Overview
During surgical procedures, maintaining optimal factor IX plasma levels in hemophilia B patients is critical to prevent severe bleeding while avoiding unnecessary over-dosing.
This project involved developing a specialized Model-Informed Precision Dosing (MIPD) application designed to assist clinicians and pharmacometricians in personalizing recombinant factor IX (rFIX-FP) dosing schedules prior to and following surgery.
Key Technical & Functional Highlights
- Clinical PK Integration: Implemented individual dosing optimization based on population pharmacokinetic (popPK) models tailored to rFIX-FP.
- Precision Dosing Interface: Engineered an intuitive interface for inputting patient demographics, baseline factor levels, and target surgical coverage profiles to simulate optimal bolus or continuous infusion regimens.
- Workflow & Visualization: Developed real-time simulation output views showing predicted plasma concentration-time profiles alongside target therapeutic windows.
- Reproducible Architecture: Designed modular computational workflows ensuring rapid Bayesian updates and robust execution.
Scientific Validation & Publication
The clinical pharmacokinetic framework and simulation logic powering this software were validated and published in Haemophilia:
Publication: Pharmacokinetic evaluation of rFIX-FP for surgical prophylaxis in patients with hemophilia B.
Reference: Haemophilia (2026) | PMID: 42227215
Role & Services Delivered
- Role: Lead Software Developer & Scientific IT Architect (via Lynxsoft SRL / Calvagone)
- Scope: Software architecture, UI/UX implementation, simulation engine integration, and clinical workflow optimization.