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Page | 1 Tuesday June 10 18.30-20.00 Registration at The Tuesday June 10 18.30-20.00 Registration at the Cruise Terminal 20.30-22.30 Welcome reception at the Santísima Trinidad located in front of Hotel Melia Wednesday June 11 08:00-08:45 Registration 08:45-09:00 Welcome and Introduction Chair: Leon Aarons and Panos 09:00-10:20 OrBiTo and Mechanistic absorption modelling Macheras Amin Rostami- OrBiTo - translating mechanistic knowledge on absorption into predictive 09:00-09:40 Hodjegan models Benjamin Mechanism-based modelling of gastric emptying and bile release in response 09:40-10:00 Guiastrennec to caloric intake Andrés An in silico physiologically-based pharmacokinetic (PBPK) study of the impact 10:00-10:20 Olivares- of the drug release rate on oral absorption, gut wall metabolism and relative Morales bioavailability 10:20-11:50 Coffee break, Poster and Software session I Posters in Group I (with poster numbers starting with I-) are accompanied by their presenter 11:50-12:40 Facilitating Modelling and Simulation Chair: Charlotte Kloft Development of Virtual Population for a Quantitative Systems Pharmacology 11:50-12:10 Kapil Gadkar model 12:10-12:30 Maciej Swat PharmML 1.0 – An Exchange Standard for Models in Pharmacometrics Marc 12:30-12:40 Proposal for a Web-Based Open Pharmacometrics Curriculum Gastonguay 12:40-14:10 Lunch 14:10-15:10 Model-based individualisation Chair: Nick Holford Pierre 14:10-14:50 Implementing model-based individualization in the clinic Marquet Page | 1 Núria Buil A step forward toward personalised medicine in oncology: Population 14:50-15:10 Bruna modelling for the early prediction of disease progression using biomarkers 15:10-16:30 Tea break, Poster and Software session II Posters in Group II (with poster numbers starting with II-) are accompanied by their presenter 16:30-17:50 Drug/Disease modeling Chair: Oscar Della Pasqua Application of a model based longitudinal network meta-analysis of FEV1 in 16:30-16:50 Julia Korell COPD trials in clinical drug development Sebastian Bayesian Drug Disease Model with Stan - Using published longitudinal data 16:50-17:10 Weber summaries in population models Angelica An integrated natural disease progression model of nine cognitive and 17:10-17:30 Quartino biomarker endpoints in patients with Alzheimer's Disease Pharmacokinetic and Pharmacodynamic Analysis Longitudinal Gd-Enhanced 17:30-17:50 Yaming Hang Lesion Count in Subjects with Relapsing Remitting Multiple Sclerosis Treated with Peginterferon beta-1a Thursday June 12 Chair: Emmanuelle Comets, 08:45-10:05 Lewis Sheiner Student Session Joachim Grevel and Panos Macheras Thi Huyen Handling data below the quantification limit in viral kinetic modeling for 08:45-09:10 Tram Nguyen model evaluation and prediction of treatment outcome Development of population based approaches to describe the complex Nikolaos 09:10-09:35 pharmacokinetics of simvastatin in different individuals. Bridging the gap Tsamandouras between population and physiologically based pharmacokinetic modelling A dynamic K-PD joint model for the kinetics of CTC (Circulating Tumor Cell) Mélanie 09:35-10:00 count and PSA concentration during treatment in metastatic castration- Wilbaux resistant prostate cancer 10.00-10.05 Presentation of Lewis Sheiner student session awards 10:05-11:30 Coffee break, Poster and Software session I Posters in Group III (with poster numbers starting with III-) are accompanied by their presenter Regulators and EFPIA initiatives for Modeling Informed Drug Chair: Dinesh Dealwis and 11:30-12:50 Discovery and Development (MID3) Marylore Chenel Proposed Modelling and Simulation good practices: Progress post EMA / 11:30-11:50 Scott Marshall EFPIA M&S workshop How European Regulators are Facilitating the Use of Modelling and 11:50-12:15 Terry Shepard Simulation: MSWG History, Activity and Future 12:15-12:35 Efthymios EMA qualification of novel methodologies: are we ready for M&S? Page | 2 Manolis 12.35-12.50 Panel discussion 12:50-14:15 Lunch Regulators and EFPIA initiatives for Modeling Informed Drug Chair: Mick Looby and Dinesh 14:15-15:15 Discovery and Development (MID3) continued Dealwis Bjoern The MCP-Mod methodology – A statistical methodology for dose-response 14:15-14:40 Bornkamp modelling 14:40-15:15 Vikram Sinha The role of MBDD in drug development - is it time to repaint the canvas? 