Comment from Trames Bio

Docket No. FDA-2026-N-4699 for Expedited IND Pilot Program; Request for Information A.2.i. What changes, if any, would you recommend regarding QRI responsibilities and expected tasks during the pilot? Are any tasks unfeasible or should be undertaken by the sponsor rather than the QRI? [Comment] The roles and responsibilities of Qualified Research Institutions (QRIs) throughout the IND review process should be clearly defined to avoid duplication of effort and unintended delays. QRIs should primarily serve as scientific and technical advisors supporting IND development and preparation, while sponsors should retain full responsibility for the content, quality, and submission of the IND. QRI participation should be optional rather than a default requirement for sponsors participating in the pilot. Sponsors vary considerably in their internal regulatory, scientific, and technical capabilities, and many already possess substantial expertise relevant to a specific IND submission. The pilot should therefore provide sponsors with the flexibility to determine whether QRI involvement would add value to a particular development program, rather than requiring an additional layer of assessment that may not improve efficiency for all programs. FDA should also clarify the role of QRIs after IND submission, particularly when FDA identifies deficiencies or requests additional information during review. It is currently unclear whether sponsor responses to FDA review comments would require additional QRI review or endorsement before submission to FDA. If QRI involvement is expected at this stage, clearly defined responsibilities and performance timelines should be established to ensure that QRI review facilitates timely issue resolution rather than introducing an additional review layer. This consideration is particularly important because many QRI subject matter experts are expected to maintain significant professional responsibilities, including clinical practice, academic research, and participation in multiple development programs. Competing commitments may affect their availability and responsiveness. FDA should therefore consider establishing minimum operational expectations for participating QRIs, including response-time commitments and adequate staffing, to support the expedited objectives of the pilot. Throughout the pilot, interactions between FDA and the sponsor should remain direct. Sponsors should remain responsible for addressing FDA review comments and making decisions regarding the content of the IND. QRI participation should complement—not complicate—the review process.