Opportunity Information: Apply for RFA TR 12 005

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for NIH Industry Pilot Program Discovering New Therapeutic Uses for Existing Molecules (UH3)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350 National Center for Advancing Translational Sciences.
  • This funding opportunity was created on Jun 12, 2012 and posted on Jun 12, 2012.
  • Applicants must submit their applications by Dec 17, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $20,000,000.00 to eligible and selected applicants.
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
  • Other Eligible Applicants include the following This FOA is a limited competition for those applicants who submitted a pre application in response to PAR 12 203 X02 and have been notified of the opportunity to submit a UH3 application.
Apply for RFA TR 12 005

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Opportunity Summary:

This funding opportunity (RFA-TR-12-005) is a National Institutes of Health (NIH) initiative led by the National Center for Advancing Translational Sciences (NCATS) to run an industry-focused therapeutics discovery pilot program aimed at drug repurposing. The central idea is to identify new therapeutic uses for existing proprietary drug candidates (referred to as "Agents") that were originally developed by pharmaceutical companies but may have unrealized potential in other diseases. Rather than starting from scratch with brand-new molecules, the program is designed to accelerate translational science by leveraging compounds that already have some level of characterization and supporting data, which can shorten the path to meaningful clinical impact if a new use is identified and validated.

The program is structured to "match" two key ingredients: (1) proprietary Agents and associated background data contributed by participating pharmaceutical company partners, and (2) compelling, well-supported ideas from the broader biomedical research community about how those Agents might be effective in different human diseases. In practical terms, investigators are expected to propose scientifically strong new-use hypotheses and a research plan to test them, while the program facilitates access to industry compounds and relevant datasets. The scope is intentionally broad, covering a wide range of human diseases rather than being restricted to a single therapeutic area, which reflects NCATS's mission to develop generalizable translational approaches and uncover opportunities that might be missed within traditional single-disease research silos.

The award mechanism is a cooperative agreement (UH3), which generally indicates a higher level of NIH program involvement than a standard research grant. In cooperative agreements, NIH typically plays an active role in shaping milestones, coordinating across teams, and helping manage programmatic elements that require collaboration between academia and industry. This is consistent with the pilot nature of the effort and the complexity of working with proprietary compounds, where alignment on objectives, data sharing, and operational details can be just as important as the laboratory or clinical experiments themselves.

Eligibility is limited rather than open competition. Applicants could not simply submit a proposal without prior participation; only those who had previously submitted a pre-application under PAR-12-203 (X02) and were subsequently invited were allowed to submit a UH3 application in response to this announcement. This limited competition format suggests NCATS used the pre-application stage to identify the most promising concepts and feasible matches between investigator ideas and available industry Agents before inviting full applications.

Administratively, the opportunity falls under the NIH discretionary category and the health funding activity category, with CFDA number 93.350 (NCATS). The FOA was posted on June 12, 2012, with an application closing date of December 17, 2012. It carried an estimated total funding level of $20,000,000, and it did not require cost sharing or matching funds. The announcement was archived on January 17, 2013, meaning it is no longer open for submission but remains available as a record of the program solicitation and its requirements.

For applicants and interested parties, the full announcement was hosted on the NIH grants site at the provided link, and NIH’s Office of Extramural Research (OER) webmaster contact information was included for technical issues accessing the FOA. Overall, the opportunity represents an early NCATS effort to operationalize drug repurposing at scale by creating a structured pathway for academic innovators to test new disease indications for industry-held molecules, using a cooperative model designed to speed translation while navigating the realities of proprietary assets and cross-sector collaboration.

Frequently Asked Questions (FAQs): NIH NCATS Therapeutics Discovery Pilot Program (RFA-TR-12-005)

What is RFA-TR-12-005?

RFA-TR-12-005 is a National Institutes of Health (NIH) funding opportunity led by the National Center for Advancing Translational Sciences (NCATS) to run an industry-focused therapeutics discovery pilot program centered on drug repurposing.

What is the main goal of this funding opportunity?

