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Toxicogenomics in drug development.

Nelson Guerreiro¹, Frank Staedtler, Olivier Grenet

¹Novartis Pharma AG, Pharmacogenomics, Preclinical Safety, Basel, Switzerland. nelson.guerreiro@pharma.novartis.com

Toxicologic Pathology

|December 25, 2003

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Toxicogenomics integrates toxicology and bioinformatics to understand drug toxicity and efficacy at the molecular level. This approach uses gene expression profiling for predictive biomarkers in drug development and risk assessment.

Area of Science:

Toxicology
Bioinformatics
Genomics

Background:

Toxicogenomics merges toxicology with advanced technologies and bioinformatics.
It offers a new paradigm for understanding drug toxicity, efficacy, and individual susceptibility.
It aims to elucidate molecular mechanisms underlying toxicological responses.

Purpose of the Study:

To provide an overview of expression profiling technologies in toxicogenomics.
To discuss the potential and challenges of applying toxicogenomics in drug development.
To highlight the role of toxicogenomics in mechanistic and predictive toxicology.

Main Methods:

Gene expression profiling using DNA microarrays.
Proteomic technologies for global analysis.

Related Experiment Videos

Bioinformatic analysis of large-scale datasets.

Main Results:

Identification and quantification of global gene expression changes.
Establishment of links between expression profiles, mode of action, and toxic endpoints.
Development of 'molecular fingerprints' as diagnostic or predictive markers.

Conclusions:

Toxicogenomics promises to significantly advance drug development and risk assessment.
It enhances understanding of molecular mechanisms of toxicity and efficacy.
Integration into drug development phases, particularly for biomarker discovery, is anticipated.