Advancing Novel Medical Isotopes for Clinical Trials | DE FOA 0002532

Opportunity Information: Apply for DE FOA 0002532

The Department of Energy (DOE) Office of Science, through its Isotope Research and Development and Production program (DOE IP), is offering grant funding to speed up the “bench-to-clinic” pipeline for newly developed medical radioisotopes. The central goal is to support research that makes it easier, faster, and more reliable to translate novel DOE-developed isotopes, along with the enabling chemistry needed to use them in medicine (such as chelating agents and linker/ligand systems), so they are ready for consideration in future pre-clinical and clinical trial settings. In practice, this means the DOE is looking for work that removes technical bottlenecks between laboratory production and a form that is suitable to be handed off for downstream biological or clinical evaluation by the appropriate entities.

A key boundary in this opportunity is what it will not fund. The funding announcement is explicit that the actual evaluation of isotopes, chelators, or ligands in pre-clinical or clinical trials is out of scope and outside DOE IPs mission for this program. Any application that requests support to conduct pre-clinical testing, clinical testing, or trial evaluation activities will be rejected without merit review. Similarly, proposals that focus on isotope R&D that is not tied to translational readiness (for example, basic isotope research without a clear path to preparing a usable, distributable, medically relevant material package) are also considered out of scope and will be declined without merit review. The intent is not to fund general isotope science, but rather targeted translational-enabling research that helps move promising materials toward the point where health-focused agencies and clinical partners could realistically evaluate them.

The opportunity is limited to medical isotopes that have been recently developed by the DOE IP (the specific eligible isotopes are listed in the FOA itself), but it is flexible on the chelator and ligand technology used with those isotopes. That flexibility is important because chelation and targeting chemistry often determines whether a radioisotope can be formulated safely, remain stable in vivo, and be delivered to the intended biological target for diagnostic imaging or therapy. Projects can therefore propose new or improved chelators, linkers, ligands, labeling methods, purification strategies, quality controls, or other translational steps, as long as the work is clearly aimed at accelerating readiness for downstream trial consideration rather than performing the trials.

Another emphasis is practical capability-building. Applications that include strong approaches to training personnel are “strongly encouraged,” especially training tied to the specialized, hands-on skills needed in isotope production and supply chains. This includes knowledge and skills related to producing, processing, purifying, and distributing enriched stable isotopes and radioactive isotopes. In other words, the DOE is not only trying to advance specific translational projects, but also to strengthen the workforce and operational know-how that makes reliable isotope availability possible for the broader medical and research ecosystem.

Program administration and review also reflect the translational focus. Although DOE IP administers the funding opportunity, proposal assessment will be coordinated with the National Institutes of Health (NIH). That coordination signals an intent to align DOE-supported translational preparation with the expectations and realities of biomedical research pathways, even while the DOE remains firmly on the side of enabling technology and materials readiness rather than clinical evaluation.

From a logistics standpoint, this is a discretionary grant opportunity under Funding Opportunity Number DE-FOA-0002532, categorized under science and technology research and development (CFDA 81.049). Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, and other eligible entities (as defined in the FOA). The posting lists an award ceiling of $500,000, with an original closing date of July 23, 2021, and a creation date of June 1, 2021. Overall, the opportunity is designed to leverage the specialized infrastructure and technical capabilities available at universities, non-profit research institutions, and DOE/NNSA National Laboratories to shorten development timelines and increase the likelihood that new diagnostic and therapeutic radioisotope tools can be advanced efficiently to the point where clinical-oriented organizations can take the next steps.

• The Office of Science in the science and technology and other research and development sector is offering a public funding opportunity titled "Advancing Novel Medical Isotopes for Clinical Trials" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 81.049.
• This funding opportunity was created on 2021-06-01.
• Applicants must submit their applications by 2021-07-23. (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 $500,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education, Private institutions of higher education, Others.

Apply for DE FOA 0002532

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