Opportunity Information: Apply for PAR 08 266
Apply for PAR 08 266
- 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 Dec 3, 2008.
- 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 $2,500,000.00 to eligible and selected applicants.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) State governments Private institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Organizations).
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Opportunity Summary:
The Alzheimer's Disease Drug Development Program (U01) is a National Institutes of Health (NIH) funding opportunity aimed specifically at pushing promising Alzheimer's therapies through the late preclinical stage and toward first-in-human testing. The central goal is to support development and testing of novel therapeutic compounds that could slow, stop, or reverse cognitive decline and help address behavioral symptoms associated with Alzheimer's disease (AD). The program also welcomes projects focused on delaying the onset of, or preventing, Alzheimer's disease as well as related conditions such as mild cognitive impairment (MCI) and age-related cognitive decline. The emphasis is on generating the kind of rigorous, decision-ready dataset needed to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, which is the key regulatory step required before clinical trials in humans can begin.
This opportunity is not meant for basic discovery science or early mechanistic work, and it is also not designed to pay for clinical trials. Instead, it targets applicants who already have a credible therapeutic candidate and are ready to carry out the practical, development-focused preclinical package that advances a compound toward the clinic. In other words, the program is structured to bridge the common gap between academic innovation and the regulatory expectations for IND submission by funding activities that de-risk a lead therapy and produce the evidence needed for regulatory review.
Funding is provided through the NIH U01 cooperative agreement mechanism, which typically indicates substantial scientific involvement from NIH staff compared with a standard research grant. The announcement (Funding Opportunity Number PAR-08-266) was issued under the health category, with a focus aligned to CFDA 93.866 (Aging Research). The National Institute on Aging (NIA) set aside an estimated total of $2.5 million in FY2009 to support awards under this initiative. Because projects can differ widely in development stage, scope, and required studies, both the size and duration of individual awards may vary, and the final number of awards depends on the volume and quality of applications, along with their proposed budgets and timelines.
Eligibility is broad and includes public and private institutions of higher education, nonprofits (including 501(c)(3) organizations and other nonprofit structures), small businesses, for-profit organizations other than small businesses, and state governments. The announcement also indicates that non-U.S. entities (foreign organizations) may be eligible, reflecting the program's interest in supporting strong drug development efforts regardless of geography, as long as the work aligns with the program's preclinical, IND-enabling purpose. No cost sharing or matching funds are required, which lowers barriers for applicants who may not have large pools of discretionary funds.
Key administrative details include the posted date of December 3, 2008, and an archived status after June 7, 2011. The application timeline shifted over the life of the announcement, with an original closing date listed as January 7, 2012, and a current closing date of May 7, 2011 (reflecting the historical record of the opportunity). Additional details and the full announcement were made available through the NIH Grants Guide website at the link provided in the source, and NIH Office of Extramural Research (OER) contact support was listed for technical access issues.
Overall, this program is best understood as a targeted, translational drug development effort: it is designed for teams that have moved beyond hypothesis-driven mechanistic research and are ready to perform the structured preclinical work needed to justify an IND filing for an Alzheimer's-related therapeutic candidate, with the ultimate intent of enabling subsequent human clinical testing funded through other mechanisms.
FAQs: Alzheimer's Disease Drug Development Program (U01) - NIH (PAR-08-266)
What is the Alzheimer's Disease Drug Development Program (U01)?
The Alzheimer's Disease Drug Development Program (U01) is an NIH funding opportunity designed to move promising Alzheimer's disease therapies through late-stage preclinical development and closer to first-in-human testing. Its focus is on generating rigorous, decision-ready data that can support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).
What is the main goal of this program?
The central goal is to support the development and testing of novel therapeutic compounds that could slow, stop, or reverse cognitive decline and help address behavioral symptoms associated with Alzheimer's disease (AD). The program also welcomes projects aimed at delaying onset of, or preventing, Alzheimer's disease and related conditions.
What kinds of diseases or conditions are within scope?
