Flagship Pioneering, a venture creation and innovation firm, supports the FDA's proposed Expedited Investigational New Drug (IND) Pilot Program to modernize the U.S. system and remain globally competitive. They advocate for specific improvements, including funding for Qualified Research Institutions (QRIs), modular review processes, and alignment with international models like Australia's clinical trial notification pathway.

Jerry Henley, CEO of Azunic AI, expresses full support for the Expedited IND initiative and proposes a collaborative partnership with Australian ethics committees and regulatory experts. He suggests establishing a bilateral relationship to exchange data and operational expertise to ensure the pilot's success and avoid potential risks.

Memorial Sloan Kettering Cancer Center (MSK), an academic research institution, supports the FDA's proposed Expedited Investigational New Drug Pilot Program. They recommend that Qualified Research Institutions (QRIs) be evaluated based on integrated institutional capabilities, maintain an advisory role to sponsors, and utilize rigorous version control for rolling reviews.

Praxis Precision Medicines, Inc., a biopharmaceutical company, opposes the proposed "Qualified Research Institutions" (QRI) pilot program for Phase 1 IND submissions. They argue that the QRI construct risks outsourcing FDA's core review functions to private, sponsor-paid entities, creating conflicts of interest, accountability gaps, and a two-tiered system that favors well-resourced sponsors.

The California Institute for Regenerative Medicine (CIRM) expresses strong support for the FDA's proposed Expedited Investigational New Drug (IND) Pilot Program. They argue that the program's Qualified Research Institution (QRI) model is well-suited for complex therapies like regenerative medicine and offer specific recommendations on qualifications, oversight, and success metrics based on their experience managing the CIRM Clinical Network.

Thermo Fisher Scientific (PPD Development, L.P.) supports the Expedited Investigational New Drug Pilot Program, providing detailed recommendations on QRI qualifications, regulatory processes, and drug eligibility. They advocate for a flexible approach to QRI requirements, emphasizing demonstrated regulatory capabilities and integrated drug development strategies over mandatory ownership of all infrastructure.

The commenter supports the proposed rolling IND submission and review process but emphasizes that the FDA must define clear timelines for feedback and ensure components are reviewed within the context of the clinical investigation. They also suggest additional improvements such as shortening pre-IND meeting timelines and providing more flexibility regarding the timing of SEND dataset submissions.

Dr. Mark C. Walters, representing UCSF School of Medicine, supports the proposed Expedited Investigational New Drug Pilot Program while advocating for specific modifications to accommodate cell and gene therapies. He recommends establishing a dedicated CGT-specific QRI track, implementing "firewalling" for dual-capacity institutions, and ensuring that success metrics prioritize safety and manufacturing quality over mere speed.