Applications of Genomic Data in Novartis Clinical Development

• Activity Number: 51
• Type: Invited
• Date/Time: Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
• Sponsor: ENAR
• Author(s): Douglas Michael Robinson*
• Companies: Novartis Pharmaceuticals
• Keywords: Genomics ; Biomarker ; Diagnostics ; Pharmaceuticals ; NGS ; Prediction

Abstract

In the pharmaceutical industry, one goal using pharmacogenomics information is to select patients who have certain characteristics that may respond to your treatment over the standard of care, or therapy of a competitor. Identification of patients is made through assays that are commonly DNA, RNA or protein based, may be multi-marker and/or may even be derived through a combination of technologies. To the health authority, assigning treatment to specific patients represents significant risk and requires the generation of a high quality companion diagnostic assay to ensure that a consistent patient population is robustly selected over time. This requires running a series of experiments to both verify and eventually validate that the assay performs according to strict specifications. In a clinical setting, there are several challenging factors that may negatively impact the quality of the diagnostic data one collects. In addition, the popularity of genomic screening presents new challenges that require open dialogue among academia, industry and regulators. These challenges, accompanied by actual examples, will be the focus of my presentation.