Opportunity Information: Apply for PAR 12 007
Apply for PAR 12 007
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovative Pilot Studies of Novel Mechanism of Action Compounds for Treating Psychiatric Disorders (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants.
- This funding opportunity was created on Feb 24, 2014 and posted on Nov 7, 2011.
- Applicants must submit their applications by Feb 25, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments For profit organizations other than small businesses Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Private institutions of higher education Special district governments 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) 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:
The NIH funding opportunity PAR 12-007, titled "Innovative Pilot Studies of Novel Mechanism of Action Compounds for Treating Psychiatric Disorders (U01)," is designed to speed up the development of new medications for mental disorders by paying for early human clinical testing of promising drug candidates. It uses a cooperative agreement mechanism (U01), which generally means NIH program staff will have an active role in shaping and monitoring the project as it runs, rather than simply providing funds with minimal involvement. The overall intent is very practical: generate high-quality, decision-making data quickly so that novel drug approaches can be "de-risked" and become more attractive for follow-on investment and larger clinical trials.
A central focus of the FOA is experimental-medicine style clinical research, specifically first-in-human (FIH) and proof-of-concept (POC) studies of compounds that have a novel mechanism of action and are IND-ready, meaning they are sufficiently mature from a preclinical and regulatory standpoint to enter human testing under an Investigational New Drug application. For FIH pharmacology studies, the announcement emphasizes collecting rigorous evidence on whether the drug actually engages its intended biological target in humans (target engagement), what pharmacological effects it produces, and whether it is safe and tolerable at the planned dose levels. These studies are meant to create a solid foundation for subsequent patient-focused trials by clarifying dose, exposure, safety margins, and whether the drug is acting on the intended pathway in living people.
For POC studies, the FOA aims to support early patient-centered testing that still stays tightly linked to pharmacology and mechanism. Rather than using purely symptom-based dosing or broad clinical endpoints alone, POC projects are expected to apply pharmacologically justified dosing strategies and to include measures that show target engagement and downstream biological or physiological impact in systems relevant to psychiatric illness. In addition to these mechanistic and physiological readouts, projects are also expected to assess clinical indicators of effect, which can help determine whether the compound is likely to produce meaningful benefit and is worth advancing into larger, more definitive efficacy trials.
Another key theme is accelerating a pipeline of innovative treatments by enabling rapid data collection that informs go/no-go decisions. The FOA is explicitly framed around reducing uncertainty for new mechanisms of action (including, where relevant, combination approaches), so that promising candidates can move forward more confidently and less promising ones can be redirected early. This is also tied to the commercialization and sustainability angle: by producing credible early human data, awardees can be in a stronger position to attract private funding for later-stage development, including larger clinical studies and eventual market progression.
The opportunity is run by the National Institutes of Health under CFDA 93.242 (Mental Health Research Grants) and sits within the health research activity category. The estimated total funding level listed is about $5,000,000 for the FOA. It does not require cost sharing or matching, which lowers the barrier for many applicants and keeps the focus on the scientific and clinical-development merits of the proposal.
Eligibility is broad across the U.S. research ecosystem and includes small businesses, for-profit organizations (including those other than small businesses), nonprofit organizations (both 501(c)(3) and certain non-501(c)(3) entities), public and private institutions of higher education, and a wide range of government entities such as state, county, city/township, special district governments, and public housing authorities. The FOA also highlights inclusivity across institution types, listing 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 or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. At the same time, it clearly restricts foreign participation in specific ways: non-U.S. (foreign) institutions are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are not eligible. However, foreign components as defined by the NIH Grants Policy Statement are allowed, which can permit certain international collaborations when appropriately structured and justified.
A notable expectation in the FOA is collaboration between academia and industry. This makes sense given the requirement for IND-ready compounds and the emphasis on rapid translation, regulatory readiness, and a path toward commercialization or later-stage development. Industry partners often control key assets (the compound, manufacturing, toxicology packages, regulatory documentation), while academic teams may contribute deep disease expertise, biomarker development, clinical-trial execution, and mechanistic evaluation. The FOA strongly encourages these partnerships to increase the odds that funded studies can be executed efficiently and lead to actionable next steps.
