Opportunity Information: Apply for PAR 12 015
Apply for PAR 12 015
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alzheimers Disease Drug Development Program (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866 Aging Research.
- This funding opportunity was created on Nov 16, 2011 and posted on Nov 16, 2011.
- Applicants must submit their applications by Jan 7, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses Private institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education County governments State governments Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities City or township governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Alzheimers Disease Drug Development Program (U01) (Funding Opportunity Number PAR-12-015) is a National Institutes of Health grant opportunity designed to push promising Alzheimer-related therapies through the later stages of preclinical development. The central aim is to support work that can either modify behavioral symptoms associated with Alzheimers disease (AD) or delay the onset, slow progression, or reduce the impact of AD, mild cognitive impairment (MCI), or age-related cognitive decline. In practical terms, the program is meant to help bridge the gap between having a credible therapeutic lead and being ready to ask the FDA for permission to begin human testing.
A key feature of this FOA is that it is focused on lead optimization and other IND-enabling activities for therapies that already have demonstrated activity against a specific, intended disease target. Applicants are expected to be far enough along that, by the end of the award period, they can submit either an Investigational New Drug (IND) application (typical for drugs and biologics) or an Investigational Device Exemption (IDE) application (for qualifying devices) to the U.S. Food and Drug Administration. This makes the program a good fit for projects that have moved beyond proof-of-concept and now need the structured set of preclinical studies, development planning, and package-building that regulators generally expect before first-in-human work.
Just as important as what the program supports is what it does not support. It does not fund early-stage discovery work such as high-throughput screening campaigns to identify new hits from large compound libraries. It also excludes clinical research, meaning this is not a mechanism to run human trials. In addition, it is not intended for basic or mechanistic research that is primarily about understanding disease biology without a clear, development-ready therapeutic lead. The emphasis is squarely on development: optimizing a candidate, generating the required preclinical evidence, and assembling a regulatory-ready submission.
This opportunity uses a cooperative agreement mechanism (U01), which signals a more hands-on partnership with the NIH compared to a standard research project grant. The program is milestone-driven, and investigators should expect active involvement from the National Institute on Aging (NIA) program staff. NIA staff participate both in shaping the project plan and in monitoring progress during the project period. In real-world terms, awardees are typically expected to propose clear go/no-go milestones, deliverables, and timelines, and then report progress against those benchmarks, with the understanding that continued support is tied to meeting agreed development objectives.
The funding category is discretionary, the activity area is health, and it is associated with CFDA number 93.866 (Aging Research). The announcement was posted and created on November 16, 2011, with an original and final closing date of January 7, 2015, and an archive date of February 7, 2015. The FOA states there is no cost sharing or matching requirement.
Eligibility is broad and includes a wide range of organizational types. Eligible applicants include small businesses, for-profit organizations (including those other than small businesses), nonprofit organizations with or without 501(c)(3) status, private and public institutions of higher education, independent school districts, and multiple levels of government (city/township, county, state, special district, and certain housing authorities). It also explicitly includes Native American tribal governments (federally recognized and other than federally recognized) and tribal organizations, as well as regional organizations. The FOA further clarifies that a variety of mission-focused institutions may apply, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities (TCCUs). Faith-based and community-based organizations are also listed as eligible. Importantly, non-U.S. entities (foreign institutions) are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed consistent with NIH policy.
For full official details, the FOA points to the NIH Grants Guide page at http://grants.nih.gov/grants/guide/pa-files/PAR-12-015.html. For access or linking issues, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the Alzheimer’s Disease Drug Development Program (U01) (PAR-12-015)?
PAR-12-015 is a National Institutes of Health (NIH) funding opportunity that supports later-stage preclinical drug (and certain device) development for Alzheimer’s disease-related therapies. It is designed to help advance a credible therapeutic lead toward a regulatory submission that would enable first-in-human testing.
What is the main purpose of this funding opportunity?
The central purpose is to push promising Alzheimer-related therapeutic candidates through lead optimization and other IND-enabling (or IDE-enabling) activities so that, by the end of the award period, the project is positioned to submit an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA).
What kinds of outcomes or disease areas does the program aim to address?
The program aims to support work that can modify behavioral symptoms associated with Alzheimer’s disease (AD), or delay onset, slow progression, or reduce the impact of Alzheimer’s disease (AD), mild cognitive impairment (MCI), or age-related cognitive decline.
What stage of development is this program intended for?
