Tuesday 7 June 14:00-18:00 Registration at the Conference Venue 19:30-21:00 Welcome reception Wednesday 8 June 08:00-08:45 Registration 08:45-09:00 Welcome and Introduction Chair: Oscar Della Pasqua, 09:00-10:20 Immune response to drug treatment and immunotherapy Dinesh De Alwis A biological perspective on immune response to drug treatment 09:00-09:40 Nigel Klein (intended and unintended effects) Intricate PK and PD for the novel immunocytokine CEA-IL2v and their 09:40-10:00 Hans Peter Grimm pre-clinical to clinical translation Investigation of anti-CTLA-4 immuno-oncology therapy through a 10:00-10:20 Kirill Peskov quantitative systems pharmacology model 10:20-11:40 Coffee break, Poster and Software session I Posters in Group I (with poster numbers starting with I-) are accompanied by their presenter 11:40-12:20 Systems pharmacology Chair: Charlotte Kloft 11:40-12:00 Kapil Gadkar A Six-Stage Workflow for Robust Application of Systems Pharmacology The zebrafish as model for translational systems pharmacology: 12:00-12:20 Rob van Wijk expanding the allometric scale in vertebrates with five orders of magnitude 12:20-13:50 Lunch Chair: Leon Aarons, Shasha 13:50-15:05 Growth (I) Jumbe Introduction to the Gates' Healthy Birth, Growth & Development 13:50-14:05 Shasha Jumbe knowledge integration project 14:05-14:45 Louise Ryan Trajectory modelling based on early childhood longitudinal growth data Page | 1 Determinants for physical growth patterns in low- and middle-income 14:45-15:05 Niclas Jonsson countries 15:05-15:10 Announcement of WCoP 2016 Nick Holford 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 Chair: Leon Aarons, Shasha 16:40-17:20 Growth (II) Jumbe Characterizing and Forecasting Individual Weight Changes in Term 16:40-17:00 Mélanie Wilbaux Neonates Growth and decline of body size and composition – Prediction of the 17:00-17:20 Nick Holford transition from pre-diabetes to Type 2 diabetes in humans Chair: Leon Aarons, Shasha 17:20-18:20 Other applications Jumbe Prediction of an acute kidney injury after a cardio-pulmonary bypass 17:20-17:40 Piotr Juszczak using a multivariate-longitudinal nonlinear mixed effect model of biomarkers concentration in blood and urine Thi Huyen Tram The paradox of highly effective sofosbuvir combo therapy despite slow 17:40-18:00 Nguyen viral decline Extrapolation of a Brivaracetam Exposure-Response Model from Adults 18:00-18:20 Rik Schoemaker to Children 18:30-18:50 Special surprise... Thursday 9 June Chair: Marylore Chenel, Aris 08:45-10:05 Lewis Sheiner Student Session Dokoumetzidis, Leonid Gibiansky Bedaquiline's exposure-response relationship revealed through modeling 08:45-09:10 Elin Svensson of mycobacterial load Joint modelling for nonlinear longitudinal PSA kinetics and survival data 09:10-09:35 Solène Desmée in metastatic prostate cancer patients A physiologically-based population pharmacokinetic analysis to assess a 09:35-10:00 Stein Schalkwijk lower efavirenz dose of 400 mg once daily in HIV-infected pregnant women 10.00-10.05 Presentation of Lewis Sheiner student session awards 10:05-11:30 Coffee break, Poster and Software session III Page | 2 Posters in Group III (with poster numbers starting with III-) are accompanied by their presenter 11:30-12:30 Oncology Chair: Ana Ruiz Time-to-Event Modeling of Peripheral Neuropathy – Platform Mega- 11:30-11:50 Matts Kågedal Analysis of Eight vc-MMAE Antibody-Drug Conjugates (ADCs) Mathematical modelling of transient tumour growth dynamics following 11:50-12:10 Lucy Hutchinson anti-angiogenic therapy Modelling of classified individual tumor lesions in metastatic colorectal 12:10-12:30 Maria Luisa Sardu cancer (mCRC) patients using delay differential equations 12:30-13:50 Lunch 13:50-14:35 Tutorial: Estimation methods Chair: France Mentré An overview of Estimation-Maximization Algorithms Used in Population 13:50-14:35 Robert Bauer Analysis Methods 14:35-14:40 Announcement of ACoP7 Brian Corrigan 14:40-16:00 Tea break, Poster and Software session IV Posters in Group IV (with poster numbers starting with IV-) are accompanied by their presenter 16:00-17:20 Stuart Beal Methodology Session Chair: Paolo Magni Adaptive dose finding for time-to-event outcomes with adaptive choice 16:00-16:20 Yevgen Ryeznik of patient number based on response rate A general pharmacodynamic interaction model based on the Bliss 16:20-16:40 Sebastian Wicha Independence criterion Improving priors for human mAb linear PK parameters by using half-lives 16:40-17:00 Martin Fink from pre-clinical studies 17:00-17:20 David McDougall The Impact of Model Selection for Personalised Dosing 20:00-01:00 Social event: Buses depart from the Conference Venue at 19:30 Page | 3 Friday 10 June Model-based approaches to aid in choice of dose and study 09:00-10:00 