Tuesday 6 June 14:00- Registration at the Conference Venue 18:00 19:00- Opening ceremony, welcome reception and dinner 22:00 Wednesday 7 June 08:00- Registration 08:45 08:45- Welcome and Introduction 09:00 09:00- Benefit-risk profile of medicinal Chair: Oscar 10:30 products Della Pasqua Overview and implementation of multi criteria 09:00- Praveen decision analysis (MCDA) for benefit-risk 09:30 Thokala assessment European regulatory views on benefit-risk 09:30- Andreas assessment methodologies - role of MCDA and 10:00 Kouroumalis other model-based approaches Current practices and gaps in benefit-risk 10:00- Kevin Marsh assessment: opportunities for combining MCDA 10:30 with model-based approaches 10:30- Coffee break, Poster and Software session I 12:00 Page | 1 Posters in Group I (with poster numbers starting with I-) are accompanied by their presenter 12:00- Benefit-risk profile of medicinal Chair: Mats 12:40 products, continued Karlsson 12:00- Neeraj Model-Informed Drug Development (MIDD) for 12:20 Gupta ixazomib, an oral proteasome inhibitor Simulation analysis of absolute lymphocytes 12:20- Nadia counts (ALC) and relapse rate (RR) following 12:40 Terranova cladribine (re-)treatment rules in subjects with relapsing-remitting multiple sclerosis (RRMS) 12:40- Announcement for ACoP8 (2017) Jin Jin 12:45 12:45- Lunch 14:10 14:10- Chair: Lutz Scaling of PD in paediatrics 15:10 Harnisch Scaling pharmacodynamics in children: Lessons 14:10- Joseph from immunology, infectious diseases and 14:50 Standing critical care Scaling renal function in neonates and infants to 14:50- Nick Holford describe the pharmacodynamics of antibiotic 15:10 nephrotoxicity 15:10- Tea break, Poster and Software session II 16:40 Posters in Group II (with poster numbers starting with II- ) are accompanied by their presenter 16:40- Chair: Marylore Study design 17:20 Chenel Hanna Using pharmacokinetic simulation to guide dose 16:40- Silber escalation decisions for targeted IL2v 17:00 Baumann immunocytokines 17:00- Simon Modelling approaches in dose finding clinical Page | 2 17:20 Buatois trial: Simulation-based study comparing predictive performances of model averaging and model selection 17:20- Chair: Dinesh Oncology 18:00 de Alwis Model-based individual managing of 17:20- Yuri Kheifetz thrombocytopenia during multi-cyclic 17:40 chemotherapy High exposure to fludarabine in conditioning 17:40- Jurgen prior to allogeneic hematopoietic cell 18:00 Langenhorst transplantation predicts impaired CD4 reconstitution and lower probability of survival Thursday 8 June Chair: Kristin 08:30- Karlsson, Julia Lewis Sheiner Student Session 09:50 Winkler, Paolo Magni Paediatric trial design optimization using prior 08:30- Elisa Borella knowledge in combination with modelling & 08:55 simulations Host-Pathogen interactions: A mechanism-based 08:55- disease progression model to describe the John Diep 09:20 pathogenesis of Acinetobacter baumannii pneumonia 09:20- Morris Model-based rationale for drug combinations in 09:45 Muliaditan tuberculosis 09.45- Presentation of Lewis Sheiner student session awards 09.50 09:50- Coffee break, Poster and Software session III 11:20 Page | 3 Posters in Group III (with poster numbers starting with III-) are accompanied by their presenter 11:20- Chair: France Estimation methods 12:20 Mentré 11:20- Tutorial 12:00 11:20- Robert An overview of non-parametric estimation 12:00 Leary methods used in population analysis A comparison of performance between 12:00- Mats parametric and nonparametric estimation for 12:20 Karlsson nonlinear mixed-effects models 12:20- Stacey Announcement for WCoP 2020 12:25 Tannenbaum 12:25- Lunch 13:45 Chair: Susan 13:45- European regulatory issues Cole & 14:45 Frederike Lentz Regulatory pharmacometrics in the EU in 13:45- Kristin practice and the role of the Modelling and 14:15 Karlsson Simulation Working Group 14:15- Anna The new draft EMA Guidance on PBPK – The 14:45 Nordmark qualification of the intended use concept 14:45- Tea break, Poster and Software session IV 16:15 Posters in Group IV (with poster numbers starting with IV-) are accompanied by their presenter Stuart Beal Methodology Session Chair: 16:15- dedicated to the memory of Matt Emmanuelle 17:40 Hutmacher Comets & Siv Page | 4 Jönsson 16:15- In memoriam Matt Hutmacher 16:20 16:20- Wojciech Correction of the likelihood function as an 16:40 Krzyzanski alternative for imputing missing covariates Henrik SADDLE_RESET: more robust parameter 16:40- Bjugård estimation with a check for local practical 17:00 Nyberg identifiability Joint modeling of overall survival and tumor size 17:00- Dmitry dynamics in non-small cell lung cancer: Clinical 17:20 Onishchenko trial simulations and validation of predictions at study and subject levels 17:20- Eva Handling frequent observations of composite 17:40 Germovsek scores: Application to PROs in COPD 19:00- Social event 01:00 Friday 9 June Chair: Anna 09:00- Systems pharmacology Nordmark & Siv 10:00 Jönsson Translational systems pharmacology for 09:00- Markus acquisition of knowledge and prediction of drug 09:20 Krauß pharmacokinetics across patient populations 09:20- Robin PBPK modeling of propofol using the middle out 09:40 Michelet approach 09:40- Miro Therapeutic antibody concentrations at the 10:00 Eigenmann biophase 10:00- Chair: Katya Modelling experience! 