Drug Combinations in Oncology, Rocchetti Tumor Growth Inhibition model Predictive PK-PD modelling of tumor growth after administration of antiangiogenic and cytotoxic drugs, as single-agents and in... Read more
Support adoption of repository and framework
Education and training in DDMoRe’s products and their use in drug/disease Modelling and Simulation.
The DDMoRe face-to-face course program will provide training on the use of DDMoRe products and demonstrate how these products can be integrated in Modelling and Simulation tasks to assist Model-Informed Drug Discovery and Development in 5 key therapeutic areas (Diabetes, Oncology, CNS, Cardiac Safety and Infectious Diseases).
Course materials will give insight into the DDMoRe standards the Model Description Language (MDL) and the Pharmacometric Markup Language (PharmML). A large variety of models from the Model Repository will be used together with the Interoperability Framework to train from coding models to executing pharmacometric analyses and reporting workflows.
The face-to-face courses are open to people interested in quantitative sciences applied in drug development from industry, regulatory agencies, health care providers and academic institutions, and will promote a tighter collaboration between DDMoRe´s key stakeholders.
| Course | Exercise | Introduction | Type of data | ||
| Oncology (basic) | Tumor growth inhibition model | Estimation, Bayesian estimation and simulation using a preclinical tumour growth inhibition model (Simeoni et al. Cancer Res 2004). | Preclinical,disease (oncology), pharmacokinetics-pharmacodynamics (PKPD), Time-course data, simultation, estimation | ||
| CNS | An agonist-antagonist interaction model for prolactin. | An agonist-antagonist interaction model for prolactin release following risperidone and paliperidone treatment. (Friberg et al. CPT, 2009) | Clinical, disease, time-course data, pharmacokinetics-pharmacodynamics (PKPD) | ||
| Cardiac Safety | Prediction of TQT study outcome based on early clinical data | Model-informed drug discovery and development online course to illustrate the principles of cardiac safety in drug discovery and development. This includes consideration on preclinical, translational, clinical, regulatory expectation and modeling and simulation prospectives. A hands-on exercise on translating preclinical QT interval (QTc) data from dogs to phase I clinical outcome in humans using pharmacokinetic–pharmacodynamic (PKPD) analysis for evaluation of Cardiac Safety risks using DDMoRe platform is available. (Parkinson et al. J Pharmacol Toxicol Methods 2013) |
preclinical, clinical, time-course data, circadian variability | ||
| Infections | PKPD of antibiotics | Online course material on antibiotics and bacterial infections adapted from the Infectious disease course in model-informed drug development. The material includes a brief background to the type of data typically used for PKPD-modelling, common PKPD-model structures with consideration of drug resistance as well as potential use in drug development. The hands-on example illustrates the application of the DDMoRe platform for estimation and prediction using a PKPD-model developed from in vitro time-kill data |
In-vitro, pharmacodynamics (PD), time-course data, infectious disease | ||
| Oncology (advanced) | Tumor growth inhibition model | Estimation, simulation and Optimal Design with a preclinical PKPD model of tumour growth under combination therapy (Rocchetti et al., Cancer Chemother Pharmacol 2013) | Preclinical, clinical, disease (oncology), pharmacokinetics-pharmacodynamics (PKPD), Time-course data, simultation, estimation, drug-drug interaction, optimal design |
Drug Combinations in Oncology, Rocchetti Tumor Growth Inhibition model Predictive PK-PD modelling of tumor growth after administration of antiangiogenic and cytotoxic drugs, as single-agents and in... Read more
Online course material on antibiotics and bacterial infections adapted from the Infectious disease course in model-informed drug development. The material includes a brief background to the type of... Read more
Model-informed drug discovery and development online course to illustrate the principles of cardiac safety in drug discovery and development. This includes consideration on preclinical,... Read more
An agonist-antagonist interaction model for prolactin release following risperidone and paliperidone treatment. Model used (Friberg et al. CPT, 2009) Material extracted from the DDMoRe face-to-face... Read more
Tumor Growth Inhibition models An estimation-simulation study with the Simeoni model Predictive PK-PD modelling of tumor growth after administration of a cytotoxic drugs as single-agent. Model used... Read more
The DDMoRe consortium concludes the series of comprehensive face-to-face courses with the first advanced course introducing the principles of model-informed drug development, covering a range of... Read more
This DDMoRe course in Infectious Diseases is one in a series of comprehensive face-to-face courses introducing the principles of model-informed drug development, covering a range of therapeutic areas... Read more
This Pharma lead DDMoRe course in Cardiac Safety evaluation is one in a series of comprehensive face-to-face courses introducing the principles of model-informed drug discovery and development,... Read more
DDMoRe consortium continues a series of comprehensive face-to-face courses introducing the principles of model-informed drug development, covering a range of therapeutic areas, via the newly-... Read more
The first public DDMoRe course launches a series of comprehensive face-to-face courses introducing the principles of model-informed drug development, covering a range of therapeutic areas, via the... Read more
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Support was received from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115156, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. The DDMoRe project is also financially supported by contributions from Academic and SME partners