Opportunity Information: Apply for RFA NS 18 025
The NIH funding opportunity "Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs)" (RFA-NS-18-025) supports collaborative, center-based efforts to create and advance PET radioligands that can detect ADRD-relevant proteinopathies and other pathological processes in humans. The intent is to speed the pipeline from promising chemistry to practical imaging tools by organizing multidisciplinary teams into a single coordinated "Center without Walls" structure, where the combined capabilities of the group are essential to achieving the scientific goals. The award mechanism is a U19 cooperative agreement, meaning NIH staff are expected to have substantial programmatic involvement compared with a standard research grant, and clinical trials are optional under this announcement.
Scientifically, the FOA focuses on PET tracer development aimed at the biology of ADRDs, not just generic neurodegeneration. Supported activities span multiple stages of ligand development: in vitro screening of existing candidate ligands using human ADRD brain tissue, medicinal chemistry to optimize compounds for improved specificity and selectivity, initial in vivo screening in appropriate animal models, and the practical work needed to move a compound into humans, such as radioligand formulation and first-in-human testing. In other words, the program is designed to cover the core translational steps required to take a tracer from "this might bind the right target" to "this can be produced reliably and tested in people."
A key structural requirement is that applications must be built as a true center with shared infrastructure and clear governance. Each application is required to include an administrative core, a medicinal chemistry core, a clinical core, and a scientific governance structure that coordinates decision-making and prioritization across the program. In addition, the application must propose at least two research projects, each with milestone plans. Those milestones are expected to lay out concrete workflows for screening both existing ligands and newly derived ligands against human ADRD tissue and in relevant animal models, creating a disciplined "go/no-go" framework for advancing the best candidates. The FOA emphasizes that synergy has to be obvious: the research projects and cores must be interdependent in a way that makes it clear the overall aims could not realistically be completed as separate, stand-alone projects without the center organization.
Programmatically, this initiative is framed as a response to the ADRD challenges identified in the 2016 update to the National Plan to Address Alzheimer's Disease. The broader public health rationale is that better PET ligands can improve diagnosis, help differentiate among dementias, support patient stratification, and enable more informative clinical research by tracking specific pathological processes in vivo. By focusing on ligand specificity and selectivity and insisting on validation against human tissue and appropriate models, the FOA signals an emphasis on biological relevance and translational credibility rather than early-stage discovery alone.
Eligibility is broad and includes many types of U.S.-based organizations, such as state, county, and local governments; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; independent school districts; special district governments; and public housing authorities/Indian housing authorities. The FOA also explicitly highlights additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions, as well as faith-based or community-based organizations and eligible federal agencies.
Foreign eligibility is limited in a specific way. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed, which generally means a U.S. applicant can include certain international collaborators or activities when well-justified and compliant with NIH policy.
Administrative details in the source information indicate the sponsoring agency is the National Institutes of Health, the opportunity category is discretionary, the activity category is health, and the CFDA numbers listed are 93.853 and 93.866. The original closing date shown is 2018-05-08, and the creation date is 2018-03-02. The award ceiling and expected number of awards are not specified in the provided source text.Apply for RFA NS 18 025
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs) (U19 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
- This funding opportunity was created on 2018-03-02.
- Applicants must submit their applications by 2018-05-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
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Frequently Asked Questions (FAQs)
What is the funding opportunity?
This opportunity is the NIH funding announcement titled "Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs)" (RFA-NS-18-025). It supports collaborative, center-based work to create and advance PET radioligands for detecting ADRD-relevant proteinopathies and other pathological processes in humans.
What is the main goal of this program?
The goal is to speed up the pipeline from promising PET ligand chemistry to practical imaging tools that can be produced reliably and tested in people. The program emphasizes coordinated, multidisciplinary teamwork to move candidates through translational steps rather than treating projects as disconnected, stand-alone efforts.
What does "Center without Walls" mean in this FOA?
What type of award mechanism is used?
The award mechanism is a U19 cooperative agreement.
What does a U19 cooperative agreement imply about NIH involvement?
