Opportunity Information: Apply for W81XWH 14 PCRP BDA
Apply for W81XWH 14 PCRP BDA
- 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 Prostate Cancer Biomarker Development 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 6, 2014 and posted on May 6, 2014.
- Applicants must submit their applications by Sep 24, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,600,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 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 Prostate Cancer Biomarker Development Award (BDA) is a Prostate Cancer Research Program (PCRP) funding opportunity designed to push already identified prostate cancer biomarkers across the gap from promising research findings to real clinical use. The core problem it targets is that, while many potential biomarkers have been reported over the past few decades, very few have been rigorously validated or qualified in ways that would support routine use in patient care, especially beyond single-institution studies. Because the field still relies heavily on prostate specific antigen (PSA) despite well-known limitations, this award focuses on near-term, high-impact work that can deliver clinically actionable tests that improve how prostate cancer is detected, risk-stratified, and managed.
The award specifically supports large-scale, multi-institutional biomarker validation and/or qualification studies that inform major clinical decisions, such as identifying aggressive versus indolent disease, improving prognosis and progression assessment, and predicting or monitoring response to therapy. The intent is to produce biomarkers with better specificity for clinically meaningful prostate cancer, so fewer men are exposed to unnecessary biopsies and overtreatment, while clinicians gain better tools to tailor treatment intensity. Applicants are expected to clearly explain how the proposed work could change clinical practice in the near term and to show that the project has a strong path toward commercialization and broad clinical adoption. Clinical trials are allowed, which underscores the program's emphasis on moving beyond academic proof-of-concept and into evidence that can support deployment in health care settings.
A key boundary of this mechanism is what it will not fund. Projects centered on discovering new biomarkers, exploratory profiling of tissues or biofluids before readiness for large-scale validation, or refinement in model systems are considered outside scope. Instead, applicants must bring forward candidate biomarker(s) that already have supporting preliminary evidence and are ready for rigorous testing in appropriately designed human studies. In this announcement, "validation" is framed as demonstrating accurate and reliable measurement of the biomarker through a fit-for-purpose assay and performance characteristics (reproducibility, accuracy, and robustness across conditions). "Qualification" is framed as the evidentiary process showing the biomarker is fit for a specific clinical purpose by linking it to biological processes and/or clinical endpoints. In practical terms, applicants must show both that the biomarker can be measured reliably and that what it measures actually matters for patient outcomes or clinical decision-making.
The PCRP signals interest in a range of biomarker types, with an emphasis on noninvasive approaches when feasible. Biomarkers could come from biofluids like blood or urine, tissue-based assays where appropriate, or imaging-based markers, including molecular, physiologic, or immunologic imaging entities. Example categories mentioned include circulating tumor cells, genetic or epigenetic signatures, specific genes/proteins/metabolites, and imaging readouts. The program also highlights the importance of prostate tumor heterogeneity, encouraging applicants to directly address how intratumoral and interpatient variability could affect biomarker performance and how the study design will account for that complexity.
Multi-institutional collaboration is not optional under this mechanism; it is a requirement. Successful applications are expected to include independent patient cohorts and demonstrate that the validation/qualification effort is not confined to one site or one narrowly defined dataset. To support this structure, the award can accommodate up to three principal investigators, with one designated as the Initiating PI and others as Partnering PIs, each receiving a separate award. Teams are expected to explain how expertise across sites will integrate into a coordinated, synergistic plan rather than parallel, loosely connected work.
Another major expectation is leveraging existing resources to avoid redundant efforts and accelerate translation. Applicants are encouraged to build on established prostate cancer infrastructure such as biorepositories, epidemiologic cohorts, clinical databases and metadata resources, and existing transcriptomic/proteomic datasets. Examples cited include the Prostate Cancer Biorepository Network (PCBN) and the North Carolina-Louisiana Prostate Cancer Project (PCaP). Proposals should demonstrate that required specimens, data, and access to patient populations are already available so the project can begin immediately after award. The application should also reflect strong study design practices for tumor marker studies (for example, considering the Tumor Marker Utility Grading System and established reporting/design guidance like REMARK) and, where relevant, align with FDA biomarker validation/qualification guidance. The opportunity strongly encourages early interaction with the FDA so that FDA-driven milestones can be incorporated into the implementation plan.
