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AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role

 
• By Sue Sutter

Regulatory uncertainty and the biopharma industry’s longstanding aversion to risk are hindering adoption of artificial intelligence and machine learning in drug and biologic development, panelists said at a recent US FDA/CTTI workshop.  

Hallucination
Humans can stop AI models from producing hallucinations, but are they always needed? • Source: Shutterstock

Uncertainty remains for inspections and automation as industry navigates the use of artificial intelligence and machine learning in product development and awaits formal US Food and Drug Administration guidance.

At a recent FDA/Clinical Trials Transformation Initiative meeting on AI in drug and biological product development, panelists said that regulatory uncertainty as well as the biopharma industry’s longstanding aversion to risk

Key Takeaways

  • Drug developers seek more clarity from the FDA about inspection expectations when AI elements are used in drug development.

  • AI models may run without any human element in some limited contexts of use, FDA officials said

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