Opportunity Information: Apply for PA 08 137
Apply for PA 08 137
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of PET and SPECT Ligands for Brain Imaging (SBIR R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs 93.866 Aging Research.
- This funding opportunity was created on Jan 26, 2009 and posted on Apr 9, 2008.
- Applicants must submit their applications by May 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The NIH grant opportunity titled "Development of PET and SPECT Ligands for Brain Imaging (SBIR R43/R44)" (Funding Opportunity Number PA 08-137) was a discretionary, NIH-administered SBIR grant program aimed at pushing new brain-imaging radiotracers toward real-world use. The central goal was to stimulate commercial development of novel radioligands for positron emission tomography (PET) and single photon emission computed tomography (SPECT) that can be used in the human brain. A notable emphasis was not just on making a compound in the lab, but on pairing development with early evidence that it can work in practice, meaning pilot or clinical feasibility evaluation could be incorporated through preclinical studies, modeling work, or clinical studies, depending on the maturity of the tracer and the approach.
From a scientific standpoint, the FOA targeted radioligands aimed at molecular targets that would matter to a broad research community, rather than highly niche targets. Examples listed include receptors, cell adhesion molecules, intracellular messengers, and disease-related proteins. The underlying idea is that if a tracer can reliably image a widely relevant target in the living brain, it can serve multiple purposes: basic neuroimaging research, translation of discoveries into human studies, and more applied uses such as biomarkers and surrogate endpoints. In practical terms, that means the tracers developed under this program were envisioned as tools that could help quantify disease processes, measure target engagement, or track treatment effects, which are all high-value capabilities in drug discovery, drug development, and clinical trials.
The announcement also made room for proposals that focused less on a single new ligand and more on enabling technology. Applications proposing new technologies for radiotracer development were considered appropriate, which could include improvements to synthesis methods, labeling chemistry, screening and optimization pipelines, or other platform-like capabilities that accelerate radioligand creation and translation. This matters because one of the biggest bottlenecks in PET/SPECT tracer work is not only finding a compound that binds the target, but also ensuring it can be labeled efficiently, behaves well in vivo, has acceptable brain penetration and kinetics, and can be produced reliably enough for broader use.
As an SBIR opportunity, eligibility was limited to small businesses, and the funding mechanism supported Phase I (R43), Phase II (R44), and Fast-Track applications. That structure is designed to encourage a stepwise progression from proof-of-concept to more advanced development. Phase I typically supports feasibility and early validation work, Phase II supports more extensive R and D and translation activities, and Fast-Track allows applicants to propose a combined Phase I/II plan when there is a strong rationale for rapid progression. The orientation toward commercialization is implied by the SBIR mechanism itself, reinforcing that NIH wanted these radioligands and related technologies to move beyond academic prototypes into products or broadly usable research tools.
Administratively, the opportunity was run by the National Institutes of Health and aligned with health-focused funding activity categories. The CFDA program numbers associated with the listing included 93.173 (Research Related to Deafness and Communication Disorders), 93.242 (Mental Health Research Grants), 93.273 (Alcohol Research Programs), and 93.866 (Aging Research), reflecting the wide range of NIH mission areas that could benefit from better brain imaging ligands. There was no cost-sharing or matching requirement. The opportunity was originally posted on April 9, 2008, had an original and current closing date of May 7, 2011, and was archived on June 7, 2011, meaning it is no longer open but remains a useful reference point for the kinds of radiotracer development projects NIH has historically encouraged. For full details, NIH pointed applicants to the official FOA page at http://grants.nih.gov/grants/guide/pa-files/PA-08-137.html, and provided NIH Office of Extramural Research webmaster contact information for access or linking issues.
FAQs: Development of PET and SPECT Ligands for Brain Imaging (SBIR R43/R44) - PA 08-137
1) What was this NIH funding opportunity?
This opportunity, titled "Development of PET and SPECT Ligands for Brain Imaging (SBIR R43/R44)" (Funding Opportunity Number PA 08-137), was an NIH-administered SBIR program intended to move new brain-imaging radiotracers toward real-world use. It supported small businesses developing novel radioligands for PET and SPECT imaging in the human brain.
2) What was the main goal of PA 08-137?
The central goal was to stimulate commercial development of new PET and SPECT radioligands that can be used in the living human brain, with an emphasis on pairing ligand development with early evidence of practical feasibility (for example, via preclinical studies, modeling work, or clinical studies depending on tracer maturity).
