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Biomarker discovery in biological fluids.

Ji Gao¹, Leah-Ann Garulacan, Stephen M Storm

¹Clinical Discovery, Pharmaceutical Research Institute, Bristol-Myers Squibb Company, P.O. Box 5400, Princeton, NJ 08543, USA.

Methods (San Diego, Calif.)

|February 22, 2005

Summary

Discovering new protein biomarkers aids drug development by improving efficacy and safety predictions. This approach outlines a three-step process for identifying, prioritizing, and validating these crucial biomarkers.

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Area of Science:

Biomarker Discovery
Proteomics
Drug Development

Background:

Novel protein biomarkers are crucial for advancing drug discovery and development.
Biomarkers enhance decision-making regarding drug efficacy, response, and toxicity.
Proteomic platforms enable rapid identification of biomarkers in diverse biological samples.

Purpose of the Study:

To delineate a systematic approach for protein biomarker discovery.
To illustrate the biomarker discovery process using drug-induced idiosyncratic hepatotoxicity as a case study.
To outline methods for marker identification, prioritization, and preliminary validation.

Main Methods:

Multi-dimensional protein identification technology for marker identification.
Prioritization based on reagent availability and disease association.

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Preliminary assay development and qualification in preclinical models.

Main Results:

A three-step strategy (identification, prioritization, validation) for biomarker discovery was detailed.
The process was successfully applied to identify potential biomarkers for drug-induced hepatotoxicity.
Methods for initial assay development and preclinical qualification were demonstrated.

Conclusions:

The presented approach provides a framework for discovering and qualifying novel protein biomarkers.
Effective biomarker discovery can accelerate drug development timelines and improve safety assessments.
This systematic process is essential for translating proteomic findings into clinical applications.