20th PAGE Meeting

  • Athens - Greece
  • 7-10 June, 2011

Tuesday June 7

08.00-19.00 Registration at Hotel Divani Caravel
19.00-21.00 Opening Ceremony at the Hotel Divani Caravel (Olympia hall), continued with cocktails at the hotel’s roof garden by the pool

Wednesday June 8

07:00-08:45 Registration
08:45-09:00 Welcome and Introduction
09:00-10:00 PKPD-modelling in Multiple Sclerosis and Infection

chair: Panos Macheras and Aris Dokoumetzidis

09:00-09:20 Pascal Girard A Semi-mechanistic Model of Lymphocyte Dynamics in Patients with Multiple Sclerosis Treated with Cladribine Tablets
09:20-09:40 Mats Karlsson Population Pharmacodynamics of Cladribine Tablets Therapy in Patients with Multiple Sclerosis: Relationship between Magnetic Resonance Imaging and Clinical Outcomes
09:40-10:00 Bambang Adiwijaya An integrated, mechanistic model of viral eradication and its clinical applications in treatment regimens with direct-acting antivirals for chronic hepatitis C
10:00-10:15 Lutz Harnisch and Mats Karlsson Presentation of DDMoRe
10:15-11:45 Coffee break, Poster (Ilissos) and Software (Olympia foyer)session I
Posters in Group I (with poster numbers starting with I-) are accompanied by their presenter
11:45-12:30 Time to event Tutorial (I) chair: France Mentré
11:45-12:45 Nick Holford and Marc Lavielle A tutorial on time to event analysis for mixed effect modellers
12:45-14:15 Lunch:Macedonia hall
14:15-14:55 Oral session chair: France Mentré
14:15-14:35 Chuanpu Hu Informative Dropout and Visual Predictive Check of Exposure-Response Modeling of Ordered Categorical Data
14:35-14:55 Chee Ng Novel GPU-based Parallelized Qausi-random Parametric Expectation-Maximization (QRPEM) Estimation Method for Population Data Analysis
14:55-16:10 Tea break, Poster (Ilissos) and Software (Olympia foyer) session II
Posters in Group II (with poster numbers starting with II-) are accompanied by their presenter
16:10-17:30 Stuart Beal Methodology Session: Modelling strategies chair: Lutz Harnisch
16:10-16:30 Patanjali Ravva Covariate Modelling in Aggregate Data Meta Analysis: A Simulation Study Evaluating Performance of Model Linearization
16:30-16:50 Marc Gastonguay Full Covariate Models as an Alternative to Methods Relying on Statistical Significance for Inferences about Covariate Effects: A Review of Methodology and 42 Case Studies.
16:50-17:10 Céline Laffont How to analyse multiple ordinal scores in a clinical trial? Multivariate vs. univariate analysis.
17:10-17:30 Julie Bertrand Some Alternatives to Likelihood ratio and Wald Tests for Pharmacogenetic studies using nonlinear mixed effect models.

Thursday June 9

08:30-09:50 Lewis Sheiner Student Session

chairs: An Vermeulen, Alison Thomson, Niclas Jonsson, Malcolm Rowland

08:30-08:55 Abhishek Gulati Linking in silico and in vitro experiments to identify and evaluate a biomarker for enoxaparin activity
08:55-09:20 Joshua Pink Pharmacokinetic-pharmacodynamic-pharmacoeconomic analysis of rituximab for follicular lymphoma
09:20-09:45 Elodie Plan Modelling Techniques Handling Dynamic Pain Scores Characteristics
09:45-09:50 Presentation of Awards
09:50-11:05 Coffee break, Poster (Ilissos) and Software (Olympia foyer) session III
Posters in Group III (with poster numbers starting with III-) are accompanied by their presenter
11:05-12:15 PBPK chair: Marylore Chenel
11:05-11:55 Malcolm Rowland Physiologically based pharmacokinetics: Advancing the clinical dimension
11:55-12:15 Ashley Strougo Scaling pharmacokinetics to estimate the “first dose in children”: comparing allometric scaling and PBPK
12:15-13:45 Lunch:Macedonia hall
13:45-15:05 PKPD-modelling of tumour effects and adverse events for anticancer drugs chair: Dinesh De Alwis
13:45-14:05 Benjamin Ribba Evaluation of the antitumor effect of PCV chemotherapy on low-grade gliomas patients with a longitudinal tumor growth inhibition model
14:05-14:25 Emma Hansson PKPD Modeling of VEGF, sVEGFR-2, sVEGFR-3 and sKIT as Biomarkers of Tumor Response and Overall Survival Following Sunitinib Treatment in GIST
14:25-14:45 Inès Paule Individual Prediction-Based Dose Adaptation Of Capecitabine: In Silico Comparison With The Standard Method, Impact On Limiting Toxicity and On Antitimour Efficacy
14:45-15:05 Coen van Hasselt Optimizing monitoring strategies of trastuzumab induced cardiotoxicity: Development and application of a population pharmacodynamic model quantifying trastuzumab induced changes in cardiac function
15:05-16:20 Tea break, Poster (Ilissos) and Software (Olympia foyer) session IV
Posters in Group IV (with poster numbers starting with IV-) are accompanied by their presenter
16:20-17:20 Design chair: Steve Duffull
16:20-16:40 Lee Kien Foo Cost minimization of a phase IIA clinical study
16:40-17:00 Sebastian Ueckert Explicit Optimization of Clinical Trials for Statistical Power
17:00-17:20 Peter Gennemark Optimal design in population kinetic experiments by set-valued methods
20:00-01:00 Social evening

