A new Reagan-Udall Foundation for the FDA report lays out a set of recommendations to preserve U.S. leadership in early-stage drug development as China expands its pipeline capabilities. The report—funded by BIO and informed by a March 2026 roundtable with academic medical centers, biopharma, CROs, patient groups, and regulatory agencies—points to declining U.S. pipeline share and fewer early Phase 1 trials. Among the report’s recommendations are modernizing Investigational New Drug (IND) requirements and processes, updating Phase 1 trial designs and tools (including AI-enabled approaches), and optimizing FDA–sponsor early-stage engagement to reduce uncertainty. The report frames regulatory speed and flexibility as central constraints, with the U.S. urged to streamline pathways so promising human testing can begin earlier while maintaining safety standards.