The Prognosis Looks Good for Pharmacogenomics, But Are CROs Ready to Respond?

Twelve months ago (March 2005) the FDA launched its final Guidance for Industry Pharmacogenomic Data Submissions, designed to encourage the voluntary submission of genomic data as part of the approval process for new chemical entities.

Already some 25 voluntary submissions have been made, and Felix Frueh, Head of the Interdisciplinary Pharmacogenomic Review Group (and Associate Director for Genomics at the FDA's Center for Drug Evaluation and Research), believes that this, and the fact that several sponsors have made a second or even third submission, indicates that the program is "progressing well"¹.

But – are CROs ready to respond fully to requests from pharmaceutical companies to include a pharmacogenomics element in their trials?

There's the chance to find out by visiting the DxS stand (No 11) at this year's DIA Annual Euro Meeting in Paris on 6th – 8th March, and talking to their CEO, Dr Stephen Little.

As DxS is already providing pharmaceutical, biotechnology and clinical research companies with pharmacogenetic services, products and technologies to support their drug discovery, clinical development and personalised medicine, they are uniquely placed to offer comment. Furthermore, Dr Little attended many of the DIA / FDA consultation meetings that provided debate and input into the FDA guidance notes during their gestation.

To arrange an interview, please contact Kevin Payne at k.payne@defacto.com (00 44 207 861 3023) or Jo Cross of DxS at joanne.cross@dxsgenotyping.com (00 44 161 606 7201).

Ref 1: From interview in Pharmacogenomics Reporter – 8th February 2006.