Opportunity Information: Apply for W81XWH 16 LCRP IITRA

  • The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Lung Cancer Research Program Investigator-Initiated Translational Research Award" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
  • This funding opportunity was created on Apr 11, 2016 and posted on Apr 11, 2016.
  • Applicants must submit their applications by Sep 14, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The number of recipients for this funding is limited to 4 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.
Apply for W81XWH 16 LCRP IITRA

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Opportunity Summary:

The DoD Lung Cancer Research Program (LCRP) Investigator-Initiated Translational Research Award (IITRA) is a U.S. Department of Defense funding opportunity designed to push promising lung cancer ideas beyond the discovery stage and closer to real-world clinical use. Its core focus is translational research, meaning work that deliberately connects basic science (such as molecular biology, genetics, pharmacology, or model systems) with clinical observations (such as patient outcomes, tumor behavior in the clinic, trial findings, or clinician-identified unmet needs). The program is aiming for projects that do more than generate interesting biology; it wants research that meaningfully positions a concept, tool, or intervention to be used in patients, clinical decision-making, or clinical trials.

A defining feature of this award is that translational research is not treated as a simple one-direction pipeline from "bench to bedside." Applicants are expected to build a research plan that shows a two-way, iterative exchange between laboratory and clinical domains. In practice, that means clinical realities should shape laboratory experiments, and laboratory results should feed back into clinically relevant hypotheses, patient stratification approaches, biomarkers, or trial-ready strategies. The most competitive projects under this mechanism are typically those that can clearly describe how patient-derived information, clinical samples, or trial context will influence the science, and how the science will return value to clinical care, trial design, or patient selection.

The IITRA mechanism is intended to support a wide range of translational activities. Examples explicitly encouraged include projects that take findings from in vitro systems and/or animal models and advance them into applications that involve human samples or human cohorts, such as validating a target, biomarker, or mechanism in patient-derived tissues, blood, or clinical datasets. Another major category is late-stage preclinical development work that directly prepares for a clinical trial. This can include the kinds of studies and documentation needed to move an intervention toward first-in-human testing, including work that supports an Investigational New Drug (IND) application submission. The opportunity also highlights correlative and endpoint-development research tied to clinical trials. That includes studies that leverage an ongoing or completed trial to analyze biomarkers, resistance mechanisms, immune responses, or predictors of response, as well as projects that develop or refine measurable endpoints that can be used in future lung cancer trials.

While the program is translational and clinically oriented, it still requires preliminary data demonstrating that the central hypothesis and proposed approach are feasible. An important flexibility point is that the preliminary evidence does not have to come specifically from lung cancer studies, as long as it credibly supports the rationale and feasibility of the lung cancer translation being proposed. This allows investigators with strong mechanistic or platform data in related cancers or biological systems to propose a lung cancer application, provided the pathway to relevance is well justified and the plan includes the necessary steps to validate and translate into the lung cancer setting.

Administratively, the opportunity was offered by DOD-AMRAA under Funding Opportunity Number W81XWH-16-LCRP-IITRA and categorized as discretionary research funding in the science and technology/research and development area (CFDA 12.420). The funding instruments listed include both cooperative agreements and grants, indicating that some awards may involve more active programmatic involvement by the funding agency depending on the specific mechanism used. Eligibility is described as unrestricted, meaning a broad range of applicant organizations could apply (subject to any clarifications provided in the full announcement). The posting date was April 11, 2016, with an application closing date of September 14, 2016, and the solicitation anticipated making approximately four awards. The announcement lists an award ceiling field but does not provide a value in the provided text, so the maximum budget would have been specified in the full funding announcement or associated program guidance.

Overall, this award is best understood as a targeted push for lung cancer projects that are ready to be translated: studies with a clear clinical destination, a concrete plan to bridge lab and clinic in an iterative way, and enough supporting evidence to show the work can realistically move toward clinical application, trial readiness, or clinically meaningful endpoints.

FAQs: DoD Lung Cancer Research Program (LCRP) Investigator-Initiated Translational Research Award (IITRA)

What is the IITRA funding opportunity?

The DoD Lung Cancer Research Program (LCRP) Investigator-Initiated Translational Research Award (IITRA) is a U.S. Department of Defense funding opportunity intended to move promising lung cancer concepts beyond discovery and closer to real-world clinical use. The emphasis is on translational research that connects laboratory science with clinical observations and needs.

What is the main goal of this award?

