Opportunity Information: Apply for W81XWH 13 PCRP LCTA
Apply for W81XWH 13 PCRP LCTA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD FY13 Prostate Cancer Laboratory Clinical Transition Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on May 13, 2013 and posted on May 13, 2013.
- Applicants must submit their applications by Oct 9, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,800,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The DoD FY13 Prostate Cancer Research Program (PCRP) Laboratory-Clinical Transition Award (LCTA) is a translational funding opportunity meant to push a prostate cancer product from late-stage preclinical development toward first-in-human testing. It was created to help principal investigators who have a promising therapeutic, imaging agent, or medical device in hand but do not yet have the resources to complete the specific preclinical work needed for an FDA submission and a realistic path into the clinic. The program is explicitly product-driven, meaning the end goal is not basic discovery, but a defined candidate that can move into an Investigational New Drug (IND) application for drugs/biologics or an Investigational Device Exemption (IDE) pathway for devices, along with steps like current Good Manufacturing Practice (cGMP) production when appropriate. Historically, the mechanism has been very selective (introduced in FY07, with 95 applications received and 12 recommended for funding at the time of this announcement), and FY13 anticipated only about two awards from an estimated total funding pool of roughly $4.8 million.
The opportunity supports two major types of projects. First are “lead agent” projects, where applicants should already have a validated biological target and should have already identified a single lead agent or, at most, a small set of closely related candidates that can be quickly narrowed down. The expectation is that funded work will generate the kind of pharmacology and toxicology package needed for an IND and/or support cGMP manufacturing steps. Lead agents can include novel therapeutic or imaging modalities such as new chemotherapeutics, antibodies, nanoparticles, or imaging contrast agents, as long as they are positioned as clinically relevant products for prostate cancer. Second are “medical device” projects, where the preclinical work is aimed at demonstrating safety and effectiveness in a way that supports an IDE submission and/or cGMP production of the device. Device examples include diagnostic or prognostic tests (including microfluidic or genomic/genetic microarray-based platforms), imaging devices, and other medical technologies, provided the project is beyond early-stage invention and is ready for rigorous preclinical validation.
A central requirement is that applicants bring solid preliminary evidence. The announcement stresses strong scientific rationale plus data that connect the product to human relevance: documentation that the target is available and appropriately distributed in relevant human tissues, and substantive model-system results that support potential efficacy in humans. For devices and, where relevant, agents, preliminary results should also speak to reliability, reproducibility, and performance characteristics such as sensitivity and specificity. Applications are also expected to include a statistical and analytical plan when applicable, and those plans should align with current FDA guidance, underscoring that the award is designed around regulatory-grade evidence rather than exploratory lab work.
The award strongly emphasizes commercialization and post-award continuity. Products supported by the LCTA are expected to have high potential for commercial licensing and continued development, so each application must include a clear transition plan describing how the work will move into clinical trials and/or toward market delivery after the PCRP funding period ends. The program encourages teams to leverage outside resources, particularly commercial partners, to strengthen the translation pathway. While cost sharing is not required, applications that include cost sharing with commercial partners are described as particularly encouraged, signaling that reviewers may view industry alignment and realistic downstream financing as major strengths.
In terms of what the award will fund, the scope is focused on late preclinical, IND/IDE-enabling activities. Allowable studies include comparative activity testing to optimize a lead agent or select a final candidate from a limited library, with a firm timing constraint: that down-selection work must be completed within 12 months of the award start date, and failure to finalize a lead agent within that window can lead to termination of the award. Other supported activities include toxicology screening; pharmacokinetics (absorption, distribution, metabolism, excretion); pharmacodynamic studies; radiation dosimetry (where relevant, such as radiolabeled imaging or therapeutics); preclinical safety and effectiveness testing of medical devices; development and validation of assays and reagents needed to measure biological responses and molecular endpoints (but only when tied directly to lead agent development); testing the lead agent in combination with agents already in clinical testing or standard practice; and cGMP production of the lead agent or device.
