Clinical Trial Funding Application v2.0, RFA-RM-27-001, Kawchak K.

Dear Dr. Labosky: ChemicalQDevice respectfully submits “Daraxonrasib Phase 1 LLM-Advised Robotic Whipple Trial in KRAS-Mutated PDAC” to the NIH Director’s Pioneer Award. The application proposes a first-in-human, combined drug-device investigation of perioperative daraxonrasib and an eight-arm robotic pancreaticoduodenectomy, with an on-premises, repository-pinned LLM acting only as a second-opinion advisory system. Three bounded generation roles are tested: synchronized drafting of protocol, consent, regulatory, and operating artifacts; task-level surgical advisories derived from verified sensor context; and perioperative daraxonrasib pause-and-restart recommendations. Every output is source-, model-, commit-, and seed-pinned, screened before generation by verification, validation, and uncertainty-quantification gates, written to an audit trail, and accepted only after qualified human review. The LLM cannot authorize treatment, enter the vendor kinematic stack, or command an actuator. This is a new research direction rather than a routine scale-up: targeted therapy, robotic Whipple execution, human authority, Combined IND/IDE obligations, LLM peer review, and computational assurance are prospectively co-designed as one falsifiable clinical-trial system. The Phase 1 Protocol provides the operative, dosing, endpoint, and oversight context used throughout this application. Sincerely,Kevin KawchakCEO, ChemicalQDevice