Chair: Justin Wilkins design Modelling and simulation of neurological endpoints (modified Rankin 09:00-09:20 Lutz Harnisch Scale [mRS] and National Institute of Health Stroke Scale [NIHSS]) to aid clinical trial design in intracerebral hemorrhage (ICH) Model-based development of the secukinumab dosing regimen for the 09:20-09:40 Oliver Sander treatment of moderate-to-severe chronic plaque psoriasis Rasmus Repeated time to event modelling of opioid consumption in 09:40-10:00 Vestergaard Juul postoperative pain Limited sampling strategy for a population pharmacokinetic modelling of 10:00-10:20 Thu Thuy Nguyen cocktail of phenotyping drugs 10.20-10.30 Preview of PAGE 2017 10:30-11:00 Coffee break and Software session 11:00-12:00 Central Nervous System Diseases Chair: Nick Holford How disease modeling and model-based meta-analyses contributed to 11:00-11:20 Sylvie Retout understanding the path forward after dose discontinuation of a Phase III study in Alzheimer's disease Marc A longitudinal Item Response Theory model to characterize cognition 11:20-11:40 Vandemeulebroecke over time in elderly subjects Utilizing the items from the MDS-UPDRS score to increase drug effect 11:40-12:00 Simon Buatois detection power in de novo idiopathic Parkinson's disease 12.00-12.10 Closing remarks 12:10-12:30 Audience input for potential PAGE2017 topics Page | 4 PAGE2016 Abstracts B-03: Nigel Klein A biological perspective on immune response to drug treatment (intended and unintended effects) ................................................................................................................. 18 B-04: Hans Peter Grimm Intricate PK and PD for the novel immunocytokine CEA-IL2v and their pre- clinical to clinical translation .................................................................................................... 19 B-05: Kirill Peskov Investigation of anti-CTLA-4 immuno-oncology therapy through a quantitative systems pharmacology model ................................................................................................. 20 B-07: Kapil Gadkar A Six-Stage Workflow for Robust Application of Systems Pharmacology .............. 21 B-08: Rob van Wijk The zebrafish as model for translational systems pharmacology: expanding the allometric scale in vertebrates with five orders of magnitude .................................................. 22 B-10: Shasha Jumbe Introduction to the Gates' Healthy Birth, Growth & Development knowledge integration project .................................................................................................................. 23 B-11: Louise Ryan Trajectory modelling based on early childhood longitudinal growth data .............. 24 B-12: Niclas Jonsson Determinants for physical growth patterns in low- and middle-income countries ................................................................................................................................. 26 B-13: Nick Holford Announcement of WCoP 2016 ............................................................................. 27 B-15: Mélanie Wilbaux Characterizing and Forecasting Individual Weight Changes in Term Neonates................................................................................................................................. 28 B-16: Nick Holford Growth and decline of body size and composition – Prediction of the transition from pre-diabetes to Type 2 diabetes in humans ..................................................................... 29 B-17: Piotr Juszczak Prediction of an acute kidney injury after a cardio-pulmonary bypass using a multivariate-longitudinal nonlinear mixed effect model of biomarkers concentration in blood and urine ................................................................................................................................. 31 B-18: Thi Huyen Tram Nguyen The paradox of highly effective sofosbuvir combo therapy despite slow viral decline ............................................................................................................................. 32 B-19: Rik Schoemaker Extrapolation of a Brivaracetam Exposure-Response Model from Adults to Children .................................................................................................................................. 34 C-01: Elin Svensson Bedaquiline's exposure-response relationship revealed through modeling of mycobacterial load .................................................................................................................. 35 C-02: Solène Desmée Joint modelling for nonlinear longitudinal PSA kinetics and survival data in metastatic prostate cancer patients .......................................................................................