Operationally, the application must include a detailed implementation plan with clear milestones, a robust statistical approach and appropriate statistical expertise, and a realistic strategy for translating results to patients in the near term. The research team section is expected to show tight coordination and communications, leadership experience in running large focused projects, and a plan for regular team meetings that includes participation by the assigned PCRP Science Officer. External scientific advisors are encouraged. Finally, for applications that advance to the later stage of programmatic review, the Initiating PI must deliver an in-person oral presentation to the PCRP Integration Panel as part of the final consideration process.
From the posted funding notice details, this opportunity (Funding Opportunity Number W81XWH-14-PCRP-BDA) was offered by the Department of the Army, USAMRAA, under the Military Medical Research and Development CFDA (12.420). It used a cooperative agreement/grant structure, did not require cost sharing, anticipated making one award, and listed an estimated total funding level of $3.6 million. The announcement was posted May 6, 2014, with an original and current closing date of September 24, 2014, and it was archived October 24, 2014. Eligibility was listed as unrestricted, meaning a wide range of organization types could apply, subject to any clarifications in the full eligibility text.
FAQs: DoD Prostate Cancer Biomarker Development Award (BDA)
What is the DoD Prostate Cancer Biomarker Development Award (BDA)?
The BDA is a Prostate Cancer Research Program (PCRP) funding opportunity intended to move already identified prostate cancer biomarkers from promising research findings into real clinical use. It focuses on near-term, high-impact work that can deliver clinically actionable tests to improve detection, risk stratification, and management of prostate cancer.
What problem is this award trying to solve?
The program targets the gap between the many prostate cancer biomarkers reported over past decades and the small number that have been rigorously validated or qualified for routine patient care, especially beyond single-institution studies. It also responds to the ongoing reliance on prostate specific antigen (PSA) despite PSA's well-known limitations.
What kinds of studies does the BDA support?
The BDA supports large-scale, multi-institutional biomarker validation and/or qualification studies designed to inform major clinical decisions. Examples include studies to distinguish aggressive versus indolent disease, improve prognosis and progression assessment, and predict or monitor response to therapy.
Are clinical trials allowed under this opportunity?
Yes. Clinical trials are allowed, reflecting the program's emphasis on generating evidence that supports deployment in health care settings rather than staying at academic proof-of-concept.
What is the intended clinical impact of projects funded by this award?
The intent is to produce biomarkers with better specificity for clinically meaningful prostate cancer so that fewer men undergo unnecessary biopsies and overtreatment, while clinicians gain better tools to tailor treatment intensity and decision-making.
Does the BDA fund discovery of new biomarkers?
No. Projects centered on discovering new biomarkers are outside the scope of this mechanism.
Are exploratory profiling studies supported (for example, early tissue or biofluid profiling)?
No. Exploratory profiling of tissues or biofluids that are not ready for large-scale validation is considered outside scope.
Does this award support refinement work in model systems?
No. Refinement in model systems is described as outside the scope of this funding mechanism.
What level of readiness is expected for the biomarker(s) proposed?
Applicants are expected to propose candidate biomarker(s) that already have supporting preliminary evidence and are ready for rigorous testing in appropriately designed human studies.
How does the announcement define "validation" for this award?
Validation is framed as demonstrating accurate and reliable measurement of the biomarker through a fit-for-purpose assay and performance characteristics such as reproducibility, accuracy, and robustness across conditions.
How does the announcement define "qualification" for this award?
Qualification is framed as the evidentiary process showing that a biomarker is fit for a specific clinical purpose by linking it to biological processes and/or clinical endpoints.
Do applicants need to address both measurement reliability and clinical relevance?
Yes. In practical terms, applicants are expected to show both that the biomarker can be measured reliably and that what it measures matters for patient outcomes or clinical decision-making.
What types of biomarkers are of interest to the PCRP in this award?
The PCRP signals interest in a range of biomarker types, with emphasis on noninvasive approaches when feasible. Biomarkers may come from biofluids (such as blood or urine), tissue-based assays where appropriate, or imaging-based markers including molecular, physiologic, or immunologic imaging entities.
