DoD Funding Opportunities for Breast Cancer Research - April Deadlines
The FY22 Defense Appropriations Act is providing funding for the BCRP to support innovative, high-impact research with clinical relevance that will accelerate progress to end breast cancer for Service Members, Veterans, and the general public. The managing agent for the anticipated program announcements/funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).
The BCRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities. This pre-announcement should not be construed as an obligation by the government. The FY22 BCRP funding opportunity announcements for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the announcements are released.
Applications submitted to the FY22 BCRP must address one or more of the following overarching challenges:
- Prevent breast cancer (primary prevention)
- Identify determinants of breast cancer initiation, risk, or susceptibility
- Distinguish deadly from non-deadly breast cancers
- Conquer the problems of overdiagnosis and overtreatment
- Identify what drives breast cancer growth; determine how to stop it
- Identify why some breast cancers become metastatic
- Determine why/how breast cancer cells lie dormant for years and then re-emerge; determine how to prevent lethal recurrence
- Revolutionize treatment regimens by replacing them with ones that are more effective, less toxic, and impact survival
- Eliminate the mortality associated with metastatic breast cancer
Breakthrough Award Level 3 – Preproposal due April 28, 2022
- · Independent investigators at all academic levels (or equivalent).
- · There are no limits on the number of pre-applications for which an investigator may be named as a PI, Initiating PI, or Partnering PI for the Breakthrough Award Level 3.
- · Investigators are discouraged from being named on multiple pre- applications unless they are clearly addressing distinct
research questions
- · Supports promising research that has high potential to lead to or make breakthroughs in breast cancer.
- · Research should have the potential for a major impact and accelerate progress toward ending breast cancer.
- · Potential impact of the research may be near-term or long-term, but it 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.
- · Partnering PI Option allows two PIs, termed Initiating and Partnering PIs, to partner on a single application.
○ 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.
○ 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.
Different funding levels, based on the scope of research are available for the Breakthrough Award. Each level has a defined research scope. It is the responsibility of the 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 and not on the amount of the budget.
The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under this funding level:
- · Funding Level 3: Advanced translational studies with a high degree of project readiness. Where relevant, proof of availability of and access to necessary data, human samples, cohort(s), and/or critical reagents must be provided. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) involvement, applications must demonstrate availability of and access to clinical reagents (e.g., therapeutic molecules) and patient population(s). Applications must state a realistic timeline for near-term clinical investigation. Small-scale clinical trials (e.g., first in human; phase 1/1b) may be appropriate.
Additional Elements
- · Pre-application submission is required; application submission is by invitation only.
- · Applications must include two or more breast cancer advocates on the research team.
- · Clinical trials are allowed.
Funding Level 3:
- · The maximum allowable funding for the entire period of performance is $4M for direct costs.
- · Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
- · The maximum period of performance is 4 years.
Funding Level 3 with Partnering PI Option:
- · The maximum allowable funding for the entire period of performance is $5M for direct costs.
- · Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
- · The maximum period of performance is 4 years.
Breakthrough Award Level 4 – Preproposal due April 28, 2022
- · Independent investigators at all academic levels (or equivalent).
- · There are no limits on the number of pre-applications for which an investigator may be named as a PI, Initiating PI, or Partnering PI for the Breakthrough Award Level 4.
Investigators are discouraged from being named on multiple pre- applications unless they are clearly addressing distinct research questions.
- · Supports promising research that has high potential to lead to or make breakthroughs in breast cancer.
- · Research should have the potential for a major impact and accelerate progress toward ending breast cancer.
- · Potential impact of the research may be near-term or long-term, but it 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.
- · Partnering PI Option allows two PIs, termed Initiating and Partnering PIs, to partner on a single application.
○ 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.
○ 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.
○ Different funding levels, based on the scope of research are available for the Breakthrough Award. Each level has a defined research scope. It is the responsibility of the 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 and not on the amount of the budget.
The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under this funding level:
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 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 or Investigational Device Exemption application to the FDA, if applicable.
Additional Elements
- · Pre-application submission is required; application submission is by invitation only.
- · Applications must include two or more breast cancer advocates on the research team.
Clinical trials are required.
Funding Level 4 and Funding Level 4 with Partnering PI Option:
- · The maximum allowable funding for the entire period of performance is $10M for direct costs.
- · Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
- · The maximum period of performance is 4 years.
Innovator Award – Preproposal due April 28, 2022
- · Associate Professor (or equivalent) or above
- · Previous BCRP Innovator Award recipients are ineligible.
