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Bridging Interventional Development Gaps

BrIDGs Frequently Asked Questions


How long is the collaboration decision process?

The decision to collaborate on a proposed project is based on an internal assessment of scientific merit, programmatic fit and the availability of NIH funds. A final decision may take several months to coordinate.

How much is a BrIDGs award worth?

BrIDGs collaborators partner with NCATS intramural scientists instead of receiving funding. The monetary value of a collaboration depends on the amount of responsibility for Investigational New Drug-directed tasks that BrIDGs assumes, which varies by project.

Is an active NIH grant required to be eligible for BrIDGs?

No.

How do I know if my business is eligible to collaborate?

A business is eligible if it meets the criteria for applying for an NIH Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) grant. An active SBIR/STTR grant is not required. Review the SBIR/STTR eligibility criteria.

Are in vivo efficacy data required before collaborating with the program?

Data from the most relevant in vivo models available should be obtained before submitting a proposal. Efficacy should be demonstrated via the intended clinical route of administration and preferably be published in a peer-reviewed journal or independently replicated. If efficacy studies have been conducted by a route which differs from that proposed for initial clinical trials, then data on these different routes must be available to compare exposure levels in target organs.

Am I required to reveal the chemical structure of the proposed compound in the proposal?

Yes. NCATS staff and external experts must have access to the chemical structure to assess the scientific merit of the proposal.

Can I out-license the proposed compound and continue to collaborate with BrIDGs?

Yes. A compound may be licensed before, during or after working with BrIDGs. The principal investigator from the collaborating organization will continue to serve as the point of contact for the project. The licensee is welcome to participate in project meetings and decisions with the permission of the principal investigator.

How does BrIDGs handle confidentiality?

Information provided to BrIDGs during the collaboration decision phase is considered confidential. When BrIDGs staff seek an opinion on the scientific merit of the project from external drug development experts, staff do so under conflict of interest and confidentiality agreements.

After a collaboration decision is made, data and products will be transferred to and from NCATS under the terms of a formal collaboration agreement. View the NCATS standard forms and model agreements.

Last updated: 09-06-2017
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