This session explores the EU COMBINE Pilot’s innovative approach to coordinated regulatory review for combined clinical trials and diagnostic studies, using real-world case studies. Learn how industry sponsors streamlined submissions, engaged with regulators, and achieved faster, harmonized approvals across Member States. 

Precision oncology is evolving from a single-analyte approach to a multimodal paradigm that integrates genomics, clinical data, and digital pathology. This presentation explores how Tempus utilizes AI-enabled platforms—including the Immune Profile Score (IPS) and Paige Predict—to extract predictive biomarkers from routine H&E imaging. We will examine the development of these AI-driven companion diagnostics (CDx) and their role in identifying therapeutic response signals that traditional molecular assays may miss. By bridging the gap between digital histopathology and clinical outcomes, we are building a more comprehensive toolkit for patient stratification and drug development.