Sponsored by:
Session Chairs:
Nicholas Dracopoli, Bristol-Myers Squibb, USA
Thomas White, Celera Diagnostics, LLC, USA
Biomarkers are being increasingly used in all aspects of drug development from target discovery to life cycle management. Early implementation of biomarker discovery and assay development strategies into the clinical development plan is essential for clinical trial design and monitoring for first-in-class compounds, as well as for second generation compounds against the same target or pathways. The definition of biomarkers is very broad and encompasses genomic biomarkers (single nucleotide polymorphisms) used in genetic association studies to dynamic markers (quantitative gene expression assays by microarrays or qPCR, proteomics and the more traditional assay formats including immunochemistry and flow cytometry). Given the breadth of opportunities for the application of biomarkers in drug development from target identification to dose selection and prediction of drug efficacy and risk of adverse events, no single biomarker strategy exists for any therapeutic area, let alone an entire discovery and development portfolio. This symposium will focus on several successful applications of both genomic and dynamic biomarkers in drug development to illustrate possible strategies to reduce attrition and accelerate clinical development.