Model-informed Drug Development Intensive Interactive Courses

March 17-21, 2025 | 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

March 17-21, 2025 | 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

April 23-25, 2025 | ONLINE A Hands-On Workshop with Simcyp Designer for Tailored PBPK-PD/QSP Models Would you like to modify and tailor population PBPK models? This course will review the principles of PBPK modelling, using the Simcyp Simulator and how to use Simcyp Designer to modify existing PBPK models with your own extension and link them to custom-built PD/QSP models. We will have lectures to introduce the PBPK models to be changed and have hands-on exercises to train the customisation of PBPK models with the Designer. No prior knowledge is required. Access to the Simcyp Simulator and Simcyp Designer will be provided.  Course Cost £700 (3 Points for Consortium Members) This course will run via Teams: Wednesday 23rd April 4-6pm (UK time) Thursday 24th April 3-6pm (UK time) Friday 25th April 3-4pm (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

May 12-23, 2025 | 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 2-6, 2025 | ONLINE Parameter Estimation and Pharmacodynamics (PE/PD) A systems pharmacology approach to modeling and simulation—accelerating model building and covariate recognition in drug development by combining top-down and bottom-up PBPK modeling of pharmacokinetics linked to drug response. The workshop covers the concepts and the practical applications of integrating in vitro data and physiological knowledge with clinical observations for the purpose of estimating unknown/uncertain model parameters. Delegates will work through different parameter estimation examples using fitting tools and explore various PD models. 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 2-6, 2025 | ONLINE Mechanistic oral absorption modelling and prediction of bioavailability for drug products incorporating inter-subject variability. Theory and applications of the Simcyp Advanced Dissolution, Absorption, and Metabolism (ADAM) Model. Gut wall permeability and first-pass metabolism Drug solubility, dissolution, precipitation and supersaturation Oral drug absorption incorporating food effects Bioavailability and the impact of physiology and dosage form including salts Entero-hepatic recirculation Inter-individual variability assessment Application of the SIVA Toolkit to the modeling of in vitro experiments to confirm and/or estimate parameters for PBPK simulations with a case study; mechanistic modeling of dissolution and precipitation in USP 2, USP 4, serial dilution, transfer and biphasic systems. 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