Opportunity Information: Apply for PA 10 205
Apply for PA 10 205
- 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 Feb 25, 2011 and posted on May 21, 2010.
- Applicants must submit their applications by May 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses Native American tribal governments (Federally recognized) For profit organizations other than small businesses Private institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities 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 County governments Special district governments City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Public and State controlled 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Alzheimers Disease Drug Development Program (U01) is a National Institutes of Health (NIH) funding opportunity designed to push promising Alzheimers therapies through the critical preclinical stage and closer to human testing. The central goal is to support the preclinical development and testing of novel therapeutic compounds that could slow, stop, or reverse cognitive decline and help address behavioral symptoms associated with Alzheimers disease (AD). The program also welcomes projects aimed at delaying the onset of, or preventing, AD as well as related conditions such as mild cognitive impairment (MCI) and age-related cognitive decline. What makes this opportunity distinct is its clear emphasis on product-oriented development: the expectation is that the supported work will generate enough rigorously documented evidence to enable submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), which is the standard gateway to initiating clinical trials in humans.
This announcement is intentionally narrow in scope, and it draws a firm line around what it will and will not fund. It is not meant to support mechanistic or basic science studies that focus primarily on understanding disease pathways, nor will it support clinical trials. Instead, applicants are expected to propose a well-structured preclinical development plan focused on advancing a therapeutic candidate toward IND readiness. In practical terms, that typically implies activities such as compound optimization and characterization, preclinical efficacy studies in relevant models, pharmacokinetics and pharmacodynamics work, dose-ranging and safety/toxicology studies appropriate for regulatory submission, and other IND-enabling experiments and documentation. The overall theme is translational development with a clear regulatory endpoint, rather than exploratory research.
The mechanism of support is a U01 cooperative agreement, meaning the NIH (and specifically the National Institute on Aging, NIA) anticipates substantial involvement in the project beyond standard grant oversight. In cooperative agreements, the funded team generally works in closer coordination with NIH program staff, which can include alignment on milestones, progress expectations, and other project-management elements. This structure is commonly used when an agency wants to actively help steer complex, goal-driven research efforts that must meet defined deliverables, such as those required for eventual FDA submission.
For funding, NIA set aside an estimated total of $3.0 million in total costs for fiscal year 2011 to support applications under this announcement. The number of awards is not fixed and depends on how many strong applications are received, along with their requested budgets, proposed timelines, and overall quality. Because drug development projects can vary widely in complexity and cost depending on the candidate and required studies, the size and duration of individual awards were expected to vary as well.
Eligibility is broad and includes a wide range of organizations that might be positioned to do preclinical therapeutic development work. Eligible applicants include small businesses; other for-profit organizations; nonprofits (including both 501(c)(3) and non-501(c)(3) entities); public and private institutions of higher education; state, county, city, township, and special district governments; independent school districts; and public housing authorities/Indian housing authorities. The opportunity also explicitly includes many institution types often highlighted in federal programs, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, and other eligible agencies of the federal government. Foreign (non-U.S.) entities and regional organizations are also listed as eligible, along with U.S. territories or possessions and certain tribal entities. No cost sharing or matching is required, lowering the barrier for applicants that may not have substantial non-federal funds available.
Key administrative details from the listing include Funding Opportunity Number PA-10-205 and the classification as a discretionary opportunity in the health area (CFDA 93.866, Aging Research). The opportunity was posted May 21, 2010, with an original closing date listed as May 7, 2013, while the current closing date shown in the provided record is May 7, 2011, and an archive date of June 7, 2011. The administering agency is NIH, with NIA as the institute setting aside the funds. Applicants seeking the full announcement or needing technical help accessing it were directed to the NIH Office of Extramural Research (OER) webmaster contact listed in the notice, and the full details were referenced via the NIH grants guide link (PA-10-205).
Frequently Asked Questions (FAQs): Alzheimer's Disease Drug Development Program (U01)
What is the Alzheimer's Disease Drug Development Program (U01)?
It is an NIH funding opportunity intended to advance promising Alzheimer's disease (AD) therapies through the preclinical stage and closer to testing in humans. The focus is on developing and testing novel therapeutic compounds that could slow, stop, or reverse cognitive decline and address behavioral symptoms associated with AD.
What is the main goal of this funding opportunity?
