Opportunity Information: Apply for PAR 15 071
Apply for PAR 15 071
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Pharmacodynamics and In vivo Efficacy Studies for Small Molecules and Biologics/Biotechnology Products (R21/R33)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Dec 12, 2014 and posted on Dec 12, 2014.
- Applicants must submit their applications by Jan 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- Eligible applicants include: Public and State controlled institutions of higher education City or township governments Small businesses Private institutions of higher education Public housing authorities/Indian housing authorities State governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The IGNITE Pharmacodynamics and In vivo Efficacy Studies FOA (PAR 15-071) is a National Institutes of Health grant opportunity designed to help move early-stage therapeutic candidates for neurological disorders closer to the point where they are ready for more advanced, milestone-driven translational development programs. The core purpose is to fund critical preclinical studies that show a proposed therapy has real biological activity in living systems and enough promise to justify continued investment. The program specifically supports work in pharmacodynamics (what the drug does to the body and whether it engages the intended biology), pharmacokinetics (how the body absorbs, distributes, metabolizes, and eliminates the agent), and in vivo efficacy (whether the agent produces beneficial effects in animal models or other in vivo systems relevant to the neurological condition).
This opportunity is aimed at therapeutic agents across several modalities, including small molecules and biologics/biotechnology-derived products. In practical terms, it is meant for projects that already have a defined therapeutic concept and candidate agent(s) and now need the kind of rigorous in vivo and exposure-response evidence that can de-risk the program. The expected outcome is not a fully developed clinical-stage package, but rather a clear demonstration that the therapeutic candidate engages its target or pathway, achieves appropriate exposure in vivo, and produces measurable efficacy signals in relevant disease or mechanism-based models. That evidence is intended to support a rational go/no-go decision and set the project up to meet entry expectations for later translational programs.
A key feature of the FOA is that it sits within a broader suite of NINDS IGNITE initiatives. The stated intent is to advance projects to the point where they can compete for or transition into larger, more development-focused programs such as the NINDS Cooperative Research to Enable and Advance Translational Enterprises (CREATE) program (particularly relevant for biologics and biotechnology products) and the Blueprint Neurotherapeutics Network (BPN) (particularly relevant for small molecules), or similar translational pipelines. In other words, IGNITE functions as an enabling step: it helps generate the pharmacology and in vivo performance data that many translational programs require before committing more extensive resources to optimization, IND-enabling studies, manufacturing scale-up, or other later-stage activities.
Administratively, the announcement is a discretionary grant mechanism using the NIH R21/R33 structure, which is commonly used for projects that start with an exploratory or developmental phase and can transition to a second phase if predefined goals are met. The total award ceiling listed is $750,000, with no cost sharing or matching requirement. The FOA falls under the NIH Health activity category and is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The opportunity was posted and created on December 12, 2014, and the original and current closing date listed is January 7, 2018, with an archive date of February 7, 2018, indicating it is no longer active as a current solicitation but remains available for reference.
Eligibility is broad and includes a wide range of academic, nonprofit, governmental, and private-sector organizations. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, small businesses, nonprofits (including both 501(c)(3) and non-501(c)(3) organizations), for-profit organizations (including those other than small businesses), and multiple levels of government (state, county, city/township, special district, independent school districts, and certain housing authorities). The FOA also explicitly includes a variety of mission- and community-focused institution types such as HBCUs, Hispanic-serving institutions, tribal colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISIs, as well as federally recognized and other tribal organizations. Notably, non-U.S. entities are eligible to apply, foreign institutions are allowed, non-U.S. components of U.S. organizations can participate, and foreign components are permitted as defined by NIH policy.
Overall, this FOA is best understood as targeted translational support for neurological therapeutics at the stage where the biggest unanswered questions are pharmacologic and functional: does the candidate reach the relevant biological compartments, does it modulate the intended target/pathway in vivo, and does that translate into meaningful efficacy signals in appropriate models. By funding these pharmacodynamics, pharmacokinetics, and in vivo efficacy studies, IGNITE PAR 15-071 is structured to help investigators generate the kind of evidence that later-stage translational programs use as entry criteria, thereby improving the chances that promising neuroscience therapies can progress efficiently into more formal development pathways.
FAQs: IGNITE Pharmacodynamics and In vivo Efficacy Studies (PAR 15-071)
What is the IGNITE Pharmacodynamics and In vivo Efficacy Studies FOA (PAR 15-071)?
