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

Ketryx

and

R&D World

June 16, 2025

[AI](https://www.ketryx.com/learn/blog?tag=generative-ai)

[Compliance](https://www.ketryx.com/learn/blog?tag=compliance)

## Table of Contents

[Section link](https://www.ketryx.com/blog/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._**](http://www.rdworldonline.com/as-fda-moves-builds-out-elsa-this-ai-compliance-ceo-underscores-that-need-for-a-hybrid-ai-approach)

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.

[Read the full article](https://www.rdworldonline.com/as-fda-moves-builds-out-elsa-this-ai-compliance-ceo-underscores-that-need-for-a-hybrid-ai-approach)

### Interview transcript

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