Day 1 – Wednesday, 8 October 2014
13:45 – 14:00 Welcome – Pre-Conference
Workshop Chair : B. Boulanger, Arlenda, Belgium14:00 – 17:30 J. Peterson, GSK, USABayesian Applications to Quality-by-Design and Assay Development J.
19:00 Drink at the Town Hall
Day 2 – Thursday, 9 October 2014
08:15 – 08:30 Welcome – Main Conference
H. Geys, Janssen Pharma, Belgium
Session 1 Chair : O. Thas, Ghent University, Belgium Translational Research
08:30 – 09:15 W. Van Criekinge, Ghent University, Belgium Translational epigenomics
Contributed papers 09:15 – 09:35 K. Gore, Pfizer, UK Helping to Drive the Robustness of Preclinical Research
09:35 – 09:55 M. Bergquist, GSK, USA Quantifying Success? Metrics for Non-Clinical Statisticians
09:55 – 10:15 G. Chen, Merck, Netherlands Bayesian tolerance interval
10:15 – 10:45 Coffee Break & Poster Session Session 2 Chair : Pierre Lebrun, Arlenda, Belgium Bioassays Chair
10:45 – 11:30 C. Tan, Pfizer, USA A Step in the Right Direction? the development of USP Chapter <1210>
Contributed papers 11:30 – 11:50 P. Sondag, B. Boulanger, E. Rozet, R. Rousseau, Arlenda, Belgium Comparison of methodologies to assess the parallelism between two four parameters logistic curves
11:50 – 12:10 J.-F. Michiels, T. Scherder, B. Boulanger, P. Lebrun, A. Jullion, Arlenda, Belgium A Bayesian framework for conducting effective bridging between references under uncertainty
12:10 – 12:30 A. Baclin, M-P. Malice, G. de Lannoy, M. Key Prato, GSK, Belgium Control Chart to Monitor Quantitative Assay Consistency
12:30 – 13:45 Lunch & Poster Session Session 3 Chair : B. Boulanger, Arlenda, Belgium Chemical Manufacturing & Control Bioassays
13:45 – 14:30 H. Yang, MedImmune, USA Using statistical innovation to impact regulatory thinking
Contributed papers 14:30 – 14:50 P. C. Ijzerman-Boon, E. R. van den Heuvel, Merck, Netherlands Validation of qualitative microbiological test methods
14:50 – 15:10 E. Talens, Merck, Netherlands Stability of reference standards
15:10 – 15:30 T. Mzolo, G. Goris, A. Di Bucchianico, E. van den Heuvel, University Medical Center Groningen, Netherlands An Evaluation of Several Statistical Methods for Monitoring the Bioactivity of an In-house Reference Standard
15:30 – 15:50 A. Baclin, C. Bievelet, G. de Lannoy, M. Key-Prato, M.-P. Malice, GSK, Belgium A statistical method to demonstrate dilutional linearity for immunoassays
15:50 – 16:20 Coffee Break & Poster Session Session 4 Chair : Z. Shkedy, Hasselt University QSTAR- an integrated analysis of biological, chemical and gene expression data in drug discovery
16:20 – 17:05 H. Goehlmann, Janssen Pharma, Belgium ADA-Cutpoint estimation – using R: assumptions, solutions, problems
Contributed papers 17:05 – 17:25 F. Mattiello, O. Thas, Ghent University, Belgium Two Explorative Data Analysis Methods for Discovering Connections Between Three Data Sources, with Applications in Early Drug Development
17:25 – 17:45 N. J. Perualila, Hasselt University, Belgium Rationalizing CMap Gene Expression Readouts via Target Prediction
17:45 – 18:05 M. Otava, Hasselt University, Belgium Regression with Enriched random forest
20:00 Conference Dinner at brewery Halve Maan
Day 3 – Friday, 10 October 2014
Session 5 Chair : L. Bijnens, Janssen Pharma, Belgium Visualisation techniques
08:30 – 09:00 D. Smeets, Icometrix, Leuven, Belgium Volumetric images as a representation of clinical data
09:00 – 09:30 R. Verbeeck, Janssen Pharma, Belgium The best of both worlds: guided analytics in the hands of the SME
09:30- 10:00 T. Verbeke, OpenAnalytics, Belgium Nonclinical Statistics Computing: The Big Picture
10:00- 10:30 Coffee Break & Poster Session Session 6 Chair : G. Verbeke, iBiostat,Omics 10:30 – 11:15 J. Goeman, Leiden University, Netherlands Flexible multiple testing for drug screening
Contributed papers 11:15 – 11:35 B. Verbist, K. Thys, J. Reumers, J. Aerssens, L. Bijnens, L. Clement, O. Thas, Janssen Pharma, Belgium Statistical methods for improved variant calling of massively parallel sequencing data within virology applications
Session 7 Chair : L. A. Hothorn, Leibniz University Hannover Toxicology
11:35 – 12:20 J. Fox, USEPA-ORD-NCEA-W, USA Test for Significant Toxicity: Time for Changes in the Analysis of Toxicity Test Data
Contributed papers 12:20 – 12:40 L. A. Hothorn, Leibniz University Hannover ADA-Cutpoint estimation – using R: assumptions, solutions, problems
12:40 – 14:00 Lunch & Poster Session Session 8 Chair : T. Jacobs, Janssen Pharma, