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Tuesday 6 June
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| 14:00-18:00 |
Registration at the Conference Venue |
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| 19:00-22:00 |
Opening ceremony, welcome reception and dinner |
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Wednesday 7 June
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| 08:00-08:45 |
Registration |
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| 08:45-09:00 |
Welcome and Introduction |
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| 09:00-10:30 |
Benefit-risk profile of medicinal products |
Chair: Oscar Della Pasqua
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| 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 gaps in benefit-risk assessment: opportunities for combining MCDA with model-based approaches |
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| 10:30-12:00 |
Coffee break, Poster and Software session I |
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Posters in Group I (with poster numbers starting with I-) are accompanied by their presenter |
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| 12:00-12:40 |
Benefit-risk profile of medicinal products, continued |
Chair: Mats Karlsson
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| 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) |
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| 12:40-12:45 |
Announcement for ACoP8 (2017) |
Jin Jin
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| 12:45-14:10 |
Lunch |
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| 14:10-15:10 |
Scaling of PD in paediatrics |
Chair: Lutz Harnisch
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| 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 |
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| 15:10-16:40 |
Tea break, Poster and Software session II |
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Posters in Group II (with poster numbers starting with II-) are accompanied by their presenter |
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| 16:40-17:20 |
Study design |
Chair: Marylore Chenel
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| 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 |
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| 17:20-18:00 |
Oncology |
Chair: Dinesh de Alwis
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| 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 |
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Thursday 8 June
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| 08:30-09:50 |
Lewis Sheiner Student Session |
Chair: Kristin Karlsson, Julia Winkler, Paolo Magni
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| 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 |
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| 09:50-11:20 |
Coffee break, Poster and Software session III |
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Posters in Group III (with poster numbers starting with III-) are accompanied by their presenter |
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| 11:20-12:20 |
Estimation methods
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Chair: France Mentré
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| 11:20-12:00 |
Tutorial |
| 11:20-12:00 |
Robert Leary |
An overview of non-parametric estimation methods used in population analysis |
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| 12:00-12:20 |
Mats Karlsson |
A comparison of performance between parametric and nonparametric estimation for nonlinear mixed-effects models |
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| 12:20-12:25 |
Announcement for WCoP 2020 |
Stacey Tannenbaum
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| 12:25-13:45 |
Lunch |
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| 13:45-14:45 |
European regulatory issues |
Chair: Susan Cole & Frederike Lentz
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| 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 |
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| 14:45-16:15 |
Tea break, Poster and Software session IV |
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Posters in Group IV (with poster numbers starting with IV-) are accompanied by their presenter |
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| 16:15-17:40 |
Stuart Beal Methodology Session dedicated to the memory of Matt Hutmacher |
Chair: Emmanuelle Comets & Siv Jönsson
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| 16:15-16:20 |
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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 |
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| 19:00-01:00 |
Social event |
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Friday 9 June
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| 09:00-10:00 |
Systems pharmacology |
Chair: Anna Nordmark & Siv Jönsson
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| 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 |
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| 10:00-10:25 |
Modelling experience! |
Chair: Katya Gibiansky
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| 10:00-10:25 |
Alan Maloney |
The 6 biggest pharmacometrics modelling mistakes! |
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| 10.25-10.30 |
Preview of PAGE 2018 |
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| 10:30-11:15 |
Coffee break and Software session |
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| 11:15-12:15 |
Infection |
Chair: Lena Friberg
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| 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 |
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| 12.15-12.25 |
Closing remarks |
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| 12:25-12:40 |
Audience input for potential PAGE2018 topics |
