Rethinking regulation: will innovation outpace the regulators?

Innovation in life sciences often outpaces regulatory frameworks, and nowhere is this more evident than in the use of AI and digital tools.

Regulatory agencies like the FDA and EMA are cautious by design, but that caution is becoming a bottleneck. 

Several participants at a recent CCO round table noted that regulatory bodies may require duplicate clinical studies, one using AI and one without, which adds cost, time, and complexity. Yet there is hope that societal, political, and industry pressure will catalyse change. 

“My hope is that we will get over the hump where things like organ chips and more efficient data use will be more accepted”

The future of regulation must be collaborative, agile, and adaptive. If agencies can evolve alongside technological innovation, they can become enablers rather than obstacles. But getting there will require open dialogue, pilot programmes, and a rethinking of how we define safety and efficacy in the digital age. 

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