Applying AI in Regulated Industries
Navigating Compliance While Unlocking Innovation For over 15 years, the narrative in regulated industries like Pharma, Diagnostics, and Forensics has been the same: "Agile and compliance will never work together." or "The EU AI Act will kill innovation." I've spent two decades proving that wrong. From leading cloud-native COVID platforms processing 300k tests daily to championing "validation-as-code," I've learned that compliance isn't a blocker—it's an engineering challenge waiting to be solved. "Integrity Before Velocity: Real-world data never sleeps, and manual validation can't keep pace. The only way to survive is continuous retraining and auto-auditing." The Failure Mosaic: Why AI Fails in Pharma We've seen the headlines. Theranos failed because of opacity and false claims. Watson Oncology failed because impressive demos didn't match the me...