As FDA moves builds out ‘Elsa,’ this AI compliance CEO underscores that need for a hybrid AI approach

This article originally appeared in R&D World on June 16, 2025.

The FDA hails the recent rollout of its internal AI tool, Elsa, as a major move to tackle the crushing weight of regulatory review where documents thousands of pages long are commonplace. But as reports of a rushed, buggy rollout surface, one regulated AI expert Erez Kaminski, a former AI strategist for Amgen and now CEO of Ketryx, says the agency may be in for an uphill battle — at least initially as it builds out the infrastructure. “I think it’s just really, really hard to make regulated AI work well,” Kaminski said.