Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R21) | Apply Online

Opportunity Summary:

The NIH grant opportunity PAR 13 282, titled "Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R21)," was a discretionary research grant program focused on creating and early-testing new radiotracers for brain imaging. The central aim was to support projects that design and develop novel PET (positron emission tomography) or SPECT (single photon emission computed tomography) imaging ligands intended for use in the human brain, with an emphasis on their value as biomarkers. In practical terms, the FOA was looking for investigators who could move beyond basic chemistry or assay development and include an initial feasibility component, such as pilot preclinical evaluations, development of quantitative imaging models, or early clinical testing that demonstrates the ligand can realistically be used to measure a relevant CNS target or process.

The opportunity was framed around accelerating drug discovery and improving understanding of disease biology in central nervous system disorders. PET and SPECT ligands can function as biomarkers by letting researchers measure target engagement (whether a drug is hitting its intended receptor or enzyme), map receptor or transporter availability, quantify pathological processes, or track changes over time in living brains. The FOA therefore encouraged work that would produce imaging tools capable of answering translational questions, such as validating a new therapeutic target, selecting appropriate patient populations, informing dose selection, or providing a sensitive readout for pharmacodynamics in early-stage trials. It also supported pathophysiological studies where imaging could clarify mechanisms underlying neuropsychiatric or neurodegenerative conditions.

Because this was an R21 mechanism, the intent was to fund exploratory and developmental research rather than large, fully validated programs. The structure of the announcement signals support for higher-risk, earlier-stage ideas that still have a clear path to demonstrating feasibility. The description specifically called for inclusion of pilot or clinical feasibility evaluation, which implies applications needed to outline not only synthesis and screening of candidate ligands, but also at least some plan to demonstrate practical imaging performance. That could include preclinical imaging studies, initial human imaging, kinetic modeling and quantification approaches, or other foundational steps needed to show the tracer can produce interpretable, reliable signals in brain.

Administratively, this FOA was issued by the National Institutes of Health and aligned with multiple NIH research areas, reflected in the CFDA listings for mental health (93.242), alcohol research (93.273), drug abuse and addiction research (93.279), and aging research (93.866). That mix highlights the broad applicability of CNS imaging biomarkers across psychiatry, addiction science, and aging-related brain disorders, where in vivo measures of molecular targets can be especially valuable. The program did not require cost sharing or matching.

In terms of funding and timing, the announcement was posted on July 24, 2013, with a closing date of September 7, 2016, and it was archived on October 8, 2016. The listed award ceiling was $175,000, indicating a capped budget level consistent with a smaller, exploratory grant intended to generate key preliminary data and proof-of-concept results. While the FOA is no longer open, the details are still useful as a template for the kinds of deliverables NIH often expects in early radiotracer development: evidence of ligand specificity and suitability for brain imaging, early demonstration of quantification strategy, and initial signals of translational readiness.

Eligibility was broad and included public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (other than small businesses were explicitly listed, and small businesses were also eligible), and a wide range of government entities (state, county, city/township, special districts, and others). The FOA also explicitly included tribal governments and tribal organizations, public housing authorities/Indian housing authorities, independent school districts, and a variety of minority-serving and community-based institutions, such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities. Importantly, non-U.S. entities were eligible as well: foreign organizations and foreign institutions could apply, non-U.S. components of U.S. organizations were allowed, and foreign components as defined in NIH policy were permitted. This reflects the global and collaborative nature of radioligand development, where specialized radiochemistry, cyclotron access, and imaging expertise are often distributed across institutions and countries.

For applicants and administrators, NIH provided a standard point of contact for access or linking issues through the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV), and the archived full announcement was hosted on the NIH grants site. Overall, the FOA was aimed at pushing new CNS PET/SPECT radioligands from concept toward real-world usability as imaging biomarkers, with enough early evaluation built in to show they could contribute meaningfully to drug development decisions and to mechanistic studies of brain disorders.

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