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NIH - National Institutes of Health National Cancer Institute Division of Cancer Treatment and Diagnosis Center for Cancer Research
NCI Experimental Therapeutics Program (NExT)
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Last Updated: 07/17/13

NExT R&D Activities

The NExT pipeline is arbitrarily divided into six discovery stages. Projects can enter at any stage based on specific need.

Example of Activities that Support NExT Discovery Stages

Target
Validation
Exploratory Screen
Development
Screening/
Hit-to-Lead
Lead
Development
Candidate
Selection
Preclinical
Evaluation

Evaluate and define
the role of therapeutic target in disease initiation and/or progression:

Is the target associated with disease pathology?

Identify causal/driver variant(s)/patient populations with
genetic backgrounds susceptible to intervention.

Conduct a technology overview

Develop a screening strategy

Identify potential biomarkers (efficacy/surrogate)

Develop a strategy for “clinical readiness”

Prepare medical needs assessment

Prepare project operational plan

Run screen(s)

Assess mechanism of action for link to disease

Determine desirable potency

Determine evidence of structure–activity relationship

Evaluate functional activity in vitro

Determine selectivity for target

Evaluate physicochemistry (Rule-of-Five compliance)/in silico modeling

Evaluate PK and PD using best available tools

Assess amenability to synthesis

Evaluate stability

Establish laboratory objectives for clinical efficacy

Resolve IP issues

Evaluate activity in validated disease models

Evaluate physicochemistry

Differentiate leads from competitors and current therapies

Evaluate preliminary safety issues

Develop PD and toxicology biomarker assays(s)

Assess achievability of human PK/PD profile

Assess feasibility of scale-up and bulk synthesis

Evaluate synthesis and proposed clinical formulation

Evaluate biopharmaceutical properties (absorption in rodents and non-rodents, clearance, and bioavailability)

Assess potency against clinical efficacy

Evaluate biodistribution

Evaluate clinical readiness of PK/PD assay(s) and specimen handling SOPs

Assess amenability to imaging

Evaluate safety issues (most sensitive species) in range-finding toxicology studies

Prepare clinical development plan

Manufacture GMP-grade bulk drug/active pharmaceutical ingredient (API)

Conduct IND-directed toxicology studies including toxicokinetics

Determine preclinical MTD, DLTs, and starting dose

Validate PK/PD assay(s) and specimen handling SOPs

Develop and validate product characterization and release assays

Characterize clinical product

Prepare CMC package and toxicology summary report

Prepare and review clinical protocol at each participating site

Prepare and file IND