The FY24 Transformative Breast Cancer Consortium Award is designed to support collaborations and ideas that will transform the lives of individuals with, and/or at risk for, breast cancer and will significantly accelerate progress toward ending breast cancer. Applicants must bring together different perspectives to develop new paradigms that will solve fundamental yet overarching problems in breast cancer. This award requires a team-based approach by a consortium of exceptional researchers and advocates, whose collaborative efforts will make a transformative impact in breast cancer. The transformation intended by the consortium must be in people’s lives, and not in the healthcare or research system.
This funding opportunity is a separate mechanism from the Transformative Breast Cancer Consortium Development Award, which is intended to provide successful applicants the time and resources needed to bring investigators and breast cancer advocates together to establish a consortium framework and conduct preliminary research to support application to a future, full Transformative Breast Cancer Consortium Award (pending availability of funds). For FY24, investigators may be named as Consortium Director on an application submitted to either (but not both) of these mechanisms. It is not necessary to receive a development award in order to apply for the current funding opportunity or anticipated full consortium awards in the future. Detailed information on the FY24 Transformative Breast Cancer Consortium Development Award is available under a separate program announcement (HT942524BCRPTBCCDA).
For the FY24 Transformative Breast Cancer Consortium Award, the consortium should have at least four, but no more than five, project teams, each investigating different projects under a central hypothesis. No more than two project teams may be based at one institution. Each team’s work must be integrated within the consortium so that every component is working toward the consortium’s central hypothesis. Note: 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.
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.
DOD FY24 Transformative Breast Cancer Consortium Award 5
The Breast Cancer Landscape describes the reality of breast cancer and identifies overarching challenges to progress the field. Research funded under this award mechanism should result in answers that will fundamentally and significantly transform and disrupt the present landscape.
Applications submitted to the Transformative Breast Cancer Consortium Award 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 FY24 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 FY24 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 FY24 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.
Synergistic, highly integrated, multidisciplinary, and multi-institutional research teams of leading scientists, clinicians, and consumer advocates must be assembled into a consortium to address a major problem in a way that could not be accomplished by a single investigator or group. While the project teams are made up of different groups, each with its own Principal Investigator (PI), the teams must be working on the major problem identified in the Transformative Breast Cancer Consortium Award application and under the leadership of the Consortium Director. The research proposed in Transformative Breast Cancer Consortium Award applications may include phase 1 clinical trials and collaborations with pharmaceutical or biotechnology industry scientists and/or companies, as appropriate. However, a clinical trial is not required, and the primary thrust of the application should not be a clinical trial.
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)
All applications submitted to the Transformative Breast Cancer Consortium Award must address the following key features:
1. IMPACT
Demonstrate potential to transform or improve the lives of individuals with, and/or at risk for, breast cancer. The time to the final impact may vary, but the outcomes of the effort must be transformative and significantly advance the BCRP’s mission of ending breast cancer. A clear and compelling presentation of how the effort will be transformative for individuals with, and/or at risk for, breast cancer must be provided. Applications proposing research that represents an incremental advance in breast cancer do not meet the intent of this award mechanism.
2. INNOVATION
Pursue innovative, high-risk/high-reward research that has the potential to change existing paradigms, or develop new paradigms. Innovative research may introduce a new paradigm, look at existing problems from new perspectives, or exhibit other highly creative qualities. In addition to the requirement that the consortium’s overall research be innovative, applications must describe a plan to support the pursuit of innovative concepts through “seed projects,” i.e., the development of new concepts that emerge during the course of the award. These “seed projects” should enable the research team to explore new avenues of high-risk/high-reward ideas that were not part of the original application, but that develop during the project and are within the scope of the overall vision of the research. A portion of the total direct budget costs (no more than 5%) must be reserved to support the “seed projects,” and these funds may not be used for equipment or travel.
3. CONSORTIUM
Integrate project teams consisting of preeminent investigators and advocates from appropriate disciplines and institutions. Applications should include a robust consortium of researchers with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the proposed research. Emphasis must be placed on integrating the most highly qualified investigators and advocates to focus on the research problem, regardless of their location. These investigators must include highly accomplished scientists, clinicians, and promising young investigators in the targeted areas of research who collectively represent the best team to solve the problem(s) identified. The proposed research effort should be broad enough to require a multidisciplinary approach that is reflected in the composition of the consortium team. Inclusion of scientists from nontraditional disciplines is encouraged.
The award mechanism is structured with a Consortium Director and at least three, but no more than four, Project Team PIs representing at least two institutions. The Consortium Director is responsible for the day-to-day management of the consortium, as well as for leading their own project team. The Consortium Director, together with the Project Team PIs, are jointly responsible for leading and executing the proposed research projects that are integrated into a central hypothesis and will result in answers that will fundamentally and significantly transform and disrupt the present breast cancer landscape. Please see the top of this section, Section II.B, Award Information, for more details.
