Opportunity Information: Apply for PAR 12 203
Apply for PAR 12 203
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "A Pre application for the NIH Industry Pilot Program Discovering New Therapeutic Uses for Existing Molecules (X02)" 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 Aug 14, 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: State governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Small businesses Public and State controlled institutions of higher education 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 Others (see text field entitled Additional Information on Eligibility for clarification) County governments Independent school districts Public housing authorities/Indian housing authorities Private institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) City or township governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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 not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
This opportunity, titled "A Pre-application for the NIH Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules (X02)" (Funding Opportunity Number PAR-12-203), was issued by the National Institutes of Health through the National Center for Advancing Translational Sciences (NCATS). The program is designed as a therapeutics discovery pilot that focuses on finding new medical uses for proprietary drug candidates that already exist. In practice, it aims to support the concept of drug repurposing by taking compounds that were previously developed by pharmaceutical companies (and may have existing preclinical or clinical data) and pairing them with strong, scientifically grounded ideas from the broader biomedical research community about how those compounds could be used to treat different diseases than originally intended.
The central feature of the program is the matchmaking model. Pharmaceutical partners contribute "Agents" (proprietary drug candidates) along with associated data, and NIH/NCATS looks to identify the best external research proposals that suggest credible new therapeutic indications for those Agents. The intent is to accelerate translation by leveraging prior industry investment in molecule discovery, optimization, and early testing, while bringing in new disease-area expertise and innovative hypotheses from academic and other research teams. Because these molecules come with existing datasets, the program is positioned to reduce early-stage uncertainty and potentially shorten the timeline needed to evaluate whether a compound could work in a new indication.
The funding mechanism is a grant and is categorized as discretionary funding within the health activity area (CFDA 93.350, NCATS). The total estimated funding listed for the opportunity is $20,000,000, and there is no cost sharing or matching requirement stated. As an X02 pre-application, it is structured to capture and evaluate proposed ideas at an early stage as part of the pilot program pipeline, rather than functioning like a typical full research project application on its own. The original posted and creation date were June 12, 2012, with a closing date of August 14, 2012, and an archive date of September 14, 2012, meaning it was time-limited and is now archived.
Eligibility is broad across many types of U.S.-based organizations. Eligible applicants include federal-recognized and other tribal governments and organizations, state and local governments (including counties, cities/townships, special districts, and independent school districts), public housing authorities/Indian housing authorities, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding universities when specified), small businesses, and for-profit organizations other than small businesses. The eligibility section also highlights specific institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Alaska Native and Native Hawaiian-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), regional organizations, and faith-based or community-based organizations, as well as U.S. territories or possessions. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components as defined under the NIH Grants Policy Statement are allowed, which typically refers to specific foreign activities that are part of an otherwise eligible U.S.-led application and are justified as necessary for the project.
From a practical standpoint, the opportunity is meant for research teams who can articulate a compelling scientific rationale for why a specific existing drug candidate might be effective in a new disease context, and who can propose a feasible plan to test that idea using the information and materials that would be available through the industry partnership structure. The overall goal is to unlock therapeutic value from molecules that already exist by connecting industry-held assets with external innovation, potentially generating new treatment options for a wide range of human diseases while making more efficient use of prior drug development efforts.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "A Pre-application for the NIH Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules (X02)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR-12-203.
Which federal agency and NIH center issued this opportunity?
This opportunity was issued by the National Institutes of Health (NIH) through the National Center for Advancing Translational Sciences (NCATS).
What is the program trying to do?
The program is a therapeutics discovery pilot focused on finding new medical uses for proprietary drug candidates that already exist. It supports the concept of drug repurposing by pairing existing compounds (often with preclinical or clinical data) with scientifically grounded proposals for new disease indications.
What types of molecules are in scope for this program?
The program focuses on proprietary drug candidates contributed by pharmaceutical partners. These are compounds that were previously developed by industry and may come with associated preclinical or clinical datasets.
What does "Discovering New Therapeutic Uses for Existing Molecules" mean in practice?
