instead, they are expected to produce precision animal model resources and provide related services to the biomedical community, effectively acting as hubs that can supply models, methods, and possibly standardized pipelines that other investigators can use. The intent is to create preclinical pipelines that support scientific discovery, disease modeling, and the development and testing of interventions grounded in innovative animal models, with an emphasis on reproducibility and utility beyond a single disease area or project.
Although each Center will likely pursue a limited number of focused projects, the program expects the underlying platform to be flexible and multifaceted rather than narrowly bespoke. The pipelines and core model systems developed should be adjustable to accommodate a broad spectrum of diseases over time. This is important because the long-term vision is that these preclinical pipelines become part of the broader ecosystem that informs diagnostics, patient care decisions, and therapeutic development. Applicants are therefore expected to explain how their Center will help bridge that translational gap, even though clinical trials are explicitly not allowed under this FOA.
From an administrative standpoint, this is a discretionary health-related opportunity from the U.S. Department of Health and Human Services through NIH, using the U54 cooperative agreement mechanism, which typically implies substantial NIH programmatic involvement and coordination during the award. The opportunity listed an award ceiling of $1,250,000 and an expectation of 2 awards. Eligible applicants are broad and include many types of U.S. organizations and governments, such as public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and various governmental and tribal entities. The FOA was created January 8, 2020, with an original closing date of March 24, 2020.Apply for PAR 20 085
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Centers for Precision Disease Modeling (U54)(Clinical Trials Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.351.
- This funding opportunity was created on Jan 08, 2020.
- Applicants must submit their applications by Mar 24, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,250,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: Pilot Centers for Precision Disease Modeling (U54) - PAR-20-085
What is the Pilot Centers for Precision Disease Modeling (U54) opportunity (PAR-20-085)?
This opportunity is a National Institutes of Health (NIH) cooperative agreement that supports a small number of collaborative Centers designed to connect findings from human precision medicine directly to advanced animal modeling. The goal is to create integrated, repeatable workflows that translate patient discoveries (especially specific genomic variants) into preclinical testing systems.
What is the main purpose of the program?
The main purpose is to tighten the link between what is discovered in patients and what can be tested in preclinical systems, using modern animal genomics, gene editing, and related technologies. By doing this systematically, the program aims to improve how well preclinical studies predict human disease biology and treatment response.
What kind of award mechanism is used for this program?
The program uses the U54 cooperative agreement mechanism. This typically indicates substantial NIH programmatic involvement and coordination during the award period, beyond what is common for standard research grants.
What makes a cooperative agreement (U54) different from other NIH awards?
Based on the opportunity description, the U54 cooperative agreement implies that NIH will have an active role in programmatic involvement and coordination during the award. Centers are also expected to serve broader community needs by creating and distributing resources and services, not only conducting internally focused research.
How many awards are expected to be made?
The opportunity indicated an expectation of 2 awards.
What is the award ceiling for this opportunity?
The opportunity listed an award ceiling of $1,250,000.
Which federal agency is sponsoring this opportunity?
This is a discretionary health-related opportunity from the U.S. Department of Health and Human Services through the National Institutes of Health (NIH).
Who is eligible to apply?
Eligible applicants are broad and include many types of U.S. organizations and governments, including:
- Public and private institutions of higher education
- Nonprofit organizations (both 501(c)(3) and non-501(c)(3))
- For-profit organizations (including small businesses)
- Various governmental entities
- Tribal entities
What types of Centers is NIH trying to launch through this program?
NIH aims to launch a small number of collaborative Centers that can directly connect human precision medicine findings to advanced animal modeling. These Centers are expected to function as hubs that develop practical pipelines, generate community resources, and provide services that extend beyond the proposing team.
What scientific approach does the program emphasize?
The program emphasizes creating an integrated workflow that links human genomic variation (including specific variants) to animal modeling using modern animal genomics, gene editing, and related technologies such as the creation of interspecies somatic hybrids.
What is a key deliverable expected from each Center?
A key deliverable is a practical, community-facing process for bringing human genomic variation into an animal model testing pipeline. The broader research community should be able to nominate unique human variants, and the Center should be able to evaluate them in a cost-effective, high-throughput way.
Does the program focus only on creating gene-edited animals?
No. The opportunity emphasizes that the work should go beyond producing edited animals. Once gene editing is confirmed to be correct, Centers are expected to implement robust assays and phenotyping strategies to conduct comprehensive functional studies of the variants.
What does "moving from 'we made the variant' to 'we can measure what it does'" mean in this context?
It means Centers are expected not only to introduce human variants into animal models, but also to measure disease-relevant effects using robust assays and phenotyping strategies. The intent is to support systematic interpretation across projects by producing functional evidence of what a variant does.
What does the FOA expect regarding phenotyping and functional studies?
The FOA expects comprehensive functional studies after confirming correct gene editing. This includes setting up robust assays and phenotyping strategies to determine whether and how a variant causes disease-relevant changes and to do so in a way that supports systematic interpretation across multiple projects.
Are the Centers intended to operate as closed, internal research efforts?
No. The Centers are explicitly not meant to be closed efforts generating data only for the proposing team. They are expected to create and distribute precision animal model resources and provide related services to the broader biomedical community.
What kinds of resources and services are Centers expected to provide?
Based on the opportunity description, Centers are expected to produce precision animal model resources and provide related services to the biomedical community. They may act as hubs that supply models, methods, and possibly standardized pipelines that other investigators can use.
Is the program limited to one disease area?
The opportunity emphasizes utility beyond a single disease area or project. Although each Center may pursue a limited number of focused projects, the underlying platform is expected to be flexible and adjustable to accommodate a broad spectrum of diseases over time.
How should applicants think about the platform versus the individual projects?
The program expects that while a Center may run a limited number of focused projects, the platform itself should be multifaceted and adaptable rather than narrowly bespoke. The pipeline and core model systems should be designed so they can be adjusted for different diseases and future needs.
What is the long-term vision for these preclinical pipelines?
The long-term vision is that these preclinical pipelines become part of a broader ecosystem that informs diagnostics, patient care decisions, and therapeutic development by improving the translation between human precision medicine findings and preclinical testing.
Does the FOA allow clinical trials?
No. Clinical trials are explicitly not allowed under this FOA.
What does the program aim to improve about preclinical studies?
The program aims to improve how well preclinical studies predict human disease biology and treatment response by strengthening the workflow that connects human findings to animal model testing using modern genomic and gene-editing approaches.
What role does variant nomination by the research community play?
The FOA describes a community-facing process where the broader research community should be able to nominate unique human variants. The Center is expected to evaluate those variants through a cost-effective, high-throughput pipeline.
What technologies are referenced as part of the modeling approach?
The opportunity references modern animal genomics, gene editing, and related technologies, including the creation of interspecies somatic hybrids.
When was this FOA created and when did it originally close?
The FOA was created on January 8, 2020, and had an original closing date of March 24, 2020.
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