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

Dear Dr. Labosky: ChemicalQDevice respectfully submits this application to the NIH Director's Pioneer Award for "Daraxonrasib Phase 1 LLM-Directed Robotic Whipple in KRAS-Mutated PDAC." The proposed work builds a first-in-human, verification-first clinical-trial architecture that combines perioperative daraxonrasib, robotic pancreaticoduodenectomy, and auditable LLM-centered document and operations support. The application is grounded in a recent public portfolio that includes the Phase 1 IND package, the companion Phase 1 protocol, the Phase 2 comparative follow-on protocol, oncology-trial repository workflows for synchronized document generation, and three PDAC modeling streams - large-scale in silico, QSP, and digital-twin studies - used to structure feasibility logic, scenario stress testing, and trial-readiness reasoning. Consistent with the Pioneer mechanism, the project is not a routine scale-up of existing work; it proposes a materially new research direction in which drug, device, verification, and regulated clinical operations are co-designed as a single governed translational system with broad implications for future Physical AI oncology trials. Sincerely, Kevin Kawchak CEO ChemicalQDevice