PAR 15-071 is a National Institutes of Health (NIH) funding opportunity designed to support critical preclinical studies for early-stage therapeutic candidates aimed at neurological disorders. The focus is on generating rigorous in vivo and pharmacology evidence that helps determine whether a therapy is ready for more advanced, milestone-driven translational development programs.
What is the main purpose of this funding opportunity?
The core purpose is to fund preclinical studies that demonstrate a proposed therapy has biological activity in living systems and enough promise to justify additional investment. The program emphasizes evidence that can support a rational go/no-go decision and prepare a project for entry into later translational pipelines.
What types of studies does this FOA support?
This FOA specifically supports work in:
- Pharmacodynamics (PD): What the drug does to the body, including whether it engages the intended target, pathway, or biology.
- Pharmacokinetics (PK): How the body absorbs, distributes, metabolizes, and eliminates the therapeutic agent.
- In vivo efficacy: Whether the agent produces beneficial effects in animal models or other in vivo systems relevant to the neurological condition.
What stage of therapeutic development is this program intended for?
It is intended for projects that already have a defined therapeutic concept and candidate agent(s) and now need strong in vivo and exposure-response evidence to de-risk the program. It is not positioned as a program for generating a fully clinical-stage development package, but rather for producing key data that demonstrate in vivo target/pathway engagement, appropriate exposure, and measurable efficacy signals.
What kinds of therapeutic agents or modalities are in scope?
The opportunity is aimed at therapeutic agents across several modalities, including small molecules and biologics/biotechnology-derived products.
What outcomes are expected from an award under this FOA?
The expected outcome is a clear demonstration that the therapeutic candidate:
- Engages its intended target or pathway in vivo (pharmacodynamics)
- Achieves appropriate exposure in vivo (pharmacokinetics and exposure-response evidence)
- Shows measurable efficacy signals in relevant disease or mechanism-based in vivo models
This package of evidence is intended to enable a rational go/no-go decision and position the project for subsequent translational development programs.
How does this FOA fit within NINDS IGNITE initiatives?
This FOA is described as part of a broader suite of National Institute of Neurological Disorders and Stroke (NINDS) IGNITE initiatives. It functions as an enabling step to generate the pharmacology and in vivo performance data often required before more extensive translational programs commit significant resources.
Which later-stage translational programs is this meant to prepare projects for?
The FOA is intended to help projects advance to a point where they can compete for or transition into larger, development-focused programs, including:
- NINDS CREATE: Highlighted as particularly relevant for biologics and biotechnology products.
- Blueprint Neurotherapeutics Network (BPN): Highlighted as particularly relevant for small molecules.
It is also framed as preparation for similar translational pipelines that require strong PD/PK and in vivo efficacy evidence before further development.
What grant mechanism is used for this opportunity?
This is a discretionary grant mechanism using the NIH R21/R33 structure. This structure is commonly used for projects that begin with an exploratory or developmental phase and may transition to a second phase if predefined goals are met.
What is the total award ceiling for PAR 15-071?
The total award ceiling listed is $750,000.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What NIH activity category and CFDA number are associated with this FOA?
The opportunity falls under the NIH Health activity category and is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was this opportunity posted, and is it still active?
The opportunity was posted and created on December 12, 2014. The original and current closing date listed is January 7, 2018, with an archive date of February 7, 2018. Based on these dates, it is no longer active as a current solicitation and is available for reference as an archived opportunity.
Who is eligible to apply?
Eligibility is broad and includes academic, nonprofit, governmental, and private-sector organizations. Eligible applicants include:
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Small businesses
- Nonprofits, including 501(c)(3) and non-501(c)(3) organizations
- For-profit organizations (including those other than small businesses)
- Government entities (state, county, city/township, special district, independent school districts, and certain housing authorities)
Are minority-serving and community-focused institutions included in eligibility?
Yes. The FOA explicitly includes institution types such as HBCUs, Hispanic-serving institutions, tribal colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISIs, as well as federally recognized and other tribal organizations.
Are non-U.S. or foreign organizations eligible?
Yes. The FOA states that non-U.S. entities are eligible to apply, foreign institutions are allowed, non-U.S. components of U.S. organizations can participate, and foreign components are permitted as defined by NIH policy.
What makes this FOA different from later-stage translational development programs?
This FOA is positioned as a targeted, enabling step focused on generating key preclinical pharmacology and in vivo efficacy evidence. It is not described as supporting later-stage activities such as IND-enabling studies, manufacturing scale-up, or extensive optimization, but rather as helping projects reach the entry expectations for more development-focused programs.
What kinds of scientific questions is the program trying to answer?
