14:00-18:00 / Registration at the Conference Venue
19:00-22:00 / Opening ceremony, welcome reception and dinner
Wednesday 7 June
08:00-08:45 / Registration
08:45-09:00 / Welcome and Introduction
09:00-10:30 / Benefit-risk profileof medicinal products / Chair: Oscar Della Pasqua
09:00-09:30 / Praveen Thokala / Overview and implementation of multi criteria decision analysis (MCDA) for benefit-risk assessment
09:30-10:00 / Andreas Kouroumalis / European regulatory views on benefit-risk assessment methodologies - role of MCDA and other model-based approaches
10:00-10:30 / Kevin Marsh / Current practices and gapsin benefit-risk assessment: opportunities for combining MCDA withmodel-based approaches
10:30-12:00 / Coffee break, Poster and Software session I
Posters in Group I(with poster numbers starting with I-) are accompanied by their presenter
12:00-12:40 / Benefit-risk profileof medicinal products, continued / Chair: Mats Karlsson
12:00-12:20 / Neeraj Gupta / Model-Informed Drug Development (MIDD) for ixazomib, an oral proteasome inhibitor
12:20-12:40 / Nadia Terranova / Simulation analysis of absolute lymphocytes counts (ALC) and relapse rate (RR) following cladribine (re-)treatment rules in subjects with relapsing-remitting multiple sclerosis (RRMS)
12:40-12:45 / Announcement for ACoP8 (2017) / Jin Jin
12:45-14:10 / Lunch
14:10-15:10 / Scaling of PD in paediatrics / Chair: Lutz Harnisch
14:10-14:50 / Joseph Standing / Scaling pharmacodynamics in children: Lessons from immunology, infectious diseases and critical care
14:50-15:10 / Nick Holford / Scaling renal function in neonates and infants to describe the pharmacodynamics of antibiotic nephrotoxicity
15:10-16:40 / Tea break, Poster and Software session II
Posters in Group II(with poster numbers starting with II-)are accompanied by their presenter
16:40-17:20 / Study design / Chair: Marylore Chenel
16:40-17:00 / Hanna Silber Baumann / Using pharmacokinetic simulation to guide dose escalation decisions for targeted IL2v immunocytokines
17:00-17:20 / Simon Buatois / Modelling approaches in dose finding clinical trial: Simulation-based study comparing predictive performances of model averaging and model selection
17:20-18:00 / Oncology / Chair: Dinesh de Alwis
17:20-17:40 / Yuri Kheifetz / Model-based individual managing of thrombocytopenia during multi-cyclic chemotherapy
17:40-18:00 / Jurgen Langenhorst / High exposure to fludarabine in conditioning prior to allogeneic hematopoietic cell transplantation predicts impaired CD4 reconstitution and lower probability of survival
Thursday 8 June
08:30-09:50 / Lewis Sheiner Student Session / Chair: Kristin Karlsson, Julia Winkler, Paolo Magni
08:30-08:55 / Elisa Borella / Paediatric trial design optimization using prior knowledge in combination with modelling & simulations
08:55-09:20 / John Diep / Host-Pathogen interactions: A mechanism-based disease progression model to describe the pathogenesis of Acinetobacter baumannii pneumonia
09:20-09:45 / Morris Muliaditan / Model-based rationale for drug combinations in tuberculosis
09.45-09.50 / Presentation of Lewis Sheiner student session awards
09:50-11:20 / Coffee break, Poster and Software session III
Posters in Group III (with poster numbers starting with III-) are accompanied by their presenter
11:20-12:20 / Estimation methods / Chair: France Mentré
11:20-12:00 / Tutorial
11:20-12:00 / Robert Leary / An overview of non-parametric estimation methods used in population analysis
12:00-12:20 / Mats Karlsson / A comparison of performance between parametric and nonparametric estimation for nonlinear mixed-effects models
12:20-12:25 / Announcement for WCoP 2020 / Stacey Tannenbaum
12:25-13:45 / Lunch
13:45-14:45 / European regulatory issues / Chair: Susan Cole & Frederike Lentz
13:45-14:15 / Kristin Karlsson / Regulatory pharmacometrics in the EU in practice and the role of the Modelling and Simulation Working Group
14:15-14:45 / Anna Nordmark / The new draft EMA Guidance on PBPK – The qualification of the intended use concept
14:45-16:15 / Tea break, Poster and Software session IV
