With growing pressures of increasing success rates for FDA approved biomarkers, there is a need for a first time right, cost-effective and reliable biomarker discovery and development strategy to secure the essential regulatory approvals. The major challenges faced in securing these approvals include identifying the right biomarkers, understanding disease mechanisms, stratification of patient groups and developing standard protocols and assay platforms.
Overcoming these challenges will help in timely discovery, proper validation, robust development of right biomarkers for appropriate application and clinical validation for drug discovery and disease diagnosis