Tuesday June 11
15:00-18:30 / Registration
18:30-19:30 / Welcome reception at the Old Fruitmarket located on Candleriggs in the Merchant City area, close to the city centre. Please see the map on http://www.glasgowconcerthalls.com/maps
Wednesday June 12
08:00-08:45 / Registration
08:45-09:00 / Welcome and introduction
09:00-10:20 / Model-based approaches in benefit-risk assessment and decision making / chair: Oscar Della Pasqua
09:00-09:40 / Dyfrig Hughes / Quantitative benefit-risk analysis based on linked PKPD and health outcome modelling
09:40-10:00 / Jonathan French / Can methods based on existing models really aid decision making in non-small-cell lung cancer (NSCLC) trials?
10:00-10:20 / Jonas Bech Møller / Optimizing clinical diabetes drug development – what is the recipe?
10:20-11:45 / Coffee break, poster and software session I
Posters in Group I (with poster numbers starting with I-) are accompanied by their presenter
11:45-12:25 / Animal health (I) / chairs: Alison Thomson & Jonathan Mochel
11:45-12:25 / Jim Riviere / Food safety: the intersection of pharmacometrics and veterinary medicine
12:25-13:50 / Lunch
13:50-14:50 / Animal health (II) / chairs: Alison Thomson & Jonathan Mochel
13:50-14:20 / George Gettinby / Two models for the control of sea lice infections using chemical treatments and biological control on farmed salmon populations
14:20-14:50 / Daniel Haydon / From epidemic to elimination: density-vague transmission and the design of mass dog vaccination programs
14:50-16:20 / Tea break, poster and software session II
Posters in Group II (with poster numbers starting with II-) are accompanied by their presenter
16:20-17:40 / Modelling and evaluation methods with (potential) application to infectious diseases / chair: Leon Aarons
16:20-16:40 / Wojciech Krzyzanski / Physiologically structured population model of intracellular hepatitis C virus dynamics
16:40-17:00 / Martin Bergstrand / Modeling of the concentration-effect relationship for piperaquine in preventive treatment of malaria
17:00-17:20 / Matt Hutmacher / A Visual Predictive Check for the evaluation of the hazard function in time-to-event analyses
17:20-17:40 / Celine Laffont / Non-inferiority clinical trials: a multivariate test for multivariate PD
Thursday June 13
08:45-10:05 / Lewis Sheiner student session / chairs: Lena Friberg, Philippe Jacqmin & Leon Aarons
08:45-09:10 / Abhishek Gulati / Simplification of a multi-scale systems coagulation model with an application to modelling PKPD data
09:10-09:35 / Nelleke Snelder / Mechanism-based PKPD modeling of cardiovascular effects in conscious rats - an application to fingolimod
09:35-10:00 / Nadia Terranova / Mathematical models of tumor growth inhibition in xenograft mice after administration of anticancer agents given in combination
10:00-10:05 / Presentation of awards
10:05-11:35 / Coffee break, poster and software session III
Posters in Group III (with poster numbers starting with III-) are accompanied by their presenter
11:35-12:35 / Mechanistic modelling / chair: Nick Holford
11:35-11:55 / James Lu / Application of a mechanistic, systems model of lipoprotein metabolism and kinetics to target selection and biomarker identification in the reverse cholesterol transport (RCT) pathway
11:55-12:15 / Rollo Hoare / A novel mechanistic model for CD4 lymphocyte reconstitution following paediatric haematopoietic stem cell transplantation
12:15-12:35 / Huub Jan Kleijn / Utilization of tracer kinetic data in endogenous pathway modeling: example from Alzheimer’s disease
12:35-14:05 / Lunch
14:05-14:55 / Reproducibility and translation / chair: Katya Gibiansky
14:05-14:35 / Niclas Jonsson and Justin Wilkins / Tutorial: Reproducible pharmacometrics
14:35-14:55 / Nick Holford
(on behalf of DDMoRe) / MDL - The DDMoRe modelling description language
14:55-16:20 / Tea break, poster and software session IV
Posters in Group IV (with poster numbers starting with IV-) are accompanied by their presenter
16:20-17:20 / New methods for population analysis / chair: France Mentré