Posters in Group IV (with poster numbers starting with IV-) are accompanied by their presenter
16:15-17:40 / Stuart Beal Methodology Session dedicated to the memory of Matt Hutmacher / Chair: Emmanuelle Comets & Siv Jönsson
16:15-16:20 / In memoriam Matt Hutmacher
16:20-16:40 / Wojciech Krzyzanski / Correction of the likelihood function as an alternative for imputing missing covariates
16:40-17:00 / Henrik Bjugård Nyberg / SADDLE_RESET: more robust parameter estimation with a check for local practical identifiability
17:00-17:20 / Dmitry Onishchenko / Joint modeling of overall survival and tumor size dynamics in non-small cell lung cancer: Clinical trial simulations and validation of predictions at study and subject levels
17:20-17:40 / Eva Germovsek / Handling frequent observations of composite scores: Application to PROs in COPD
19:00-01:00 / Social event
Friday 9 June
09:00-10:00 / Systems pharmacology / Chair: Anna Nordmark & Siv Jönsson
09:00-09:20 / Markus Krauß / Translational systems pharmacology for acquisition of knowledge and prediction of drug pharmacokinetics across patient populations
09:20-09:40 / Robin Michelet / PBPK modeling of propofol using the middle out approach
09:40-10:00 / Miro Eigenmann / Therapeutic antibody concentrations at the biophase
10:00-10:25 / Modelling experience! / Chair: Katya Gibiansky
10:00-10:25 / Alan Maloney / The 6 biggest pharmacometrics modelling mistakes!
10.25-10.30 / Preview of PAGE 2018
10:30-11:15 / Coffee break and Software session
11:15-12:15 / Infection / Chair: Lena Friberg
11:15-11:35 / Richard Höglund / Pharmacokinetic-pharmacodynamic modelling of artesunate in patients with drug resistant and sensitive malaria
11:35-11:55 / Salvatore D'Agate / Model-based screening of compounds for the treatment of Chagas disease, a neglected tropical disease
11:55-12:15 / Carolina Llanos-Paez / Balancing efficacy and reduction in renal function to optimize initial gentamicin dosing in children with cancer
12.15-12.25 / Closing remarks
12:25-12:40 / Audience input for potential PAGE2018 topics
PAGE2017 Abstracts
B-03: Praveen Thokala Overview and implementation of multi criteria decision analysis (MCDA) for benefit-risk assessment 16
B-04: Andreas Kouroumalis European regulatory views on benefit-risk assessment methodologies - role of MCDA and other model-based approaches 17
B-05: Kevin Marsh Current practices and gaps in benefit-risk assessment: opportunities for combining MCDA with model-based approaches 18
B-07: Neeraj Gupta Model-Informed Drug Development (MIDD) for ixazomib, an oral proteasome inhibitor 19
B-08: Nadia Terranova Simulation analysis of absolute lymphocytes counts (ALC) and relapse rate (RR) following cladribine (re-)treatment rules in subjects with relapsing-remitting multiple sclerosis (RRMS) 21
B-11: Joe Standing Scaling pharmacodynamics in children: Lessons from immunology, infectious diseases and critical care 23
B-12: Nick Holford Scaling renal function in neonates and infants to describe the pharmacodynamics of antibiotic nephrotoxicity 24
B-14: Hanna Silber Baumann Using pharmacokinetic simulation to guide dose escalation decisions for targeted IL2v immunocytokines 25
B-15: Simon Buatois Modelling approaches in dose finding clinical trial: Simulation-based study comparing predictive performances of model averaging and model selection. 26
B-16: Yuri Kheifetz Model-based individual managing of thrombocytopenia during multi-cyclic chemotherapy 28
B-17: Jurgen Langenhorst High exposure to fludarabine in conditioning prior to allogeneic hematopoietic cell transplantation predicts impaired CD4 reconstitution and lower probability of survival 29
C-01: Elisa Borella Paediatric trial design optimization using prior knowledge in combination with modelling & simulations 31
C-02: John Diep Host-Pathogen interactions: A mechanism-based disease progression model to describe the pathogenesis of Acinetobacter baumannii pneumonia 34
C-03: Morris Muliaditan Model-based rationale for drug combinations in tuberculosis 37
C-06: Robert Leary An overview of non-parametric estimation methods used in population analysis 39
