Gentris attended the DIA/FDA sponsored 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making in Washington DC February 2-4. Many members, if not all, from the I-PWG (Industry-Pharmacogenomics Working Group) presented information on the state of pharmacogenomics today.

The I-PWG is comprised of individuals from 19 pharmaceutical companies. Some of the topics included labeling of pharmaceuticals to include pharmacogenomic testing such as the new relabeled drug, warfarin. The label now reads, "The patient's CYP2C9 and VKORC1 genotype information, when available, can assist in selection of the starting dose." The use of retrospective data during drug development was also discussed with K-ras testing for cetuximab (Erbitux) and panitumumab (Vectibix) being used as an example.

The importance of sample collection and storage was discussed in detail. If samples are not collected, shipped, or stored properly prior to analysis, data generated from those samples may skew results. Harmonization of proper collection, shipping, and storage conditions is essential for generating accurate results. The conference provided an excellent opportunity to discuss where pharmacogenomics is today and where the field needs to go in the future.