The commenter, representing a global coalition of patient advocacy groups, acknowledges the benefits of the proposed program but argues it is currently ill-equipped for rare and pediatric cancers. They request further revisions to the guidance to better accommodate these specific patient communities and offer to participate in future efforts.

Concordare Trials, Inc., a clinical trial technology company, supports the Expedited IND Pilot Program and advocates for the use of structured, machine-readable protocol data to achieve the program's parallelization goals. They recommend specific technical criteria for Qualified Research Institutions (QRIs), including standards alignment with ICH M11 and CDISC USDM, and offer to share operational data and participate in technical discussions.

Dr. Jordan Despanie supports the establishment of the Expedited Investigational New Drug (IND) Acceleration Pilot Program to accelerate First-in-Human timelines and maintain U.S. biopharmaceutical competitiveness. The commenter proposes a five-pillar regulatory architecture involving Bayesian clinical trial design, AI-driven preclinical de-risking, an "Architecture of Trust" for AI governance, site-specific infrastructure, and alignment with late-stage incentives.

ICON Clinical Research, LLC expresses strong support for the FDA's Expedited Investigational New Drug Pilot Program, noting its potential to improve IND submission quality and efficiency. The company recommends specific criteria for Qualified Research Institution (QRI) qualification, the use of structured risk-benefit assessment frameworks, and the development of standardized review templates and manuals.

Dr. Ansuman Satpathy, a physician-scientist and biotechnology entrepreneur, supports the proposed Expedited Investigational New Drug (IND) Pilot Program. He recommends specific structural improvements, such as allowing QRI consortia, and suggests a future phase where proven QRIs could be granted greater decision-making authority to further accelerate drug development.

GATC Health Corp., a tech-bio company, strongly supports the FDA's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. They argue that the pilot should focus on using AI to improve decision quality—such as patient selection, dose optimization, and safety prediction—rather than just operational efficiency, while emphasizing rigorous validation, human oversight, and trustworthy AI principles.

James Foote, CEO of First Ascent Biomedical, Inc., supports the Expedited Investigational New Drug (IND) Pilot Program but urges the FDA to be more ambitious in its scope. He argues that the FDA should modernize its evidentiary standards to recognize human-derived functional evidence as translational data and establish a pathway for platform diagnostics to support new indications for already approved drugs.

The Cystic Fibrosis Foundation supports the FDA's initiative to create an expedited Investigational New Drug (IND) pilot program to accelerate early-stage drug development. They recommend a staged implementation focusing on low-risk products and suggest exploring elements of the Australian Clinical Trial Notification (CTN) scheme to streamline the process.

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.

Biocom, a trade association representing California's life science sector, supports the FDA's proposed Expedited Investigational New Drug (IND) pilot program to reduce time to first-in-human clinical trials. They offer specific recommendations to improve the program's design, including clarifying Qualified Research Institution (QRI) roles, establishing clear success metrics, and ensuring consistent regulatory oversight.