An investigator may be named as PI on only one Innovator Award pre- application.
- · Supports visionary individuals who have demonstrated exceptional creativity, innovative work, and paradigm-shifting leadership in any field including, but not limited to, breast cancer.
- · Provides these individuals with the opportunity and freedom to pursue novel, visionary, high-risk ideas that could accelerate progress toward ending breast cancer.
- · 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.
- · Applications must include two or more breast cancer advocates on the research team.
- · Pre-application submission is required; application submission is by invitation only.
- · Clinical Trials are allowed.
- · The maximum allowable funding for the entire period of performance is $7M for direct costs.
- · Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
- · The maximum period of performance is 4 years.
Transformative Breast Cancer Consortium Award – Preproposal due April 28, 2022
- · Independent investigators at all academic levels (or equivalent)
- · The Consortium Director is required to commit and maintain at least 25% level of time and effort during the award period.
- · An investigator may be named as Consortium Director on only one pre- application.
- · There are no limits on the number of pre-applications for which an investigator may be named as a Project Team PI.
- · Supports collaborations and ideas that will transform or improve the lives of individuals with, and/or at risk for, breast cancer and will significantly accelerate progress toward ending breast cancer.
- · Requires a synergistic, highly integrated, multidisciplinary, and multi-institutional research team of leading scientists, clinicians, and consumer advocates who will be assembled into a consortium to address a major problem in a way that could not be accomplished by a single investigator or group.
- · The consortium should have at least four, but no more than five, project teams, each investigating different projects under a central hypothesis. Each team’s work must be integrated within the consortium so that every component is working toward the consortium’s central hypothesis.
- · The proposed consortium’s overall work is expected to be innovative. In addition, the Transformative Breast Cancer Consortium Award will include funds for “seed projects” to pursue brand new, high-risk/high-reward concepts that arise from the work, during the award period.
- · This award is not intended to replace, supplement, duplicate, or compete with other collaborative research efforts, such as the National Cancer Institute (NCI) Specialized Programs of Research Excellence (SPOREs), and it should not represent a collection of related Program Project grants or subprojects.
- · Research funded under this award mechanism should result in answers that will fundamentally and significantly transform and disrupt the present breast cancer landscape.
Applications must include the following:
- · Research that includes truly innovative and brand-new paradigm-shifting work in breast cancer that will address vital issues in a unique way. The issues may be one (or more) of the FY22 BCRP Overarching Challenges or, with justification, may be a different issue that meets the intent of the award mechanism and addresses the mission of ending breast cancer. If the application identifies a different fundamental issue, it must be coupled with at least one of the FY22 BCRP Overarching Challenges.
- · Research that includes different disciplines that come together to address ending breast cancer with an ecologic approach. The consortium’s proposed research must look at all aspects of the disease and bring together these different perspectives into one overarching plan for a deep, definitive dive into the FY22 BCRP Overarching Challenge(s) or other fundamental issue identified in the application. The plan also should include issues related to the hypothesis that have not been previously addressed or answered.
- · A plan that describes in detail the integration across the consortium in all aspects, including administration, logistics, and substance. Applications must describe the substantive integration across and among teams that are necessary for the work. The required communication plan and administrative management plan will not suffice to show integration, nor will identifying individual team members who will cross teams. A detailed explanation of the substantive research processes that will be integrated is required.
- · Although not all inclusive, applications that propose the following as the primary effort(s) or central hypothesis of the consortium will not meet the intent of this award mechanism:
- · NCI Program Project or SPORE grants or applications
- · Conducting drug screens or testing a “cocktail” of therapeutics
- · Targeting a single gene or protein
- · Developing a new derivative or formulation of an old drug
- · Conducting genomic landscape mapping analyses
- · Seeking to improve existing technologies (e.g., mammography or magnetic resonance imaging screening)
Additional Elements
- · Pre-application submission is required; application submission is by invitation only.
- · The award mechanism is structured with a Consortium Director and at least three, but not more than four, Project Team PIs.
- · Applications must include at least one breast cancer consumer advocate per project team.
- · Clinical trials (up to and including phase 1 or equivalent) are allowed but not required, and the primary thrust of the application should not be a clinical trial.
- · The maximum allowable funding for the entire period of performance is $25M for direct costs.
- · Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
- · The maximum period of performance is 4 years.
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final funding opportunity announcements available for downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
For email notification when announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the BCRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).
Point of Contact:
CDMRP Help Desk
301-682-5507
help@eBrap.org
For more information, please contact Jill Sherman, International Research Facilitator, at intl.research@lakeheadu.ca.