The central goal is product-oriented preclinical development that produces rigorously documented evidence sufficient to enable submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), which is typically required to begin clinical trials in humans.
What kinds of projects are encouraged under this program?
Projects that support the preclinical development and testing of novel therapeutic compounds aimed at slowing, stopping, or reversing cognitive decline in Alzheimer's disease, and helping address behavioral symptoms. The program also welcomes projects aimed at delaying the onset of, or preventing, AD.
Does the program support work related to conditions other than Alzheimer's disease?
Yes. In addition to Alzheimer's disease, the opportunity welcomes projects related to delaying onset or prevention in related conditions such as mild cognitive impairment (MCI) and age-related cognitive decline.
What makes this opportunity distinct compared to other research grants?
It has a clear emphasis on translational, product-oriented development with a defined regulatory endpoint. The expectation is that funded work will generate evidence and documentation needed to support an FDA IND submission, rather than exploratory research that primarily seeks to understand disease mechanisms.
Is this funding intended for basic science or mechanistic studies?
No. The announcement is intentionally narrow and is not meant to support mechanistic or basic science studies focused primarily on understanding disease pathways.
Does this opportunity fund clinical trials?
No. The announcement draws a firm line that it will not support clinical trials. The focus is preclinical development to reach IND readiness.
What types of activities are typically included in a competitive preclinical development plan?
The opportunity describes a preclinical, IND-enabling development theme. Examples of activities typically implied include compound optimization and characterization, preclinical efficacy studies in relevant models, pharmacokinetics and pharmacodynamics work, dose-ranging studies, safety/toxicology studies appropriate for regulatory submission, and other IND-enabling experiments and documentation.
What is an IND, and why is it important for this program?
An Investigational New Drug (IND) application is a submission to the FDA that is generally required before initiating clinical trials in humans. This program expects funded projects to generate sufficient evidence and documentation to enable an IND submission.
What funding mechanism is used for this opportunity?
The mechanism is a U01 cooperative agreement.
What does a U01 cooperative agreement mean in practice?
A cooperative agreement means NIH anticipates substantial involvement in the project beyond standard grant oversight. Under this structure, funded teams generally work in closer coordination with NIH program staff, including alignment on milestones, progress expectations, and other project-management elements.
Which NIH Institute is primarily involved?
The administering agency is NIH, and the National Institute on Aging (NIA) is the institute that set aside funds for this announcement and anticipates substantial involvement consistent with the cooperative agreement structure.
How much funding was set aside for this opportunity?
NIA set aside an estimated total of $3.0 million in total costs for fiscal year 2011 to support applications under this announcement.
How many awards will be made?
The number of awards is not fixed. It depends on the number of strong applications received, along with requested budgets, proposed timelines, and overall application quality.
Will award size and project duration be the same for all recipients?
No. The size and duration of individual awards were expected to vary because drug development projects can differ widely in complexity, cost, and the studies required to reach IND readiness.
Who is eligible to apply?
Eligibility is broad and includes small businesses; other for-profit organizations; nonprofits (including 501(c)(3) and non-501(c)(3)); public and private institutions of higher education; state, county, city, township, and special district governments; independent school districts; and public housing authorities/Indian housing authorities.
Are minority-serving and community-based institutions included as eligible applicants?
Yes. The opportunity explicitly includes institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, and other eligible agencies of the federal government.
Are foreign (non-U.S.) entities eligible to apply?
Yes. Foreign (non-U.S.) entities and regional organizations are listed as eligible in the provided record.
Are U.S. territories or tribal entities eligible?
Yes. The opportunity includes U.S. territories or possessions and certain tribal entities among eligible applicants.
Is cost sharing or matching required?
No. The listing states that no cost sharing or matching is required.
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is PA-10-205.
What is the CFDA number and program area associated with this opportunity?
The listing cites CFDA 93.866, Aging Research, and classifies the opportunity in the health area.
When was the opportunity posted, and what dates are listed for closing and archiving?
The opportunity was posted May 21, 2010. The original closing date listed is May 7, 2013. The current closing date shown in the provided record is May 7, 2011, and the archive date is June 7, 2011.
Where can applicants find the full announcement and official details?
The provided record references the NIH grants guide link for PA-10-205 for full details.
Who should applicants contact for technical help accessing the announcement?
Applicants needing technical help accessing the full announcement were directed to the NIH Office of Extramural Research (OER) webmaster contact listed in the notice.
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