Equally important, the announcement is clear about what is out of bounds because it does not fit a late translational objective. The LCTA will not support target discovery, broad drug screening, early development of medical devices, or general mechanism-of-action studies as a primary aim. It also excludes new combinations, formulations, or modifications of agents that are already in clinical testing or practice, except when those established agents are used specifically in combination with the new lead agent being advanced under the award. Prevention agents are also listed as not supported. In other words, the mechanism is designed for teams that have already done the foundational science and now need to complete the “regulatory homework” required to cross the preclinical-to-clinical threshold.
Administratively, this FY13 opportunity was issued by the Department of the Army (USAMRAA) under Funding Opportunity Number W81XWH-13-PCRP-LCTA. It was posted May 13, 2013, with an original and current closing date of October 9, 2013, and it was later archived on November 8, 2013. The funding instrument is listed as a cooperative agreement/grant under a research and development category, with CFDA 12.420 (Military Medical Research and Development). Eligibility was described as unrestricted (open to any entity type, subject to any specific clarifications in the full announcement), and no cost-sharing or matching requirement was imposed, even though partner cost sharing is encouraged as a competitiveness factor. For access issues, the announcement directs applicants to the CDMRP Help Desk (301-682-5507).
FAQs: DoD FY13 Prostate Cancer Research Program (PCRP) Laboratory-Clinical Transition Award (LCTA)
What is the purpose of the PCRP Laboratory-Clinical Transition Award (LCTA)?
The LCTA is a translational funding opportunity designed to move a prostate cancer product from late-stage preclinical development to the point where it is ready for first-in-human testing. It specifically supports the preclinical work needed to prepare for an FDA regulatory submission (IND for drugs/biologics or IDE for devices) and a realistic pathway into clinical use.
Is this award intended for basic research or discovery?
No. The LCTA is explicitly product-driven. It is not meant for basic discovery or exploratory laboratory research; it is intended to advance a defined therapeutic, imaging agent, or medical device toward regulatory-ready, clinic-oriented milestones.
What types of products can be supported under this award?
The opportunity supports prostate cancer products in two broad categories: (1) lead agent projects (therapeutics or imaging agents) and (2) medical device projects (including diagnostics/prognostics and imaging technologies) that are beyond early invention and ready for rigorous preclinical validation.
What are “lead agent” projects under the LCTA?
Lead agent projects are those where the applicant already has a validated biological target and has identified a single lead agent, or at most a small set of closely related candidates that can be quickly narrowed down. The funded work is expected to generate an IND-enabling package (for example, pharmacology/toxicology data and, when appropriate, cGMP manufacturing steps).
What are examples of lead agents that may be appropriate?
Examples mentioned include novel therapeutic or imaging modalities such as new chemotherapeutics, antibodies, nanoparticles, or imaging contrast agents, provided they are positioned as clinically relevant products for prostate cancer and aligned with IND-enabling development.
What are “medical device” projects under the LCTA?
Medical device projects focus on preclinical work intended to demonstrate safety and effectiveness in a way that supports an IDE submission and/or cGMP production of the device. The device should be beyond early-stage invention and ready for rigorous preclinical validation.
What types of medical devices are included as examples?
The announcement gives examples including diagnostic or prognostic tests (including microfluidic or genomic/genetic microarray-based platforms), imaging devices, and other medical technologies that are sufficiently mature for late preclinical validation.
What regulatory pathway is the program designed to support?
The LCTA is designed to support the activities needed for an FDA submission, including an Investigational New Drug (IND) application for drugs/biologics or an Investigational Device Exemption (IDE) pathway for devices. It also references current Good Manufacturing Practice (cGMP) production when appropriate.
What kind of preliminary evidence is required?
Applications are expected to include strong scientific rationale and solid preliminary evidence linking the product to human relevance. This includes documentation that the target is available and appropriately distributed in relevant human tissues, and substantive model-system results supporting potential efficacy in humans.
Are there specific expectations for device performance data in the preliminary evidence?
Yes. For devices and, where relevant, agents, preliminary results should address reliability, reproducibility, and performance characteristics such as sensitivity and specificity.
Does the application need a statistical and analytical plan?