3) What imaging modalities did this FOA focus on?
The FOA focused on radioligands for positron emission tomography (PET) and single photon emission computed tomography (SPECT) for brain imaging.
4) Who was eligible to apply?
Eligibility was limited to small businesses, consistent with the SBIR (Small Business Innovation Research) mechanism.
5) What SBIR mechanisms were supported under this program?
The FOA supported Phase I (R43), Phase II (R44), and Fast-Track applications, enabling projects to progress from feasibility to more advanced development and translation.
6) What is the intended progression from Phase I to Phase II under this opportunity?
Phase I typically supported feasibility and early validation. Phase II supported more extensive research and development and translation activities. Fast-Track allowed a combined Phase I/II plan when there was a strong rationale for rapid progression.
7) Was commercialization an expectation of this opportunity?
Yes. While specific commercialization plans are not detailed in the summary provided, the SBIR mechanism implies an orientation toward commercialization, encouraging radioligands and enabling technologies to move beyond academic prototypes into products or broadly usable research tools.
8) What kinds of molecular targets were considered in scope?
The FOA targeted radioligands aimed at molecular targets relevant to a broad research community rather than highly niche targets. Examples listed included receptors, cell adhesion molecules, intracellular messengers, and disease-related proteins.
9) Why did NIH emphasize broadly relevant targets?
The idea was that tracers for widely relevant targets could serve multiple purposes across the neuroimaging field: basic research, translation of discoveries into human studies, and applied uses such as biomarkers and surrogate endpoints.
10) What practical uses were envisioned for the tracers developed under this FOA?
The tracers were envisioned as tools to help quantify disease processes, measure target engagement, or track treatment effects. These capabilities are particularly valuable for drug discovery, drug development, and clinical trials.
11) Did the FOA require only laboratory synthesis of a new compound?
No. A notable emphasis was on not just making a compound in the lab, but pairing development with early evidence that it can work in practice. The FOA allowed pilot or clinical feasibility evaluation to be incorporated depending on the maturity of the tracer and the proposed approach.
12) What types of feasibility evidence could be included?
Depending on tracer maturity and approach, feasibility evaluation could be supported through preclinical studies, modeling work, or clinical studies.
13) Were enabling technologies for radiotracer development considered responsive?
Yes. The FOA explicitly made room for proposals focused on enabling technology, not only a single new ligand.
14) What kinds of enabling technologies were mentioned as examples?
Examples included improvements to synthesis methods, labeling chemistry, screening and optimization pipelines, or other platform-like capabilities that accelerate radioligand creation and translation.
15) What development bottlenecks did the FOA highlight for PET/SPECT tracers?
The summary emphasized that bottlenecks include not only finding a compound that binds the target, but also ensuring it can be labeled efficiently, behaves well in vivo, has acceptable brain penetration and kinetics, and can be produced reliably enough for broader use.
16) Which federal agency administered this program?
The opportunity was administered by the National Institutes of Health (NIH).
17) What NIH mission areas were associated with the opportunity (CFDA numbers)?
The listing referenced CFDA program numbers 93.173 (Research Related to Deafness and Communication Disorders), 93.242 (Mental Health Research Grants), 93.273 (Alcohol Research Programs), and 93.866 (Aging Research), indicating that improved brain imaging ligands could benefit multiple NIH mission areas.
18) Was cost sharing or matching required?
No. The opportunity stated that there was no cost-sharing or matching requirement.
19) When was this opportunity posted and when did it close?
It was originally posted on April 9, 2008. The original and current closing date was May 7, 2011.
20) Is this FOA still open?
No. It was archived on June 7, 2011, meaning it is no longer open, though it can still be used as a reference for the types of projects NIH has historically encouraged in radiotracer development.
21) Where can someone find the official FOA details?
NIH directed applicants to the official FOA page at http://grants.nih.gov/grants/guide/pa-files/PA-08-137.html for full details.
22) Who was listed as a contact for access or linking issues?
The summary indicates NIH provided the NIH Office of Extramural Research webmaster contact information for access or linking issues.
Browse more opportunities from the same category: Health
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Previous opportunity: Small Business Innovation Research Competing Renewal Awards for Biomedical and Behavior Research Tools (SBIR R44)
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