Comment from Precigenetics, Inc.
AnonymousSupportBusiness
Summary: Precigeneics, Inc., a nonclinical drug development platform company, strongly endorses the draft guidance and its four-pillar validation framework. They provide fourteen specific recommendations aimed at making the framework more operationally credible for integrated, AI/ML-enabled New Approach Methodologies (NAMs) without lowering evidentiary standards.
Precigenetics, Inc. submits the attached comment on Docket No. FDA-2025-D-6131. We strongly endorse the four-pillar framework and the clarification at lines 34–40 that formal validation is not a precondition for review. Our fourteen recommendations focus on making the framework operationally credible for the emerging class of integrated, longitudinal, information-rich, and AI/ML-enabled NAMs — including measurement methods whose Context of Use is best defined at the platform level, modular validation for separable system components, technical-characterization expectations for machine-learning and mechanism-grounded computational models (with explicit treatment of interpretability, black-box risk, and multimodal class imbalance), and a fourth Fit-for-Purpose objective for integrated platform NAMs. We also propose operational infrastructure to reduce reviewer and sponsor friction: a glossary, a priority drug-class × NAM-type matrix, a structured Context-of-Use briefing template, structured Information Requests, reviewer rubrics, NAM specialist reviewer pairings, and a public cross-species toxicology discordance registry within the Complement-ARIE NAM Data Hub. None of our recommendations asks FDA to lower the evidentiary standard; each asks FDA to make the standard more precise, actionable, and consistently applied. Full comment and a proposed NAM Context-of-Use briefing template attached.