title: Progress in applying genomics in drug development.
abstract: Genomics has had an impact on two areas of drug development, "predictive" toxicology and mechanism-based risk assessment. Predictive toxicology studies are aimed at identifying the potential for a compound to be toxic. By developing databases of expression profiles for a wide variety of toxic compounds and toxic models it has been possible to create statistical and computational methods which provide an indication of the toxic potential of a drug from the pattern of gene expression changes it elicits in in vitro or in vivo systems. Because gene expression is central to many responses to xenobiotics, genomic approaches lend themselves very readily to mechanistic toxicology studies. By examining changes in gene expression in cells and tissues in response to drugs it is possible to generate hypotheses as to the underlying mechanism and in some cases it is possible to evaluate hypotheses of toxic mechanism. Some concerns remain about the use of the technology but toxicogenomics can no longer be regarded as "new" technology in drug development. The investments made in applying the technology are maturing and there is a determined effort to bring the full power of the technology into drug development.
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development LLC, 1000 Route 202, P.O. Box 300, Raritan, NJ 08869, USA. plord@prdus.jnj.com
authors.forename: Peter G
authors.initials: PG
authors.lastname: Lord
mesh_terms: D000818:Animals; D015195:Drug Design; D064420:Drug-Related Side Effects and Adverse Reactions; D005544:Forecasting; D015870:Gene Expression / Q000187:drug effects; D006801:Humans; D018570:Risk Assessment; D043922:Toxicogenetics / Q000639:trends*; D014116:Toxicology