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Project Selection and Implementation

Project Selection

Application receipt deadlines for the BrIDGs program are scheduled once a year. After an application is received, it is assessed for responsiveness to the program’s scope. Responsive applications are then reviewed by a panel of external experts in drug development. BrIDGs staff will conduct due diligence on the highest-scoring applications. The most competitive applicants will be invited to meet with NIH scientific staff to further discuss the merit of their projects. Final decisions will be made based on the results of the review process and the availability of funding and contract capacity.

Project Implementation

After a project is approved, BrIDGs staff works with principal investigators to develop a plan for the conduct of proposed studies. Development proceeds sequentially in most cases, and the start of one segment of the project (e.g., toxicology) may depend on satisfactory completion of preceding segments (e.g., formulation).

Once a plan is in place, BrIDGs staff members assign studies to existing contractors, or competitively solicit new contracts as needed. Selected contractors perform tasks under the direction of BrIDGs scientists. Interim study updates are provided to investigators monthly. Meetings or conference calls may be held as needed with the principal investigator to discuss the direction of the project. Final study reports are provided, as they become available, in a format ready for an Investigational New Drug (IND) application. Although formal regulatory affairs assistance is not provided by BrIDGs, our staff can provide advice on filing the IND and participate in pre-IND meetings, if desired.

The principal investigator or a collaborator is responsible for filing the IND application. After the IND is cleared, BrIDGs will release to the principal investigator any clinical trial material that has been made. Investigators are responsible for securing resources for the funding and conduct of clinical trials enabled by BrIDGs data and material.

Material Transfer Agreement

The output of BrIDGs activities, in the form of research material and data, will be made fully available to the applicant organization in support of its IND application and Phase I clinical trials. Data and material will be transferred under the terms of a non-negotiable Material Transfer Agreement.

Intellectual Property

As noted previously, NIH contractors complete tasks for BrIDGs awardees. NIH contractors, under the Bayh-Dole Act, may elect to retain rights for a contribution they make that rises to the level of invention. However, some contractors, as a term of their funding agreements, have agreed to offer a first option to the originating investigator institution for license negotiation. Other contractors or subcontractors may be subject to a Determination of Exceptional Circumstances, through which their rights in subject inventions may be assigned to the originating investigator institution.

Normally, the NIH does not acquire intellectual property rights to inventions made by its staff under this program, unless the originating investigator institution and NIH agree that to do so would be in the best interest of the project, consistent with NIH policies, law and regulations. If NIH does file a patent application, the originating investigator institution may be given the opportunity to negotiate an exclusive license under procedures set forth in 37 CFR Part 404.

Project Discontinuation

BrIDGs is not a complete drug development program or an unconditional commitment to develop a particular therapeutic agent for the clinic. Insurmountable difficulties encountered during the development process may force the discontinuation of an entire project.

Related Links

Apply to BrIDGs


BrIDGs Projects