In a chemical emergency, minutes matter and a rapid deployment of medical countermeasures (MCM) is necessary to save lives and minimize injury. Centralized stockpiling of MCMs in preparation for a chemical emergency - despite working well for some incidents – is often impractical. The ReDIRECT program, a partnership between BARDA's Chemical MCM branch and DRIVe, is partnering with innovators to repurpose commonly available therapeutics to treat conditions resulting from exposure to chemical agents and enable a rapid response.
Drug repurposing, or label expansion, is a strategy that is used to identify new uses for FDA approved or late-stage investigational, therapeutics that are outside of their original, clinical indication. Drug repurposing efforts for REDIRECT are based on a “treat the symptom”, approach that is agnostic to the chemical injury itself. Candidates for repurposing will focus on treating the symptoms associated with exposure to the chemical threat, rather than the agent.
The identification of existing therapeutics for repurposing as MCMs holds the potential to expand current response capabilities to chemical threats and mitigate the costs and risks associated with conventional drug discovery. Repurposing drugs will ensure that these therapeutics are easily accessible during an emergency and reduce the reliance on centralized stockpiles or logistically challenging forward deployment programs.
Treat the Injury, Not the Agent
Identify early and late-stage therapeutic candidates for development as MCMS against a range of chemical threats.
Repurpose Therapeutics for New Indications
Develop improved methods for rapidly identifying promising repurposing candidates.
Is this Funding Opportunity open 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 amendments.
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. Applicants from outside of the United States are eligible to apply for funding.
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% minimum ,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 below 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 in 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.