Comment from Praxis Precision Medicines

Summary: Praxis Precision Medicines, Inc., a biopharmaceutical company, opposes the proposed "Qualified Research Institutions" (QRI) pilot program for Phase 1 IND submissions. They argue that the QRI construct risks outsourcing FDA's core review functions to private, sponsor-paid entities, creating conflicts of interest, accountability gaps, and a two-tiered system that favors well-resourced sponsors.