Pre-Conference Day

• Leveraging digital pathology fibrosis measures to generate more detailed assessments of tissue-level changes, improving evaluation of therapeutic impact and supporting more informed development decisions
• Evaluating markers of portal hypertension alongside fibrosis endpoints to provide a broader understanding of disease progression, enabling enhanced patient characterization and improving clinical trial interpretation
• Integrating innovative measures of advanced liver disease into therapeutic assessment strategies to strengthen efficacy evaluation, supporting development planning and accelerating progress toward meaningful patient outcomes

•  Evaluating complementary imaging and biomarker approaches to generate a more comprehensive understanding of disease progression and treatment response, enabling more informed development decisions and strengthening clinical confidence
• Correlating non-invasive biomarker changes with clinically meaningful fibrosis outcomes to improve endpoint relevance, supporting broader adoption across MASH development programs
• Integrating scalable monitoring approaches into late-stage clinical strategies to improve operational efficiency, strengthening long-term applicability and future treatment implementation

Step away from the slide decks and join informal, peer-led discussion groups. Share experiences, debate novel methodologies, and benchmark strategies with your peers in an intimate, high-value networking environment.

• Defining regulatory expectations for non-invasive endpoint qualification provide greater clarity around evidence requirements, enabling more efficient biomarker and drug development
• Building fit-for-purpose evidence packages that align with evolving regulatory frameworks and support acceptance of non-invasive endpoints across multiple contexts of use
• Establishing clinically meaningful endpoints that can improve trial efficiency, reduce reliance on invasive procedures, and expand patient access to innovation

• Generating deeper insights into disease progression and treatment response through integrated biomarker approaches to better characterize patient populations, enabling more informed development strategies and improving trial precision
• Leveraging exploratory biomarker readouts to improve decision-making, reducing development risk and accelerating program progression
• Aligning biomarker strategies with regulatory and clinical endpoints to strengthen translational confidence, improving development efficiency and supporting future adoption of non-invasive approaches

• Evaluating which translational tools are most effectively predicting clinical success to strengthen target validation and reduce late-stage development risk
• Identifying gaps between preclinical efficacy signals and clinical outcomes to improve development decision-making and accelerate candidate progression
• Exploring how AI-enabled discovery platforms, advanced models and translational biomarkers can improve confidence in next-generation therapeutic development

• Defining regulatory expectations for non-invasive endpoint qualification to improve development confidence, enabling clearer validation strategies and accelerating clinical progression
• Aligning biomarker evidence packages with evolving regulatory frameworks to strengthen endpoint acceptance, improving approval readiness and reducing development uncertainty
• Establishing clinically meaningful non-invasive endpoints to support broader adoption across trials, improving scalability and future patient accessibility
• Leveraging public-private partnerships to generate the shared data, expertise, and regulatory science needed to advance qualification efforts that no single organization could achieve alone

Step away from the slide decks and join informal, peer-led discussion groups. Share experiences, debate novel methodologies, and benchmark strategies with your peers in an intimate, high-value networking environment.

• Assessing how biomarker-driven patient stratification strategies can reduce heterogeneity and improve therapeutic signal detection in clinical studies
• Exploring emerging endpoint approaches that better capture disease progression and treatment impact, enabling stronger efficacy assessment
• Discussing how sponsors can balance scientific rigor, operational feasibility and regulatory expectations to optimize future trial design