10:25 Gibiansky 10:00- Alan The 6 biggest pharmacometrics modelling 10:25 Maloney mistakes! Page | 5 10.25- Preview of PAGE 2018 10.30 10:30- Coffee break and Software session 11:15 11:15- Chair: Lena Infection 12:15 Friberg Pharmacokinetic-pharmacodynamic modelling of 11:15- Richard artesunate in patients with drug resistant and 11:35 Höglund sensitive malaria Model-based screening of compounds for the 11:35- Salvatore treatment of Chagas disease, a neglected 11:55 D'Agate tropical disease Balancing efficacy and reduction in renal 11:55- Carolina function to optimize initial gentamicin dosing in 12:15 Llanos-Paez children with cancer 12.15- Closing remarks 12.25 12:25- Audience input for potential PAGE2018 topics 12:40 Page | 6 PAGE2017 Abstracts B-03: Praveen Thokala Overview and implementation of multi criteria decision analysis (MCDA) for benefit-risk assessment ............................................................................................................................................. 33 B-04: Andreas Kouroumalis European regulatory views on benefit-risk assessment methodologies - role of MCDA and other model-based approaches ....................................................................................................... 35 B-05: Kevin Marsh Current practices and gaps in benefit-risk assessment: opportunities for combining MCDA with model-based approaches ....................................................................................................................... 37 B-07: Neeraj Gupta Model-Informed Drug Development (MIDD) for ixazomib, an oral proteasome inhibitor ............................................................................... 39 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) ............................................................................... 42 B-11: Joe Standing Scaling pharmacodynamics in children: Lessons from immunology, infectious diseases and critical care .............................................................................................................................................. 45 B-12: Nick Holford Scaling renal function in neonates and infants to describe the pharmacodynamics of antibiotic nephrotoxicity ......................................................................................................................................... 47 B-14: Hanna Silber Baumann Using pharmacokinetic simulation to guide dose escalation decisions for targeted IL2v immunocytokines ............................................................................................................. 49 B-15: Simon Buatois Modelling approaches in dose finding clinical trial: Simulation-based study comparing predictive performances of model averaging and model selection. ................................................................................................................................................. 51 B-16: Yuri Kheifetz Model-based individual managing of thrombocytopenia during multi-cyclic chemotherapy ........................................................................... 54 B-17: Jurgen Langenhorst High exposure to fludarabine in conditioning prior to allogeneic hematopoietic cell Page | 7 transplantation predicts impaired CD4 reconstitution and lower probability of survival ............................................................................................................ 56 C-01: Elisa Borella Paediatric trial design optimization using prior knowledge in combination with modelling & simulations .............................................................................................................................................. 59 C-02: John Diep Host-Pathogen interactions: A mechanism- based disease progression model to describe the pathogenesis of Acinetobacter baumannii pneumonia ......................................................................... 66 C-03: Morris Muliaditan Model-based rationale for drug combinations in tuberculosis .................................................................................................................