Model-informed Drug Development Intensive Interactive Courses

November 17-21, 2025 | ONLINE This course broadens the range and utilization of in silico-based mechanistic prediction and analysis of drug absorption after oral delivery, including the development of mechanistic physiologically based in vitro-in vivo correlations (IVIVCs), virtual bioequivalence (VBE) concepts, and application of biopharmaceutic IVIVE using the SIVA Toolkit.  We strongly recommend attending Oral Absorption I before taking this workshop. Read more

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.     Read more

March 2-4, 2025 | IN PERSON (Chevy Chase, Washington DC) This workshop aims to enhance understanding and practical application of PBPK modelling in drug development and regulatory interactions. It covers both foundational concepts and real-world case studies, providing valuable insights for researchers in industry, academia, and regulators. The workshop will cover: 1. A quick introduction to PBPK modelling and exploration of extrinsic (e.g., concomitant medications) and intrinsic factors (e.g., age, organ dysfunction, genetics) on drug exposures. 2. Best Practices in PBPK model development covering integration of data from various sources, context of use and model assessment. When you can use PBPK models for extrapolation and regulatory applications. 3. Real-World case studies including drug-drug interactions, supporting dosing recommendations, application of PBPK in diverse patient groups (e.g., paediatrics, elderly, organ dysfunction) and Biopharmaceutical applications.   VENUE: Embassy Suites by Hilton Washington DC Chevy Chase Pavilion, 4300 Military Road NW, Washington, District of Columbia, 20015, USA TIME: 09:00 - 17:00 each day  CONSORTIUM MEMBER PONTS: 3 points per person LAPTOP: Delegates are required to bring a laptop computer, and will be provided with access to the Simcyp Simulator via Amazon Workspaces for the duration of the course.  COURSE MATERIAL: will be provided electronically via LearnUpon Read more

March 2-3, 2025 | IN PERSON (Chevy Chase, Washington DC)  Overview: This hands-on workshop is designed to deepen your understanding of the biopharmaceutic aspects of physiologically based pharmacokinetic (PBPK) modelling and its practical applications, including formulation development, virtual bioequivalence and automated safe space assessment. Covering both foundational concepts and case studies. This event offers a comprehensive learning experience for professionals in industry, academia, and regulatory agencies. Workshop Highlights: 1. Overview of the biopharmaceutic/oral absorption modelling tools including modelling of in vitro solubility and dissolution experiments to better understand your data and parameterise biopharmaceutic aspects of PBPK models. 2. Handling of different formulations ranging from suspensions and IR to controlled and modified release including ASDs and salts. 3. Mechanistic modelling of food effects including advanced aspects such as the Magenstrasse. 4. Application of virtual bioequivalence (VBE) and automated safe space tools. 5. Learning best practices and regulatory requirements through case studies. Read more