American biotechnology still leads in scientific innovation, but its advantage in turning science into medicine is eroding. Part 1 examines how slower, more expensive clinical development is shifting the competitive edge toward China, and what’s at stake for the future of U.S. biotech.

Industry leaders share real-world insights on using agentic AI to streamline clinical trials, accelerate decisions, and improve study execution.

The ground has shifted for FSO (functional service outsourcing) and Unitized FSP (functional service providers) contract research organizations (CROs). 

For years, the playbook for managing these types of CRO economics was familiar. Sponsors negotiated rates while CROs managed headcount and utilization around those rates .

That playbook still holds true today in theory. However, the conditions underneath it have shifted enough that it no longer produces the results it used to. Funding is tighter, sponsors are smaller and more price-sensitive, timelines are compressing ahead of the patent cliff, and AI has moved from an experiment on the roadmap to a baseline expectation in every RFP.

None of that is unique to any one segment of the market, but these pressures land differently for FSO and unitized FSP providers than they do for full-service CROs. That’s because these businesses are built on rate cards for CRAs, monitors, and other functional resources. When sponsors squeeze rates or expect more output per unit, there's no broader program fee to absorb the hit, here the unit economics are the business.

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