Binil Benny

Consultant Pbpk & Qsp Modeling Clinical Pharmacology @Vial

CA, US

As a pharmacometric consultant at Vial Health Technology, I provide advanced physiologically based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) modeling support to guide dose selection, clinical trial simulations, and regulatory submissions. My work focuses on simulating the in vivo disposition and exposure of biologics to enable data-driven model-informed drug development (MIDD) decisions.Key responsibilities include:Designing and executing PBPK models for monoclonal antibodies (mAbs), integrating FcRn-mediated recycling, target binding, and subcutaneous absorption dynamics.Building and validating multi-compartment models.Performing cross-species allometric scaling (mouse → human) and applying IVIVE principles to refine human PK predictions.Generating exposure-matching and dose-equivalence analyses for clinical translation.Preparing technical documentation, model summaries, and exposure–response reports in alignment with FDA/EMA regulatory expectations.