This program is intended for projects that are beyond early discovery and proof-of-concept and are ready for structured preclinical development work. Applicants are expected to already have a therapeutic lead that has demonstrated activity against a specific, intended disease target and to use the award period to complete work needed for a regulatory-ready IND or IDE submission.
What does “lead optimization†mean in the context of this FOA?
Based on the description provided, “lead optimization†refers to development-focused activities that refine an existing therapeutic lead (rather than discovering a new one) and generate the preclinical evidence, development planning, and documentation typically needed for an IND or IDE submission.
What are “IND-enabling†activities under this program?
IND-enabling activities are the preclinical development steps and package-building work that regulators generally expect before first-in-human studies can be authorized. The FOA emphasizes that funded work should support readiness to submit an IND (for drugs/biologics) by the end of the award period.
Does this opportunity support IDE-enabling work for devices?
Yes. The FOA notes that projects may be expected to submit an IDE to the FDA by the end of the award period for qualifying devices.
Is this funding meant to bridge the gap to first-in-human testing?
Yes. In practical terms, the program is described as bridging the gap between having a credible therapeutic lead and being ready to request FDA permission to begin human testing via an IND or IDE submission.
What kinds of research are explicitly not supported?
The FOA does not support early-stage discovery work such as high-throughput screening campaigns to identify new hits from large compound libraries. It also excludes clinical research (so it is not a mechanism to run human trials). Additionally, it is not intended for basic or mechanistic research focused primarily on understanding disease biology without a clear, development-ready therapeutic lead.
Can this funding be used for human clinical trials?
No. The opportunity explicitly excludes clinical research and is not intended to run human trials.
Can this funding be used for high-throughput screening to find new hits?
No. The FOA specifically states it does not fund early-stage discovery work such as high-throughput screening campaigns to identify new hits from large compound libraries.
Is basic or mechanistic Alzheimer’s biology research eligible under this program?
Not if the work is primarily about understanding disease biology without a clear, development-ready therapeutic lead. The FOA emphasizes development activities tied to an existing lead with demonstrated activity against a specific target.
What is the funding mechanism and what does it imply?
The mechanism is a cooperative agreement (U01). This indicates a more hands-on partnership with NIH than a standard research project grant, including active involvement from the National Institute on Aging (NIA) program staff.
How involved is NIH/NIA during the project?
NIA program staff are expected to participate in shaping the project plan and monitoring progress during the project period. The program is milestone-driven, and progress is tracked against agreed go/no-go milestones, deliverables, and timelines.
What does “milestone-driven†mean for applicants and awardees?
It means applicants should propose clear go/no-go milestones, deliverables, and timelines, and awardees should report progress against those benchmarks. Continued support is tied to meeting agreed development objectives.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.866, listed as Aging Research.
What is the activity area and funding category?
The activity area is health, and the funding category is discretionary.
Who is eligible to apply?
Eligibility is broad and includes small businesses; for-profit organizations (including those other than small businesses); nonprofit organizations with or without 501(c)(3) status; private and public institutions of higher education; independent school districts; and multiple levels of government (city/township, county, state, special district, and certain housing authorities).
Are tribal governments and tribal organizations eligible?
Yes. The FOA explicitly includes Native American tribal governments (federally recognized and other than federally recognized) and tribal organizations as eligible applicants.
Are mission-focused higher education institutions specifically included?
Yes. The FOA notes that eligible applicants include Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities (TCCUs).
Are faith-based and community-based organizations eligible?
Yes. Faith-based and community-based organizations are listed among eligible applicants.
Can non-U.S. (foreign) organizations apply?
Yes. The FOA states that non-U.S. entities (foreign institutions) are eligible to apply. It also allows non-U.S. components of U.S. organizations and foreign components consistent with NIH policy.
What are the key dates for this announcement?
The announcement was posted and created on November 16, 2011. The original and final closing date was January 7, 2015. The archive date was February 7, 2015.
Where can applicants find the official funding opportunity details?
The FOA points to the NIH Grants Guide page: http://grants.nih.gov/grants/guide/pa-files/PAR-12-015.html
Who should be contacted if there are access or linking issues with the FOA page?
The contact listed for access or linking issues is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What is the overall “fit†of a strong project for this program?
Based on the description, a strong-fit project is one that already has a demonstrated, target-specific therapeutic lead for AD-related indications and needs structured, milestone-driven preclinical development work to reach an IND or IDE submission-ready package, rather than early discovery, clinical trials, or purely mechanistic/basic research.
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