The goal is to identify new therapeutic uses for existing proprietary drug candidates (called "Agents") that were originally developed by pharmaceutical companies but may have unrealized potential in other diseases.

What does "drug repurposing" mean in the context of this program?

In this program, drug repurposing means taking an existing proprietary drug candidate that already has some characterization and supporting data, and testing a new hypothesis that it could be effective in a different human disease than originally intended.

What are "Agents" in this program?

"Agents" are proprietary drug candidates contributed by participating pharmaceutical company partners, along with associated background data relevant to those compounds.

How is the program structured?

The program is designed to match two elements: (1) proprietary Agents and supporting data contributed by industry partners, and (2) strong, well-supported new-use ideas from the broader biomedical research community, including a research plan to test those hypotheses.

What are investigators expected to propose?

Investigators are expected to propose scientifically compelling hypotheses for new therapeutic uses of the available Agents and provide a research plan to test those hypotheses, leveraging access to the industry compounds and related datasets facilitated by the program.

Is the program limited to a specific disease area?

No. The scope is intentionally broad and can cover a wide range of human diseases rather than focusing on a single therapeutic area.

Why does the program emphasize a broad disease scope?

The broad scope aligns with NCATS's mission to develop generalizable translational approaches and uncover opportunities that might be missed in traditional single-disease research silos.

What funding mechanism is used for awards under this opportunity?

The award mechanism is a cooperative agreement (UH3).

What does it mean that the award is a cooperative agreement (UH3)?

A cooperative agreement generally involves a higher level of NIH program involvement than a standard research grant. NIH typically plays an active role in shaping milestones, coordinating across teams, and helping manage program elements that require collaboration between academia and industry.

Why is NIH involvement important for this program?

NIH involvement is consistent with the pilot nature of the program and the complexities of working with proprietary compounds, where alignment on objectives, data sharing, and operational coordination can be as important as the scientific experiments.

Is this a fully open competition?

No. Eligibility is limited.

Who was eligible to apply?

Only applicants who previously submitted a pre-application under PAR-12-203 (X02) and were subsequently invited were eligible to submit a UH3 application in response to this announcement.

Can an investigator apply without having participated in the pre-application stage?

No. According to the opportunity description, investigators could not submit a proposal without prior participation and an invitation following the PAR-12-203 (X02) pre-application process.

What does the limited competition format suggest about how projects were selected?

It suggests NCATS used the pre-application stage to identify the most promising concepts and feasible matches between investigator ideas and available industry Agents before inviting full applications.

Which NIH center leads this initiative?

The initiative is led by the National Center for Advancing Translational Sciences (NCATS).

What is the CFDA number associated with this opportunity?

The CFDA number listed for this opportunity is 93.350 (NCATS).

What is the estimated total funding level for the opportunity?

The estimated total funding level is $20,000,000.

Was cost sharing or matching funds required?

No. The opportunity did not require cost sharing or matching funds.

When was the funding opportunity posted?

The FOA was posted on June 12, 2012.

What was the application closing date?

The application closing date was December 17, 2012.

Is this funding opportunity still open?

No. The announcement was archived on January 17, 2013, indicating it is no longer open for submission.

What does it mean that the announcement is archived?

It means the opportunity remains available as a record of the program solicitation and its requirements, but it is no longer accepting applications.

What category does this opportunity fall under?

Administratively, it falls under the NIH discretionary category and the health funding activity category.

Where could applicants find the full announcement?

The full announcement was hosted on the NIH grants site at the provided link in the original posting.

Who could be contacted for technical issues accessing the FOA?

NIH Office of Extramural Research (OER) webmaster contact information was included for technical issues accessing the FOA.

How does this program aim to accelerate translational science?

By leveraging existing compounds that already have some characterization and supporting data, the program aims to shorten the path to meaningful clinical impact if a new therapeutic use is identified and validated.

What is the overall approach described for advancing repurposing efforts?

The approach is to operationalize drug repurposing at scale by creating a structured pathway for academic innovators to test new disease indications for industry-held molecules, using a cooperative model intended to speed translation while navigating proprietary assets and cross-sector collaboration.

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