DoD Breast Cancer, Breakthrough Award Levels 1 and 2

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

credit:


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 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.
Related Programs

Military Medical Research and Development

Department Of Defense


Agency: Department of Defense

Office: Dept. of the Army -- USAMRAA

Estimated Funding: $33,700,000


Who's Eligible





Obtain Full Opportunity Text:
FULL ANNOUNCEMENT - RFA-FD-21-018

Additional Information of Eligibility:
Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U. S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions)

Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-21-018.html

Contact:


Agency Email Description:
CDMRP Help Desk

Agency Email:


Date Posted:
2021-01-06

Application Due Date:


Archive Date:
2021-04-24


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