Model-informed Drug Development Intensive Interactive Courses

Clinical Applications of Endogenous Biomarkers using PBPK  Tutors: Matt Harwood, Aneesh Karkhanis, Jakub Witkowski, Xian Pa Date: November 16-20, 2026 | ONLINE Time: 15:00-18:00 Daily (UK time)  Number of participants: Minimum 6 / Maximum 40  Course Title: A Hands-On Workshop to explore the clinical applications of Endogenous Biomarkers using PBPK  This course provides a mixture of lectures, demonstrations, and hands-on exercises focusing on clinical applications of endogenous biomarkers using PBPK models. Details of model development and assumptions along with model verification and application will be described. Attendees will be able to view ‘live’ lectures, simulator demonstrations and gain access to the Simcyp simulator to undertake guided hands-on exercises, facilitate recognising the core aspects of endogenous molecule modelling within PBPK. The hands-on exercises will be provided to reinforce the presented concepts.  This workshop particularly lends itself to individuals keen to explore the development and clinical/regulatory applications of endogenous molecule PBPK models that are sensitive, specific and selective markers of ADME-related enzymes and transporters. Attendees will explore the role of PBPK biomarker models to evaluate the potential risk of metabolic and transporter-mediated DDI risk, while the practical advantages of employing biomarkers as a tool to refine the PBPK model for application in disease states are presented. The utility of the simulator to use its firmly established features available to ‘small molecule’ files for development of endogenous biomarkers are introduced, which then progresses into hands-on application of the Simulators recently incorporated endogenous module.   Read more