16:20-16:40 / Vittal Shivva / Identifiability of population pharmacokinetic-pharmacodynamic models
16:40-17:00 / Leonid Gibiansky / Methods to detect non-compliance and minimize its impact on population PK parameter estimates
17:00-17:20 / Julie Bertrand / Penalized regression implementation within the SAEM algorithm to advance high-throughput personalized drug therapy
Social evening
Friday June 14
09:00-10:00 / Development and application of models in oncology / chair: Marylore Chenel
09:00-09:20 / Shelby Wilson / Modeling the synergism between the anti-angiogenic drug sunitinib and irinotecan in xenografted mice
09:20-09:40 / Amy Cheung / Using a model based approach to inform dose escalation in a Ph I Study by combining emerging clinical and prior preclinical information: an example in oncology
09:40-10:00 / Sonya Tate / Tumour growth inhibition modelling and prediction of overall survival in patients with metastatic breast cancer treated with paclitaxel alone or in combination with gemcitabine
10:00-10:10 / Preview of PAGE 2014
10:10-10:50 / Coffee break
10:50-12:10 / Stuart Beal methodology session / chair: Steve Duffull
10:50-11:10 / Chuanpu Hu / Latent variable indirect response modeling of continuous and categorical clinical endpoints
11:10-11:30 / Anne-Gaelle Dosne / Application of Sampling Importance Resampling to estimate parameter uncertainty distributions
11:30-11:50 / Hoai Thu Thai / Bootstrap methods for estimating uncertainty of parameters in mixed-effects models
11:50-12:10 / Celia Barthelemy / New methods for complex models defined by a large number of ODEs: application to a glucose/insulin model
12:10-12:20 / Closing remarks
12:20-12:40 / Audience input for the PAGE 2014 program
PAGE2013 Abstracts
Oral presentations Wednesday 15
Dyfrig Hughes A-05 Quantitative benefit-risk analysis based on linked PKPD and health outcome modelling 15
Jonathan French A-06 Can methods based on existing models really aid decision making in non-small-cell lung cancer (NSCLC) trials? 16
Jonas Bech Møller A-07 Optimizing clinical diabetes drug development – what is the recipe? 18
Jim Riviere A-09 Food safety: the intersection of pharmacometrics and veterinary medicine 20
George Gettinby A-11 Two models for the control of sea lice infections using chemical treatments and biological control on farmed salmon populations 22
Dan Haydon A-12 From Epidemic to Elimination: Density-Vague Transmission and the Design of Mass Dog Vaccination Programs 24
Wojciech Krzyzanski A-14 Physiologically Structured Population Model of Intracellular Hepatitis C Virus Dynamics 25
Martin Bergstrand A-15 Modeling of the concentration-effect relationship for piperaquine in preventive treatment of malaria 27
Matt Hutmacher A-16 A Visual Predictive Check for the Evaluation of the Hazard Function in Time-to-Event Analyses 29
Celine M. Laffont A-17 Non-inferiority clinical trials: a multivariate test for multivariate PD 30
Oral presentations Thursday 31
Abhishek Gulati A-18 Simplification of a multi-scale systems coagulation model with an application to modelling PKPD data 31
Nelleke Snelder A-19 Mechanism-based PKPD modeling of cardiovascular effects in conscious rats - an application to fingolimod 34
Nadia Terranova A-20 Mathematical models of tumor growth inhibition in xenograft mice after administration of anticancer agents given in combination 36
James Lu A-23 Application of a mechanistic, systems model of lipoprotein metabolism and kinetics to target selection and biomarker identification in the reverse cholesterol transport (RCT) pathway 38
Rollo Hoare A-24 A Novel Mechanistic Model for CD4 Lymphocyte Reconstitution Following Paediatric Haematopoietic Stem Cell Transplantation 40
Huub Jan Kleijn A-25 Utilization of Tracer Kinetic Data in Endogenous Pathway Modeling: Example from Alzheimer’s Disease 41
Justin Wilkins A-27 Reproducible pharmacometrics 42
Nick Holford A-28 MDL - The DDMoRe Modelling Description Language 43
Vittal Shivva A-30 Identifiability of Population Pharmacokinetic-Pharmacodynamic Models 44
