When the Scientist Is an Agent: Governing AI Before It Reaches the IND
Ono Pharmaceutical's rollout of agentic AI to every discovery scientist exposes a governance gap that sits upstream of any device or wearable regulation.
Ono Pharmaceutical's rollout of agentic AI to every discovery scientist exposes a governance gap that sits upstream of any device or wearable regulation.
Discovery-stage AI funding is surging, but the mismatch compliance leaders should track is structural, not a simple case of regulation lagging money.
Closed-loop AI discovery platforms are compressing timelines faster than biopharma governance functions can build the audit trail regulators will eventually demand.
AI drug discovery's funding-to-approval gap echoes a governance failure regulators have already documented in medical devices, and the fix is the same.
Generative AI is accelerating molecule design, but no AI-discovered drug has cleared trials, and regulators have yet to define how AI governs the trials themselves.
Drug discovery leaders are validating AI systems as if they were complicated, when the real risk is that they behave as complex, emergent systems.