Intensive 2-day Workshops
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a dataset collected by the EU Commission in June-September 2018
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Owner/Developer: Certara/Simcyp
| Country: |
United States of America |
|---|---|
| Languages: |
English |
| Url: |
https://www.certara.com/resource-library/simcyp-workshops/pre-consortium-focused-workshops/ |
| Created: |
10 September 2018 |
| Locations: |
United Kingdom |
| City: |
Sheffield |
| Description: | Flyer: https://www.certara.com/wp-content/uploads/Resources/Workshops/FL_SimcypConsortium2018.pdf Pre-Consortium Focused Workshops Due to previous success, the focused workshops will once again run in parallel sessions before the Consortium meeting. All workshops will be held in Sheffield at the Certara Simcyp offices. Focused workshops offer an in-depth insight into specialist areas of modeling such as: Best Practice in PBPK Model Building Pediatrics Transporters Biologics Absorption I Absorption II Parameter Estimation and Pharmacodynamics (PE/PD) Drug-Drug Interactions (DDIs) From Discovery to First-in-human (FIH) Using IVIVE-PBPK Modeling Cardiac Safety Simcyp workshops are an ideal way to enhance the continuous education of scientists working in clinical pharmacology and drug development. These events provide an excellent opportunity to develop skills, stay up-to-date with the latest scientific advances and network with delegates from industry, academia and regulatory agencies. The model-informed approach to various aspects of drug development is rapidly being adopted by many of 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 Drug (IND) and New Drug Applications (NDA) 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 implementing precision medicine. |
| Format: |
Workshops, Other |
| Presence: |
Optional / Voluntary |
| Access: |
Fee-based |
| Content type: |
Theoretical, Practical |
| Duration: |
2 days |
| Frequency: |
Recurrent event |
| Target audience: |
Researchers, Regulators and policy-makers, Teachers and educators, Managers, Scientific officers / Project managers, Professionals (e.g. veterinarians) |
| Target sectors: |
Academia, Industry, Governmental bodies, Contract Research Organizations (CROs), Consulting, SMEs |
| Educational level: |
Continuing Professional Development |
| 3rs relevance: |
Replacement |
| Topics covered: |
Computational methods |
| 3rs coverage: |
Full coverage (a dedicated course) |
| Details on the topic or technology covered: |
Best Practice in PBPK Model Building: 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. Biologics: This workshop will highlight how the Simcyp Simulator can be used to predict the pharmacokinetics and pharmacodynamics of therapeutic proteins. Transporters: The ABC of modeling drug transporter data— mechanistic approaches to predict the impact of drug transport proteins on ADME/pharmacokinetics and toxicity. Pediatrics: Predicting age related changes to pharmacokinetics (PK) and drug-drug interactions including associated variability—linking this information to drug response in the pediatric population. Participants will learn how PK behaviour can be modeled in neonates, infants, and children and how it can be linked to PD. Absorption I: Mechanistic oral absorption modeling and prediction of bioavailability for drug products incorporating inter-subject variability. Applications of the Simcyp Advanced Dissolution, Absorption, and Metabolism (ADAM) Model. Absorption II: Broadening the area and utilization of in silicobased mechanistic prediction and analysis of drug absorption. Mechanistic modeling of the topical drug application, development of mechanistic physiologically-based in vitro-in vivo correlations (IVIVCs), and virtual bioequivalence (V-BE) concepts. We strongly recommend taking Absorption I before taking this workshop. 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 modeling of pharmacokinetics linked to drug response. Drug-drug Interactions (DDIs): Predicting and evaluating complex DDIs—application of the Simcyp Population-based Simulator to real-life cases. Participants will learn good practices in combining data from both in vitro and clinical studies, whilst gaining experience in using such data within physiologically-based dynamic models to evaluate the DDI liability of drug candidates. From Discovery to First-in-human (FIH) Using IVIVE-PBPK Modeling: In this focused workshop, attendees will use the dynamic models within the Simcyp simulator to prioritize compounds for progress to the next stage of development using information available in early drug discovery. Attendees 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. Cardiac Safety: Mechanistic approaches for the assessment of a drug’s pro-arrhythmic potency within target populations. Druginduced cardiovascular adverse events were one of the leading causes of drug withdrawals from the market and of drug label restrictions. At present, these safety concerns are among the main reasons compounds’ development have stopped. |
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