Opportunity Information: Apply for RFA AG 18 013
The funding opportunity titled "Continuation of the AMP-AD Target Discovery and Preclinical Validation Consortium (U01 Clinical Trial Optional)" (RFA-AG-18-013) is a National Institutes of Health (NIH) cooperative agreement intended to keep building and enlarging the Accelerating Medicines Partnership - Alzheimer’s Disease (AMP-AD) effort. The core aim is to strengthen an open-science, systems-biology program that uses large-scale biological data and computational methods to uncover new therapeutic targets and biomarkers for Alzheimer’s disease (AD) and AD-related dementias. Rather than focusing on a single gene or pathway at a time, the program emphasizes data-driven discovery, where multiple layers of molecular and clinical information are integrated to better explain how brain health shifts into disease and to identify points where an intervention could realistically change that trajectory.
A central feature of this announcement is the push to develop predictive network models of brain health and disease. In practice, that means using systems biology approaches to map and analyze complex biological networks (for example, gene regulation networks, protein interaction networks, pathway-level networks, and multi-omic relationships) and then using those models to predict which genes, proteins, cell types, or pathways are most likely to be causal drivers or strong modifiers of disease. The goal is not only to generate hypotheses, but also to prioritize targets in a rational way and connect them to measurable biomarkers that could help track disease progression, stratify patients, or monitor response to treatment. The "preclinical validation" component signals that targets emerging from these models are expected to be tested in experimental systems to build confidence that they are truly relevant and actionable before moving toward clinical development.
This opportunity uses a U01 mechanism, which is a cooperative agreement. That matters because a cooperative agreement typically involves substantial scientific and programmatic involvement from the NIH compared to a standard investigator-initiated grant. The intent is to operate as a consortium with coordinated milestones, shared standards, and active collaboration across participating teams. The open-science aspect is also a defining requirement in spirit: consortium work is expected to contribute broadly usable datasets, analytic outputs, and target/biomarker findings to the research community, accelerating progress beyond the walls of any single institution. In the AMP model, rapid data sharing, harmonized methods, and collaborative governance are usually treated as essential for speed and reproducibility, especially in a field as complex and historically difficult as AD drug discovery.
The activity category is health, and the administering agency is the U.S. Department of Health and Human Services through NIH, with the CFDA number listed as 93.866. The announcement was created on September 27, 2017, with an original closing date of February 20, 2018. The expected number of awards is six, and the award ceiling is $1,000,000, indicating that each project is expected to be substantial but still bounded, likely with an emphasis on defined deliverables that fit within consortium priorities and timelines.
Eligibility is broad and includes many types of organizations, reflecting the consortium nature of the work and the mix of expertise needed for systems biology and translational neuroscience. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized) and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities as allowed under the additional eligibility information. This wide net is consistent with the reality that meaningful target discovery and preclinical validation often require cross-sector collaboration among academic groups, computational biology teams, biotech and pharma partners, and organizations capable of generating or analyzing high-dimensional data at scale.
The "Clinical Trial Optional" label indicates that applicants may propose clinical trial components if they are appropriate, but a clinical trial is not mandatory for the overall purpose of the announcement. Given the stated emphasis on target discovery, network modeling, and preclinical validation, many responsive applications would likely focus primarily on computational modeling, multi-omic integration, mechanistic studies in model systems, and biomarker development or validation in existing cohorts, with optional clinical elements where they directly support target/biomarker validation.
Overall, this grant opportunity is designed to move the AD field toward a more predictive, data-integrated model of disease biology, where targets and biomarkers are not chosen simply because they are associated with pathology, but because they emerge from coherent network-based evidence and can be validated experimentally. By continuing and expanding the AMP-AD consortium under an open-science framework, the program aims to shorten the path from big data to credible drug targets, improve reproducibility, and create shared resources that help the entire research community push toward more effective therapies for Alzheimer’s disease and related dementias.Apply for RFA AG 18 013
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Continuation of the AMP-AD Target Discovery and Preclinical Validation Consortium (U01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
- This funding opportunity was created on Sep 27, 2017.
- Applicants must submit their applications by Feb 20, 2018. (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 $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 6 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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Frequently Asked Questions (FAQs)
What is the name and identifier of this funding opportunity?
The opportunity is titled "Continuation of the AMP-AD Target Discovery and Preclinical Validation Consortium (U01 Clinical Trial Optional)" and is identified as RFA-AG-18-013.
Which agency is offering this grant?
The administering agency is the U.S. Department of Health and Human Services through the National Institutes of Health (NIH).
What is the CFDA number listed for this opportunity?
The CFDA number listed is 93.866.
What is the activity category for this funding opportunity?
The activity category is health.
What is the overall purpose of this opportunity?
The purpose is to continue building and expanding the Accelerating Medicines Partnership - Alzheimer’s Disease (AMP-AD) effort by strengthening an open-science, systems-biology program that uses large-scale biological data and computational methods to uncover new therapeutic targets and biomarkers for Alzheimer’s disease (AD) and AD-related dementias.