Leonid Gibiansky A-31 Methods to Detect Non-Compliance and Minimize its Impact on Population PK Parameter Estimates 45
Julie Bertrand A-32 Penalized regression implementation within the SAEM algorithm to advance high-throughput personalized drug therapy 46
Oral presentations Friday 47
Shelby Wilson A-34 Modeling the synergism between the anti-angiogenic drug sunitinib and irinotecan in xenografted mice 47
S. Y. Amy Cheung A-35 Using a model based approach to inform dose escalation in a Ph I Study by combining emerging clinical and prior preclinical information: an example in oncology 48
Sonya Tate A-36 Tumour growth inhibition modelling and prediction of overall survival in patients with metastatic breast cancer treated with paclitaxel alone or in combination with gemcitabine 49
Chuanpu Hu A-39 Latent variable indirect response modeling of continuous and categorical clinical endpoints 50
Anne-Gaelle Dosne A-40 Application of Sampling Importance Resampling to estimate parameter uncertainty distributions 51
Hoai Thu Thai A-41 Bootstrap methods for estimating uncertainty of parameters in mixed-effects models 52
Celia Barthelemy A-42 New methods for complex models defined by a large number of ODEs. Application to a Glucose/Insulin model 54
Poster session I: Wednesday morning 10:05-11:40 55
Andrijana Radivojevic I-01 Enhancing population PK modeling efficiency using an integrated workflow 55
Gauri Rao I-02 A Proposed Adaptive Feedback Control (AFC) Algorithm for Linezolid (L) based on Population Pharmacokinetics (PK)/Pharmacodynamics (PD)/Toxicodynamics(TD) 56
Sylvie Retout I-03 A drug development tool for trial simulation in prodromal Alzheimer’s patient using the Clinical Dementia Rating scale Sum of Boxes score (CDR-SOB). 57
Philippe Jacqmin I-04 Constructing the disease trajectory of CDR-SOB in Alzheimer’s disease progression modelling 58
Rachel Rose I-05 Application of a Physiologically Based Pharmacokinetic/Pharmacodynamic (PBPK/PD) Model to Investigate the Effect of OATP1B1 Genotypes on the Cholesterol Synthesis Inhibitory Effect of Rosuvastatin 59
Elisabeth Rouits I-06 Population pharmacokinetic model for Debio 1143, a novel antagonist of IAPs in cancer treatment 60
Alberto Russu I-07 Second-order indirect response modelling of complex biomarker dynamics 61
Teijo Saari I-08 Pharmacokinetics of free hydromorphone concentrations in patients after cardiac surgery 63
Tarjinder Sahota I-09 Real data comparisons of NONMEM 7.2 estimation methods with parallel processing on target-mediated drug disposition models 64
Maria Luisa Sardu I-10 Tumour Growth Inhibition In Preclinical Animal Studies: Steady-State Analysis Of Biomarker-Driven Models. 65
Emilie Schindler I-11 PKPD-Modeling of VEGF, sVEGFR-1, sVEGFR-2, sVEGFR-3 and tumor size following axitinib treatment in metastatic renal cell carcinoma (mRCC) patients 66
Alessandro Schipani I-12 Population pharmacokinetic of rifampicine in Malawian children. 67
Henning Schmidt I-13 The “SBPOP Package”: Efficient Support for Model Based Drug Development – From Mechanistic Models to Complex Trial Simulation 68
Stephan Schmidt I-14 Mechanistic Prediction of Acetaminophen Metabolism and Pharmacokinetics in Children using a Physiologically-Based Pharmacokinetic (PBPK) Modeling Approach 69
Rik Schoemaker I-15 Scaling brivaracetam pharmacokinetic parameters from adult to pediatric epilepsy patients 71
Yoon Seonghae I-16 Population pharmacokinetic analysis of two different formulations of tacrolimus in stable pediatric kidney transplant recipients 72
Catherine Sherwin I-17 Dense Data - Methods to Handle Massive Data Sets without Compromise 73
Giovanni Smania I-18 Identifying the translational gap in the evaluation of drug-induced QTc interval prolongation 74
Alexander Solms I-19 Translating physiologically based Parameterization and Inter-Individual Variability into the Analysis of Population Pharmacokinetics 75
Hankil Son I-20 A conditional repeated time-to-event analysis of onset and retention times of sildenafil erectile response 77
