Model-informed Drug Development Intensive Interactive Courses

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

March 16-20, 2026 | ONLINE The aim of this workshop is to provide an overview of PBPK models to predict the pharmacokinetics of complex large molecules such as antibody-drug conjugates (ADCs), bispecific antibodies, and oligonucleotides. Of special interest will be the prediction of therapeutic protein concentration in the tumour and the application of a tumour model. Furthermore, the simulation of large molecules in the monkey and paediatrics will be discussed. Several model applications will also be presented. The course runs live online sesions via Teams for approximatley 3 hours per day with optinal hands on learning outside of the sessions.  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

May 11-22, 2026 | ONLINE  Live sessions typically run for 3hrs per day via Teams with assignments to complete out of session. Incorporating population variability into mechanistic prediction of PK and modeling PK/PD The model-informed approach to various aspects of drug development is rapidly being adopted by the leading pharmaceutical companies. The Simcyp workshops focus on the optimal use of compound-specific in vitro and in vivo data together with system specific information related to humans to simulate and understand drug behavior in various target populations. This integrated approach informs decisions related to Investigational New Drugs and assists with the conduct and optimal design of clinical studies. The ultimate aim is to better understand drug PK/PD properties, reduce the cost and time of drug development, improve the quality of regulatory submissions, and eventually implement precision medicine. 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

June 8-12, 2026 | ONLINE From Discovery to First-in-human (FIH) Using IVIVE-PBPK Modeling In this focused workshop you will use the dynamic models within the Simcyp Discovery Simulator to prioritise compounds for progress to the next stage of development using information available in early drug discovery. You will use information on clearance, absorption, tissue distribution and DDI liability to inform compound selection. Finally, from the originally large database, only a few compounds will be selected for FIH and the simulation results compared with available clinical data. The case studies will cover various elements of model development including absorption, distribution and elimination. Optimal in vitro and clinical data sets will be discussed. Participants will learn how to choose the most suitable models and also investigate the impact of various relevant assumptions on model performance. Requirements for regulatory submissions will also be discussed. It is assumed that the participants have some familiarity with the fundamentals of PBPK modeling and have hands-on experience. 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

June 8-12, 2026 | 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 £1450 (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