In practice, it means proposing credible new therapeutic indications for existing proprietary drug candidates, rather than starting from scratch with discovery of a brand-new compound.
What is the central feature of the program?
The central feature is a matchmaking model. Pharmaceutical partners contribute proprietary "Agents" (drug candidates) and associated data, and NIH/NCATS seeks external research proposals that provide strong scientific rationales for new therapeutic uses of those Agents.
Who provides the drug candidates and data?
Pharmaceutical partners provide the proprietary drug candidates (referred to as "Agents") along with associated data.
What role does NIH/NCATS play in this model?
NIH/NCATS facilitates the pilot program and aims to identify the strongest external proposals that suggest credible new therapeutic indications for the contributed Agents, leveraging both industry-provided assets and external scientific innovation.
Why does the program emphasize existing datasets?
Because the molecules come with existing datasets from prior industry investment (such as discovery, optimization, and early testing), the program is positioned to reduce early-stage uncertainty and may shorten the timeline needed to evaluate whether a compound could work in a new indication.
What is the funding mechanism for this opportunity?
The funding mechanism is a grant, and the opportunity is structured as an X02 pre-application.
What does it mean that this is an X02 pre-application?
It means the application is intended to capture and evaluate proposed ideas at an early stage as part of the pilot program pipeline, rather than functioning like a typical full research project application on its own.
How is this opportunity categorized?
It is categorized as discretionary funding within the health activity area.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.350 (NCATS).
What is the total estimated funding amount listed for the opportunity?
The total estimated funding listed is $20,000,000.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated for this opportunity.
When was this opportunity originally posted?
The original posted and creation date was June 12, 2012.
What was the application closing date?
The closing date was August 14, 2012.
Is this opportunity still open?
No. The opportunity is time-limited and is now archived.
When was the opportunity archived?
The archive date was September 14, 2012.
Who is eligible to apply?
Eligibility is broad across many types of U.S.-based organizations, including tribal governments and organizations, state and local governments, public housing authorities/Indian housing authorities, public and private institutions of higher education, nonprofit organizations (501(c)(3) and non-501(c)(3), excluding universities when specified), small businesses, and for-profit organizations other than small businesses.
Are tribal governments and tribal organizations eligible?
Yes. Federal-recognized tribal governments and other tribal governments and organizations are listed among eligible applicants.
Are state and local government entities eligible?
Yes. State governments and local governments are eligible, including counties, cities/townships, special districts, and independent school districts.
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.
Are colleges and universities eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with 501(c)(3) status and nonprofit organizations without 501(c)(3) status are listed as eligible applicants (with a note that universities may be excluded when specified).
Are small businesses eligible?
Yes. Small businesses are listed as eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible applicants.
Are certain institution types specifically highlighted as eligible?
Yes. The eligibility section highlights institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Alaska Native and Native Hawaiian-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), regional organizations, and faith-based or community-based organizations.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included in the eligibility list.
Are non-U.S. (foreign) institutions eligible to apply directly?
No. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply.
Are any foreign activities allowed as part of an otherwise eligible application?
Yes. Foreign components, as defined under the NIH Grants Policy Statement, are allowed. This typically refers to specific foreign activities that are part of an otherwise eligible U.S.-led application and are justified as necessary for the project.
Who is this opportunity meant for, in practical terms?
It is meant for research teams that can articulate a compelling scientific rationale for why a specific existing proprietary drug candidate might be effective in a new disease context and propose a feasible plan to test that idea using information and materials available through the industry partnership structure.
What kind of project idea fits this program best?
A strong fit is an idea that proposes a scientifically credible new therapeutic indication for an existing proprietary drug candidate and outlines a feasible approach for evaluating that hypothesis within the pilot program framework.
What is the overall goal of the pilot program?
The overall goal is to unlock therapeutic value from molecules that already exist by connecting industry-held assets with external innovation, potentially generating new treatment options for a wide range of human diseases while making more efficient use of prior drug development efforts.
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