Tomoyuki Mizuno, PhD, FCP

I am a clinical pharmacologist specializing in integrating pharmacometrics, AI/ML, and digital health technologies to advance precision therapeutics. My team collaborates with clinicians and scientists across disciplines to develop and implement AI-driven and model-informed precision dosing strategies.

Most therapies rely on “average” dosing recommendations, despite wide variability in drug exposure, efficacy, and toxicity. These limitations are particularly pronounced in neonates and infants, whose rapidly evolving physiology profoundly alters drug disposition. To address this, our overarching goal is to improve the safety and effectiveness of pediatric pharmacotherapy by leveraging data-driven, mechanism-based, and machine-learning–enabled quantitative modeling.

Our group is actively developing next-generation digital tools, including Bayesian and ML-enabled dosing algorithms, digital twins, and EHR-integrated clinical decision support dashboards (e.g., RoadMABTM), to enable individualized therapy for children with complex diseases such as inflammatory bowel disease, critical illness, and immune-mediated conditions. These platforms aim to support real-time clinical decision-making and facilitate the scalable implementation of precision dosing.

I serve as director of the Pharmacometrics Center of Excellence program, providing strategic clinical pharmacology and pharmacometrics support for pharmaceutical and biotechnology companies, including pediatric clinical trial design and initial Pediatric Study Plans (iPSPs) for FDA submission. I also lead the Clinical Pharmacokinetics Consultation Service at Cincinnati Children’s, delivering real-time MIPD support to guide clinicians’ point-of-care dosing decisions.

Our research has been recognized through several prestigious awards, including the Tanabe Young Investigator Award from ACCP, the Victor Armstrong Young Investigator Award from IATDMCT, the Young Scientist Award from MEXT in Japan, and multiple manuscript honors such as Simcyp’s Most Informative Scientific Manuscript Award.

I enjoy collaborating with colleagues worldwide through my roles in scientific communities, including serving as Secretary of IATDMCT, former Chair of the Precision Dosing Community of ASCPT, and Associate Editor of Therapeutic Drug Monitoring.