As a cooperative agreement, a U19 generally involves substantial programmatic involvement by NIH staff compared with a standard research grant. Under this announcement, NIH staff are expected to have substantial involvement.
Are clinical trials required?
No. Clinical trials are optional under this announcement.
What scientific focus does the FOA emphasize?
The FOA focuses on PET tracer development aimed specifically at the biology of Alzheimer's disease related dementias (ADRDs), not just generic neurodegeneration. It emphasizes biological relevance, including validation against human ADRD brain tissue and appropriate model systems.
What kinds of activities across the tracer development pipeline are supported?
Supported activities span multiple stages, including in vitro screening of existing candidate ligands using human ADRD brain tissue, medicinal chemistry to optimize compounds (including improving specificity and selectivity), initial in vivo screening in appropriate animal models, and translational steps needed to move a compound into humans (such as radioligand formulation and first-in-human testing).
Does the FOA support only early discovery, or does it include translational work?
It is designed to include core translational steps needed to move from "candidate binding" to "reliable production and testing in people." The emphasis is on translational credibility and biological relevance rather than early-stage discovery alone.
What is required in terms of center structure and shared infrastructure?
Applications must be built as a true center with shared infrastructure and clear governance. The FOA requires an administrative core, a medicinal chemistry core, a clinical core, and a scientific governance structure to coordinate decision-making and prioritization across the program.
What research components must be included in the application?
The application must propose at least two research projects. Each research project must include milestone plans.
What are the milestone plans expected to cover?
Milestones are expected to lay out concrete workflows for screening both existing ligands and newly derived ligands against human ADRD tissue and in relevant animal models. The FOA describes this as a disciplined "go/no-go" framework to advance the best candidates.
Why does the FOA emphasize synergy and interdependence?
The FOA expects it to be obvious that the projects and cores depend on one another and that the overall aims could not realistically be completed as separate, stand-alone projects without the coordinated center organization.
What disease areas and biological targets are the PET ligands intended to address?
The ligands are intended to detect ADRD-relevant proteinopathies and other pathological processes in humans. The FOA emphasizes targeting the biology of ADRDs rather than general neurodegeneration.
What is the public health rationale for developing better PET ligands for ADRDs?
According to the program framing, improved PET ligands can support better diagnosis, help differentiate among dementias, improve patient stratification, and enable more informative clinical research by tracking specific pathological processes in vivo.
How is this initiative connected to national ADRD priorities?
The initiative is framed as a response to ADRD challenges identified in the 2016 update to the National Plan to Address Alzheimer's Disease.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the opportunity category and activity category?
The opportunity category is discretionary, and the activity category is health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.853 and 93.866.
Which U.S.-based organizations are eligible to apply?
Eligibility is broad and includes U.S.-based organizations such as state, county, and local governments; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; independent school districts; special district governments; and public housing authorities/Indian housing authorities.
Are certain institution types explicitly highlighted as eligible?
Yes. The FOA explicitly highlights additional eligible applicant categories including HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions. It also notes faith-based or community-based organizations and eligible federal agencies.
Can a non-U.S. (foreign) institution apply as the primary applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization.
Are any international components allowed under a U.S. applicant?
Yes. Non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. This generally means a U.S. applicant can include certain international collaborators or activities when well-justified and compliant with NIH policy.
What important administrative dates are provided?
The creation date shown is 2018-03-02, and the original closing date shown is 2018-05-08.
Is the award ceiling specified in the provided information?
No. The award ceiling is not specified in the provided source text.
Is the expected number of awards specified in the provided information?
No. The expected number of awards is not specified in the provided source text.
Does the FOA require validation against human tissue?
Yes. The FOA emphasizes screening and validation against human ADRD brain tissue as part of the development workflow.
Does the FOA include animal model work?
Yes. It includes initial in vivo screening in appropriate animal models, and milestone workflows are expected to include screening in relevant animal models.
Does the FOA mention moving tracers into first-in-human testing?
Yes. The supported activities include practical work needed to move a compound into humans, including radioligand formulation and first-in-human testing.
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