Yes, when applicable. Applications are expected to include a statistical and analytical plan aligned with current FDA guidance, reflecting the award’s emphasis on regulatory-grade evidence rather than exploratory studies.
What kinds of studies and activities can the LCTA fund?
The award focuses on late preclinical, IND/IDE-enabling work. Allowable activities described include comparative activity testing for lead optimization or down-selection, toxicology screening, pharmacokinetics (ADME), pharmacodynamic studies, radiation dosimetry (when relevant), preclinical safety and effectiveness testing of medical devices, assay/reagent development and validation tied directly to lead agent development, combination testing with agents already in clinical testing or standard practice (as combinations with the new lead agent), and cGMP production of the lead agent or device.
Is lead optimization or candidate down-selection allowed?
Yes, but with a strict requirement: if comparative activity testing is used to optimize or select a final candidate from a limited library, the down-selection must be completed within 12 months of the award start date.
What happens if a lead agent is not finalized within 12 months?
The announcement states that failure to finalize a lead agent within that 12-month window can lead to termination of the award.
Does the award support cGMP manufacturing?
Yes. The LCTA includes cGMP production of the lead agent or device as an allowable activity when appropriate, consistent with preparing for IND/IDE-enabling development.
Can the award support combination studies?
Yes. Testing a new lead agent in combination with agents already in clinical testing or standard practice is listed as an allowable activity, provided the established agents are being used specifically in combination with the new lead agent being advanced under the award.
What kinds of projects or activities are explicitly not supported?
The LCTA will not support target discovery, broad drug screening, early development of medical devices, or general mechanism-of-action studies as a primary aim. It also excludes new combinations, formulations, or modifications of agents already in clinical testing or practice (except where those established agents are used specifically in combination with the new lead agent being advanced). Prevention agents are also not supported.
Is the award aimed at early-stage device invention?
No. Early development of medical devices is listed as out of scope. Device projects must be beyond early-stage invention and ready for rigorous preclinical safety/effectiveness testing that supports an IDE pathway and/or cGMP production.
How important is commercialization and post-award continuation?
Commercialization and continuity are emphasized strongly. Products supported by the LCTA are expected to have high potential for commercial licensing and continued development, and applications must include a clear transition plan explaining how the work will move into clinical trials and/or toward market delivery after the PCRP funding period ends.
Is a transition plan required?
Yes. Each application must include a transition plan describing how the product will progress into clinical trials and/or toward market delivery after the LCTA funding period.
Are commercial partners encouraged?
Yes. The program encourages leveraging outside resources, particularly commercial partners, to strengthen the translation pathway and demonstrate realistic downstream financing and development.
Is cost sharing or matching required?
No. The opportunity states that no cost-sharing or matching requirement is imposed.
If cost sharing is not required, can it still help an application?
Yes. While not required, cost sharing with commercial partners is described as particularly encouraged, indicating that partner alignment and shared investment may be viewed as a competitive strength.
How selective is this funding mechanism?
Historically, it has been very selective. The announcement notes that the mechanism was introduced in FY07 and, at the time of this announcement, had received 95 applications with 12 recommended for funding. For FY13, it anticipated making about two awards.
What is the estimated total funding pool for FY13?
The estimated total funding pool for FY13 was roughly $4.8 million, with about two awards anticipated.
Who issued this funding opportunity?
The FY13 LCTA opportunity was issued by the Department of the Army (USAMRAA) under the DoD Prostate Cancer Research Program (PCRP).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is W81XWH-13-PCRP-LCTA.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 12.420 (Military Medical Research and Development).
What kind of award instrument is used?
The funding instrument is listed as a cooperative agreement/grant under a research and development category.
Who is eligible to apply?
Eligibility is described as unrestricted (open to any entity type), subject to any specific clarifications in the full announcement.
When was this opportunity posted and when did it close?
It was posted on May 13, 2013. The original and current closing date was October 9, 2013.
Was this opportunity archived?
Yes. The announcement indicates it was archived on November 8, 2013.
Where can applicants get help with access issues?
The announcement directs applicants to the CDMRP Help Desk at 301-682-5507 for access issues.
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