Model-informed Drug Development Intensive Interactive Courses

November 3-7, 2025 | ONLINE Predicting age related changes to pharmacokinetics (PK) and drug-drug interactions including associated variability—linking this information to drug response in the pediatric population. Participants will learn how PK behavior can be modeled in preterm and term neonates, infants, and children and how it can be linked to predict the drug response (PD) within the PBPK platform. Hands-on exercises explore how this valuable information is relevant to early and informed decisions to assist in the improved design of pediatric clinical studies. Live Online Courses There are no refunds for Live Online courses. Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

November 10-14, 2025 | ONLINE A Hands-On Workshop: Advanced Simcyp Designer for Tailored Biologics PBPK-PD/QSP Modelling This advanced hands-on workshop builds upon foundational knowledge of biologics PBPK modelling and guides you through the creation and extension of large molecule models using Simcyp Simulator’s biologics module and Simcyp Designer’s biologics platform. Participants will engage in hands-on exercises to build and refine models for monoclonal antibodies and other biologics, integrating mechanistic PK, complex distribution processes, and downstream PD/QSP components. This workshop focuses on applying Simcyp Designer to rapidly prototype and iterate advanced biologics models, with emphasis on building reusable components and tailoring models to fit specific mechanisms, data, or hypotheses. Lectures and tutorials are informed by a published biologics PBPK tutorial (Link), extended with new case studies and model structures. Prerequisites: Basic biologics PBPK modelling knowledge is recommended. Access to the Simcyp Simulator and Simcyp Designer will be provided.  Course Cost £1350 (3 Points for Consortium Members) This course will run via Teams: Monday10th November 3-6pm (UK time) Tuesday11th November 3-6pm (UK time) Wednesday 12th November 3-6pm (UK time) Thursday 13th November 3-6pm (UK time) Friday 14th November 3-5pm (UK time) Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

November 17-21, 2025 | ONLINE The ABC of modelling drug transporter data: Mechanistic approaches to predict the impact of drug transport proteins on ADME, Pharmacokinetics, and Toxicity Overview: This course provides a dynamic mixture of lectures, demonstrations and hands-on exercises providing a wide-array of theory and practical know how. Live demonstrations of the simulation platforms essential for consideration in developing PBPK models with transporters are given, which will facilitate the attendees learning, driven through hands-on sessions to be attempted remotely. The hands-on sessions will be re-visited the following day with the tutors providing guidance, troubleshooting tips and facilitating interactive Q&A on the exercises. Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

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