Funding Wizard

The FY21 PCARP Translational Research Partnership Award supports partnerships between clinicians and research scientists that will accelerate the movement of promising ideas in pancreatic cancer toward clinical applications. This award supports the development of translational research collaborations between two independent investigators to address a central problem or question in pancreatic cancer in a manner that would be less readily achievable through separate efforts. One partner in the collaboration must function as a research scientist and the other partner as a clinician investigator. It should be clear that both have had equal intellectual input in the design of the research project. Multi-institutional and multi-discipline partnerships are strongly encouraged. At least one partner must have expertise either in pancreatic cancer research or pancreatic cancer patient care. Inclusion of experts from outside the pancreatic cancer field is encouraged. A proposed project in which the clinical partner merely supplies tissue samples or access to patients will not meet the intent of this award mechanism. Full support for large-scale clinical trials is not expected; retrospective tissue analysis, correlative studies, or small pilot clinical trials are permitted. Significant features of the Translational Research Partnership Award: · Partnership: The success of the project should depend on the unique skills and contributions of each partner. · Translation: The application should provide evidence for the reciprocal transfer of information between basic and clinical science, or vice versa, in developing and implementing the research plan. Translational research may include correlative studies and/or development of or use of annotated biorepositories. The application should demonstrate how the study will leverage clinical information to address knowledge gaps in resulting outcomes, validate key research findings, expand upon potentially transformative results, and/or investigate novel findings. · Impact: The proposed research should indicate the potential to have a significant impact on pancreatic cancer research and/or patient care and have the potential to accelerate the movement of promising ideas (in prevention, diagnosis, detection, prognosis, treatment, and/or survivorship) into clinical applications. · Feasibility: The application should demonstrate that the investigators have access to the necessary specimens, data, and/or intervention, as applicable. · Preliminary Data: Published and/or unpublished results from the laboratory of the PIs or collaborators named on the application that are relevant to pancreatic cancer and the proposed research project, are required. Preliminary data to support the feasibility of the research hypothesis(es) and research approaches are required; however, these data do not necessarily need to be derived from studies of pancreatic cancer. Observations that drive a research idea may be derived from a laboratory discovery, population- based studies, or a clinician’s firsthand knowledge of patients and anecdotal data. The ultimate goal of translational research is to move a concept or observation forward into clinical application that is relevant to active duty Service Members, Veterans, other military beneficiaries, and the American public. However, translational research should not be viewed as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between basic and clinical science. There should be an intellectual synergistic partnership between the clinic and the laboratory. The success of the project must be supported by the unique skills and contributions of each partner. The proposed study must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved. The plans must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award. The Translational Research Partnership Award requires two PIs. One will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other 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. 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 PIs, refer to Section II.D.2, Content and Form of the Application Submission. It is the responsibility of the PIs to describe how their combined expertise will better address the research question and explain why the work should be done together rather than through separate efforts.

The FY21 RTRP Advanced Technology Development Award is intended to support research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation. Important aspects of this award mechanism include: • Study Design and Feasibility: The proposed study design should be clearly described, rigorous, well-integrated, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, if applicable. It should be clear how the proposed study design of this project will position the product for the next phase of development as described in the post-award Transition Plan (Attachment 9). • Impact/Military Relevance: The short- and long-term impact of the proposed research should be clearly articulated. Projects must address at least one of the FY21 RTRP Advanced Technology Development Award Focus Areas listed in Section II.A.1 above. All products to be developed should be responsive to the healthcare needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their family members, caregivers, or clinicians, as well as the general public. Collaboration with military and VA researchers and clinicians is encouraged but not required. • Transition Plan: The post-award Transition Plan (Attachment 9) should include potential funding and resources and show how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the successful completion of this award. A regulatory strategy as applicable to the proposed research/product should also be included. • Preliminary Data: Proof of concept demonstrating potential utility of the proposed product, or a prototype/preliminary version of the proposed product, must already be established. Preliminary and/or published data that are relevant to reconstructive transplantation, and that support the rationale for the proposed study, must be included (these data may be unpublished if from a member of the research team, or from the published literature). Proposed research and products to be developed may be materiel products such as drugs, biologic agents, or devices, or knowledge-based products such as technical reports and clinical practice guidelines that inform clinical/operational decisions and promote evidence-based changes in clinical practice and standard of care. Proposed research may include animal research and/or human subjects research, as appropriate; however, clinical trials are not allowed under this funding opportunity.

