Comment from Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center's Investigational New Drug/Investigational Device Exemption Office supports FDA’s goal of improving first-in-human IND readiness through earlier identification of material issues and coordinated multidisciplinary review. MSK recommends that Qualified Research Institutions be evaluated based on their ability to provide an integrated institutional assessment of the development program, supported by accountable governance, appropriate clinical, nonclinical, CMC, regulatory, statistical, operational, and quality expertise, and controlled processes for documentation, issue escalation, and quality review. QRI recommendations should remain advisory, sponsors should retain responsibility for development decisions and IND submissions, and FDA should retain full regulatory authority. Rolling review should be supported by rigorous version control, change management, issue tracking, and final reconciliation so that QRI recommendations and FDA feedback remain linked to the specific materials reviewed. The pilot should preserve protections for human research participants, maintain scientific rigor, and ensure independent IRB decision-making. MSK also addresses practical implementation considerations, including reviewer qualifications, conflict management, technology infrastructure, staffing, and sustainable cost-recovery arrangements. Please find our detailed comments and responses to the RFI in the attached .pdf.