It is clear that gene expression profiling systems have a role to play in many facets of drug discovery and development but several questions remain. We take a look at the use of DNA microarray for gene expression or expression profiling and how DNA chips are used for drug discovery and development as a whole.
Toxicological safety testing of compounds has not yet advanced to the point where measurement of gene expression is being incorporated in the internal decision process of most companies, much less the FDA approval process. The FDA has asked for voluntary submissions, is preparing guidelines for gene expression data and has identified surrogate biomarker assays as the avenue to escape the dilemma highlighted in the FDA white paper �Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products
The art and science of prediction is a risky and humiliating exercise.As bad as we are at it, predicting things remains one of the fundamental human instincts, undoubtedly linked to a Darwinian selective advantage for our species. So no matter that the umbrella was left behind because rain was not predicted or the bridge falls down because we did not know enough about harmonics, our predictions for the next decade of gene expression profiling will undoubtedly be accurate.