Friday June 10

09:00-10:20 Target-mediated drug disposition chair: Charlotte Kloft
09:00-09:40 Leonid Gibiansky Modeling of Drugs with Target-Mediated Disposition
09:40-10:00 Stefaan Rossenu Population Pharmacokinetic/Pharmacodynamic Modeling of a New Antithrombotic Drug, The Nanobody® ALX-0081
10:00-10:20 Angelica Quartino An integrated G-CSF-myelosuppression model characterizing the target mediated disposition of endogenous G-CSF in breast cancer patients following chemotherapy
10:20-10:30 Preview of PAGE 2012
10:30-10:40 Preview of WCoP 2012
10:40-11:10 Coffee Break
11:10-12:30 Modelling and methods for complex systems chair: Oscar Della Pasqua
11:10-11:30 Stephan Schmidt Coping with Time Scales in Disease Systems Analysis: Application to Bone Remodelling
11:30-11:50 Elba Romero Coupling complex mechanistic PK/PD modelling with dynamic system analysis to obtain relevant clinical/biological insights. Application to gonadotropin hormone release agonist
11:50-12:10 Wojciech Krzyzanski Solving Delay Differential Equations in S-ADAPT by Method of Steps
12:10-12:30 S. Y. Amy Cheung Structural identifiability of parallel pharmacokinetic experiments as constrained systems
12:30-12:40 Closing Remarks
12:40-12:55 Audience Input for the PAGE 2012 Program

Software demonstrations: Olympia foyer (Level -1)

Kajsa Harling Perl speaks NONMEM (PsN) and Xpose
Marc Lavielle Analysing population PK/PD data with MONOLIX 4.0
Joakim Nyberg PopED - An optimal experimental design software
Coen van Hasselt Piraña: The flexible modeling environment for NONMEM
Stephane Vellay Pipeline Pilot - Data Integration, Analysis, and Reporting Platform

Posters: Absorption and physiology-based PK

I-10 Christian Bartels Population PK Model for Pooled Data of Different Oral Diclofenac Formulations
I-35 Vicente G. Casabo Bioequivalence trials simulation to select the best analyte for acetylsalicylic acid
I-62 Kristin Dickschen Pharmacogenomics of Tamoxifen In Female Patients: A PBPK Model-based Investigation Including The Three Main Metabolites
II-20 Ludivine Fronton Monoclonal Antibody Disposition beyond Target Binding: Impact of FcRn on Clearance and Derivation of Mechanistic Compartment Models
II-40 Emilie Hénin Meta-analysis of Magnetic Marker Monitoring data to characterize tablet movement through the gastrointestinal tract
III-9 Donghwan Lee Development of a population model to describe diurnal and chronokinetic variation in cilostazol pharmacokinetics
III-26 Eugeniy Metelkin A Systems Pharmacology Model of Anandamide Dynamics After FAAH Inhibitor Administration
III-35 Christoph Niederalt Development of a detailed physiologically based computational kidney model to describe the renal excretion of hydrophilic agents in rats
III-40 Kayode Ogungbenro A semi-mechanistic gastric emptying pharmacokinetic model for 13C-octanoic acid: an evaluation using simulation
III-54 Anna Pieper Development of a PBPK model of doxorubicin
IV-8 Alexander Solms Modelling Inter-Individual Variability in PBPK Models and Deriving Mechanistic Covariate Models for PopPK
IV-21 Sonya Tate The Importance of Enterohepatic Recirculation in the Disposition of Pravastatin and Rosuvastatin: A Physiologically-Based Pharmacokinetic Modelling Approach
IV-47 Thomas Wendl Development of a physiologically-based pharmacokinetic (PBPK) model for Moxifloxacin and its metabolites in healthy adults
IV-65 Kirill Zhudenkov Pharmacokinetics of PEG-IFN Alpha in HCV Infected Patients

