Recognizing that early-stage drug development is the gateway through which laboratory discoveries become next-generation medicines, the Reagan-Udall Foundation for the FDA convened an invitation-only roundtable to explore opportunities to strengthen the U.S. early-stage drug development ecosystem.
The resulting report, Enhancing Early-Stage Drug Development in the United States, presents recommendations and supporting solutions to modernize Investigational New Drug requirements and review processes and streamline and expedite initiation of Phase 1 clinical trials in the United States.
The report is organized around five key areas: modernizing IND requirements and processes; modernizing Phase 1 clinical trials and tools; optimizing FDA-sponsor early-stage engagements and processes; building a streamlined and dedicated U.S. Phase 1 infrastructure as part of a national clinical trial infrastructure and coordinating strategy; and mitigating litigation risk for First in Human and Phase 1 clinical trial sites.
The report includes 17 recommendations and a consolidated table of solutions and stakeholder leads. The intent of this project is to support focused action across regulators, sponsors, clinical trial sites, patient communities, and policymakers to help maintain U.S. leadership in early-stage drug development.
Biotechnology Innovation Organization provided funding for this meeting.