What example biomarker categories are mentioned?
Examples mentioned include circulating tumor cells, genetic or epigenetic signatures, specific genes/proteins/metabolites, and imaging readouts.
Does the opportunity address prostate tumor heterogeneity?
Yes. The program highlights prostate tumor heterogeneity and encourages applicants to address how intratumoral and interpatient variability could affect biomarker performance and how the study design will account for that complexity.
Is multi-institutional collaboration required?
Yes. Multi-institutional collaboration is a requirement under this mechanism, not an optional feature.
What does "multi-institutional" mean in the context of this award?
Successful applications are expected to include independent patient cohorts and demonstrate that the effort is not confined to one site or a narrowly defined dataset.
How many principal investigators (PIs) can be included?
The award can accommodate up to three principal investigators, with one designated as the Initiating PI and others as Partnering PIs.
Do the Initiating PI and Partnering PIs receive separate awards?
Yes. Each PI can receive a separate award under the structure described.
How should teams describe collaboration across sites?
Teams are expected to explain how expertise across sites will integrate into a coordinated, synergistic plan rather than parallel, loosely connected work.
Are applicants expected to leverage existing specimens and datasets?
Yes. Applicants are encouraged to leverage established prostate cancer infrastructure such as biorepositories, epidemiologic cohorts, clinical databases and metadata resources, and existing transcriptomic/proteomic datasets to avoid redundant efforts and accelerate translation.
What existing resources are specifically cited as examples?
Examples cited include the Prostate Cancer Biorepository Network (PCBN) and the North Carolina-Louisiana Prostate Cancer Project (PCaP).
Do proposals need to show that specimens and data are already available?
Yes. Proposals should demonstrate that required specimens, data, and access to patient populations are already available so the project can begin immediately after award.
What kinds of study design and reporting practices are encouraged?
The application is expected to reflect strong study design practices for tumor marker studies, including consideration of the Tumor Marker Utility Grading System and established reporting/design guidance such as REMARK.
Is alignment with FDA biomarker guidance mentioned?
Yes. Where relevant, proposals are encouraged to align with FDA biomarker validation/qualification guidance.
Is early interaction with the FDA encouraged?
Yes. The opportunity strongly encourages early interaction with the FDA so that FDA-driven milestones can be incorporated into the implementation plan.
What must be included in the application from an execution and planning standpoint?
The application must include a detailed implementation plan with clear milestones, a robust statistical approach supported by appropriate statistical expertise, and a realistic strategy for translating results to patients in the near term.
What expectations are described for the research team structure and management?
The research team section is expected to show tight coordination and communications, leadership experience in running large focused projects, and a plan for regular team meetings that includes participation by the assigned PCRP Science Officer.
Are external scientific advisors allowed or encouraged?
External scientific advisors are encouraged.
Is there an oral presentation requirement during the review process?
Yes. For applications that advance to the later stage of programmatic review, the Initiating PI must deliver an in-person oral presentation to the PCRP Integration Panel as part of final consideration.
What is the Funding Opportunity Number for this BDA?
The Funding Opportunity Number is W81XWH-14-PCRP-BDA.
Which agency offered this funding opportunity?
This opportunity was offered by the Department of the Army, USAMRAA.
What CFDA program is associated with this opportunity?
It is associated with the Military Medical Research and Development CFDA (12.420).
What type of funding mechanism was used?
The notice describes a cooperative agreement/grant structure.
Was cost sharing required?
No. The funding notice states that cost sharing was not required.
How many awards were anticipated?
The notice anticipated making one award.
What was the estimated total funding level?
The estimated total funding level was $3.6 million.
When was the opportunity posted and when did it close?
The announcement was posted May 6, 2014, and listed an original and current closing date of September 24, 2014.
Is this opportunity currently open?
No. The notice indicates the opportunity was archived October 24, 2014.
Who was eligible to apply based on the notice summary?
Eligibility was listed as unrestricted, meaning a wide range of organization types could apply, subject to any clarifications in the full eligibility text.
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