The intent of the FY22 PRARP ADRA is to support high-impact advancement of robust diagnostic and/or prognostic factors pertaining to AD/ADRD following military service and/or TBI. Applications meeting the intent of this mechanism will accelerate clinically useful factors for rapid transfer to clinical practice to bridge a critical gap between identification of relevant factors and clinical usage. The proposed factors for investigation must correlate with clinical endpoints relevant to AD/ADRD following military service and/or TBI. Inclusion of preliminary data is required. Applicants should clearly describe the intent, purpose, as well as the clinical and practical utility of the diagnostic and/or prognostic factors being studied. Considerations for how the diagnostic/prognostic factors meaningfully inform care and disease management should be described both at the provider and individual living with AD/ADRD level. As part of the application, the proposed prognostic or diagnostic factors should demonstrate their potential for improved specificity and sensitivity with respect to diagnosis and/or prognosis of AD/ADRD as the study endpoint. Additionally, applications should address the utility of the diagnostic/ prognostic factor(s) in rural or resource-limited environments. Applications may consider elements of biomarker and risk factor validation as part of the application, particularly if validation is intended to widen the diversity of the population to which the factors/biomarkers will be applicable. Biomarker validation is defined as assessing the biomarker’s measurement performance characteristics in terms of reproducibility, accuracy, precision, and limits of sensitivity. Risk factors may include modifiable and non-modifiable factors that influence a person’s likelihood to develop AD/ADRD. Clinical trials are not allowed; however, the FY22 ADRA may use data and/or human anatomical substances from an existing clinical trial to carry out the research.

The FY22 PRARP IIRA is intended to support studies that will make important contributions to TBI and/or military-service-related factors as they pertain to AD/ADRD research, patient care, and quality of life. The work should innovatively challenge existing paradigms or exhibit high levels of creativity. Important aspects of this award mechanism include: Impact: Applications should address the short- and long-term impact of the proposed research on the intersectional TBI, and/or AD/ADRD research field as well as persons with dementia and/or their support network. Innovation: Applications must address research under one or more of the PRARP IIRA Focus Areas using innovative approaches that represent novel directions, ideas, or advances in the field. Innovative research may introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives, or exhibit other highly creative qualities. Relevance to Military Health: Projects must have relevance to military Service Members, Veterans, and/or their family members and care partners. Applicants are encouraged to integrate and/or align their research projects with Department of Defense (DOD) and/or Department of Veterans Affairs (VA) research laboratories and programs. Collaborations between researchers, at military or Veterans institutions and non-military institutions, are strongly encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 2. IIRA applications may focus on any phase of research from basic through translational. Permitted research includes preclinical studies in animal models (except where otherwise specified), research with human subjects, or human anatomical substances, as well as ancillary studies associated with an existing clinical trial. Inclusion of preliminary data is required. Use of animal models, if allowable, must be fully justified for relevance to human health. Clinical research applications are required to include a community collaboration research element.

The intent of the FY22 PRARP TRA is to support translational research that will accelerate the movement of promising products and knowledge in AD/ADRD research into clinical applications, including healthcare products and interventions, technologies, behavioral modalities, social modalities, and/or clinical practice guidelines. This mechanism supports both preclinical-to-clinical translational research (e.g., studies of interventions and medical devices in preclinical systems) and clinical research-to-clinical care translation (e.g., comparative effectiveness, implementation science, healthcare services research). Observations that support a research idea may be derived from a laboratory discovery, population-based studies, or a clinician’s first-hand knowledge of patients and anecdotal data. Inclusion of preliminary data is required. Use of animal models, if applicable, must be fully justified for relevance to human health. Clinical research applications are required to include a community collaboration research element. Important aspects of this award mechanism include: Translational Potential: The PRARP does not view translational research as a one-way continuum from bench to bedside. The research plan is encouraged to involve a reciprocal flow of ideas and information between basic and clinical science or clinical and implementation science as appropriate. The application should detail steps to move the research along the research and development continuum. Relevance to Military Health: Projects must have relevance to military Service Members, Veterans, and/or their family members and care partners. Applicants are encouraged to integrate and/or align their research projects with Department of Defense (DOD) and/or Department of Veterans Affairs (VA) research laboratories and programs. Collaborations between researchers, at military or Veterans institutions and non-military institutions, are strongly encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 2.

The FY22 RCRP Concept Award supports highly innovative, untested, potentially groundbreaking novel concepts in rare cancers. The Concept Award is not intended to support an incremental progression of an already established research project; instead, it allows Principal Investigators (PIs) the opportunity to pursue serendipitous observations. Preliminary data are not required. This award mechanism supports high-risk studies that have the potential to reveal entirely new avenues for investigation. Applications must describe how the new idea will enhance the existing knowledge of rare cancers or develop an innovative and novel course of investigation. Research completed through a Concept Award may generate sufficient preliminary data to enable the PI to prepare an application for future research.

