Funding Wizard

The IIRA supports highly rigorous, high-impact research projects that have the potential to make an important contribution to MS research and/or patient care. Research projects may focus on any phase of research, excluding clinical trials. The rationale for a research idea may be derived from laboratory discovery, clinical trial results, population-based studies, a clinician’s firsthand knowledge of patients, or anecdotal data. Applications must include preliminary and/or published data that are relevant to MS and the proposed research project.

The intent of the FY22 CPMRP TRA is to support translational research that will accelerate the movement of evidence-based ideas in chronic pain management research into clinical applications, such as healthcare products, technologies, clinical practice guidelines, and/or models of care. TRA applications should explain how the proposed work will inform the development, refinement, and/or revision of existing standards of care, recommendations, or guidelines for managing chronic pain. Studies seeking to advance new and novel opioid-based therapeutic interventions do not meet the intent of the award mechanism and will not be selected for funding. Studies seeking to understand and reduce opioid utilization in chronic pain management within the context of current prescribing practices are acceptable.

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are: Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a new approach that is fundamentally better than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Research Scope: The Breakthrough Award is structured with four different funding levels. The levels are designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research. The funding level should be selected based on the research scope defined in the program announcement, and not on the amount of the budget. The current program announcement discusses the Breakthrough Award Levels 1 and 2. Funding Levels 3 and 4 are available under other program announcements (W81XWH-22-BCRP-BTA3-2 and W81XWH-22-BCRP-BTA4-2, respectively). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcement before submitting the pre-application. An application that does not meet the intent of the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level. The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current program announcement: · Funding Level 1: Innovative, high-risk/high-reward research that is in the earliest stages of idea development or is an untested theory that addresses an important problem. To foster research that yields new avenues of investigation, preliminary data are not required. Proof of concept is the anticipated outcome. · Funding Level 2: Research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the breast cancer landscape. · Funding Level 2: Population Science and Prevention Studies: Research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the breast cancer landscape. With compelling justification, population science and prevention studies may request higher levels of funding and an additional year in the period of performance. Such studies may require additional resources due to the participation of human subjects and/or use of human biospecimens. Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. New partnerships are encouraged, but not required. The application is expected to describe how the PIs’ unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Levels 1 and 2 applications unless they are clearly addressing distinct research questions. Applications in which a mentor and their current postdoctoral fellow or junior investigator are named as Initiating and Partnering PIs do not meet the intent of the Partnering PI Option. Applications where one PI is providing samples, animal models, or investigational agents while the other PI is conducting most or all of the experiments and analyses do not meet the intent of the Partnering PI Option. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission. Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project.

The FY22 TERP IIRA is intended to support studies that will make an important contribution toward research and/or patient care for a disease or condition related to toxic exposures. Research projects may focus on any phase of research from basic laboratory research through translational research, including preclinical studies in animal models and human subjects, as well as correlative studies associated with an existing clinical trial. New Approach Methodologies may also be used.Impact: The application should explicitly state how the proposed research will have a significant impact on toxic exposure research and/or patient care with the intent to transition outcomes into clinical practice for Service Members, Veterans, and/or the American public who have been, or could potentially be, impacted by toxic exposures. State both the short- and long-term impacts and how the proposed research will ultimately lead to new treatments/therapeutics, diagnostic assays, or prevention strategies to improve the quality of life for those that have been impacted by, or are likely to encounter, toxic substances.Applications should clearly demonstrate the project’s potential near-term and long-term outcome(s)/product(s) (intellectual knowledge and/or tangible materiel) and how they will impact a critical problem or question in the field of research and/or patient care in at least one of the FY22 TERP Program Goals and at least one of the FY22 TERP Topic Areas addressed.Preliminary data are required. The rationale for a research idea may be derived from laboratory discovery, population-based studies, a clinician’s firsthand knowledge of patients, or anecdotal data. Applications must include relevant preliminary data that support the rationale for the proposed study. These data may be unpublished or from published literature.Proposed research may be related to diseases, conditions, or symptoms supported by other CDMRP programs; however, TERP applications must be relevant to toxic exposures and be responsive to the FY22 TERP Program Goals and Topic Areas.