Posters: Cardiovascular, QT-prolongation

I-14 Francesco Bellanti Relevance of QT-RR correlations in the assessment of QTc-interval prolongation in clinical trial simulations
I-28 Christine Brandquist PK/PD Modeling of the Effect of Intravenous Doses of Anzemet® (dolasetron mesylate) and Its Metabolite (hydrodolasetron) on the QT Interval in Healthy Subjects
I-37 Anne Chain Can First-Time-In-Human Trials Replace Thorough QT Studies?
I-63 Jeroen Diepstraten Pharmacodynamics of nadroparin using anti-Xa levels in morbidly obese patients upon subcutaneous administration of 5700 IU
II-1 Vincent Dubois Translation of drug-induced QTc prolongation in early drug development.
II-11 Farkad Ezzet Meta-Analysis of Antiplatelets in Patients with Atrial Fibrillation: A survival Model
II-44 Eleanor Howgate PKPD Modelling Of Cardiovascular Safety Pharmacology Data
II-55 Helene Karcher Probabilistic risk assessment for QT prolongation and heart rate increase
III-41 Oliver Ackaert Population modelling of blood pressure: assessing clinically important factors for cardiovascular diseases
IV-6 Nelleke Snelder Quantitative understanding of drug effects on the interrelationship between mean arterial blood pressure, cardiac output and total peripheral resistance
IV-36 Piet van der Graaf Towards a Thorough Preclinical QT (“TpQT”) study paradigm: Pharmacokinetic-Pharmacodynamic (PKPD) Modelling of QTc Effects of Moxifloxacin in Cynomolgus Monkeys

Posters: CNS

I-22 Irina Bondareva Sequential Interacting Multiple Model (IMM) Bayesian Analysis of Carbamazepine and Valproate Repeated Therapeutic Drug Monitoring (TDM) Data from Epileptic Patients
I-32 Jacob Brogren Separate vs. simultaneous analysis of co-primary endpoints in Alzheimer’s disease clinical trials
I-56 Elizabeth de Lange Mechanism-based PK-PD model of remoxipride with rat-to-human extrapolation: characterizing remoxipride target site PK and systems homeostatic feedback
II-25 Martin Gnanamuthu Johnson Predicting Dopamine D2 Receptor Occupancy in humans using a physiology-based approach
II-26 Martin Gnanamuthu Johnson Pharmacokinetic-Pharmacodynamic Modeling of Dopamine D2 Receptor Occupancy in humans using Bayesian modeling tools
II-34 Zheng Guan Population pharmacokinetic and pharmacodynamic analysis of cortisol in serum and saliva in healthy male volunteers after an acute 5-hydroxytryptophan (5-HTP) challenge test
II-42 Eef Hoeben Population pharmacokinetic analysis of JNJ-37822681, a specific and fast-dissociating D2 antagonist for the treatment of schizophrenia
II-48 Masoud Jamei A physiologically-based pharmacokinetic (PBPK) brain model and its application in simulating drug disposition in brain
II-65 Huub Jan kleijn Development and Application of a Semi-Mechanistic Model for Modulation of Amyloid-beta in Cerebrospinal Fluid after Inhibition of γ-secretase.
III-16 Arianna Madrid Modelling the sleep effects of Zolpidem in rats using non-homogeneous Markov chain models
III-25 François Mercier A Bayesian meta-analysis of longitudinal lesion count data in multiple sclerosis patients
III-56 Venkatesh Pilla Reddy Exposure-Response Relationship of Typical and Atypical Antipsychotics Assessed by the Positive and Negative Syndrome Scale (PANSS) and its Subscales
III-58 Bart Ploeger Confirmation of symptomatic and disease modifying effects of levodopa using the ELLDOPA study
IV-15 Ahmed Suleiman A Mixed-Effects Markov Model for Characterizing the Time Course of the Transitions between Different Extrapyramidal Side Effects Severity Levels
IV-19 Stina Syvänen Quinidine Microdialysis Reveals Altered P-glycoprotein Function in Epileptic Rats in the Brain Parenchyma Rather than at the Blood-Brain Barrier
IV-30 Karin Tunblad A pharmacokinetic/pharmacodynamic analysis of central and peripheral effects of GSK3 inhibitors

Posters: Endocrine

I-45 Steve Choy Application of an integrated glucose-insulin model to investigate the effects of glibenclamide and its active metabolites on postprandial glucose and insulin concentrations in healthy volunteers
II-7 Petra Ekerot Mechanism-based Pharmacokinetic-Pharmacodynamic Feedback Model of Thyroid Hormones after Inhibition of Thyroperoxidase in the Dog. Cross-species Prediction of Thyroid Hormone Profiles in Rats and Humans.
III-6 Anna Largajolli Meal Tolerance Test (MTT): Nonlinear Mixed-Effects Modeling of Insulin Secretion
III-29 Jonas Bech Møller Model-based Analysis of the GLP-1 Response following an Oral Glucose Tolerance Test (OGTT)
III-46 Joanna Peng A Mechanistic Model for the Effects of A Novel Drug on Glucose, Glucagon and Insulin Applied to Adaptive Phase II Design
III-49 Kirill Peskov A Quantitative Systems Pharmacology Model Provides Insights into