The main goal is to support lung cancer research that does more than generate new biology. Projects are expected to position a concept, tool, biomarker, or intervention for use in patients, clinical decision-making, or clinical trials, with a clear clinical destination.

What does "translational research" mean in this program?

In this program, translational research means deliberately linking basic science (for example molecular biology, genetics, pharmacology, or model systems) to clinical observations (for example patient outcomes, tumor behavior in the clinic, trial findings, or clinician-identified unmet needs) in a way that advances the work toward clinical application.

Does the program view translation as only "bench to bedside"?

No. A defining feature is that translation is expected to be two-way and iterative. Clinical realities should shape lab experiments, and lab findings should feed back into clinically relevant hypotheses, biomarkers, patient stratification approaches, or trial-ready strategies.

What makes an application especially competitive under this mechanism?

The most competitive projects are typically those that clearly describe (1) how patient-derived information, clinical samples, or trial context will influence the scientific work, and (2) how the scientific results will return value to clinical care, trial design, or patient selection.

What types of projects are explicitly encouraged?

Examples explicitly encouraged include: (1) advancing findings from in vitro systems and/or animal models into applications involving human samples or human cohorts; (2) validating a target, biomarker, or mechanism in patient-derived tissues, blood, or clinical datasets; (3) late-stage preclinical development work that directly prepares for a clinical trial, including work supporting an Investigational New Drug (IND) application submission; and (4) correlative and endpoint-development research tied to clinical trials.

Can projects use human samples or clinical datasets?

Yes. The opportunity highlights moving work into human-relevant contexts, such as validation using patient-derived tissues, blood, or clinical datasets, and projects involving human samples or cohorts as part of the translational pathway.

Does the award support research that prepares for clinical trials?

Yes. A major category described is late-stage preclinical development work that directly prepares for a clinical trial, including studies and documentation that support moving an intervention toward first-in-human testing and work that supports an IND application submission.

What is meant by correlative and endpoint-development research tied to clinical trials?

This refers to studies that leverage an ongoing or completed clinical trial to analyze biomarkers, resistance mechanisms, immune responses, or predictors of response, as well as projects that develop or refine measurable endpoints that could be used in future lung cancer trials.

Is preliminary data required?

Yes. The program requires preliminary data demonstrating that the central hypothesis and proposed approach are feasible.

Does the preliminary data have to come from lung cancer studies?

No. The opportunity states that preliminary evidence does not have to be specifically from lung cancer, as long as it credibly supports the rationale and feasibility of the lung cancer translation being proposed. The application is still expected to justify relevance to lung cancer and include steps to validate and translate into the lung cancer setting.

Can investigators bring in data from related cancers or other biological systems?

Yes. The program allows investigators with strong mechanistic or platform data in related cancers or biological systems to propose a lung cancer application, provided the pathway to lung cancer relevance is well justified and the plan includes the necessary validation and translation steps.

What agency offered this opportunity?

The opportunity was offered by DOD-AMRAA (U.S. Department of Defense) as part of the Lung Cancer Research Program.

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number listed is W81XWH-16-LCRP-IITRA.

How is this funding categorized?

It is categorized as discretionary research funding in the science and technology/research and development area, with CFDA 12.420.

What funding instruments are available (grant vs. cooperative agreement)?

The funding instruments listed include both cooperative agreements and grants. This indicates that some awards may involve more active programmatic involvement by the funding agency, depending on the specific mechanism used.

Who is eligible to apply?

Eligibility is described as unrestricted, meaning a broad range of applicant organizations could apply, subject to any clarifications provided in the full announcement.

When was the opportunity posted and when did it close?

The posting date was April 11, 2016, and the application closing date was September 14, 2016.

How many awards were anticipated?

The solicitation anticipated making approximately four awards.

What is the maximum award amount (award ceiling)?

An award ceiling field is referenced, but no value is provided in the information given here. The maximum budget would have been specified in the full funding announcement or associated program guidance.

What kinds of outcomes is the program trying to achieve?

The program is aiming for lung cancer projects that are ready to be translated, with enough supporting evidence and a concrete plan to move toward clinical application, clinical trial readiness (including IND-supporting steps where relevant), or clinically meaningful endpoints that can be used in trials.

What should applicants emphasize in the research plan, based on the description provided?

Applicants should emphasize a deliberate bridge between lab and clinic that works in both directions: how clinical needs and observations inform experiments, and how experimental results will feed back into clinical hypotheses, biomarkers, patient stratification, trial-ready strategies, clinical decision-making, or endpoint development.

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