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Tuesday June 2 14:00- Registration 18:30 19:30 Welcome reception Wednesday June 3 08:00- Registration 09:00 09:00- Welcome and Introduction 09:15 09:15- Targeting Ebola Chair: Steven Kern 10:45 09:15- Conducting clinical trials in challenging Steven Kern 09:30 environments 09:30- France Estimating an effective dose for a repurposed 09:55 Mentré drug to treat Ebola: the case of favipiravir Estimating an effective dose for a new drug to 09:55- Matthias treat Ebola with incomplete information: the 10:20 Machacek case of Zmapp 10:20- An Adaptive Platform Trial for Ebola: Scott Berry 10:45 Application to Future Epidemics 10:45- Coffee break, Poster and Software session I 12:15 Posters in Group I (with poster numbers starting with I-) are accompanied by their presenter 12:15- Diabetes Chair: IñakiTrocóniz 12:55 Page | 1 12:15- Roberto A model of glucose clearance to improve the 12:35 Bizzotto description of glucose homeostasis A longitudinal HbA1c model elucidates genes 12:35- Rada Savic linked to disease progression on metformin 12:55 therapy 12:55- Lunch 14:25 On the 20th anniversary of 'Nonlinear 14:25- Chair: France models for repeated measurement 15:15 Mentré data' 14:25- David Why write a book in 1995 on nonlinear mixed 14:50 Giltinan effects modeling? 14:50- Marie Subsequent developments in nonlinear mixed 15:15 Davidian effects modeling 15:15- 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- Other diseases Chair: Ana Ruiz 17:40 José David Towards patient stratification and treatment in 16:40- Gómez- the autoimmune disease lupus erythematosus 17:00 Mantilla using a systems pharmacology approach 17:00- Gopichand Modeling of a composite score in Parkinson’s 17:20 Gottipati disease using item response theory Determination of effective blood 17:20- concentrations of cyclosporine in pediatric Emilie Hénin 17:40 severe aplastic anemia based on a time-to- response model Thursday June 4 Page | 2 Chair: Rada Savic, 09:00- Lewis Sheiner Student Session Steven Kern and 10:20 Michael Looby Development of a tumour growth inhibition model to elucidate the effect of ritonavir on 09:00- Huixin Yu intratumoural metabolism and anti-tumour 09:25 effect of docetaxel in a mouse model for hereditary breast cancer 09:25- Automated proper lumping for simplification of Shan Pan 09:50 systems models 09:50- Adrien Modelling pharmacogenetic data in population 10:15 Tessier studies during drug development 10.15- Presentation of Lewis Sheiner student session awards 10.20 10:20- Coffee break, Poster and Software session III 11:45 Posters in Group III (with poster numbers starting with III-) are accompanied by their presenter 11:45- Applied Bayesian Inference for Chair: Paolo Magni 12:50 Pharmacometrics Michael Betancourt 11:45- Building Robust PK/PD Population Models with and 12:30 Bayesian Inference Sebastian Weber Application of a Bayesian population approach 12:30- Thierry to physiologically-based modelling and 12:50 Wendling simulation of mavoglurant pharmacokinetics 12:50- Lunch 14:10 Chair: Oscar Della 14:10- PKPD and drug resistance in infectious Pasqua and Jonathan 15:10 diseases Mochel 14:10- Rong Deng Towards Model-Based Drug Development of Page | 3 14:30 New Therapeutics for Hepatitis C Virus 14:30- Treating resistant Gram-negatives: bedside to Joe Standing 14:50 bench and back 14:50- Anders A PKPD model characterizing resistance for 15:10 Kristoffersson predictions of bacterial kill in vivo 15:10- Announcement of WCoP 2016 Nick Holford 15:15 15:15- Tea break, Poster and Software session IV 16:30 Posters in Group IV (with poster numbers starting with IV-) are accompanied by their presenter 16:30- Stuart Beal Methodology Session Chair: Pascal Girard 17:30 Preconditioning of nonlinear mixed effect 16:30- Andrew models for stabilization of the covariance 16:50 Hooker matrix computation Simulated model based adaptive optimal 16:50- Eric design of adult to children bridging study using 17:10 Strömberg FDA stopping criteria Alternative to resampling methods in 17:10- Sebastian maximum likelihood estimation for NLMEMs by 17:30 Ueckert borrowing from Bayesian methodology Friday June 5 09:15- Chair: Marylore Infectious diseases 10:15 Chenel 09:15- Semi-mechanistic time-to-event modelling in Joel Tarning 09:35 malaria Page | 4 Modeling the PK/PD of hepatitis B 09:35- Natalie immunoglobulin after hepatitis B induced liver 09:55 Filmann transplantation by an extended target mediated drug disposition model 09:55- Dimitra Bon Multiscale modelling for hepatitis C treatment 10:15 10.15- Preview of PAGE 2016 10.25 10:25- Coffee break and Software session 10:55 10:55- Chair: Dinesh De Modelling in oncology 12:15 Alwis Analysis of individual target lesions for tumor 10:55- Nadia size models of drug