Model-informed Drug Development Intensive Interactive Courses

Simcyp Focused Workshop: Best Practice, June 3-7, 2024 | ONLINE It is assumed that the participants are familiar with the fundamentals of PBPK modeling and have hands-on experience. The main aim of this focused workshop is to demonstrate the application of best practices in developing PBPK models, and to indicate how to qualify and refine model performance. Various case studies, including some real-life examples, will be presented. The case studies will cover various elements of model development including DDIs, special populations, transporters, and different formulations. 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 are familiar 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 3-7 2024 | ONLINE This workshop will provide an in depth overview of generation of populations for mechanistic PBPK, focusing on key covariates to inform prediction of pharmacokinetics in healthy as well as disease populations. Key aspects of the course: – Building populations and Correlated Monte Carlo Sampling – Age matching clinical trial design – Bridging Studies - Japanese and Chinese Populations – Mechanistically accounting for impact of Disease – Renal Impairment, Cirrhosis populations – Oncology populations 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

A Hands-On Workshop with Simcyp Designer for Tailored PBPK-PD/QSP Models June 25, 2024 | IN PERSON, Rome, Italy 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. Participant are required to bring their own laptops as the workshop is hands-on intensive. Read more

July 15-19, 2024 | ONLINE This workshop will explain the principle of therapeutic protein pharmacokinetic and pharmacodynamic modelling. Distribution, clearance, FcRn recycling, target-mediated drug disposition (TMDD), and subcutaneous absorption will be covered for monoclonal antibodies and other therapeutic proteins. Additionally, the suppression of CYP enzymes by cytokines and thus interactions between biologics and small molecule drugs will be simulated. Participants will learn how to apply these models using case 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

Lectures in Japanese Intensive 5-day Workshop on Model-informed Drug Development - August 5-9, 2024  Venue: TKP Tokyo Station Conference Centre Early Registration Rate   January 22nd – March 26th 2024  GBP £3780 Regular Registration       March 27th – June 20th 2024        GBP £4500 Late Registration             June 21st – July 22nd 2024           GBP £5400 大手製薬会社を中心に、医薬品開発の様々な側面で、モデルを用いたアプローチの活用が進んでいます。 Simcypのワークショップは、in vitro, in vivo試験から得られる各薬物固有の性質と、様々な被験者集団に固有のデータを的確に統合して薬物動態をシミュレーションし、対象とする集団における薬物の挙動を理解することにフォーカスしています。このようなモデルに基づくアプローチにより、医薬品開発における意思決定に必要な情報提供し、臨床試験の実施及び試験デザインの最適化することが可能となります。 開発品のPK/PDを十分に理解し、開発期間とコストを削減するとともに、承認申請の質を向上させPrecision Medicineを実現することを目指しています。 Read more

This Workshop will take place in Princeton NJ, USA October 14-18, 2024 VENUE: HYATT REGENCY PRINCETON, 102 Carnegie Center,  Princeton, NJ 08540, US HOTEL: Bedrooms can be booked at - coming soon  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  COURSE COST:  £3,780          7th February to 20th June £4,500           21st June to 22nd August £5,400           23rd August to 7th October 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. Read more