Biomarkers have many potential applications in the development of drugs. These include potentially improving the predictability of treatment effect and/or major safety concerns, screening compounds for toxicity before entering clinical development, monitoring the development of toxicity, forecasting adverse events given wider exposure, and understanding the mechanism by which a drug works. In this session, knowledgeable statisticians and expert molecular scientists are invited to give their professional, research and practical perspectives. Topics range from biomarker development in preclinical studies along with its challenges of bridging biomarker utility from preclinical to clinical development, to statistical trends in trial durations and underlying drivers with a focus on biomarker in oncology, to challenges and utility of genomic biomarker development from an industry perspective. Additionally, examples from a few disease areas, such as Alzheimer's and oncology, will be used to elucidate biomarker development and utility assessment.