Description
Simcyp Workshop – Clinical Applications of Endogenous Biomarkers using PBPK
Tutors: Matt Harwood, Aneesh Karkhanis, Olha Shuklinova
Date: 1-5 December 2025
Time: 15:00-18:00 Daily
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.
Objectives
Key aspects of the course:
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An introduction to the broad field of clinical biomarkers, their historical utility and current considerations in PBPK modelling.
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To gain an appreciation as to the processes to be considered for the development, verification and limitations biomarker models for metabolic DDIs for example 4-beta-hydroxycholesterol as a metabolic biomarker for CYP3A induction.
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Become familiar with the key features and operation of the endogenous module within the Simcyp simulator.
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Development and verification of endogenous molecule files within the endogenous module of Simcyp with a focus on hepatic and renal transporter interactions.
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Exploring the significance of biomarkers in understanding the effects of disease on ADME proteins activities.
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Utilizing endogenous biomarker PBPK models to better understand clinical observations and inform regulatory requirements.
Certificate
By completing/passing this course, you will attain the certificate Biomarkers Certificate Online
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