Comment from Dyne Therapeutics, Inc
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Summary: Dyne Therapeutics, Inc. supports the FDA's proposed Expedited Investigational New Drug Pilot Program aimed at shortening the time to first-in-human clinical study initiation. They recommend specific criteria for qualifying Qualified Review Institutions (QRIs), emphasizing expertise in rare diseases and complex modalities, while ensuring sponsors retain regulatory strategy ownership and that success is measured by end-to-end acceleration.
Dyne Therapeutics, Inc. (Dyne) appreciates the opportunity to comment on FDA’s proposed Expedited Investigational New Drug Pilot Program. Dyne supports FDA’s objective of shortening the time from drug identification to first-in-human clinical (FIH) study initiation while maintaining rigorous scientific review and protections for clinical trial participants.
Based on Dyne’s experience developing innovative therapies for serious diseases, we recommend that FDA focus the pilot on ensuring that:
• QRIs have demonstrated expertise relevant to the specific therapeutic modality under review;
• Sponsors retain ownership of their regulatory strategy and direct communication with the FDA; and
• Pilot success is measured based on true end-to-end acceleration through first-participant dosing, rather than only the duration of FDA’s formal IND review
Dyne’s comments are attached as a separate document and have been organized to follow the structure of the RFI with select responses provided under the corresponding category/question heading.