The PRP EIRA supports research opportunities for investigators in the early stages of their careers, under the guidance of one or two designated Mentor(s). The Early Investigator is considered the Principal Investigator (PI) of the application and must exhibit strong potential for, and commitment to, pursuing a career as an investigator at the forefront of PD research; however, the PI is not required to have previous PD research experience. Applications must include at least one Mentor, appropriate to the proposed research project, who has experience in PD research and mentoring as demonstrated by a record of active funding, recent publications, and successful mentorship.

The LRP Idea Award supports innovative, high-risk/high-reward research that could ultimately lead to a critical discovery or major advancement relevant to lupus. This award mechanism supports studies that have the potential to reveal entirely new avenues for investigation. The application must describe how the new idea will enhance the existing knowledge of lupus or develop a hypothesis(es) or an innovative and novel course of investigation. The Idea Award is not intended to support an incremental progression of an already established research project. Research completed through an Idea Award may generate sufficient preliminary data to enable the Principal Investigator (PI) to prepare an application for future research. Inclusion of preliminary data is not required.The following are important aspects of the Idea Award:• Innovation: Innovative research may introduce a new paradigm, look at existing problems from new perspectives, or exhibit other highly creative qualities. It is the responsibility of the PI to clearly and explicitly describe how the proposed research is innovative and will lead to novel avenues of investigation in lupus research.• Impact: The proposed research, if successful, should impact an area of paramount importance in lupus disease. Applications should clearly and explicitly describe the potential impact(s) of the proposed study for individuals living with lupus and to convey its level of significance. Research that represents an incremental advancement on previously published work is not considered impactful.• Research Strategy: The scientific rationale and experimental methodology should demonstrate critical understanding and in-depth analysis of lupus. Experimental strategies may be novel or may be based on strong rationale derived from a literature review.• Focus Areas: The proposed research must address at least one of the FY22 LRP Focus Areas.• Clinical trials are not allowed under this program announcement.The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.The anticipated total costs budgeted for the entire period of performance for an FY22 Idea Award will not exceed $300,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2023. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $1.2M to fund approximately four Idea Award applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY22 funding opportunity will be funded with FY22funds, which will expire for use on September 30, 2023.

The PRP SIA supports new ideas that represent synergistic approaches to PD research involving two to four Principal Investigators (PIs) at the Assistant Professor (or equivalent) level or above. These investigators should utilize their complementary and synergistic perspectives to address a central problem or question in Parkinson’s research. This award is designed to support both new and pre-existing partnerships and encourages participation of PIs from other research fields. The PRP Synergistic Idea Award seeks applications from investigators working in a wide spectrum of disciplines including, but not limited to, basic science, engineering, bioinformatics, population science, translational research, and clinical research.

The TVA supports applications that will fulfill an extraordinary vision for dramatically improving the quality of life of persons with lupus using an intervention at the individual and/or healthcare system level. This award requires a plan that will test and achieve the vision through the translation of research ideas which, when addressed, will result in a near-term impact on the quality of life of persons living with lupus. Applications may address various quality-of-life issues in lupus patients of any age, including but not limited to those with disproportionate health burdens. Preliminary data are required. Human subject research and clinical trials are allowed under this program announcement.The following are important aspects of the Transformative Vision Award:• Impact: The proposed research, if successful, should have a major impact on the quality of life of lupus patients. Applications should clearly and explicitly describe the potential impact(s) of the proposed study for individuals living with lupus and to convey its level of significance. The TVA supports high-risk, high-reward studies that have an intervention with the potential to make a significant, near-term impact on the quality of life of lupus patients.• Research Strategy: The scientific rationale and experimental methodology should demonstrate critical understanding and in-depth analysis of lupus. Experimental strategies may be novel or may be based on strong rationale derived from a literature review.• Focus Areas: The proposed research must address at least one of the FY22 LRP Focus Areas for the TVA.• Research Team: The research team’s background should be appropriate with respect to its ability to successfully complete the proposed work.• Consumer Advocate: Applications are required to include consumer advocate involvement. The research team must include one or more consumer advocate(s), 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 lupus or a caregiver, and they should be active in a lupus 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, lupus. The consumer advocate(s) should have a high level of knowledge of current lupus issues and the appropriate background or training in lupus research to contribute to the project.• Budget: The proposed budget should be appropriate for the proposed research and within the limitations of this program announcement.Animal research is not allowed under this program announcement.Partnering Principal Investigator (PI) Option:The Transformative Vision Award encourages applications that include meaningful and productive collaborations between investigators. 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(s) will be identified as a Partnering PI(s), with a maximum of two Partnering PIs. All PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. 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.The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.The anticipated total] costs budgeted for the entire period of performance for an FY22 LRP Translational Vision Award will not exceed $2,500,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2023. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $2.5M to fund approximately one Transformative Vision Award applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2023.