DoD Prostate Cancer Laboratory Clinical Transition Award | Apply Online

FAQs: DoD Prostate Cancer Research Program (PCRP) Laboratory Clinical Transition Award (LCTA)

What is the PCRP Laboratory Clinical Transition Award (LCTA)?

The LCTA is a translational funding opportunity from the DoD Prostate Cancer Research Program designed to move a prostate cancer-related product from the laboratory toward clinical use. It focuses on generating the data and deliverables typically needed for next regulatory and commercialization steps (for example, preparing for FDA submissions and real-world clinical adoption).

What kinds of products can be supported under this award?

The opportunity supports late-stage preclinical development of: (1) a promising lead therapeutic or imaging agent, (2) a medical device, with the explicit intent of advancing toward the clinic in prostate cancer.

What does “product-driven” development mean in the context of this award?

It means the work should be centered on a defined candidate product (a lead agent or device) and on producing practical development outputs that reduce risk and support regulatory/commercial next steps, rather than open-ended scientific discovery.

How competitive has this mechanism been historically?

Since its introduction in FY07, the program has been highly competitive, with 114 applications received and 13 recommended for funding.

What stage should a lead therapeutic or imaging agent be at for the LCTA?

Applicants are expected to have a validated biological target and at least one defined lead candidate (or a very small set of candidates requiring limited optimization). The emphasis is on late-stage preclinical development work that supports an FDA Investigational New Drug (IND) submission and/or enables production under current Good Manufacturing Practice (cGMP).

How does the announcement define “lead agents”?

Lead agents are defined broadly as novel biologic, molecular, or chemical therapeutic or imaging agents with potential clinical application in prostate cancer. Examples mentioned include new chemotherapeutics, antibodies, nanoparticles, imaging contrast agents, and similar technologies.

What kinds of preliminary evidence are expected for a lead agent?

The LCTA expects solid preliminary evidence about how the agent works, plus data demonstrating reliability, reproducibility, and effectiveness. Where relevant, performance characteristics such as sensitivity and specificity should be included. Applicants are also expected to provide evidence that the target is available and appropriately distributed in relevant human tissues, and model-system evidence that increases confidence in human relevance is encouraged.

What stage should a medical device be at for the LCTA?

The award supports preclinical testing intended to lead to an FDA Investigational Device Exemption (IDE) application and/or cGMP production readiness. The device should already have enough preliminary data to justify a clinical transition-focused development plan.

What types of medical devices are in scope?

Devices can include diagnostic or prognostic platforms (for example microfluidic systems or genomic/genetic microarray devices), imaging devices, and other medical technologies relevant to prostate cancer care.

What kinds of preliminary evidence are expected for a medical device?

Applicants should provide preliminary data indicating the device is reliable, reproducible, and effective (including sensitivity and specificity when appropriate). If the device depends on a biological target, applicants should address target availability and distribution in human tissues. Model-system evidence supporting likely human utility is encouraged.

What is the central goal of the LCTA?

The central goal is to bridge the gap between compelling early scientific results and the practical package of data and deliverables needed to move toward FDA submission and clinical adoption.

Is a transition plan required?

Yes. The application must include a transition plan explaining how the product will advance after the PCRP-funded work ends, including funding sources, partnerships, and resources to reach the next phase (such as first-in-human studies, clinical trials, and/or steps toward market delivery).

Does the program expect commercialization potential?

Yes. A central expectation is that the supported agent or device has credible potential for commercial licensing and continued development beyond the award period.

Are commercial partners encouraged?

Yes. The program explicitly encourages leveraging commercial partners and existing development infrastructure.

Is cost sharing required?

No. There was no stated cost sharing or matching requirement. However, applications demonstrating cost sharing with commercial partners are viewed favorably.

What kinds of studies are examples of a good fit for this mechanism?

Examples provided include comparative activity testing to optimize and down-select a single lead agent from a limited set of candidates, toxicology screening, pharmacokinetic studies (absorption, distribution, metabolism, excretion), pharmacodynamic studies, radiation dosimetry (when relevant), and preclinical safety/effectiveness testing of medical devices.

Is there a time limit for down-selecting a lead agent?

Yes. If comparative activity testing is proposed to down-select a single lead agent from a limited set, there is a strict expectation that down-selection be completed within 12 months of the award start, or funding restrictions may occur.

Can the award support assay and reagent development?

Yes, but with limits. The award can support development and validation of assays and reagents needed to measure biological responses and molecular endpoints, but only when proposed alongside lead agent development.

Can the award support cGMP production activities?

Yes. The LCTA supports cGMP production activities for either the lead agent or the medical device.

Can a lead agent be tested in combination with other agents?

Yes. The award allows testing a lead agent in combination with agents already in clinical testing or standard practice.

What types of projects are explicitly out of scope?

The LCTA is not meant for early discovery or exploratory work. Activities called out as outside scope include target discovery, broad drug screening, early-stage medical device development, and mechanism-of-action studies (because a sufficiently developed understanding is expected for a true clinical transition effort).

Are prevention-focused proposals encouraged?

No. The announcement discourages proposals focused on prevention agents.

Can applicants propose new formulations or modifications of agents already in clinical testing or practice?

No. The opportunity does not support creating new formulations, new combinations, or modifications of agents already in clinical testing or practice, except where an already-established clinical agent is being paired with the proposed lead agent as part of the transition strategy.

What are the expectations around intellectual property (IP) and freedom to operate?

The opportunity places strong emphasis on IP readiness and freedom to operate. Applicants must disclose any issued or pending patents and any existing or pending licenses tied to the lead agent or device, as well as any known third-party patents that could block development.

What documentation is required to show access to materials and IP?

Applicants must provide documentation (such as Material Transfer Agreements and/or licensing agreements) demonstrating access to and permission to use all necessary materials and IP.

How should multi-institution projects handle IP and material access challenges?

Participating organizations are expected to be prepared to resolve IP and material access issues and remove organizational barriers that could disrupt coordination needed to complete the work.

Which agency released this funding opportunity?

The opportunity was released by the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under the DoD Prostate Cancer Research Program (PCRP).

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is W81XWH-14-PCRP-LCTA.

What type of funding instrument was used?

This opportunity used a cooperative agreement grant instrument.

What category and CFDA number were associated with this opportunity?

The category was Science and Technology / Research and Development, and the CFDA number was 12.420.

What were the key dates for this opportunity?

The posting date was May 30, 2014. The original and current closing date was October 29, 2014. The archive date was November 28, 2014.

How much total funding was estimated, and how many awards were expected?

The estimated total funding amount was $4.8 million, with an expectation of making about two awards.

Who was eligible to apply?

Eligibility was described as unrestricted (open to any type of entity), subject to any additional eligibility clarifications in the full announcement.

Where could applicants get help accessing the full announcement?

For access issues with the full announcement, applicants were directed to the CDMRP Help Desk at 301-682-5507.

Does the opportunity suggest any planning framework for translational development?

Yes. Applicants were pointed to National Cancer Institute translational development pathways as a helpful framework for planning studies across the development continuum.