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Lewis Sheiner

Stockholm, Sweden

Montreux, Switzerland

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