The opportunity is focused on Alzheimer's disease and also includes related conditions such as mild cognitive impairment (MCI) and age-related cognitive decline, particularly where the work is aligned with a late preclinical, IND-enabling development package.
What stage of research and development is this program intended to support?
This program targets late preclinical development activities that push a credible therapeutic candidate toward first-in-human testing. It is meant for applicants who already have a promising therapeutic compound and are ready to complete practical, development-focused studies that strengthen an IND submission.
Is this opportunity meant for basic discovery or early mechanistic research?
No. The program is not intended for basic discovery science or early mechanistic work. It is structured to fund applied, translational preclinical development work that helps meet regulatory expectations for an IND submission.
Does this program fund clinical trials in humans?
No. The opportunity is not designed to pay for clinical trials. Its purpose is to support the preclinical, IND-enabling work needed to justify moving a therapeutic candidate into human testing through other funding mechanisms.
What is an IND and why is it important for this program?
An Investigational New Drug (IND) application is the key FDA regulatory step required before clinical trials in humans can begin. This program emphasizes producing the rigorous dataset needed to support an IND filing.
What does "IND-enabling" mean in the context of this program?
In this context, "IND-enabling" refers to the structured preclinical work that de-risks a lead therapeutic candidate and produces the evidence expected for regulatory review, with the aim of supporting an FDA IND application.
What funding mechanism is used for this opportunity?
Funding is provided through the NIH U01 cooperative agreement mechanism, which typically involves substantial scientific involvement from NIH staff compared with a standard research grant.
What does a U01 cooperative agreement imply for NIH involvement?
A U01 cooperative agreement generally indicates that NIH staff will have substantial scientific involvement during the project compared with a typical grant mechanism, reflecting a more collaborative approach to achieving program goals.
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is PAR-08-266.
Which NIH institute is associated with this program?
The opportunity is associated with the National Institute on Aging (NIA).
What is the CFDA number and program area associated with this opportunity?
The announcement is aligned with CFDA 93.866, which is categorized as Aging Research.
How much funding was set aside for this initiative?
The National Institute on Aging (NIA) set aside an estimated total of $2.5 million in FY2009 to support awards under this initiative.
Are award sizes and project durations fixed?
No. Because projects can differ widely in development stage, scope, and required studies, both the size and duration of individual awards may vary. The number of awards depends on application volume and quality, as well as proposed budgets and timelines.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits (including 501(c)(3) organizations and other nonprofit structures), small businesses, for-profit organizations other than small businesses, and state governments.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The announcement indicates that non-U.S. entities (foreign organizations) may be eligible, reflecting interest in supporting strong drug development efforts regardless of geography, as long as the proposed work fits the program's preclinical, IND-enabling purpose.
Is cost sharing or matching funding required?
No. No cost sharing or matching funds are required under this opportunity.
When was this funding opportunity posted?
The posted date listed for the announcement is December 3, 2008.
Is this opportunity still active?
No. The opportunity is listed as archived after June 7, 2011.
What are the relevant closing dates mentioned for this announcement?
The application timeline shifted over the life of the announcement. An original closing date is listed as January 7, 2012, while a current closing date is listed as May 7, 2011, reflecting the historical record of the opportunity.
Where could applicants find the full announcement and official details?
Additional details and the full announcement were made available through the NIH Grants Guide website at the link provided in the source information for the opportunity.
Who was listed for help with technical access issues?
NIH Office of Extramural Research (OER) contact support was listed for technical access issues related to the announcement.
What type of applicant or team is this program best suited for?
This program is best suited for teams that have moved beyond hypothesis-driven mechanistic research and already have a credible therapeutic candidate, and who are ready to carry out the structured late preclinical work needed to support an IND filing for an Alzheimer's-related therapy.
What problem is this program designed to address in the development pipeline?
It is designed to bridge the gap between academic innovation and regulatory expectations by funding the practical preclinical development package that helps de-risk a lead therapy and produce evidence suitable for regulatory review.
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