CSO Huahui Health Biotech Beijing, China (People's Republic)
Non-invasive biomarkers leveraging digital and Precision Healthcare: Liver diseases, including viral hepatitis, non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and cancer, present significant challenges due to their genetic-environmental complexity. This complexity complicates our understanding of disease progression and the mechanisms of drug action. The limited availability of biopsies underscores the urgent need for the discovery and validation of non-invasive biomarkers (NITs) to improve diagnostics and therapeutic monitoring, including the special patient population.
Learning Objectives:
Biomarker-Driven Drug Development and Precision Medicine: From early-phase discovery to Phase II integration, learn how biomarker combinations can establish proof of concept and enhance therapeutic strategies.
Leveraging Limited Data Sets and Advanced Modeling Techniques: Understand the differences between predictive and prognostic modeling, and explore how machine learning can address data limitations in biomarker research.
Validation Processes: Gain insights into the critical steps of analytical validation and clinical validation to ensure robustness and reliability in biomarker applications.
Regulatory and Guideline Considerations: Learn about regulatory frameworks and engagement strategies that guide biomarker implementation, ensuring compliance and fostering collaboration between stakeholders
Statistical Approaches and Composite Biomarker Scores: Discover how statistical considerations and composite serum biomarker scores can optimize enrichment trials for diseases such as HBV-related advanced HCC and other liver disorders.