The announcement was originally posted on November 7, 2011, with key dates indicating it was open during a defined period and is now archived (archive date March 25, 2014). The funding opportunity number is PAR 12-007, and the full announcement was hosted through the NIH grants guide. For access or technical issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV, reflecting that questions in this listing are geared toward accessing the opportunity materials rather than scientific program contact details.
In practical terms, this FOA is a good fit for teams that already have a well-characterized, IND-ready psychiatric drug candidate with a clearly articulated novel mechanism, along with a credible plan to demonstrate target engagement in humans and to link that engagement to measurable biological effects and early signals of clinical impact. The emphasis is less on large, definitive efficacy trials and more on smart, mechanism-driven early studies that can quickly clarify whether a compound is behaving as intended in humans and deserves larger investments.
Frequently Asked Questions (FAQs)
What is PAR 12-007?
PAR 12-007 is an NIH funding opportunity titled "Innovative Pilot Studies of Novel Mechanism of Action Compounds for Treating Psychiatric Disorders (U01)." It is intended to accelerate the development of new medications for mental disorders by supporting early clinical testing in humans for promising, novel drug candidates.
What is the main goal of this funding opportunity?
The goal is to generate high-quality, decision-making data quickly so that novel drug approaches can be "de-risked" and become more attractive for follow-on investment and larger clinical trials. The focus is practical: produce credible early human evidence about mechanism, target engagement, dosing/exposure, and early signals that help inform go/no-go decisions.
What type of award mechanism is used (U01) and what does it imply?
This FOA uses a cooperative agreement mechanism (U01). In general, this means NIH program staff are expected to have an active role in shaping and monitoring the project during execution, rather than simply providing funds with minimal involvement.
What kinds of studies does the FOA support?
The FOA supports experimental-medicine style clinical research, specifically first-in-human (FIH) and proof-of-concept (POC) studies of novel mechanism-of-action compounds for psychiatric disorders, when those compounds are sufficiently mature to enter human testing.
What does "first-in-human (FIH)" mean in this FOA?
In this FOA, FIH refers to early human pharmacology studies designed to establish whether a compound engages its intended biological target in humans (target engagement), what pharmacological effects it produces, and whether it is safe and tolerable at planned dose levels.
What data are emphasized for first-in-human pharmacology studies?
FIH studies are expected to produce rigorous evidence on target engagement, pharmacological effects, and safety/tolerability. They are also intended to help clarify dose, exposure, safety margins, and whether the drug is acting on the intended pathway in living people, creating a foundation for subsequent patient-focused trials.
What does "proof-of-concept (POC)" mean in this FOA?
POC studies are early patient-centered tests that remain tightly linked to pharmacology and mechanism. Rather than relying only on broad symptom endpoints or purely symptom-based dosing, POC projects are expected to use pharmacologically justified dosing strategies and include measures of target engagement and downstream biological or physiological impact relevant to psychiatric illness.
Are clinical indicators of effect expected in proof-of-concept studies?
Yes. Alongside mechanistic and physiological readouts (such as target engagement and downstream impact), projects are expected to assess clinical indicators of effect to help determine whether the compound is likely to produce meaningful benefit and is worth advancing to larger efficacy trials.
What is meant by "experimental medicine" in the context of this FOA?
Here, "experimental medicine" refers to mechanism-driven clinical research that tests whether a compound engages a target and produces measurable downstream biological effects in humans, and then links those effects to early clinical signals. The emphasis is on understanding how and whether the drug works in people, not on running large definitive efficacy trials.
What does "IND-ready" mean for eligibility of compounds in this program?
"IND-ready" means the compound is sufficiently mature from a preclinical and regulatory standpoint to enter human testing under an Investigational New Drug application. The FOA is aimed at compounds that are ready for early human clinical studies.
Is this FOA intended to fund large, definitive efficacy trials?
