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.
FDA's AI-enabled device authorizations are scaling faster than lifecycle governance infrastructure, and the same gap is now stalling AI drug discovery approvals.