15:15-16:40 Tea break, Poster and Software session IV Posters in Group IV (with poster numbers starting with IV-) are accompanied by their presenter Pharmacometric models for dose-finding and cost 16:40-17:20 Chair: Lena Friberg effectiveness In silico comparison of MTD determination in a phase I dose-finding 16:40-17:00 Camille Vong framework Coen van Towards early integrated mechanism-based prediction of clinical outcome 17:00-17:20 Hasselt and cost-effectiveness in castration-resistant prostate cancer Friday June 13 09:00-10:00 Stuart Beal Methodology Session Chair: France Mentré Group comparison with fused lasso penalized likelihood: an alternative to 09:00-09:20 Edouard Ollier test based methods Prediction of pharmacokinetic interactions for drugs with a long half-life – 09:20-09:40 Elin Svensson evidence for the need of model-based analysis 09:40-10:00 Yasunori Aoki Averaged Model Based Decision Making for Dose Selection Studies 10.00-10.05 Preview of PAGE 2015 10:00-10:40 Coffee break and Software session 10:50-12:10 Modelling in oncology Chair: René Bruno 10:50-11:10 Sharon Hori Modeling cancer blood biomarker dynamics in relation to tumor growth Modeling of tumor size reduction patterns in advanced melanoma under 11:10-11:30 Rik de Greef treatment with MK-3475, a potent antibody against PD-1 11:30-11:50 Pauline A mixed-effect modeling framework to personalize treatment of low-grade Page | 3 Mazzocco glioma patients 11:50-12:10 Nick Holford Power and Type 1 Error of Tumour Size Metrics Used to Predict Survival 12.10-12.20 Closing remarks 12:20-12:40 Audience Input for the PAGE 2015 Program Page | 4 PAGE2014 Abstracts: Oral Program Amin Rostami B-03 OrBiTo - translating mechanistic knowledge on absorption into predictive models ....... 15 Benjamin Guiastrennec B-04 Mechanism-based modelling of gastric emptying and bile release in response to caloric intake .................................................................................................................. 16 Andrés Olivares-Morales B-05 An in silico physiologically-based pharmacokinetic (PBPK) study of the impact of the drug release rate on oral absorption, gut wall metabolism and relative bioavailability .................................................................................................................................... 18 Kapil Gadkar B-07 Development of Virtual Population for a Quantitative Systems Pharmacology model ................................................................................................................................................ 20 Maciej Swat B-08 PharmML 1.0 - An Exchange Standard for Models in Pharmacometrics ........................... 21 Marc Gastonguay B-09 Proposal for a Web-Based Open Pharmacometrics Curriculum ............................... 22 Pierre Marquet B-11 Model-based personalized medicine in transplantation .............................................. 23 Núria Buil Bruna B-12 A step forward toward personalised medicine in oncology: Population modelling for the early prediction of disease progression using biomarkers ...................................... 24 Julia Korell B-14 Application of a model based longitudinal network meta-analysis of FEV1 in COPD trials in clinical drug development ..................................................................................................... 26 Sebastian Weber B-15 Bayesian Drug Disease Model with Stan - Using published longitudinal data summaries in population models ....................................................................................................... 27 Angelica Quartino B-16 An integrated natural disease progression model of nine cognitive and biomarker endpoints in patients with Alzheimer's Disease ................................................................ 28 Yaming Hang B-17 Pharmacokinetic and Pharmacodynamic Analysis of Longitudinal Gd-Enhanced Lesion Count in Subjects with Relapsing Remitting Multiple Sclerosis Treated with Peginterferon beta-1a ....................................................................................................................... 29 Thi Huyen Tram Nguyen C-01 Handling data below the quantification limit in viral kinetic modeling for model evaluation and prediction of treatment outcome .............................................................. 30 Nikolaos Tsamandouras C-02 Development of population based approaches to describe the complex pharmacokinetics of simvastatin in different individuals. Bridging the gap between population and physiologically based pharmacokinetic modelling. ...................................................................... 33 Mélanie Wilbaux C-03 A dynamic K-PD joint model for the kinetics of CTC (Circulating Tumor Cell) count and PSA concentration during treatment in metastatic castration-resistant prostate cancer ............................................................................................................................................... 36 Scott Marshall C-06 Good Practices in Model Informed Drug Discovery and Development (MID3): Practice, Application, Documentation and Reporting ......................................................................... 39 Terry Shepard C-07 How European
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