C-07: Mats Karlsson A comparison of performance between parametric and nonparametric estimation for nonlinear mixed-effects models 41
C-11: Kristin Karlsson Regulatory pharmacometrics in the EU in practice and the role of the Modelling and Simulation Working Group 42
C-12: Anna Nordmark The new draft EMA Guidance on PBPK – The qualification of the intended use concept 43
C-15: Wojciech Krzyzanski Correction of the likelihood function as an alternative for imputing missing covariates 44
C-16: Henrik Bjugård Nyberg SADDLE_RESET: more robust parameter estimation with a check for local practical identifiability 45
C-17: Dmitry Onishchenko Joint modeling of overall survival and tumor size dynamics in non-small cell lung cancer: Clinical trial simulations and validation of predictions at study and subject levels 47
C-18: Eva Germovsek Handling frequent observations of composite scores: Application to PROs in COPD 48
D-01: Markus Krauß Translational systems pharmacology for acquisition of knowledge and prediction of drug pharmacokinetics across patient populations 49
D-02: Robin Michelet PBPK modeling of propofol using the middle out approach 51
D-03: Miro Eigenmann Therapeutic antibody concentrations at the biophase 53
D-04: Alan Maloney The 6 biggest pharmacometrics modelling mistakes! 55
D-07: Richard Höglund Pharmacokinetic-pharmacodynamic modelling of artesunate in patients with drug resistant and sensitive malaria 56
D-08: Salvatore D'Agate Model-based screening of compounds for the treatment of Chagas disease, a neglected tropical disease. 57
D-09: Carolina Llanos-Paez Balancing efficacy and reduction in renal function to optimize initial gentamicin dosing in children with cancer 58
I-01: Martina Liebich Modelling of Dexamethasone in Paediatric Leukaemia Patients using a Population Pharmacokinetic Approach 61
I-02: Klaus Lindauer Model Simplification 62
I-03: Dan Liu Application of Global Sensitivity Analysis Methods to Determine the most Influential Parameters of a Minimal PBPK Model of Quinidine 63
I-04: Rocio Lledo PK/PD modelling of an anti-FcRn mAb to optimise FIM design - translation from cyno to human 64
I-05: Florence Loingeville Using Hamiltonian Monte-Carlo to design longitudinal count studies accounting for parameter and model uncertainties 65
I-06: Amelia Deitchman Tigecycline-Tetracycline Combination Modeling against Pseudomonas aeruginosa: Application of the General Pharmacodynamic Interaction Term in Various Interaction Models 66
I-07: Dominik Lott Tolerance modeling: effects of the selective S1P1 receptor modulator ponesimod on heart rate 68
I-08: Rubin Lubomirov Population pharmacokinetic-based interspecies allometric scaling and prediction of first-in-human (FIH) pharmacokinetics of a new anticancer agent 70
I-09: Inga Ludwig Correlative analysis of response to treatment and biomarker levels in a setting with a time-to-event efficacy outcome and sparse biomarker data 71
I-10: John C Lukas Order in patch absorption rates? 72
I-11: Sreenath M Krishnan Influence of the number of tumor size measurements on model-derived tumor size metrics and prediction of survival 73
I-12: Lei Ma Dupilumab dose selection for a phase 3 study in asthma patients: pharmacokinetic/pharmacodynamic (PK/PD) modelling and clinical trial simulation 74
I-13: Vincent Madelain Modeling viral kinetics predicts a rapid establishment of the cytotoxic immune response targeting distinct infected cell compartments in SIV controller macaques (ANRS SIC study) 75
I-14: Paolo Magni Execution of complex Bayesian workflows with the DDMoRe Interoperability Framework: a case study in the diabetes area 76
I-15: Corinna Maier Robust parameter estimation for dynamical systems from outlier-corrupted data 78
I-16: Victor Mangas-Sanjuan Semi-mechanistic Pharmacodynamic model of complex receptor-hormone dynamics 79
I-17: Ben Margetts Modelling Cytomegalovirus Growth Kinetics in Immunocompromised Children 80
I-18: Dimitris Maris Asymptotic Analysis on a TMDD model: Control of the process 81
