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In drug development, go/no-go decisions concentrate translational risk and expose real consequences. When AI or digital biomarkers influence that call, decision-grade evidence in a regulated environment is not optional. This episode sits in the moment every executive recognizes: the slide is on the screen and someone asks, “Do we advance?” Here’s the tension. We love the word validated, but what happens when the next dataset disagrees? We introduce a practical discipline we call the decision warranty: clear scope, clear evidence chain, clear boundaries, and explicit triggers for pause, rerun, or escalation. Someone has to own that call. Takeaway: if you cannot write the stop triggers and the decision owner on one page, do not let the tool move the decision.

• (00:00) - Forward Looking Themes for 2025
• (01:00) - Reproducibility Crisis and Foundational Biology
• (02:00) - Digital Measures and Preventive Health
• (03:00) - Multimodal AI and Foundation Models
• (06:00) - Closed Loop Data Generation and Innovation
• (09:00) - Decision Making as a Core Capability
• (13:00) - Human in the Loop and Accountability
• (16:00) - Micro Physiological Endpoints and Decision Use Limits
• (21:00) - Democratizing Data and Model Access
• (24:00) - Biology as Foundation for Modeling Systems
• (28:00) - Opportunity, Effort, and Due Diligence