DoD Prostate Cancer Laboratory Clinical Transition Award | Apply Online

Opportunity Summary:

The DoD Prostate Cancer Research Program (PCRP) Laboratory Clinical Transition Award (LCTA) is a funding opportunity from the Department of the Army (USAMRAA) designed to push promising prostate cancer lead agents through the critical late-preclinical steps needed to reach first-in-human testing. The award is explicitly product-driven and geared toward investigators who have a strong candidate therapeutic or imaging agent but do not have the support or infrastructure to complete the pharmacology and toxicology package typically required for a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application. In practical terms, the program is meant to help bridge the gap between an academically discovered agent and the kind of regulated, decision-quality data package that can justify moving toward clinical development.

A central requirement is that applicants come in with a validated biological target and either a single lead agent or a very small, well-justified set of candidate leads that can be optimized quickly. The application is expected to include preliminary data demonstrating that the target is present and appropriately distributed in relevant human tissues, along with substantive evidence from model systems suggesting the agent could be effective in humans. Applicants must also already have data supporting how the lead agent acts on the target; the award is not intended to fund exploratory mechanism-of-action work, but rather to capitalize on an established rationale and move into IND-enabling style studies.

The scope of work is focused on generating data needed for an IND submission prior to current Good Manufacturing Practice (cGMP) manufacturing of the agent. This boundary matters: the award supports development up to, but not including, cGMP production. Within that pre-cGMP window, appropriate projects can include comparative activity or efficacy studies to optimize and down-select to a single lead from a limited library of candidates, but these comparative/optimization studies must be completed within 12 months from the award start date. The announcement is unusually strict on this point, stating the government reserves the right to terminate the award if that 12-month milestone is not met. Other allowable activities include toxicology screening; pharmacokinetics (absorption, distribution, metabolism, excretion); pharmacodynamic studies; radiation dosimetry (when relevant, such as for imaging or radiolabeled agents); development and validation of assays and reagents needed to measure biological responses and molecular endpoints (only when tied directly to lead-agent development); and testing the lead agent in combination with agents already in clinical testing or standard practice.

Just as important, the announcement clearly outlines what is not supported. Projects should not propose target discovery, broad drug screening, device development, new combinations/formulations/modifications of agents already in clinical use (except combining an existing clinical agent with the new lead), mechanism-of-action studies, or prevention agents. Clinical trials are not allowed. Human subjects or human specimens can only be used if the work qualifies as exempt under 32 CFR 219.101(b)(4) or qualifies for expedited review under 32 CFR 219.110 or 21 CFR 56.110; proposals that require full board review outside those pathways are subject to administrative withdrawal. This structure keeps the program squarely in preclinical translational development rather than clinical experimentation.

Because late-stage preclinical development often requires collaboration across multiple labs, contractors, or specialized cores, the program also emphasizes intellectual property (IP) readiness and freedom to operate. Investigators must disclose issued or pending patents, licenses (granted or pending), and any known blocking patents that could hinder development. They must also document access and permission to use all necessary intellectual and material property (for example, through Material Transfer Agreements). Participating institutions are expected to actively resolve IP and material-sharing barriers so that the work can be completed on schedule, which aligns with the program’s emphasis on generating a commercially viable asset that can be licensed and further developed.

The scientific and regulatory expectations are framed around FDA standards. Applicants are expected to follow FDA guidance relevant to preliminary studies and data collection for an IND, and they must include statistical analysis plans that align with current FDA expectations. The announcement also points applicants to National Cancer Institute (NCI) translational research developmental pathways as a planning aid, reinforcing that proposals should look like a coherent translational package rather than a collection of disconnected experiments.

From an administrative standpoint, this FY10 opportunity (Funding Opportunity Number W81XWH-10-PCRP-LCTA) was offered as a discretionary cooperative agreement/grant in the Science and Technology / R&D category under CFDA 12.420 (Military Medical Research and Development). It projected about two awards with an estimated total funding of $2.4 million, had no cost sharing requirement, and was open to unrestricted applicant types (subject to any clarifications in the full announcement). Historically, the mechanism appeared highly competitive: since its introduction in FY07, 36 applications had been received and 6 recommended for funding at the time of the posting, signaling a strong preference for mature, well-justified lead agents with a realistic path to an IND-enabling package and eventual commercial licensing.

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