Incorporate breast cancer consumer advocates into every aspect of the proposed consortium’s activities. Applications are required to include consumer advocate involvement. The consortium team must include at least one breast cancer consumer advocate per project team. The consumer advocates are expected to represent the perspective of the patient population(s) that are most relevant to the consortium’s proposed research. Breast cancer consumer advocates must have an active role in every aspect of the proposed consortium’s work including consortium conception and design, ongoing discussion, decisions and oversight, program evaluation, and dissemination of information to the public. Consumer advocates must be integrated into and play an active role in the leadership and decision-making committees for the consortium at each participating institution. Examples of appropriate integration include membership on the advisory board(s) and steering committee(s), participation in each project team, and attendance at all consortium-related meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer, they should be part of a breast cancer advocacy organization, and their role in the project should be independent of their employment. They cannot be employees of any of the institutions participating in the application. They must have a high level of familiarity and training involving science and current issues in breast cancer research.
4. INTEGRATION
Provide a plan that describes in detail the integration across the consortium in all aspects, including administration, logistics, and substance. Applications must demonstrate the substantive integration across and among teams that are necessary for the work. The integration plan must provide a detailed explanation of the substantive research processes that will be integrated.
5. IMPLEMENTATION
Provide a strategy for implementation. Projects must demonstrate solid scientific rationale, and applications must include published and/or preliminary data that support the feasibility of their hypotheses and/or approaches. The application must include a detailed research management plan that identifies critical milestones, outlines the innovations and technical solutions that will be implemented to accomplish the milestones, and explains how these solutions will ultimately be translated to individuals with, and/or at risk for, breast cancer. It is expected that the proposed plan will present an exceptional level of innovation and creativity.
Accelerate research progress through communication. Communication between and among consortium team members is essential to the success of the consortium. Applications must include a strategy for sharing data in real time and using information technologies to facilitate timely and effective communication and cooperation. The communication plan should specify the processes and tools to be used for regular and structured communication. The consortium should take full advantage of state-of-the-art communication and data sharing tools in addition to formal and informal meetings. The framework for the communication plan must be part of the application and the individual(s) who will maintain the data sharing and communications technologies must be identified.
Provide an effective, coordinated administrative management plan that integrates and optimizes the research and collaborations. The Consortium Director is required to commit a minimum level of time and effort of 25% to direct and manage an initiative of this magnitude, as well as lead their own project team. The Consortium Director must have the scientific ability and proven administrative ability to oversee large research programs and a proven record of leadership, including experience in the effective use of communication tools and the management of multifaceted and multidisciplinary projects. The administrative management plan must explain how the consortium will be organized and managed, and specify the processes and tools to be used for project meeting scheduling, reviews of research findings, ensuring multidisciplinary authorship of all publications arising from the consortium’s work, and other issues of common concern to the consortium and its investigators. The administrative management plan also must describe procedures and processes that will be used to maximize the resources (e.g., databases, animal models) and products (e.g., antibodies) generated by the consortium and how these resources and products will be made available to the scientific community. A portion of the total direct budget costs must be reserved for a program manager.
Award Structure: The Transformative Breast Cancer Consortium Award is structured to accommodate up to five PIs (the Consortium Director and three or four Project Team PIs). The Consortium Director will be responsible for the majority of the administrative tasks associated with application submission and the day-to-day management of the consortium. In addition, the Consortium Director will be responsible for leading their own project team. The Consortium Director and Project Team PIs each have different submission requirements; however, 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 on separate awards to the recipient organizations. For individual submission requirements for the Consortium Director and Project Team PIs, refer to Section II.D.2, Content and Form of the Application Submission.
The Consortium Director, Project Team PIs, and consumer advocates will be required to present an update on progress toward accomplishing research milestones and goals of the consortium and each project at an annual In-Progress Review (IPR) Meeting for the Transformative Breast Cancer Consortium Award. The intent of the IPR Meeting is to assess research progress, address problems, and define future directions. Annual IPR Meetings will be held at the conclusion of year 1 and every subsequent year in the period of performance and will be attended by members of the BCRP Programmatic Panel, CDMRP staff, and the USAMRAA Grants Officer to facilitate oversight and provide feedback to the consortium. IPR Meetings will either be held in person in the National Capital Region or virtually, at the discretion of the government. Continued funding may be contingent upon the successful completion of specific research milestones and goals. Research milestones from the approved SOW will be determined during the award negotiation process.
In addition to IPR Meetings, each consortium must hold biannual workshops, which may be held at the PIs’ institutions or virtually, to facilitate ongoing communication and exchange of information within the consortium, as well as with advisory board(s) and/or steering committee(s).
