2017 - Budapest - Hungary

2017 - Budapest - Hungary


Tuesday 6 June


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 profile of 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 gaps in benefit-risk assessment: opportunities for combining MCDA with model-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 profile of 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