Program

Pre-conference workshop

Tuesday, 23 September 2008
13:45 - 14:00	Welcome - Pre-Conference Workshop		Chair : G. Verbeke Katholieke Universiteit Leuven, Belgium
14:00 - 17:30	An Introduction to Nonlinear Mixed-Effects Models		M. Davidian, North Carolina State University, Raleigh NC, USA
17:30	City tour of Leuven
19:00	Drink at the Town Hall

Main Conference

Wednesday, 24 September 2008
08:15 - 08:30	Welcome - Main Conference		L Bijnens, Janssen Pharma, Beerse, Belgium
Session1	Model Based Drug Development		Chair : F. De Ridder, Janssen Pharma, Beerse, Belgium
08:30 - 09:15	Some principles of modelling and simulation in preclinical research and development		Ph. Jacqmin, Exprimo NV, Mechelen, Belgium
09:15 - 10:30	Contributed papers
09:15 - 9:35	Using desirability indices for decision making in drug development		Didier Renard, Novartis Pharma AG - Basel - Switzerland
09:35 - 9:55	Adaptive model-based dose selection methods		François Vandenhende, Clinbay, Genappe, Belgium
09:55 - 10:15	Clinical relevance of dissolution specifications		Tom Jacobs, Center for Statistics, Hasselt University, Diepenbeek, Belgium
10:15 - 10:45	Coffee Break & poster session
Session 2	Methodology I		Chair : Bruno Boulanger, UCB Pharma SA, Braine-L'alleud, Belgium
10:45 - 12:05	Contributed papers
10:45 - 11:05	Statistics in high-content biology		Rebecca Walls, AstraZeneca, Loughborough, UK
11:05 - 11:25	Combination of independent component analysis and statistical modelling for the identification of metabonomic biomarkers in H-NMR spectroscopy		Réjane Rousseau, Université Catholique de Louvain, Belgium
11:25 - 11:45	Expected and credible design space for analytical methods: a new perspective based on modeling and prediction		Pierre Lebrun, Université de Liège, Belgium
11:45 - 12:05	Symmetric and Asymmetric Sigmoid Curves: a close look at their statistical, numerical and mathematical properties		Charles Tan, Merck, West Point - USA
12:05 - 13:30	Lunch & Poster Session
Session 3	Translational Medicine & Biomarkers		Chair : L. Bijnens, Janssen Pharma, Beerse, Belgium
13:30 - 14:15	Unified approaches for surrogate marker evaluation from multiple randomized trials		G. Molenberghs, Censtat, Hasselt University, Belgium
14:15 - 15:15	Contributed papers
14:15 - 14:35	Fit for purpose limits and tolerance intervals: connecting the biomarker assay performance to the clinical trial		Astrid Jullion, UCB Pharma SA, Braine-L'alleud, Belgium
14:35 - 14:55	Investigating association between behavior, corticosterone, heart rate, and blood pressure in rats using surrogate marker evaluation methodology		Abel Tilahun, Center for Statistics, Hasselt University, Diepenbeek, Belgium
14:55 - 15:15	Genomic biomarkers for a binary response in early drug development microarray experiments		Suzy Van Sanden, Center for Statistics, Hasselt University, Diepenbeek, Belgium
15:15 - 15:45	Coffee Break & Poster Session
Session 4	Methodology II		Chair : P. Lambert, Université de Liège, Belgium
15:45 - 16:30	Estimation of nonlinear mixed effects models in pharmacokinetics with the SAEM algorithm implemented in MONOLIX		France Mentré, Université Paris-7, France
16:30 - 17:50	Contributed papers
16:30 - 17:50	A framework for estimation of area under the concentration versus time curves (AUC's) in complete and incomplete sampling designs		Thomas Jaki, Lancaster University, Lancaster, UK
16:50 - 17:10	Assessing repeatability and reproducibility of dose-response experiments		Marc Weimer, German Cancer Research Centre, Heidelberg, Germany
17:10 - 17:30	Mixed modeling using the SAS® PROC MIXED procedure: A simulation based approach to assess sample sizes and deal with a daily biostatistician dilemma for preclinical trialsv		Lisa Maiofiss, SFdS, Suresnes, France
17:30 - 17:50	Modeling Spatial Learning in rats based on morris water maze experiments		Christel Faes, Center for Statistics, Hasselt University, Diepenbeek, Belgium
20:00	Conference Dinner at Salon Georges

Thursday, 25 September 2008
Session 5	Chemical Manifacturing & Control		Chair : B.Govaerts Université Catholique de Louvain, Belgium
08:30 - 09:15	Application of the tolerance interval concept in quality assurance assessment of pharmaceutical products		Y. Tsong, Office of Biometrics, Center for Drug Evaluation, FDA, USA
09:15 - 10:30	Contributed papers
09:15 - 09:35	Reconsidering shelf life: An update from the PQRI stability shelf life working group		James Schwenke, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, U.S.A.
09:35 - 9:55	Evaluation tolerance interval estimates: to capture or not to capture		Michelle Quinlan, University of Nebraska-Lincoln, Lincoln, U.S.A.
09:55 - 10:15	Development of statistical tools to test the equivalence between two measurement methods		Bernard Francq, Université Catholique de Louvain, Belgium
10:15 - 10:40	Coffee Break & poster session
Session 6	Toxicology		Chair : L. A. Hothorn, Leibniz University Hannover
10:40 - 10:55	Semi- and non-parametric approaches to concentration-response modelling		C. Ritz, University of Copenhagen, Denmark
10:55 - 11:20	Evaluation of the in vitro mutagenicity assays		D. Gerhard, Leibniz University Hannover, Germany
11:20 - 11:45	Invitrostat: An open-source R-GUI for the statistical evaluation of in vitro assays in toxicology		F. Schaarschmidt, Leibniz University Hannover, Germany
11:45 - 12:30	Contributed papers
11:45 - 12:00	The algae growth inhibition test - robust initial values for parameter estimation		Anke Schulz, Bayer Schering Pharma AG - Berlin, Germany
12:00 - 12:15	Assessing the similarity of bioanalytical methods		Jason Liao, Merck, USA
12:15 - 12:30	Dose-response evaluation using a combined parametric/non-parametric approach		John-Philip Lawo, Baxter BioScience, Vienna, Austria
12:30 - 14:00	Lunch & Poster Session
Session 7	Omics		Chair : Z. Shkedy, Censtat, Hasselt University, Belgium
14:00-14:45	Tentacular analysis of high throughput omics data		D. Amaratunga, Johnson & Johnson Pharmaceutical Research & Development LLC, Raritan, NJ, USA
14:45-16:05	Contributed papers
14:45 - 15:05	Estimation of power and analysis of qPCR data with normal mixed models		Auli Partanen, Orion Corporation ORION PHARMA, Turku - Finland
15:05 - 15:25	Order restricted clustering for dose-response microarray experiments		Adetayo Kasim, Center for Statistics, Hasselt University, Diepenbeek, Belgium
15:25 - 15:45	FARMS: a probabilistic latent variable model for summarizing Affymetrix array data at probe level		Djork-Arné Clevert, Institute of Bioinformatics, Johannes Kepler Universität Linz, Austria
15:45 - 16:05	A flexible probe level approach to improving the quality and relevance of affymetrix microarray Data		Chris Harbron, AstraZeneca, Macclesfield, UK
16:05-16:20	Closing and concluding remark		Bruno Boulanger, UCB Pharma SA, Braine-L'alleud, Belgium