A Virtual Pharma Organization
With private funding and Duke’s help, Roses focuses on discovery and development.
June 10, 2008 | Last year, Allen Roses left his position as senior vice president, pharmacogenetics, at GlaxoSmithKline to return to Duke University Medical Center, where he is director of the Duke Drug Discovery Institute (and Jefferson-Pilot Professor of Neurobiology and Genetics and a member of the Duke Institute for Genome Sciences and Policy). Ricki Lewis caught up with Roses, who keynoted Bio-IT World Expo in 2006 (See “Personalized Medicine’s Rosy Picture,” Bio-IT World, May 2006), to review pharma’s approach to genome-wide screening, his new freedoms back in academia, and the latest on pharmacogenomics and Alzheimer’s research.
Bio-IT World: How is the pharmaceutical industry using genome-wide association studies (GWAS)?
Roses: Genome wide screening for pharma will be most important in confirming candidate gene variants that differentiate patients with efficacy, using the particular end-points of the clinical trial. This is most important at the critical proof-of-concept (POC) step. Let’s say a molecule has made it through preclinical safety and first time in humans. The first efficacy indication would come from a small Phase IIA trial, then a larger Phase IIB proof of efficacy trial. During these smaller trials, an extensive list of polymorphisms from candidate genes, immunological genes and HLA antigens would be tested for possible associations. At this early stage, genome wide screening—and correction for the number of tests performed—would not be productive. The candidate list is small and more focused. The efficacy PGX experiment is designed to compare patients who met the proposed clinical endpoints against patients who did not. In this way early hypotheses could be incorporated into Phase III registration studies and, if re-confirmed, provide more information for targeting therapy. Read more.