Toxicogenomics Challenges
Next to drug efficacy, drug toxicity has been highlighted as the main reason for candidate molecule failure in drug development. The crucial need to focus on toxicity was highlighted in a, now often-cited, US FDA white paper, "Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products".
Toxicogenomics has been seen as a 'better, cheaper and faster' tool to greatly improve current toxicology, speed up chemical/drug development and reduce the burden on animal testing.
As with many 'omic' technologies, there has been much hype, but it has begun maturing primarily as two types of gene-expression applications:
- Microarray bioinformatics, where gene expression can be used to identify often poorly understood toxic processes, or to better discover underlying mechanisms.
- Database-driven pattern-recognition tool. Gene-expression profiles might be seen as unique drug 'fingerprints', the idea being that if a fingerprint closely matches that of similar toxicants in a database, there is suggestion of toxicity. However, this is only 'toxicity by association', and how novel and robust enough these fingerprints are for useful predictive tools in any large-scale way has yet to be seen.