Insight
Pharma Is Deploying AI Faster Than It Can Understand Its Risk
30 July, 2026

The FDA has stated that a lack of proper AI governance can result in them directly shutting down the production lines... and when clinical trials can run into the nine-figure range, not getting things right the first time can cost pharma companies tens or even hundreds of millions of dollars due to the delay. This places a dollar figure on the value of AI governance and is proof that over-reliance and a lack of sufficient human review can result in a cost greater than most companies' risk tolerance would normally allow.
In my decades of supporting security and compliance at SaaS companies and regulated organizations, governing AI has been the most challenging hurdle I've seen organizations face... and I've had to deal with FedRAMP! When AI solution providers offer a surplus of value with their products, it is imperative that companies build structure in their AI governance and manage the risk of such tools instead of letting the risk manage them.
In my decades of supporting security and compliance at SaaS companies and regulated organizations, governing AI has been the most challenging hurdle I've seen organizations face... and I've had to deal with FedRAMP! When AI solution providers offer a surplus of value with their products, it is imperative that companies build structure in their AI governance and manage the risk of such tools instead of letting the risk manage them.
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