Opportunity Information: Apply for RFA NS 19 014
The NIH funding opportunity RFA-NS-19-014, titled "Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs) (U19 Clinical Trial Optional)," is a cooperative agreement designed to accelerate the creation and early clinical testing of new PET radioligands for ADRD research. The central goal is to produce imaging tracers that can reliably detect specific proteinopathies or other disease-relevant biological processes tied to the human biology of ADRDs, helping the field move beyond general clinical symptom labels and toward objective, in vivo measures of pathology. In practical terms, the FOA is aimed at building an end-to-end translational pipeline that can take promising ligand concepts and move them through screening, optimization, and initial human evaluation.
The scope of work explicitly spans multiple stages of development. Supported activities include in vitro screening of existing candidate ligands using human ADRD brain tissue (to ensure binding and selectivity are relevant to real human disease), medicinal chemistry to design new compounds or improve the performance of existing ones (for example, improving specificity, selectivity, affinity, brain penetration, and reducing off-target binding), initial in vivo screening in appropriate animal models (to assess pharmacokinetics, brain uptake, specificity, and signal-to-noise), and radioligand formulation plus first-in-human testing. The overall expectation is that the funded Center will function like an integrated development engine, continuously prioritizing candidates, troubleshooting weaknesses, and pushing the best-performing ligands forward until at least some reach early clinical evaluation.
A defining feature is the required "Center without Walls" structure, meaning the program is intended to operate as a coordinated consortium rather than a single-lab effort. Applications must be organized around a set of shared cores and multiple interdependent research projects, with clear workflows and milestone-driven plans. At minimum, applicants must propose an Administrative Core (to manage operations, timelines, reporting, and coordination), a Medicinal Chemistry Core (to generate and optimize chemical entities and support structure-activity work), and a Clinical Core (to handle radioligand production readiness, regulatory and clinical translation, and first-in-human studies). In addition, the application must describe a scientific governance structure that lays out decision-making processes, prioritization criteria, and how the consortium will manage go/no-go decisions based on milestone data.
Beyond the cores, the FOA requires at least two distinct research projects, each with milestone plans. Those milestones need to explicitly address practical workflows for screening both existing ligands and newly derived compounds against human ADRD tissue and in appropriate animal models. The emphasis on milestones signals that the program is meant to be managed with clear performance benchmarks, enabling the consortium and NIH program staff to judge whether candidate ligands are advancing efficiently toward the next stage. The FOA also stresses that synergy has to be obvious: the proposed projects and cores should be so interconnected that the key aims would not be realistically achievable as separate, loosely related grants. In other words, this is not a bundle of independent projects; it is a single coordinated development program with shared infrastructure and coordinated decision-making.
The opportunity is positioned as a response to ADRD challenges highlighted in the 2016 update to the National Plan to Address Alzheimer's Disease, reflecting a broader federal priority to improve tools for diagnosis, staging, and therapy development across dementias beyond typical Alzheimer's disease alone. PET ligands that can measure specific pathologies in living patients are increasingly important for patient stratification in trials, understanding mixed pathologies, tracking disease progression, and verifying target engagement for new therapeutics. This FOA is set up to push that tool-building work forward by funding the chemistry, biology, imaging, and early clinical translation together under one coordinated structure.
From an administrative standpoint, this is a discretionary NIH opportunity using the cooperative agreement mechanism (U19), which typically involves substantial NIH programmatic involvement compared to standard investigator-initiated grants. The activity category is health, and the CFDA numbers listed are 93.853 and 93.866. The original closing date shown is February 13, 2019, and the FOA creation date is December 11, 2018.
Eligibility is broad across U.S.-based organizations and includes many government and nonprofit entities as well as academic and industry participants. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; certain non-federally recognized tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other eligible organizations. The FOA also highlights outreach to and eligibility for specific institution types such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations and eligible federal agencies.
Foreign eligibility is restricted in a nuanced way. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply directly as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning an otherwise eligible U.S. applicant can include certain international collaborations or activities when justified and compliant with NIH policy.
Overall, the FOA is best understood as a structured, milestone-driven consortium program meant to deliver tangible PET radioligand candidates for ADRD biology, moving from tissue-based validation and chemistry optimization through animal testing and into first-in-human studies, with the required cores and governance ensuring that the pieces operate as a single, efficient development pipeline rather than isolated academic projects.Apply for RFA NS 19 014
- 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 2018-12-11.
- Applicants must submit their applications by 2019-02-13. (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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FAQs: NIH RFA-NS-19-014 (U19) - Center without Walls for PET Ligand Development for ADRDs
What is this funding opportunity?
This is an NIH cooperative agreement opportunity (U19) under RFA-NS-19-014 titled "Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs) (U19 Clinical Trial Optional)." It is designed to speed up the development and early clinical testing of new PET radioligands that can measure ADRD-related biology in living people.
What is the main goal of the program?
The central goal is to produce PET imaging tracers that can reliably detect specific proteinopathies or other disease-relevant biological processes tied to ADRD human biology. The program is intended to help the field move beyond broad clinical symptom labels and toward objective, in vivo measurements of pathology.
What does "Center without Walls" mean in this FOA?
"Center without Walls" means the funded effort is expected to function as a coordinated consortium rather than a single laboratory project. The application should be structured as an integrated program with shared cores, multiple interdependent research projects, clear workflows, and milestone-driven management.
What mechanism is being used, and what does it imply?