resistance: a new 11:15 Terranova methodology encompassing signal processing and machine learning PKPD modelling of the relationship between 11:15- Nelleke testosterone and PSA in patients with prostate 11:35 Snelder cancer during treatment with leuprorelin – What is the optimal testosterone level? Model-based analysis of the relationship Anna 11:35- between pembrolizumab exposure and efficacy Georgieva 11:55 in patients with melanoma and NSCLC: across Kondic indication comparison Modeling the emergence of resistance in low- 11:55- Pauline grade glioma patients treated with 12:15 Mazzocco temozolomide, and simulations using a stochastic approach 12.15- Closing remarks 12.25 12:25- Audience Input for the PAGE 2016 Program 12:45 Page | 5 PAGE2015 Abstracts Steven Kern Conducting clinical trials in challenging environments ......................................................................... 34 France Mentré Estimating an effective dose for a repurposed drug to treat Ebola: the case of favipiravir ............................ 36 Matthias Machacek Estimating an effective dose for a new drug to treat Ebola with incomplete information: the case of Zmapp ........................................................................ 40 Scott Berry An Adaptive Platform Trial for Ebola: Application to Future Epidemics ............................................................... 42 Roberto Bizzotto A model of glucose clearance to improve the description of glucose homeostasis....................................... 43 Rada Savic A Longitudinal HbA1c Model Elucidates Genes Linked to Disease Progression on Metformin Therapy ......... 46 José David Gómez-Mantilla Towards Patient Stratification and Treatment in the Autoimmune Disease Lupus Erythematosus using a Systems Pharmacology approach. ............................................................................... 49 Gopichand Gottipati Modeling of a composite score in Parkinson’s Disease using Item Response Theory ................. 52 Emilie Hénin Determination of effective blood concentrations of cyclosporine in pediatric severe aplastic anemia based on a time-to-response model...................................... 55 Huixin Yu Development of a tumour growth inhibition model to elucidate the effect of ritonavir on intratumoural metabolism and anti-tumour effect of docetaxel in a mouse model for hereditary breast cancer ........................... 58 Shan Pan Automated proper lumping for simplification of systems models ..................................................................... 65 Adrien Tessier Modelling pharmacogenetic data in population studies during drug development ......................................... 70 Sebastian Weber Building Robust PK/PD Population Models with Bayesian Inference ........................................................ 76 Page | 6 Michael Betancourt Building Robust PK/PD Population Models with Bayesian Inference ........................................................ 77 Thierry Wendling Application of a Bayesian population approach to physiologically-based modelling and simulation of mavoglurant pharmacokinetics ....................... 78 Rong Deng Towards Model-Based Drug Development of New Therapeutics for Hepatitis C Virus ......................................... 80 Joe Standing Treating Resistant Gram-Negatives: Bedside to Bench and Back ...................................................................... 82 Anders Kristoffersson A Pharmacokinetic-Pharmacodynamic (PKPD) Model Characterizing Resistance for Predictions of Bacterial Kill in vivo ............................................................ 84 Nick Holford Announcement of WCoP 2016 ................................... 87 Andrew Hooker Preconditioning of Nonlinear Mixed Effect models for Stabilization of the Covariance Matrix Computation .......................................................................... 89 Eric Strömberg Simulated model based adaptive optimal design of adult to children bridging study using FDA stopping criteria. .................................................................... 92 Sebastian Ueckert Alternative to Resampling Methods in Maximum Likelihood Estimation for NLMEMs by Borrowing from Bayesian Methodology ................................ 95 Joel Tarning Semi-mechanistic time-to-event modelling in malaria ................................................................................... 98 Natalie Filmann Modeling the PK/PD of hepatitis B immunoglobulin after hepatitis B induced liver transplantation by an extended Target Mediated Drug Disposition Model ................................................................ 100 Dimitra Bon Multiscale modelling for hepatitis C treatment
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