Pharmacogenomic-guided drug development: regulatory perspective

Pharmacogenetics (PGt) and now the more global term, pharmacogenomics (PGx), have come to the forefront after an evolutionary period of more than 30 years. Several transforming events in the past 5 years, not the least of which was the completion of the human genome sequence in 2001, have created an expectation that genetic and genomic information will produce sweeping changes in the practice of medicine and the prescribing of drugs. The almost daily press reports of new gene discoveries lend credence to the argument that personal genetic/genomic profiles will have a tremendous impact on health by the year 2010. This vision has not been without naysayers; however, we believe that the central issue is not whether PGt- or PGx-guided drug prescriptions will happen, but when and how.