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& Support
The OCBN offers biomarker discovery, development, and validation services
to support our industry partners in the use of biomarkers to support the decision making process during clinical development of an NCE.
In addition, the OCBN offers clinical and analytical validation services to our industry partners to support the co-development of a biomarker or panel of biomarkers with
a new chemical entity.
In the drug development process, appropriately qualified biomarkers
can be utilized as:
Risk assessment markers
Identification of susceptible population
Indicator for early intervention
Diagnostic markers
Screening markers
Identification of treatment population
Entry criteria for clinical trials
Enrichment strategies for clinical trials
Stratification of patients in clinical trials
Prognostic markers
Severity of disease and probable course (‘slow’ vs. ‘fast’ progressors)
Determine aggressiveness of treatment
Response markers
Predict and monitor efficacy
Dose selection for pivotal trials
Dose adjustments
Surrogate endpoint
Predict and monitor safety
Dose selection for pivotal trials
Dose adjustments
Drug discovery support:
Identification of new targets
Identification of mechanism of action-related biomarker targets
Drug Development Support:
Through partnerships, full range of Phase I services
Seamless integration of biomarker measures in Phase I and II
Clinical, analytical, validation and consulting services to support the co-development of a biomarker or panel of biomarkers with a new chemical entity
