Report
New report details how U.S. can maintain biotech competitiveness
Overview
A new report from the Reagan-Udall Foundation for the FDA, funded by BIO, warns that the United States is on the verge of losing its historic lead in drug development—its share of the global pipeline has slipped from 47% in 2013 to 36% in 2025 as China closes the gap. To stay competitive, the report calls for modernizing Investigational New Drug requirements, redesigning Phase 1 trials with AI-enabled tools and earlier patient input, improving FDA–sponsor engagement, building a dedicated U.S. Phase 1 trial infrastructure, and reducing litigation risk for trial sites.
The Big Picture
New York is already moving on much of this agenda. The state’s $620 million Life Science Initiative and New York City’s $1 billion LifeSci NYC program—including $450 million to spur new research and $430 million for lab and incubator space are building the blueprint for early-stage trial and research infrastructure the report says the country lacks. With more than 100 research centers, New York offers a ready-made backbone for a national Phase 1 network. As Washington debates how to defend U.S. biotech leadership, New York is already showing what the playbook looks like.