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are: Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a fundamentally new approach that is significantly more effective than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Research Scope: The Breakthrough Award is structured with four different funding levels. The levels are designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research. The funding level should be selected based on the research scope defined in the program announcement, and not on the amount of the budget. The current program announcement discusses the Breakthrough Award Level 4. Funding Levels 1, 2, and 3 are available under other program announcements (HT9425-23-BCRP-BTA12 for Levels 1 and 2 and HT9425-23-BCRP-BTA3 for Level 3). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcements before submitting the pre-application. An application that does not meet the intent of Funding Level 4 will not be recommended for funding, even if it might meet the intent of a different funding level. The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current program announcement: Funding Level 4: Large-scale projects that will transform and revolutionize the clinical management and/or prevention of breast cancer. Human clinical trials are required. PIs are expected to have experience in successfully leading large-scale projects and demonstrated ability (through personal experience or via a commitment from a collaborating clinical investigator) to implement a clinical project successfully. Where relevant, applications must demonstrate availability of and access to necessary data, human samples, cohort(s), and/or critical reagents. For proposed research that will require U.S. Food and Drug Administration (FDA) involvement, project readiness requirements at the time of application submission include: proof of availability of and access to clinical reagents (e.g., therapeutics) that meet regulatory compliance guidelines, proof of availability of and access to appropriate subject population(s), validated projections for patient recruitment, and submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA, if applicable. Funding from this award mechanism must support a clinical trial. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Documen…. PIs seeking funding for a research project other than a clinical trial should consider one of the other FY23 BCRP program announcements being offered. Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials. For the purposes of this funding opportunity Regulatory Agency refers to the FDA or any relevant international regulatory agency unless otherwise noted. Note: An invited oral presentation is a requirement for application review of Funding Level 4 projects, as described in Section II.D, Full Application Submission Content. Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. New partnerships are encouraged, but not required. The application is expected to describe how the PIs’ unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Level 4 applications unless they are clearly addressing distinct research questions. Applications where one PI is providing samples or investigational agents while the other PI is performing most or all of the research and analyses do not meet the intent of the Partnering PI Option. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating PI and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission. Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project. Consumer Advocates: Applications are required to include consumer advocate involvement. The research team must include two or more breast cancer consumer advocates, who will be integral throughout the planning and implementation of the research project. Consumer advocates should be involved in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer, and they should be active in a breast cancer advocacy organization. Their role in the project should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, breast cancer. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project.

The FY23 LCRP Career Development Award supports early-career, independent investigators to conduct impactful research under the mentorship of an experienced lung cancer researcher as an opportunity to obtain the funding, mentoring, and experience necessary for productive, independent careers at the forefront of lung cancer research. Research applications only in the area of mesothelioma will not be accepted. This award is intended to support impactful research projects with an emphasis on discovery.Preliminary data are not required. However, logical reasoning and a sound scientific rationale for the proposed research must be demonstrated.Key elements of this award are as follows:Principal Investigator (PI): PIs must be research- or physician-scientists at an early stage of their independent research careers. PIs must be within 5 years of their first faculty appointment (or equivalent) and exhibit a strong desire to pursue a career in lung cancer research.Mentorship: The Mentor(s) must be an experienced lung cancer researcher(s) as demonstrated by a strong record of funding and publications in lung cancer research. In addition, the Mentor(s) must demonstrate a commitment to developing the PI’s career in lung cancer research.Career Development: A Career Development Plan is required and should be prepared with appropriate guidance from the Mentor(s). A clearly articulated strategy for acquiring the necessary skills, competence, and expertise to have a career at the forefront of lung cancer research should be included. The plan should outline how the PI will gain experience in lung cancer research. Because career development is the focus of this award, the PI must commit a minimum of a 25% level of time and effort during the period of performance to conduct lung cancer research under this award.Impact: Research that has high potential impact may lead to major advancements and significantly accelerate progress toward eradicating deaths and suffering from lung cancer.Relevance to Military Health System (MHS) Beneficiaries: The application should clearly articulate how the proposed research is relevant to Service Members, Veterans, and their families.The PI is required to attend a Department of Defense (DOD) one day in progress review meeting prior to the end of the second year of the award.

