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Molecular biomarkers in drug development.

David A Lewin¹, Michael P Weiner

¹CuraGen Corporation, Pharmacogenomics Services & Biomarkers, 555 Long Wharf Drive, New Haven, CT 065011, USA. david.lewin.grd.biol@aya.yale.edu

Drug Discovery Today

|November 13, 2004

Summary

Biomarkers from the genomics era promise to improve drug development. They aid early decisions and patient stratification, ultimately benefiting patients and accelerating therapeutic discovery.

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Area of Science:

Biomarker discovery and application in pharmaceutical research.

Background:

The genomics era has introduced biomarkers as a key tool in drug development.
Biomarkers offer potential to enhance preclinical and clinical decision-making.

Purpose of the Study:

To explore the role and promise of biomarkers in accelerating drug development.
To highlight how biomarkers can improve understanding of preclinical and clinical data.

Main Methods:

Review of biomarker applications in various stages of drug development.
Analysis of potential benefits for patients and pharmaceutical companies.

Main Results:

Biomarkers can guide early decisions like dose ranging and treatment regimens.
Biomarkers facilitate patient stratification and the definition of surrogate endpoints in clinical trials.

Conclusions:

Realizing the promise of biomarkers will integrate them as routine components in drug development.
Biomarkers are poised to become essential companions to novel therapeutic agents.

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