Model-informed Drug Development Intensive Interactive Courses

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 The US FDA has released its draft guidance on this in Oct 2020: ‘The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development,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

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

April 15-26, 2024 | ONLINE  Live sessions typically run for 3hrs per day 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

May 13-17, 2024 | 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

Simcyp Focused Workshop: Absorption I, May13-17, 2024 | 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