Céline Brochot

Head of Mechanistic Modelling, CERTARA

Céline Brochot is an internationally recognized expert in physiologically based pharmacokinetic (PBPK) modeling, with over two decades of experience in model development and application across drug development and chemical risk assessment. She holds a PhD in Biomathematics from the University of Paris VI and has led PBPK workstreams across several European risk assessment programs. Céline has served as a PBPK expert for ANSES, EFSA, and the OECD, and has authored more than 65 peer-reviewed publications. Since joining Certara in 2023, she has contributed to a diverse range of programs, including the development of advanced methods for sensitivity analysis and model fitting, platform qualification efforts, and investigations into liver toxicity.

Presentation: Integrating Population Variability and Virtual Twins in physiologically based pharmacokinetic (PBPK) to Enable Precision Medicine

Physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) modeling has emerged as a powerful approach to support drug development and precision medicine by providing a mechanistic framework to understand variability in drug exposure and response. PBPK models integrate drug properties with physiological and population variability, including differences in demographics, organ function, disease status, metabolic capacity, and concomitant medications, enabling characterization of inter-individual variability, prediction of exposure–response relationships, optimization of dosing strategies, and support of regulatory decision-making. By leveraging virtual populations and advanced simulations, Virtual Twin approaches in PBPK modeling are emerging as a means to advance precision dosing and accelerate the transition from one-size-fits-all treatment toward individualized therapies. Virtual Twins are individualized in silico representations of patients generated by integrating patient-specific characteristics with mechanistic PBPK/PD models. This presentation will first describe the development of virtual populations and their role in capturing human variability, followed by selected case studies illustrating PBPK modeling applications and the emerging use of Virtual Twins to support personalized treatment strategies.

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