Heiner Speth I-21 Referenced Visual Predictive Check (rVPC) 78
Michael Spigarelli I-22 Title: Rapid Repeat Dosing of Zolpidem - Apparent Kinetic Change Between Doses 79
Christine Staatz I-23 Dosage individulisation of tacroliums in adult kidney transplant recipients 80
Gabriel Stillemans I-24 A generic population pharmacokinetic model for tacrolimus in pediatric and adult kidney and liver allograft recipients 81
Elisabet Størset I-25 Predicting tacrolimus doses early after kidney transplantation - superiority of theory based models 82
Fran Stringer I-26 A Semi-Mechanistic Modeling approach to support Phase III dose selection for TAK-875 Integrating Glucose and HbA1c Data in Japanese Type 2 Diabetes Patients 83
Eric Strömberg I-27 FIM approximation, spreading of optimal sampling times and their effect on parameter bias and precision. 84
Herbert Struemper I-28 Population pharmacokinetics of belimumab in systemic lupus erythematosus: insights for monoclonal antibody covariate modeling from a large data set 86
Elin Svensson I-29 Individualization of fixed-dose combination (FDC) regimens - methodology and application to pediatric tuberculosis 87
Eva Sverrisdóttir I-30 Modelling analgesia-concentration relationships for morphine in an experimental pain setting 89
Maciej Swat I-31 PharmML – An Exchange Standard for Models in Pharmacometrics 90
Amit Taneja I-32 From Behaviour to Target: Evaluating the putative correlation between clinical pain scales and biomarkers. 91
Joel Tarning I-33 The population pharmacokinetic and pharmacodynamic properties of intramuscular artesunate and quinine in Tanzanian children with severe falciparum malaria; implications for a practical dosing regimen. 92
David Ternant I-34 Adalimumab pharmacokinetics and concentration-effect relationship in rheumatoid arthritis 94
Adrien Tessier I-35 High-throughput genetic screening and pharmacokinetic population modeling in drug development 95
Iñaki F. Trocóniz I-36 Modelling and simulation applied to personalised medicine 96
Nikolaos Tsamandouras I-37 A mechanistic population pharmacokinetic model for simvastatin and its active metabolite simvastatin acid 97
Sebastian Ueckert I-38 AD i.d.e.a. – Alzheimer’s Disease integrated dynamic electronic assessment of Cognition 99
Wanchana Ungphakorn I-39 Development of a Physiologically Based Pharmacokinetic Model for Children with Severe Malnutrition 101
Elodie Valade I-40 Population Pharmacokinetics of Emtricitabine in HIV-1-infected Patients 102
Georgia Valsami I-41 Population exchangeability in Bayesian dose individualization of oral Busulfan 103
Sven van Dijkman I-42 Predicting antiepileptic drug concentrations for combination therapy in children with epilepsy. 104
Coen van Hasselt I-43 Design and analysis of studies investigating the pharmacokinetics of anti-cancer agents during pregnancy 106
Anne van Rongen I-44 Population pharmacokinetic model characterising the influence of circadian rhythm on the pharmacokinetics of oral and intravenous midazolam in healthy volunteers 107
Marc Vandemeulebroecke I-45 Literature databases: integrating information on diseases and their treatments. 108
Nieves Velez de Mendizabal I-46 A Population PK Model For Citalopram And Its Major Metabolite, N-desmethyl Citalopram, In Rats 109
An Vermeulen I-47 Population Pharmacokinetic Analysis of Canagliflozin, an Orally Active Inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2) for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) 110
Marie Vigan I-48 Modelling the evolution of two biomarkers in Gaucher patients receiving enzyme replacement therapy. 111
Paul Vigneaux I-49 Extending Monolix to use models with Partial Differential Equations 112
Winnie Vogt I-50 Paediatric PBPK drug-disease modelling and simulation towards optimisation of drug therapy: an example of milrinone for the treatment and prevention of low cardiac output syndrome in paediatric patients after open heart surgery 113
Max von Kleist I-51 Systems Pharmacology of Chain-Terminating Nucleoside Analogs 116