DoD FY11 Prostate Cancer Research Program Laboratory Clinical Transition Award | Apply Online

Opportunity Summary:

The DoD FY11 Prostate Cancer Research Program (PCRP) Laboratory Clinical Transition Award (LCTA) is a translational, product-focused funding opportunity aimed at moving a specific prostate cancer "lead agent" from late-stage laboratory development into the preclinical package needed for first-in-human testing. Run by the Department of the Army through USAMRAA under the Military Medical Research and Development program (CFDA 12.420), this mechanism is meant for principal investigators who have a promising therapeutic or imaging agent but lack sufficient support to complete the pharmacology, toxicology, and related development steps that are typically required before submitting an FDA Investigational New Drug (IND) application. A key FY11 addition is that the award can also support current Good Manufacturing Practice (cGMP) production of the lead agent, recognizing that manufacturing readiness is often a major barrier to clinical translation.

This award is specifically designed for projects that are already past early discovery. Applicants are expected to come in with a validated biological target and either a single lead agent or a very small, well-justified set of lead candidates that can be narrowed to one through optimization work. The application needs preliminary data generated by the PI's laboratory or collaborating team that demonstrates the target is present and appropriately distributed in relevant human tissues, and that evidence from model systems supports the agent's potential efficacy in humans. The proposal also needs to include a statistical and analytical plan aligned with current FDA expectations, emphasizing that the work should be executed in a way that produces regulatory-relevant data rather than purely exploratory academic findings.

The types of studies supported are the practical, IND-enabling activities that help turn a lead into a real development candidate. Examples include comparative activity and efficacy testing used to optimize the agent and select a single lead from a limited library (with a strict requirement that this optimization decision work be completed within 12 months of the award start date, or the government may terminate the award), toxicology screening, pharmacokinetics and ADME studies (absorption, distribution, metabolism, and excretion), pharmacodynamic studies, and radiation dosimetry when relevant (for example, imaging or radiolabeled approaches). The award can also cover development and validation of assays and reagents needed to measure biological responses and molecular endpoints, but only when those assay efforts are directly tied to lead agent development. Another allowable direction is testing the lead agent in combination with agents already in clinical testing or standard practice, and, as noted, cGMP manufacturing of the lead agent can be supported.

Just as important, the announcement draws clear boundaries around what the LCTA will not fund. It is not intended for target discovery, broad drug screening campaigns, device development, or prevention agents. It also does not support mechanism of action studies as a primary aim, and it will not fund new combinations, formulations, or modifications of drugs that are already in clinical testing or clinical use (other than combining an existing clinical agent with the new lead agent). In other words, the mechanism is meant to accelerate a defined product toward IND readiness, not to underwrite earlier-stage science or major re-engineering of already clinical-stage drugs.

Because translation commonly requires multiple organizations and raises commercialization and ownership issues, the program places strong emphasis on intellectual property and freedom to operate. Investigators must disclose patents issued or pending, licenses issued or pending, and any known third-party patents that could block development. Applicants must also document access to any needed materials and rights (for example, via Material Transfer Agreements), and participating organizations are expected to remove institutional barriers that could slow or prevent collaborative development work. The award explicitly anticipates that supported agents should have strong potential for commercial licensing, since continued development and eventual clinical use will typically require significant investment beyond the period of DoD support.

A defining feature of the LCTA is the required transition plan. Applicants must explain, in concrete terms, how the product will move forward after the PCRP funding ends, including likely funding sources, development resources, and the path into clinical trials and/or market delivery. While clinical impact is the ultimate objective, clinical trials themselves are not allowed under this mechanism. Any project involving human subjects or human anatomical substances is only eligible if it qualifies for exempt or expedited review under the specified federal regulations (32 CFR 219.101(b)(4), 32 CFR 219.110, or 21 CFR 56.110), and proposals that do not meet those criteria will be administratively withdrawn. The announcement also points investigators toward a separate FY11 PCRP Clinical Trial Award if they need to run an actual interventional human study.

Administratively, the FY11 opportunity (Funding Opportunity Number W81XWH-11-PCRP-LCTA) was posted May 5, 2011, and closed September 1, 2011, with an archive date of October 1, 2011. The program anticipated around 2 awards with an estimated total funding of $2.4 million, did not require cost sharing, and was open to essentially any applicant organization type (unrestricted eligibility, subject to any clarifications in the full announcement). The award instrument is described as a cooperative agreement/grant, reflecting the expectation of close alignment with program goals and regulatory-quality development practices. For planning, the announcement also highlights NCI translational developmental pathway resources as a helpful framework for structuring milestone-driven projects that move from lead optimization through IND-enabling studies.

Overall, the LCTA is best understood as a bridge mechanism: it supports late preclinical development work for a clearly defined prostate cancer therapeutic or imaging agent, with the explicit aim of generating FDA-appropriate pharmacology/toxicology and/or cGMP manufacturing outputs, ensuring intellectual property readiness, and positioning the product for rapid continuation into formal clinical development after the award period.

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