DoD Prostate Cancer Laboratory Clinical Transition Award | Apply Online

Frequently Asked Questions (FAQs) - DoD Prostate Cancer Laboratory Clinical Transition Award (LCTA)

What is the DoD Prostate Cancer Laboratory Clinical Transition Award (LCTA)?

The DoD Prostate Cancer Laboratory Clinical Transition Award (LCTA) is a U.S. Department of the Army funding opportunity administered through the Congressionally Directed Medical Research Programs (CDMRP) and USAMRAA. Its purpose is to move highly promising prostate cancer technologies out of the laboratory and toward real clinical use.

What is the main goal of this award?

The award is explicitly product-driven. Projects are expected to focus on developing a specific therapeutic lead agent (such as a drug candidate or biologic) or a medical device with a credible path to improving patient care, including progress toward a first-in-human setting when appropriate.

What kinds of projects are a fit for this opportunity?

This opportunity supports projects aimed at transitioning a prostate cancer therapeutic lead agent or a medical device from the laboratory toward clinical utility. The emphasis is on translational and preclinical work that helps position a candidate intervention for clinical use rather than purely exploratory research.

Does the program support preclinical and translational activities?

Yes. The LCTA is intended to support preclinical and translational activities that are often needed to advance a candidate intervention toward first-in-human readiness. This can include work extending through cGMP-related production when needed.

Is the award focused on basic science or product development?

The focus is product development. The opportunity is described as explicitly product-driven, prioritizing work that develops a specific therapeutic lead or device and demonstrates a credible clinical path, rather than exploratory or hypothesis-generating basic research.

For therapeutic lead agent applications, what must already be in place?

Applications centered on novel lead agents are expected to include several key elements: a validated biological target, access to a single lead agent or a small manageable set of leads suitable for optimization, and a mechanism of action that is understood well enough to justify advancement.

What does "target validation" mean in the context of this opportunity?

Based on the opportunity description, target validation means applicants must demonstrate that the proposed biological target is validated and supported well enough to justify advancing a specific therapeutic lead agent toward clinical transition.

How many lead agents should an application propose?

The opportunity expects applicants to have access to a single lead agent or a small, manageable set of leads that are suitable for optimization, rather than a large collection of early-stage candidates.

Is understanding the mechanism of action required for therapeutic projects?

Yes. For novel lead agent projects, the mechanism of action should be understood well enough to justify advancing the agent toward clinical transition.

What human-tissue evidence is expected for therapeutic lead agents?

The opportunity emphasizes providing preliminary evidence that the target is present and appropriately distributed in relevant human tissues, not only demonstrated in cell lines or animal models.

What type of supporting efficacy data is expected for therapeutic lead agents?

Applicants should provide substantive supporting data from model systems that credibly indicates the lead agent could be efficacious in humans. The program signals a preference for translational relevance over purely exploratory science.

How does the program define translational relevance?

From the information provided, translational relevance is reflected by evidence and data that credibly support potential human efficacy and clinical utility, including human-tissue relevance and model-system data that goes beyond exploratory findings.

What are the expectations for medical device applications?

For medical device-focused applications, the program expects meaningful readiness supported by preliminary data, including evidence of reliability and reproducibility and evidence of effectiveness for the intended use.

What does reliability and reproducibility mean for a device proposal?

In practice, it means the device should perform consistently, generate stable outputs, or function as designed across repeats and settings, with performance data supporting continued development toward clinical utility.

Does the LCTA require preliminary data for device proposals?

Yes. Device proposals are expected to include preliminary data demonstrating reliability, reproducibility, and effectiveness for the intended use.

What is the Funding Opportunity Number for this award?

The Funding Opportunity Number listed is W81XWH-12-PCRP-LCTA.

Which agencies administer or manage this opportunity?

The program is a U.S. Department of the Army effort administered through the Congressionally Directed Medical Research Programs (CDMRP) and USAMRAA.

What type of funding instrument is used?

The opportunity uses a cooperative agreement or grant structure, within the Science and Technology and other Research and Development category.

Was this a discretionary funding opportunity?

Yes. It was released as a discretionary program.

When was the opportunity posted and created?

The opportunity was posted and created on March 20, 2012.

What were the closing dates for submission?

The original closing date and the final closing date were both August 23, 2012.

When was the opportunity archived?

The archive date listed is September 22, 2012.

How much total funding was estimated to be available?

The estimated total funding available was $4,800,000.

How many awards were expected?

The opportunity indicated an expectation of making two awards.

Is cost sharing or matching required?

No. The opportunity states that no cost sharing or matching was required.

Who was eligible to apply?

Eligibility was described as unrestricted, meaning it was broadly open to different types of applicant organizations, subject to any additional eligibility clarifications included in the full announcement.

What is the CFDA number associated with this opportunity?

The CFDA listing associated with the opportunity was 12.420 (Military Medical Research and Development).

Who should be contacted for access issues related to the full announcement?

For access issues related to the full announcement, the contact listed was the CDMRP Help Desk at 301-682-5507.