Topic: Overview of the Coordination of the Experimental Therapeutics Clinical

To address the new opportunities and challenges in the development of novel targeted cancer therapeutics, the NCI has established a systematic approach with several interacting functional components. The NCI Experimental Therapeutics Program (NExT) is the portal through which NCI brings investigational agents into DCTD/CTEP for development. After a new agent is chosen for development, the Investigational Drug Branch (IDB) Project Team Leader will form an NCI Project Team from the various clinical, translational, and basic biology programs at NCI. Members of the Project Team will draft a preliminary drug/biomarker/assay development plan. Once this plan is reviewed and approved by the NCI Senior Advisory Committee (SAC), part of the NeXT approval process, NCI will send out a request for a Project Team Application (PTAs) to the ET-CTN members, awardees of the NCI Phase 2 Contracts Program, NCTN awardees, and other appropriate investigators.

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