The Society for Clinical Research Sites (SCRS) supports the FDA's Expedited IND Pilot Program and its goal of restoring U.S. leadership in early-phase research. However, they argue that the current proposal lacks sufficient input from clinical research sites and recommend including sites as Qualified Research Institutions (QRIs) and making site feasibility assessments a formal deliverable.

The University of California, Davis (UC Davis) expresses enthusiastic support for the FDA's proposed Expedited Investigational New Drug (IND) Pilot Program. They argue that their vertically integrated infrastructure, which combines GMP manufacturing, translational science, and clinical trial capabilities, makes them an ideal "Qualified Research Institution" (QRI) to help accelerate the development of complex therapies like cell and gene therapies.

Duke University expresses strong support for the FDA's Expedited Investigational New Drug (IND) Pilot Program, highlighting its own extensive infrastructure and expertise in early-phase drug development. They provide detailed recommendations on QRI qualification, pilot design, and funding to ensure the program effectively accelerates first-in-human clinical trials while maintaining safety and scientific rigor.

The Association for Multisite Research Corporations (AMRC) supports the FDA's proposed Expedited IND Pilot Program to accelerate drug development while maintaining safety standards. They recommend recognizing experienced Phase 1 clinical trial networks as Qualified Research Institutions (QRIs) and suggest measuring program success through operational metrics like site activation and recruitment performance.

The National Center for Health Research (NCHR), a nonprofit organization, opposes the proposed Expedited Investigational New Drug (IND) Pilot Program as currently structured. They argue that the sponsor-funded model creates significant conflicts of interest and potential biases that could compromise participant safety and independent scientific oversight.

Insmed Incorporated provides detailed feedback on the proposed Expedited Investigational New Drug Pilot Program, offering specific recommendations on QRI qualifications, conflict of interest mitigations, and success metrics. While they express concerns about potential resource burdens and the need for clear FDA oversight, they generally support the initiative as a means to accelerate Phase 1 FIH study initiation.

The commenter supports the Expedited IND Pilot Program but requests that the roles of Qualified Research Institutions (QRIs) be clearly defined to avoid duplication of effort. They argue that QRI participation should be optional, that sponsors should retain primary responsibility for IND content, and that the FDA should establish clear performance timelines for QRIs to ensure efficiency.

Breakthrough T1D, a type 1 diabetes research and advocacy organization, supports the FDA's Expedited Investigational New Drug Pilot Program. They advocate for specific modifications, including establishing a cell and gene therapy (CGT) specialization track, prioritizing products with high unmet medical needs, and ensuring equitable access for smaller innovators.

Allucent (US) LLC, a global contract research organization, supports the FDA's proposed Expedited Investigational New Drug (IND) Pilot Program (Operation TrialBlazer). They provide specific recommendations to ensure the pilot effectively shortens the timeline to first-in-human initiation through objective QRI qualification, modular tracks, and clear success metrics while maintaining safety standards.

Melinda B. Chu, CEO of Intellicite Labs, submits a technical roadmap outlining a long-term research agenda for AI-enabled regulatory science and pharmaceutical development. The submission supports the modernization of regulatory science by proposing a computational ecosystem to improve evidence generation, drug discovery, and clinical development.