Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01 Clinical Trial Optional) | PAR 20 038

Frequently Asked Questions (FAQs)

What is the funding opportunity PAR 20-038 about?

PAR 20-038 is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) supporting R01 research grants focused on creating and testing new PET or SPECT radioligands for imaging biological targets in the human brain. The intent is to advance promising imaging agents far enough that they are ready for real clinical research use, especially as biomarkers that support drug discovery and improve understanding of central nervous system (CNS) disorders.

What is the main goal of this FOA?

The main goal is translational readiness: generating practical, decision-making evidence that justifies advancing a candidate PET/SPECT ligand toward human studies and clinical research utility. Projects are expected to go beyond exploratory chemistry or early laboratory proof-of-concept and instead produce a package of data that helps de-risk moving forward.

What types of imaging technologies are supported?

This FOA supports radiotracer development and evaluation for positron emission tomography (PET) and single photon emission computed tomography (SPECT) imaging in the brain.

What kinds of projects are responsive to this announcement?

Responsive projects typically include developing and evaluating novel PET/SPECT radioligands, optimizing key ligand properties, and demonstrating measurable, interpretable binding to the intended target in the brain. The overall emphasis is on readiness for clinical research use as a biomarker in CNS research and therapeutic development contexts.

What ligand or tracer properties does NIH emphasize for optimization?

The FOA highlights optimizing properties such as selectivity, affinity, brain penetration, metabolic stability, and signal-to-noise characteristics, with the broader aim of producing a robust imaging signal suitable for brain imaging.

What kind of evidence is expected to support advancing a ligand toward human imaging studies?

Studies are expected to produce a de-risking evidence package, which may include performance data in relevant biological models, reproducibility of imaging signals, and early indicators that the ligand will be robust enough for human brain imaging and clinical research utility.

Does the FOA require purely exploratory chemistry work?

No. The FOA explicitly emphasizes generating practical, decision-making data needed to justify moving a candidate ligand forward, rather than stopping at exploratory chemistry or early proof-of-concept work alone.

Is the focus only on making new tracers, or also on testing and evaluation?

It includes both. The FOA centers on development and evaluation, meaning applicants are expected to not only create or optimize radioligands but also demonstrate target binding in the brain and generate evidence supporting biomarker utility for CNS research and therapeutic development.

Can applicants use existing preclinical data in their application?

Yes. A notable feature is that the FOA welcomes incorporation of pilot or clinical feasibility evaluations using previously collected preclinical data. Applicants can leverage existing datasets to strengthen the rationale and demonstrate readiness for translation.

What does it mean that this FOA is "biomarker-driven"?

It means the broader intent is to enable measurement of molecular processes in vivo using PET/SPECT radioligands, supporting drug development and mechanistic understanding of CNS disorders. Examples described include enabling measures relevant to target engagement, receptor occupancy, or pathway modulation, and illuminating pathophysiological features of neurological or psychiatric illnesses.

What grant mechanism does this FOA use?

The FOA uses the NIH R01 research project grant mechanism.

Are clinical trials required under this opportunity?

No. The FOA is listed as "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial component if appropriate, but a clinical trial is not required.

What is the funding instrument type?

The funding instrument is a discretionary grant under the NIH health research umbrella.

Which CFDA numbers are associated with this opportunity?

The activity is aligned to health-related research under CFDA numbers 93.242 and 93.273.

What is the original posting (creation) date for this FOA?

The posting reflects an original creation date of January 7, 2020.

What is the original closing date shown in the provided information?

The original closing date shown in the source data is January 7, 2023.

Who is eligible to apply?

Eligibility is broad and includes many domestic and non-domestic organizations. Eligible applicants include federal, state, county, and municipal governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

Are non-U.S. (foreign) organizations eligible?

Yes. The FOA states that non-domestic entities (foreign organizations) are eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly included among eligible applicants.

Does NIH encourage applications from institutions serving underrepresented communities?

The FOA explicitly highlights additional eligible applicants such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISISs, among others. This signals that NIH welcomes competitive proposals from a wide range of institution types, including those serving underrepresented communities.

Are tribal governments or tribal organizations eligible?

Yes. The FOA lists non-federally recognized tribal governments and tribal organizations as eligible applicants, and also references Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based and community-based organizations are explicitly listed as eligible applicants.

Can for-profit organizations apply?

Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also listed as eligible applicants.

What kinds of teams or expertise are a good fit for this program?

This opportunity is aimed at teams that can combine radiochemistry, imaging science, and CNS biology to produce radioligands that are ready to function as credible PET/SPECT biomarkers in human brain research.

What is the intended end use of the radioligands developed under this FOA?

The intended end use is clinical research utility in human brain imaging, particularly as biomarkers to aid drug discovery and deepen understanding of CNS disorders, including neurological or psychiatric illnesses.