RePAIR

What is within scope of the RePAIR program?

BARDA is requesting abstract submissions for projects that evaluate existing drugs as MCMs for treating ARS.

The ideal drug should have efficacy when administered 24 hours or later following exposure to ionizing radiation. If commercially available, the drug should be familiar to end users, easy to administer, and available at multiple points of care (e.g., pharmacies and hospitals).

What types of abstracts/proposals is the RePAIR program looking for?

The RePAIR program will primarily focus on proposals for preclinical efficacy studies (i.e., efficacy in animal models of ARS). To be considered responsive under this AOI, respondents should have the following:

• A drug that is a candidate for repurposing as a MCM by label expansion with a mechanism against cell death, vascular injury, bleeding or coagulating disorders, or ischemia associated with ARS
• Is FDA-approved or is currently in Phase 2 clinical trial(s) or further, with a mechanism anticipated to have efficacy for treating the above pathologies associated with ARS; evidenced by a clinical study report(s)
• Established an initial safety profile from a Phase 1 Clinical Trial with acceptable risk: benefit profile.
• A clear rationale as to why the candidate should be effective as a post-exposure therapy to treat ARS
• Outline of appropriate facilities (or description of subcontractor or other partner) demonstrating ability to execute radiation exposure experiments in appropriate models.
• Freedom to operate for other indications using your proposed drug.
• Outcome measures and proposed threshold for study success

Proposals focusing on chemistry manufacturing and controls (CMC) activities, safety/toxicity, or other studies that will facilitate evaluation of the product as a viable candidate to treat ARS will also be considered.

What is out of scope for the RePAIR program?

Evaluation of MCMs which already have an indication for the hematopoietic sub-syndrome of ARS.

Prophylactic administration of drug prior to exposure to ionizing radiation.

MCMs that do not have a defined mechanism of action (MOA) and relevant pharmacodynamic (PD) markers.

Evaluation of MCMs outside the context of injuries resulting from a nuclear detonation.

Projects that propose drugs that will only be developed as MCMs (even for more than one threat)

Is this funding opportunity open to to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in the EZ-BAA and the special instructions.

Can large companies apply to this funding program?

Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov

Can companies/universities outside of the United States apply for DRIVe funding?

Yes

Do academic institutions also need to provide a 30% cost share?

Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50%, unless you satisfy the regulatory exception (included below for reference). Currently, none of the DRIVe partners under the DRIVe EZ-BAA have been awarded a contract that does not include a cost-share component range, including all universities and non-profit organizations. Cost-share may be in-kind or cash contributions. It may also come from a third-party investor/sponsor, however it is up to you to ensure you receive their contribution toward the proposed project. Many organizations offer to cover Overhead or Fringe Benefits. Some also offer pro-bono labor hours or sponsored equipment, materials, or subcontractor costs. A combination of all of the above could be acceptable. It would need to be indicated on a submission what is being cost-shared. To qualify for no cost-share under an EZ-BAA award, a respondent must show that there is "no probability that the respondent will receive present or future benefits from participation as described in Federal Acquisition Regulation (FAR) 16.303". Examples of present or future benefits include increased technical know-how, training for employees, acquisition of goods or services, development of a commercially viable product that can be sold in the commercial market, and use of background knowledge of future contracts.

What are the data sharing requirements of this program?

Projects funded under this program have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government use consistent with the regulation.

The EZ-BAA application is so short. Can I include links to figures or references?

While you can include links to figures or references, it is not mandated that reviewers view that outside information. At this time, the abstract format does not accept any figures, only text.