Brian Drapeau

The business case for regulated AI turns on the cost of producing an outcome that the quality system can accept.

Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.

Agentic AI changes the question from what a model can produce to what a system is allowed to decide.

EMA’s draft GMP Annex 22 sidelines LLMs in critical manufacturing, fueling a push for risk-based guardrails and human accountability.

Pharma's AI ROI gap isn't strategy or tech; it's the missing workforce qualification step every other regulated capability requires.

The future of compliant AI is not better content generation. It is better control over what happens next.

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships play a role.

A warning letter, a hard look at why “a human reviews it” doesn’t settle anything, and one company’s argument that accuracy was never the real problem.

The cell and gene therapy manufacturing workforce is having to expand on deliverables while remaining under trained.