Model-informed Drug Development Intensive Interactive Courses

Online & In-Person options available

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A Short presentation from Professor Amin Rostami, Certara SVP of R&D and Chief Scientific Officer.  Read more

1 Day IN PERSON EVENT - Simcyp Biopharmaceutics – Recent Advances and Applications 22 May 2024 – Sannomiya Training Center, Kobe, Japan The impact and acceptance of Physiologically-Based Pharmacokinetic (PBPK) modelling continues to exhibit strong growth within the pharmaceutical industry, and PBPK approaches are increasingly being advocated by regulatory agencies to streamline drug development. The US FDA has released its draft guidance on this in Oct 2020: ‘The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls’ https://www.fda.gov/media/142500/download. PBPK or Physiologically-Based Biopharmaceutics modelling (PBBM), whether for new drugs or generics, clinical stage or biopharmaceutics/formulation, has clearly demonstrated its value in saving time and budget, while strengthening internal decision-making. At this event we will present recent development in the biopharmaceutics module of the Simcyp Simulator and through several real-word case studies illustrate the increased adoption of Model Informed Formulation Development (MIFD) by sponsors and acceptance by regulators. There are many applications to integrate these technologies into drug programs, specifically to support: Predicting the outcome of a Bioequivalence (BE) study comparing test and reference formulations Formulation changes in late stage clinical development Dissolution specification setting Manufacturing site change Waiver of BE study Minimize the number of “pilot” PK studies Provide more confidence in the outcome of a “pivotal” BE study Read more

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

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