The FOA is aimed at answering practical translational questions such as:
- Does the candidate reach relevant biological compartments in vivo?
- Does it modulate the intended target or pathway (pharmacodynamics)?
- Does it achieve appropriate exposure and a meaningful exposure-response relationship (pharmacokinetics)?
- Does target/pathway engagement translate into measurable efficacy signals in relevant in vivo models?
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Previous opportunity: Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Assay Development and Therapeutic Agent Identification and Characterization to Support Therapeutic Discovery (R21/R33)
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 15 071) also looked into and applied for these:
| Funding Opportunity |
|---|
| NINDS Morris K. Udall Centers of Excellence for Parkinsons Disease Research (P50) Apply for RFA NS 15 002 Funding Number: RFA NS 15 002 Agency: National Institutes of Health Category: Health Funding Amount: $1,500,000 |
| Positive Health Check Evaluation Trial Apply for RFA PS 15 001 Funding Number: RFA PS 15 001 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $300,000 |
| Mobile Messaging Intervention to Present New HIV Prevention Apply for RFA PS 15 002 Funding Number: RFA PS 15 002 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $600,000 |
| NIMH Administrative Supplement Program Providing Research Experiences for Physicians and Medical Students from Diverse Backgrounds Apply for PA 15 069 Funding Number: PA 15 069 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| FY15 FY16 Department of Defense HIV/AIDS Prevention Program Military Specific HIV/AIDS Prevention, Care, and Treatment Program for non PEPFAR (Presidents Emergency Plan for AIDS Relief Apply for DHAPP BAA 15 001 Funding Number: DHAPP BAA 15 001 Agency: Naval Supply Systems Command Category: Health Funding Amount: Case Dependent |
| Centers for Common Disease Genomics (UM1) Apply for RFA HG 15 001 Funding Number: RFA HG 15 001 Agency: National Institutes of Health Category: Health Funding Amount: $40,000,000 |
| FY15 FY16 Department of Defense HIV/AIDS Prevention Program Military Specific HIV/AIDS Prevention, Care, and Treatment Program for PEPFAR (Presidents Emergency Plan for AIDS Relief) Funded Countries Apply for DHAPP BAA 15 002 Funding Number: DHAPP BAA 15 002 Agency: Naval Supply Systems Command Category: Health Funding Amount: Case Dependent |
| Centers for Mendelian Genomics (UM1) Apply for RFA HG 15 002 Funding Number: RFA HG 15 002 Agency: National Institutes of Health Category: Health Funding Amount: $5,000,000 |
| Strengthening Clinical and Laboratory Services at the National Referral Level to Improve HIV Prevention, Care, and Treatment in the Republic of Zambia under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH15 1603 Funding Number: CDC RFA GH15 1603 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $27,475,000 |
| Geriatrics Workforce Enhancement Program Apply for HRSA 15 057 Funding Number: HRSA 15 057 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Childrens Safety Network Program Apply for HRSA 15 067 Funding Number: HRSA 15 067 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| National Coordinating Center for the Regional Genetic Service Collaboratives Apply for HRSA 15 081 Funding Number: HRSA 15 081 Agency: Health Resources and Services Administration Category: Health Funding Amount: $800,000 |
| Strengthening the Delivery and Expanding Access to Quality Laboratory Services and Enhancing Healthcare Worker and Laboratory Safety in the Republic of South Africa under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH15 1575 Funding Number: CDC RFA GH15 1575 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $5,000,000 |
| Support the Strengthening and Utilization of Strategic Information Activities in the Republic of South Africa under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH15 1576 Funding Number: CDC RFA GH15 1576 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $25,000,000 |
| Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (UT2) Apply for PAR 15 073 Funding Number: PAR 15 073 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (U44) Apply for PAR 15 074 Funding Number: PAR 15 074 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Evaluating Innovative and Promising Strategies to Prevent Suicide among Middle Aged Men Apply for RFA CE 15 004 Funding Number: RFA CE 15 004 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $330,000 |
| Establish a Vision and Eye Health Surveillance System for the Nation Apply for RFA DP 15 004 Funding Number: RFA DP 15 004 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $1,000,000 |
| Consortium on the Neurobiology of Adolescent Drinking in Adulthood (NADIA) Research Projects (U01) Apply for RFA AA 15 004 Funding Number: RFA AA 15 004 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Consortium on the Neurobiology of Adolescent Drinking in Adulthood (NADIA) Administrative Resource (U24) Apply for RFA AA 15 005 Funding Number: RFA AA 15 005 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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