Maria Trujillo

This intensive workshop will delve into the advanced quantitative strategies necessary for navigating the complexity and high investment of developing multi-target and combination GLP-1 therapeutics. Leveraging deep experience from both large pharma and pioneering biotech, the session will focus on transforming traditional trial execution into a continuous, model-informed decision engine to minimize risk, maximize capital efficiency, and accelerate time to market for novel cardiometabolic solutions.

This workshop will gather experts to discuss:

• Integrating model-informed drug development (MIDD) strategies to reduce the required size and duration of costly Phase 2 and 3 combination trials, ensuring dose selection is robust and scientifically grounded
• Applying advanced pharmacometric (PMX) and PBPK modeling to predict synergistic or antagonistic effects of novel GLP-1 combinations (including oral formulations) and optimize dosing schedules before committing to large-scale clinical studies
• Designing efficient, adaptive clinical protocols that incorporate Bayesian and other quantitative methods to dynamically adjust dose levels, target populations, and hypothesis testing in real-time
• Quantifying the translational power of combination therapies by linking pre-clinical data (neurobiology, whole animal response) directly to human efficacy and safety endpoints to justify increased development spend
• Establishing effective cross-functional decision-making gates between Quantitative Pharmacology, Clinical Development, and Research to accelerate development timelines for therapeutics targeting obesity and MASH/NASH