What scientific approach does the program emphasize?
The program emphasizes data-driven discovery that integrates multiple layers of molecular and clinical information. Instead of focusing on a single gene or pathway at a time, it aims to integrate large-scale data to better explain how brain health shifts into disease and to identify intervention points that could realistically change that trajectory.
What does "systems biology" mean in the context of this announcement?
In this context, systems biology refers to approaches that map and analyze complex biological networks and relationships, including gene regulation networks, protein interaction networks, pathway-level networks, and multi-omic relationships, with the goal of understanding disease mechanisms in an integrated, network-based way.
What are "predictive network models of brain health and disease"?
Predictive network models are systems biology models designed to predict which genes, proteins, cell types, or pathways are most likely to be causal drivers or strong modifiers of Alzheimer’s disease and related dementias, based on integrated analysis of large-scale biological and clinical data.
What kinds of networks or data relationships are explicitly mentioned?
The announcement mentions gene regulation networks, protein interaction networks, pathway-level networks, and multi-omic relationships as examples of the types of networks and relationships that may be modeled and analyzed.
What is the program trying to produce besides scientific hypotheses?
The program aims to prioritize targets in a rational way and connect those targets to measurable biomarkers that could help track disease progression, stratify patients, or monitor response to treatment.
What is meant by "therapeutic targets" in this program?
Therapeutic targets are genes, proteins, cell types, pathways, or other biological points of intervention that emerge from network-based evidence as potentially causal drivers or strong modifiers of disease, and that could be actionable for developing interventions.
What is meant by "biomarkers" in this program?
Biomarkers are measurable indicators that could be linked to targets and used to track disease progression, stratify patients, or monitor response to treatment, as described in the announcement.
What does "preclinical validation" mean here?
Preclinical validation means that targets emerging from predictive network models are expected to be tested in experimental systems to build confidence that they are relevant and actionable before moving toward clinical development.
Is this opportunity focused on a single gene or pathway?
No. A stated motivation of the program is to move away from focusing on one gene or pathway at a time and toward integrated, data-driven discovery across multiple molecular and clinical layers.
What funding mechanism is used for this opportunity?
This opportunity uses the U01 mechanism, which is a cooperative agreement.
What does it mean that this is a cooperative agreement (U01)?
A cooperative agreement typically involves substantial scientific and programmatic involvement from NIH compared to a standard investigator-initiated grant. The announcement describes an intent to operate as a consortium with coordinated milestones, shared standards, and active collaboration across participating teams.
What does "consortium" imply for funded projects?
The announcement indicates that funded work is intended to operate as a consortium, meaning coordinated milestones, shared standards, and active collaboration across teams, with a strong emphasis on open-science contributions that benefit the broader research community.
What is the role of open science in this opportunity?
Open science is described as a defining requirement in spirit. Consortium work is expected to contribute broadly usable datasets, analytic outputs, and target/biomarker findings to the research community, consistent with rapid data sharing, harmonized methods, and collaborative governance.
How does this opportunity aim to improve Alzheimer’s drug discovery?
It aims to shorten the path from big data to credible drug targets by using predictive, network-based evidence, validating targets experimentally, improving reproducibility through shared standards and harmonized methods, and creating shared resources under an open-science framework.
What does "Clinical Trial Optional" mean?
"Clinical Trial Optional" means applicants may propose clinical trial components if appropriate, but a clinical trial is not mandatory for the overall purpose of the announcement.
If clinical trials are optional, what types of work are likely to be central?
Based on the stated emphasis, many responsive applications would likely focus primarily on computational modeling, multi-omic integration, mechanistic studies in model systems, and biomarker development or validation in existing cohorts, with optional clinical elements where they directly support target or biomarker validation.
When was this announcement created, and what was the original closing date?
The announcement was created on September 27, 2017, with an original closing date of February 20, 2018.
How many awards were expected?
The expected number of awards is six.
What is the award ceiling?
The award ceiling is $1,000,000.
What does the award ceiling suggest about project scope?
The announcement indicates projects are expected to be substantial but bounded, likely emphasizing defined deliverables that fit within consortium priorities and timelines.
Who is eligible to apply?
Eligibility is broad and includes: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized) and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities as allowed under additional eligibility information.
Why is eligibility so broad for this opportunity?
The announcement frames the effort as a consortium requiring a mix of expertise for systems biology and translational neuroscience, and notes that meaningful target discovery and preclinical validation often require cross-sector collaboration among academic groups, computational biology teams, biotech/pharma partners, and organizations capable of generating or analyzing high-dimensional data at scale.
What diseases or conditions are the focus of this program?
The focus is Alzheimer’s disease (AD) and AD-related dementias.
What kinds of outputs are expected to benefit the broader community?
The announcement highlights broadly usable datasets, analytic outputs, and target/biomarker findings contributed under an open-science framework to accelerate progress beyond any single institution.
How does the program define progress toward better targets?
Progress is framed as moving toward targets and biomarkers that are selected not simply because they are associated with pathology, but because they emerge from coherent network-based evidence and can be validated experimentally.
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