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.

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.

Optisources, Inc., a small business technology consulting firm, supports the Expedited IND Pilot Program but recommends specific technical requirements to ensure data integrity and equity. They advocate for a platform featuring tamper-evident provenance, a governed semantic layer for heterogeneous data ingestion, AI-assisted classification, and a common submission platform to lower barriers for smaller organizations.

Veeva Systems, a life sciences software provider, supports the proposed Expedited IND Pilot Program and urges the FDA to include technology partners in the initiative. They argue that a single, streamlined technology platform is essential for standardizing data, ensuring auditability, and enabling cross-QRI comparison.

Edward H. You, Founder and Principal of EHY Consulting LLC, supports the FDA's Expedited Investigational New Drug (IND) Pilot Program. He argues for accelerating promising therapies while ensuring patient safety, manufacturing integrity, and robust clinical data stewardship.