I-19: Emma Martin Using mixed effects modelling improves detection of drug-gene interactions in mouse trials 82
I-20: Paolo Mazzei Translational model-based approach to assist the dose-range selection of an antibody-drug conjugate entering Phase I 83
I-21: Nicola Melillo Multiscale mechanistic models in Systems Pharmacology: development of a model describing Atorvastatin pharmacokinetics through integration of metabolic network in Physiologically Based Pharmacokinetic models. 85
I-22: Sandrine Micallef Evaluation of tumor kinetics metrics as early endpoint to support decision making in early drug development 87
I-23: Joske Millecam A new approach in pediatric drug design: the development of a pediatric pig model. Part II: The maturation of hepatic cytochrome P450 enzymes using enzyme activity and proteomics 88
I-24: Jonathan Mochel One Health: Translational and Reverse Translational Modeling of Inflammatory Bowel Disease using an advanced Boolean Network 90
I-25: Daniel Moj Application of a physiologically-based pharmacokinetic and pharmacodynamic (PBPK/PD) model of the histone deacetylase (HDAC) inhibitor vorinostat to improve dosing regimens in adults 91
I-26: Tadakatsu Nakamura Population Pharmacokinetic Analysis of Compound A and Its Metabolite in Healthy Subjects and Patients with Diabetic Nephropathy 92
I-27: Srividya Neelakantan Population Pharmacokinetic Analysis of Recombinant Factor VIII Fc Fusion Protein in Subjects with Severe Hemophilia A Across All Ages 93
I-28: Asuka Nemoto A Bayesian approach for population pharmacokinetic modeling of alcohol in Japanese Subjects 94
I-29: Thu Thuy Nguyen Population pharmacodynamic model of bronchodilator response to salbutamol in wheezy preschool children 95
I-30: Rikard Nordgren Calling C functions from NONMEM 97
I-31: Ana Novakovic A longitudinal model linking absolute lymphocyte count (ALC) and volume of T2 lesions to expanded disability status scale (EDSS) in patients with relapsing-remitting multiple sclerosis (RRMS) 98
I-32: Kayode Ogungbenro Sparse sampling design for characterizing individual PK of recombinant factor VIII fusion protein (rFVIIIFc) in prophylactic treatment of Hemophilia A 99
I-33: Boram Ohk Population Pharmacokinetics of Tacrolimus in Healhty Korean Subjects:role of CYP3A5 genotype and metabolite 100
I-34: Olafuyi Olusola The Use of Physiological Based Pharmacokinetic Modelling in Assessing Drug–drug Interactions Associated with Antimalarial Treatment in Paediatrics 101
I-35: Sean Oosterholt PKPD modelling of MYCN-inhibition in vitro and in vivo in a mouse model of neuroblastoma 103
I-36: Shan Pan Investigation of Bayesian inference in predicting tissue concentrations using RStan 104
I-37: Maria Panselina Dose-saturable model for amoxicillin used to predict probability of response in normal and obese pediatrics 105
I-38: Sang-In Park Population pharmacokinetic analysis of evogliptin in subjects with varying degrees of renal function 106
I-39: Zinnia Parra-Guillen Exploring the impact of study design on unperturbed tumour growth inhibition modelling 107
I-40: Christophe Passot In-depth assessment of the influence of anti-drug antibodies on adalimumab pharmacokinetics and concentration-effect relationship in rheumatoid arthritis 108
I-41: Dimple Patel Informing modeling and clinical trial simulation using the real world data: data content, quality and availability assessment 110
I-42: Dimitrios Patsatzis Construction and evaluation of "global" Micahelis-Menten reduced models 111
I-43: Sophie Peigne How to handle non-linearity in absorption: a case study in oncology 112
I-44: Nathalie Perdaems Multi-species translational PK/PD modelling in type 2 diabetes 113
I-45: Belén Pérez Solans Modelling tumour growth and progression free survival of breast cancer patients treated with neoadjuvant therapy 114
I-46: Jonás Samuel Pérez-Blanco Population PK and exposure-response analysis of sleep parameters for JNJ-42847922, a novel Orexin 2 receptor antagonist 116
I-47: Carlos Perez-Ruixo Identifying lack of adherence to antipsychotic treatment using plasma concentrations measurements 118