The NCI Experimental Therapeutics Program (NExT)
DCTD and the Center for Cancer Research (CCR) are working in close collaboration to reinvigorate cancer drug development at NCI. Through a joint early therapeutics development program, extramural and intramural teams have prioritized a pipeline of NCI-driven targeted therapeutics for development. This program, called the NCI Experimental Therapeutics (NExT) program, combines the strengths of DCTD’s extensive expertise in anticancer drug development with CCR’s dynamic in-house research and its location within state-of-the-art facilities at the NIH Clinical Center.
The NExT program requires research resources that are not readily available at most medical centers engaged in anticancer drug development. The goal of the NExT program is to shave up to 1 year off the typical 10- to 12-year drug-development cycle.
The NExT program has grown out of the reality that the number of new anticancer agents reaching human clinical trials has been modest. Even when compounds do proceed to clinical testing, they often fail because of unexpected toxicities or are not effective. NExT not only allows phase 0 trials to be conducted in humans, it brings together the teams of scientists necessary to develop and perform assays that can measure the biological effects of potential new anticancer agents. The assays provide a tool for the systematic removal of investigational agents from NCI's drug development pipeline that do not show expected biological effects and inform and expedite decisions about further clinical development.
- The Chemical Biology Consortium - A New NCI Initiative
- Validated Assays, Specimen Handling Procedures and Reagent Sources for Clinical Pharmacodynamic Studies
- Phase 0 Imaging Agent Study
- More Phase 0 Activities
- 2007 Workshop Archived Videocast: Phase 0 Trials in Oncologic Drug Development
- NCI Experimental Therapeutics Program (NExT)
- Testing a New Oncology Drug Development Paradigm
- Accelerating Cancer Drug Development
- New NCI Experimental Therapeutics (NExT) Program Heralds Shortened Timeline for Anticancer Drug Development
- New Study Heralds Shortened Timeline for Anticancer Drug Development
- New Approaches to Cancer Drug Development and Clinical Trials: Questions and Answers
About the Director
James H. Doroshow, M.D., FACP, has been the Director of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), National Institutes of Health (NIH), since 2004. He is responsible for integrating the activities of DCTD with NCI’s other divisions and offices, as well as extramural scientists and clinicians, patient advocates, and professional cancer organizations. More…