ABOUT NExT

The NCI’s Experimental Therapeutics (NExT) Program, a partnership between NCI’s Division of Cancer Treatment and Diagnosis (DCTD) and the Center for Cancer Research (CCR), consolidates NCI’s anticancer drug discovery and development resources in support of a robust, balanced, goal-driven therapeutics pipeline. Combined, these resources are capable of supporting a discovery and development continuum from initial discovery through Phase II clinical trial evaluation. The NCI is focused on moving high-priority discovery and development projects through to proof-of-concept clinical trials and, when warranted, will continue non-commercial research and development activities (up through and including clinical trials) on any discovery project in the NExT Program.

The discovery engine of this program is the Chemical Biology Consortium (CBC). The NCI has established this collaborative network comprising 12 of the top Specialized and Comprehensive Screening and Chemistry Centers with world-class capabilities covering high-throughput methods, bioinformatics, medicinal chemistry, and structural biology. Additionally, the highly successful Developmental Therapeutic Program (DTP) provides the resources needed to facilitate discovery and late-stage preclinical development through the final steps of development to first-in-human studies. Concurrent molecular imaging and/or pharmacodynamic assay development provided by the Cancer Imaging Program (CIP), National Clinical Target Validation Laboratory (NCTVL), and CCR allow early assessment of potential clinical biomarkers. These coordinated and focused R&D processes enable continued incorporation of new data and disease insights into every step of the discovery and development process, thereby increasing the potential for successful clinical evaluation of agents.

Clinical evaluation is supported by the Cancer Therapy Evaluation Program (CTEP), NCI. The development program will be a collaborative effort between NCI and industry for agents in the late preclinical stage or early clinical stage to further develop the clinical program in the niche area that is outside the pharmaceutical industry's scope. Agents requiring IND-directed toxicology data or agents already in Phase I or II clinical trials are of interest. Companies seeking NCI collaboration are encouraged to apply to the NExT Program.

Recognizing the importance of an integrated approach to therapeutics development, NCI Senior Leadership has organized a unified governance structure for the NExT Program responsible for coordinating and integrating available resources. With a goal of reaching go/no-go decisions as efficiently as possible, the purpose of NExT governance is to ensure a pragmatic approach to drug discovery and development and a clear path to market. With the governance structure and unified NExT Program Mission, NCI will make data-driven decisions following NExT Stage Gate guidelines to maximize the potential for success at each consecutive stage. As such, the NExT Program is envisioned to streamline the development and testing of promising new anticancer drugs and expedite their delivery to bedside.