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Lewis Sheiner

Budapest, Hungary

Lisboa, Portugal

Hersonissos, Crete, Greece

Alicante, Spain

Glasgow, Scotland

Venice, Italy

Athens, Greece

Berlin, Germany

St. Petersburg, Russia

Marseille, France

KÝbenhavn, Denmark

Brugge/Bruges, Belgium

Pamplona, Spain

Uppsala, Sweden

Verona, Italy

Paris, France

Basel, Switzerland

Salamanca, Spain

Saintes, France

Wuppertal, Germany

Glasgow, Scotland

Sandwich, UK

Frankfurt, Germany

Greenford, UK

Paris, France

Basel, Switzerland

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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
09:00-10:20 OrBiTo and Mechanistic absorption modelling

Chair: Leon Aarons and Panos Macheras

09:00-09:40 Amin Rostami-Hodjegan OrBiTo - translating mechanistic knowledge on absorption into predictive models
09:40-10:00 Benjamin Guiastrennec Mechanism-based modelling of gastric emptying and bile release in response to caloric intake
10:00-10:20 Andrés Olivares-Morales 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
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

11:50-12:10 Kapil Gadkar Development of Virtual Population for a Quantitative Systems Pharmacology model
12:10-12:30 Maciej Swat PharmML 1.0 – An Exchange Standard for Models in Pharmacometrics
12:30-12:40 Marc Gastonguay Proposal for a Web-Based Open Pharmacometrics Curriculum
12:40-14:10 Lunch
14:10-15:10 Model-based individualisation

Chair: Nick Holford

14:10-14:50 Pierre Marquet Implementing model-based individualization in the clinic
14:50-15:10 Núria Buil Bruna A step forward toward personalised medicine in oncology: Population 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

16:30-16:50 Julia Korell Application of a model based longitudinal network meta-analysis of FEV1 in COPD trials in clinical drug development
16:50-17:10 Sebastian Weber Bayesian Drug Disease Model with Stan - Using published longitudinal data summaries in population models
17:10-17:30 Angelica Quartino An integrated natural disease progression model of nine cognitive and biomarker endpoints in patients with Alzheimer's Disease
17:30-17:50 Yaming Hang Pharmacokinetic and Pharmacodynamic Analysis Longitudinal Gd-Enhanced Lesion Count in Subjects with Relapsing Remitting Multiple Sclerosis Treated with Peginterferon beta-1a


Thursday June 12


08:45-10:05 Lewis Sheiner Student Session

Chair: Emmanuelle Comets, Joachim Grevel and Panos Macheras

08:45-09:10 Thi Huyen Tram Nguyen Handling data below the quantification limit in viral kinetic modeling for model evaluation and prediction of treatment outcome
09:10-09:35 Nikolaos Tsamandouras 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
09:35-10:00 Mélanie Wilbaux 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
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
11:30-12:50 Regulators and EFPIA initiatives for Modeling Informed Drug Discovery and Development (MID3)

Chair: Dinesh Dealwis and Marylore Chenel

11:30-11:50 Scott Marshall Proposed Modelling and Simulation good practices: Progress post EMA / EFPIA M&S workshop
11:50-12:15 Terry Shepard How European Regulators are Facilitating the Use of Modelling and Simulation: MSWG History, Activity and Future
12:15-12:35 Efthymios Manolis EMA qualification of novel methodologies: are we ready for M&S?
12.35-12.50 Panel discussion
12:50-14:15 Lunch
14:15-15:15 Regulators and EFPIA initiatives for Modeling Informed Drug Discovery and Development (MID3) continued

Chair: Mick Looby and Dinesh Dealwis

14:15-14:40 Bjoern Bornkamp The MCP-Mod methodology – A statistical methodology for dose-response 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
16:40-17:20 Pharmacometric models for dose-finding and cost effectiveness

Chair: Lena Friberg

16:40-17:00 Camille Vong In silico comparison of MTD determination in a phase I dose-finding framework
17:00-17:20 Coen van Hasselt Towards early integrated mechanism-based prediction of clinical outcome and cost-effectiveness in castration-resistant prostate cancer


Friday June 13


09:00-10:00 Stuart Beal Methodology Session

Chair: France Mentré

09:00-09:20 Edouard Ollier Group comparison with fused lasso penalized likelihood: an alternative to test based methods
09:20-09:40 Elin Svensson Prediction of pharmacokinetic interactions for drugs with a long half-life – 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
11:10-11:30 Rik de Greef Modeling of tumor size reduction patterns in advanced melanoma under treatment with MK-3475, a potent antibody against PD-1
11:30-11:50 Pauline Mazzocco A mixed-effect modeling framework to personalize treatment of low-grade 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