RePAIR

Repurposing and Advancing Innovations Against Rad/Nuc Threats

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OVERVIEW

Strengthening our ability to respond to physical threats is a critical part of BARDA's strategy. Exposure to substantial doses of ionizing radiation, causes widespread cell death and leads to a spectrum of injuries across multiple organs, also known as Acute Radiation Syndrome (ARS). Due to the systemic multi-organ pathologies of ARS, fast-acting, effective medical countermeasures (MCM) are needed.

With the Repurposing and Advancing Innovations Against Rad/Nuc (RePAIR) program, DRIVe and BARDA's Chemical, Biological, and Nuclear (CBRN) Division aim to support the testing and evaluation of repurposed drugs that have potential efficacy against ARS.

APPROACH

Drug repurposing, or label expansion, is a strategy that is used to identify new uses for approved or late-stage therapeutics beyond their original clinical indication. With RePAIR, efforts are focused on repurposing licensed or late-stage therapeutics as MCMs against ARS.

This includes therapeutics for treating:

  • Cell Death
  • Vascular Injury
  • Bleeding/Coagulation
  • Ischemia

Program Goals

Repurpose Promising Drugs

Candidate drugs are FDA-approved or late-stage (met Phase 2 endpoints) with the potential to treat ARS.

Support Critical Proof-of-Concept Studies

Preclinical efficacy studies in relevant nonclinical models of ARS will be the primary focus.

Transition Successful Candidates

Enable development under FDA's Animal Rule; expand treatment options and support pre-deployed MCM strategies.

RePAIR

Funding
Opened

11/8/22

Special
Instructions

#002

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Funding Closes

2/28/23

PROGRAM SPECIFIC FAQ

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 to the fufnding opportunity, proposals should have the following:

  • A drug that is a candidate for repurposing as a MCM against vascular injury, cell death, bleeding or coagulating disorders, or ischemia associated with ARS.
  • Is FDA-approved or has met its prinary endpoint in Phase 2 clinical trial; evidenced by a clinical study report(s).
  • A clear rationale as to why the candidate should be efficacious as a post-exposure ARS MCM.
  • Outline of appropriate facilities (or description of subcontractor or other partner) demonstrating ability to execute radiation exposure experiments
  • 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 filovirus infection will also be considered.

What is out of scope for the RePAIR program?

Projects proposing to evaluate MCMs that already have an H-ARS indication.

Projects involving prophylactic drugs that require administration prior to exposure to ionizing radiation.

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

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

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.

Looking for General FAQ?

RePAIR program is open until Feb 28 2023