DoD Breast Cancer, Breakthrough Award Level 4 | W81XWH 19 BCRP BTA4 2

FAQs: DoD BCRP Breakthrough Award Level 4 (W81XWH-19-BCRP-BTA4-2)

1) What is the purpose of the BCRP Breakthrough Award Level 4?

Breakthrough Award Level 4 is intended to support ambitious, high-impact breast cancer research that is positioned to produce true breakthroughs rather than incremental progress. The expectation is that the proposed work can accelerate progress toward ending breast cancer by enabling a fundamentally better approach than what is already approved or currently in clinical development.

2) What kind of impact does the program expect from proposed projects?

The program emphasizes research that can transform or revolutionize clinical management and/or prevention of breast cancer. Projects are expected to be clinically relevant and oriented toward real-world patient impact, not just scientific advancement in isolation.

3) Who should benefit from the research, and how should applicants describe that?

Applicants are expected to clearly identify the breast cancer patient populations or at-risk individuals that the research results are intended to help. The program’s focus is on patient impact and clinical relevance, so applications should explicitly state who benefits and why.

4) Is this award meant for early exploratory or preliminary research?

No. Level 4 is not a mechanism for early exploratory work. It targets large-scale efforts that are ready to be executed at a maturity consistent with human clinical testing.

5) Are human clinical trials required for Level 4?

Yes. Breakthrough Award Level 4 requires human clinical trials. It is specifically aimed at projects prepared for clinical study execution.

6) How is Level 4 different from Breakthrough Award Levels 1 through 3?

The Breakthrough Award structure includes four levels, each tied to a specific stage or scope of translational progress toward clinical application. Level 4 is the large-scale, clinical trial-requiring level covered by this announcement. Levels 1 through 3 are offered through separate program announcements with different scopes.

7) How should applicants choose the correct Breakthrough Award level?

Investigators must choose the funding level based on the scientific scope defined in the program announcement, not based on a preferred budget size. Applications that do not align with the chosen level’s intent and scope are not recommended for funding, even if they might fit another Breakthrough Award level.

8) What happens if an application does not align with the scope of Level 4?

Applications that do not align with the chosen level’s intent and scope are not recommended for funding, even if the proposed work might fit a different Breakthrough Award level.

9) What kind of experience is expected from the Principal Investigator (PI)?

Because Level 4 supports large, complex clinical efforts, the PI is expected to have a track record of successfully leading large-scale projects. The PI must also demonstrate the capability to carry out a clinical study effectively.

10) Can a team include a collaborating clinical investigator to meet clinical trial leadership requirements?

Yes. If the PI does not personally have the necessary clinical study experience, the application should include a collaborating clinical investigator with the expertise and commitment needed to carry out the clinical study effectively.

11) What readiness and feasibility factors does the program emphasize?

Proposals should demonstrate practical readiness to conduct the clinical trial. Where applicable, applicants are expected to show access to essential resources such as relevant datasets, human biospecimens, patient cohorts, and critical reagents needed to execute the study.

12) What types of resources may need to be in place at the time of application?

Where applicable, the program expects evidence that the team already has access to key enabling resources, including datasets, human biospecimens, patient cohorts, and any critical reagents necessary for the clinical trial.

13) What if the project is likely to require U.S. Food and Drug Administration (FDA) involvement?

For projects likely to require FDA involvement, the program includes explicit readiness expectations at the time the application is submitted. These expectations are meant to show the project is operationally prepared for clinical testing.

14) What FDA-related readiness expectations are described for Level 4 applications (when applicable)?

When applicable, the announcement describes readiness expectations at submission that include: proof that clinical reagents or therapeutics are available and meet regulatory compliance requirements; proof of access to an appropriate subject population; credible and validated projections for patient recruitment; and submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA.

15) Is submission of an IND or IDE required?

When applicable to the project, submission of an IND or IDE to the FDA is listed as an expectation at the time the application is submitted.

16) What does the program expect regarding access to trial participants and recruitment planning?

The program expects proof of access to an appropriate subject population and credible, validated projections for patient recruitment (when applicable). This reflects the emphasis on feasibility and the ability to complete a demanding clinical trial.

17) What agency is offering this funding opportunity?

The opportunity is offered by the Department of Defense through the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA).

18) What types of assistance instruments are anticipated?

The assistance instruments listed include grants and cooperative agreements.

19) What is the CFDA number and activity category associated with this opportunity?

The activity category is Science and Technology and other Research and Development, and the CFDA listing is 12.420.

20) Who is eligible to apply?

Eligibility is described as unrestricted, meaning it is broadly open to many entity types, subject to any specific clarifications in the full program announcement.

21) How many awards were anticipated?

The posting anticipated making one award.

22) What are the key dates shown in the posting?

The posting indicates it was created on May 7, 2019, with an original closing date of September 25, 2019.

23) What is the funding cap or award ceiling?

The summary data lists an award ceiling of 0, which typically indicates applicants should rely on the full program announcement for actual allowable budget parameters and funding constraints rather than the simplified listing field.

24) Why does the award ceiling show as 0 in the summary?

The provided information notes that an award ceiling of 0 in the summary data typically means the simplified listing field is not providing the true budget limit, and applicants should consult the program announcement for the real budget parameters and constraints.

25) Where can applicants confirm the correct scope for Level 4 versus other levels?

Applicants are encouraged to review the separate program announcements for Breakthrough Award Levels 1 through 3 and compare those scopes to Level 4 before committing, since scope misalignment can prevent an application from being recommended for funding.