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.
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
INDdirected 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
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.
Your feedback and comments on all aspects of the NExT Program are important to us
and should be directed to Barbara Mroczkowski via NCINExTinfo@mail.nih.gov.
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