BIO responded to the FDA’s request for information on its Expedited Investigational New Drug (IND) Pilot Program under Trialblazer, praising the concept of rolling review but warning that a proposed Qualified Research Institution (QRI) scientific partner layer could add delay. BIO argued that, unless QRI review is clearly decoupled from FDA’s review, the model risks increasing workload rather than accelerating time-to-safe-to-proceed. BIO also flagged uncertainty around QRI regulatory status, variability in QRI quality, over-reliance on QRI recommendations, and potential bottlenecks tied to limited QRI resources or qualification questions. The FDA’s pilot is designed to test whether QRIs can ensure sponsors submit complete, standardized IND packages with external expert recommendations, but BIO urged tighter guardrails around implementation.