The mechanism is a cooperative agreement (U19). As described in the opportunity summary, this typically involves substantial NIH programmatic involvement compared with standard investigator-initiated grant mechanisms, reflecting the program's coordinated, milestone-driven nature.
Is this opportunity focused on basic research, clinical research, or both?
It spans translational stages from early screening and optimization through preparation for, and execution of, first-in-human evaluation. The title also notes "Clinical Trial Optional," and the description emphasizes early clinical testing as part of the end-to-end pipeline.
What kinds of activities and stages of work are supported?
The scope explicitly covers multiple development stages, including:
- In vitro screening of candidate ligands using human ADRD brain tissue
- Medicinal chemistry to design new compounds or improve existing ligands
- Initial in vivo screening in appropriate animal models
- Radioligand formulation and readiness for clinical translation
- First-in-human testing of selected PET radioligands
Why is screening against human ADRD brain tissue emphasized?
The FOA highlights in vitro screening using human ADRD brain tissue to help ensure that ligand binding and selectivity are relevant to real human disease biology, rather than only model systems.
What improvements are expected from medicinal chemistry work?
The opportunity specifically calls out improving properties such as specificity, selectivity, affinity, brain penetration, and reducing off-target binding. The Medicinal Chemistry Core is expected to generate and optimize chemical entities and support structure-activity efforts.
What is expected from animal model testing?
The FOA includes initial in vivo screening in appropriate animal models to evaluate pharmacokinetics, brain uptake, specificity, and signal-to-noise, helping to identify which candidates are strong enough to advance.
What does the FOA mean by an "end-to-end translational pipeline"?
It refers to a coordinated workflow that can take ligand concepts from screening and optimization through in vivo evaluation, radioligand formulation, and initial human testing, with continuous prioritization and troubleshooting to move the best candidates forward.
What cores are required at a minimum?
Applicants must propose at least the following required cores:
- Administrative Core: manages operations, timelines, reporting, and coordination
- Medicinal Chemistry Core: generates and optimizes compounds and supports structure-activity work
- Clinical Core: supports radioligand production readiness, regulatory and clinical translation, and first-in-human studies
What is the role of the Administrative Core?
The Administrative Core is expected to coordinate the consortium's operations, maintain timelines, support reporting, and keep the overall program aligned so that projects and cores function together as a single development engine.
What is the role of the Clinical Core?
The Clinical Core is responsible for functions related to getting radioligands ready for clinical use, supporting regulatory and clinical translation, and conducting first-in-human studies of selected candidates as they reach that stage.
How many research projects are required?
The FOA requires at least two distinct research projects in addition to the required cores.
Do research projects need milestones?
Yes. Each research project is required to include milestone plans. The FOA frames the overall program as milestone-driven, with benchmarks that allow the consortium and NIH program staff to evaluate whether candidates are advancing efficiently.
What should the milestone plans cover?
Milestones must explicitly address practical workflows for screening both existing ligands and newly derived compounds against human ADRD tissue and in appropriate animal models, supporting clear go/no-go advancement decisions.
What is meant by "scientific governance structure"?
The application must describe a governance structure that explains decision-making processes, prioritization criteria, and how the consortium will manage go/no-go decisions based on milestone data. This is intended to keep the program coordinated and focused on advancing the strongest ligand candidates.
How important is "synergy" across projects and cores?
Synergy is a major expectation. The FOA emphasizes that projects and cores should be so interconnected that the key aims would not be realistically achievable as separate, loosely related grants. The intent is a single coordinated development program rather than a bundle of independent studies.
What disease areas are included under ADRDs for this program?
The opportunity is aimed at Alzheimer's disease related dementias (ADRDs) broadly, and it is positioned as supporting tools and biology relevant to dementias beyond typical Alzheimer's disease alone.
Why is NIH prioritizing PET ligands for ADRDs?
The description ties the program to federal priorities highlighted in the 2016 update to the National Plan to Address Alzheimer's Disease. PET ligands that measure specific pathologies in living patients can support patient stratification in trials, improve understanding of mixed pathologies, track progression, and verify target engagement for therapeutics.
What is the expected deliverable or outcome of the Center?
The Center is expected to function as an integrated development engine that continuously prioritizes candidates and advances the best-performing radioligands through screening, optimization, animal testing, and into early clinical evaluation, with at least some candidates reaching first-in-human testing.
What is the activity category and CFDA listing?
The activity category is health. The CFDA numbers listed are 93.853 and 93.866.
When was this FOA created, and what was the closing date shown?
The FOA creation date is December 11, 2018, and the original closing date shown is February 13, 2019.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations, including government, nonprofit, academic, and industry participants. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; certain non-federally recognized tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other eligible organizations.
Are minority-serving institutions and community-based organizations included in eligibility outreach?
Yes. The FOA highlights outreach to and eligibility for institution types such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations and eligible federal agencies.
Can foreign institutions apply as the main applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply directly as the applicant organization under this FOA.
Are any international components allowed at all?
Yes, in a limited way. Non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. That means a U.S. applicant can include certain international collaborations or activities when justified and consistent with NIH policy.
Is this intended to be a collection of separate projects submitted together?
No. The FOA stresses that this should not be a bundle of independent projects. It is intended to be a single coordinated program with shared infrastructure, integrated workflows, and consortium-level decision-making.
What kinds of PET radioligands are being targeted?
The focus is on radioligands that can detect specific proteinopathies or other disease-relevant biological processes related to ADRD human biology, enabling objective in vivo measurement of pathology rather than relying only on clinical syndrome labels.
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