After a proposal is approved, BrIDGs staff work with the principal investigator 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) depends on satisfactory completion of preceding segments (e.g., formulation).
Once a plan is in place, BrIDGs staff assign studies to existing contractors or competitively solicit new contracts as needed. Selected contractors perform tasks under the direction of BrIDGs scientists. Principal investigators receive monthly study updates. Meetings or conference calls may be held as needed with the principal investigator to discuss the direction of the project. BrIDGs staff provide final study reports, as they become available, in a format ready for an Investigational New Drug (IND) application. Although BrIDGs staff do not provide formal regulatory affairs assistance, staff can provide advice on filing the IND and participate in pre-IND meetings, if desired.
The principal investigator or a third-party collaborator is responsible for filing the IND application. After the IND clears, BrIDGs staff will release to the principal investigator any clinical trial material developed during the collaboration. Investigators are responsible for securing resources for the funding and conduct of clinical trials enabled by BrIDGs data and material.
Material and Data Transfer
The output of BrIDGs activities, in the form of research material and data, is available to the collaborating organization in support of its IND application and clinical trials. Data and material will be transferred under the terms of a collaboration agreement.
Collaborators are encouraged to pursue licensing discussions with third parties during the course of collaboration with BrIDGs. If a licensing agreement is completed, the principal investigator from the collaborating organization will continue to serve as the point of contact for the project. The licensee can participate in project meetings and decisions, with the permission of the principal investigator.
Project Delays and Discontinuations
BrIDGs is not a complete drug development program or an unconditional commitment to develop a particular therapeutic agent for the clinic. The collaboration may encounter difficulties that are scientific (e.g., unwieldy synthesis, poor safety margin, unanticipated toxicity) or administrative (e.g., cuts to program funding or contract capacity). Insurmountable difficulties encountered during the development process may force the delay or discontinuation of an entire collaboration.