The SCIRP CTRA is intended to support high-impact and/or new/emerging clinical research that may not be ready for a larger-scale clinical trial and for which feasibility/pilot studies are necessary. Projects should demonstrate potential to impact the standard of care, both immediate and long term, or contribute to evidence-based guidelines for the evaluation and care of military Service Members, Veterans, and other individuals living with SCI.• One goal of the FY23 SCIRP CTRA is to translate current and emerging techniques and interventions into the clinical space to de-risk and inform the design of more advanced trials.• Another goal is to identify the most effective diagnosis, treatment, and rehabilitation options available to support critical decision-making for patients, clinicians, care partners, and policymakers.The application should clearly articulate the scientific and strategic steps and/or preparations the research team will take during AND after the project’s period of performance to advance the research to the next stage of clinical development/implementation.The proposed studies may be interventional or observational and may involve some retrospective data analysis. Note that purely retrospective or database-related research will not be supported under this funding opportunity, some element of prospective human enrollment should be included in the project. Small/pilot clinical trials with human subjects are allowable. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. If a clinical trial is proposed, utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged.The FY23 SCIRP CTRA differs from the FY23 SCIRP Clinical Trial Award (Funding Opportunity Number HT9425-23-SCIRP-CTA) in that the CTRA allows for the execution of both clinical research projects and clinical trials, whereas the Clinical Trial Award is restricted to the execution of clinical trials only.The FY23 CTRA differs from the FY23 SCIRP Translational Research Award (Funding Opportunity Number HT9425-23-SCIRP-TRA) in that the study proposed within an application to the FY23 SCIRP CTRA may consist entirely of a clinical trial. In contrast, if a clinical trial is proposed within a Translational Research Award application, it must make up only a portion of the project’s Statement of Work.Applications to the FY23 SCIRP CTRA mechanism must support prospective clinical research or clinical trials and may not be used for animal research. Investigators seeking support to conduct studies involving animal research should consider applying to the FY23 SCIRP Translational Research Award mechanism (Funding Opportunity Number HT9425-23-SCIRP-TRA) or FY23 SCIRP Investigator-Initiated Research Award mechanism (Funding Opportunity Number HT9425-23-SCIRP-IIRA).

The Exploration - Hypothesis Development Research Award supports the initial exploration of innovative, high-risk, high-gain, and potentially groundbreaking concepts in the MS research field. The studies supported by this award mechanism are expected to lay the groundwork for future avenues of scientific investigation. The proposed research project should include a well-formulated, testable hypothesis based on strong scientific rationale and study design. The presentation of preliminary and/or published data is not required. The proposed research project must be innovative. Innovative research may examine a novel paradigm, challenge current paradigms, look at existing problems from novel perspectives, or exhibit other highly creative qualities. Research that is an incremental advance beyond ongoing research and published data is not considered innovative and is not consistent with the intent of this award mechanism. It is the responsibility of the Principal Investigator (PI) to clearly and explicitly articulate how the proposed research project is innovative in the field of MS research.

The intent of the FY22 CPMRP CEA is to support proof-of-principle pilot studies, clinical trials, and correlative studies to investigate hypothesis-based, innovative interventions and/or avenues of research that have the potential to resolve current clinical barriers and result in a profound impact on the management of chronic pain. While therapeutic approaches proposed for testing through the CEA must represent novel, hypothesis-based, “outside-the-box” approaches for managing chronic pain, they may include therapies already in clinical use, or undergoing clinical testing, for other diseases, provided that the proposed use for chronic pain management would lead to a major advancement in patient care. In addition, while not required, applications focusing on Complementary and Integrative Health (CIH) or non-pharmacological interventions are encouraged. CEA applications should explain how the proposed work will address a gap in clinical knowledge and enable future studies to transform clinical care for chronic pain management. It is anticipated that outcomes from studies funded by this award will provide scientific rationale for subsequent larger clinical trials of interventions that will transform chronic pain management and/or clinical care. Studies seeking to advance new and novel opioid-based therapeutic interventions do not meet the intent of the award mechanism and will not be selected for funding. Studies seeking to understand and reduce opioid utilization in chronic pain management within the context of current prescribing practices are acceptable.

The Innovator Award supports visionary individuals who have demonstrated exceptional creativity, innovative work, and paradigm-shifting leadership in any field including, but not limited to, breast cancer. The Innovator Award will provide these individuals with the funding and freedom to pursue their most novel, visionary, high-risk ideas that could accelerate progress to ending breast cancer. Because the intent of the Innovator Award mechanism is to recognize these remarkably creative and innovative visionary individuals, rather than projects, the central feature of the award is the innovative contribution that the Principal Investigator (PI) can make toward ending breast cancer. The PI should have a record of challenging the status quo, shifting paradigms by changing a field of research or approach to patient care, exhibiting high levels of creativity, and demonstrating promise for continued innovation in future work. These rare individuals will be able to articulate a vision for ending breast cancer that challenges current dogma and demonstrates an ability to look beyond tradition and convention. The PI is also expected to be established in their field and have demonstrated success at forming and leading effective partnerships and collaborations. To further the development of innovative individuals and spark the generation of novel ideas, applications are required to incorporate the mentoring of promising junior investigators. Experience in breast cancer research is not required; however, the application must focus on breast cancer, and the PI must maintain a 50% dedication of their full-time effort during the award period to breast cancer research. This effort in breast cancer research can be through a combination of this award and other current support. Individual from other disciplines who will apply novel concepts to breast cancer are encouraged to submit. The PI is expected to assemble a research team that will provide the necessary expertise and collaborative efforts toward accomplishing the research goals. The PI’s research team must include two or more breast cancer consumer advocates. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. Their role should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at a risk for, breast cancer.