No. The FOA emphasizes smart, mechanism-driven early studies (FIH and POC) designed to quickly clarify whether a compound behaves as intended in humans and whether it merits larger follow-on investments and more definitive efficacy trials.
How does this program support go/no-go decision-making?
It is explicitly framed around accelerating rapid data collection to reduce uncertainty for new mechanisms of action, so teams can make informed go/no-go decisions earlier. The intent is to move promising candidates forward more confidently and redirect less promising candidates sooner.
Does the FOA support novel mechanisms of action and combination approaches?
Yes. The FOA is framed around reducing uncertainty for new mechanisms of action and notes that this can include, where relevant, combination approaches.
Why is target engagement so important in this FOA?
Target engagement is a central requirement because the FOA aims to show whether the compound is actually affecting its intended biological target in humans. Demonstrating target engagement, along with downstream effects and tolerability, helps de-risk development and supports rational decisions about dosing and future trials.
What is the estimated total funding level for this FOA?
The estimated total funding level listed for the FOA is about $5,000,000.
Is cost sharing or matching required?
No. The FOA states that it does not require cost sharing or matching.
Which NIH program area/category is associated with this opportunity?
The opportunity is run by the National Institutes of Health and is associated with CFDA 93.242 (Mental Health Research Grants) within the health research activity category.
Who is eligible to apply?
Eligibility is broad and includes small businesses, for-profit organizations (including those other than small businesses), nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), public and private institutions of higher education, and many types of government entities (such as state, county, city/township, special district governments, and public housing authorities).
Does the FOA specifically mention certain institution types as eligible?
Yes. It highlights a range of institution types, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.
Are foreign (non-U.S.) institutions eligible to apply as the applicant organization?
No. Non-U.S. (foreign) institutions are not eligible to apply as the applicant organization for this FOA.
Are non-U.S. components of U.S. organizations eligible?
No. The FOA states that non-U.S. components of U.S. organizations are not eligible.
Are any types of international collaboration allowed?
Yes. While foreign institutions cannot be the applicant organization and non-U.S. components of U.S. organizations are not eligible, foreign components (as defined by the NIH Grants Policy Statement) are allowed, which can permit certain international collaborations when appropriately structured and justified.
Is collaboration between academia and industry expected or encouraged?
Yes. A notable expectation is collaboration between academia and industry. This aligns with the IND-ready requirement and the emphasis on efficient translation, regulatory readiness, and a path toward commercialization or later-stage development.
Why does the FOA encourage academia-industry partnerships?
The FOA emphasizes rapid execution and actionable development decisions for IND-ready compounds. Industry partners often control key assets (such as the compound, manufacturing, toxicology packages, and regulatory documentation), while academic teams may contribute disease expertise, biomarker development, clinical trial execution, and mechanistic evaluation.
How does this FOA relate to commercialization or follow-on funding?
By producing credible early human data (mechanism, target engagement, safety/tolerability, and early clinical indicators), awardees may be better positioned to attract private funding for later-stage development, including larger clinical studies and eventual market progression.
When was this funding opportunity posted and what is its current status?
The announcement was originally posted on November 7, 2011. It is now archived, with an archive date of March 25, 2014.
Where was the full announcement hosted?
The full announcement was hosted through the NIH grants guide.
Who is listed as a contact for access or technical issues?
The contact listed for access or technical issues is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Is the listed contact a scientific/program contact?
Based on the provided information, the listed contact is geared toward access to the opportunity materials or technical issues rather than scientific program contact details.
What kinds of teams are a good fit for PAR 12-007?
This FOA is a good fit for teams that already have a well-characterized, IND-ready psychiatric drug candidate with a clearly articulated novel mechanism of action and a credible plan to demonstrate target engagement in humans, link engagement to downstream biological effects, and assess early clinical indicators of impact.
What is the overall "success case" this FOA is trying to enable?
The FOA is designed to enable rapid, rigorous early human studies that clarify whether a novel compound is working on its intended pathway, identify appropriate dosing/exposure and safety margins, and provide mechanistic and early clinical evidence strong enough to support confident next-step decisions and follow-on investment.
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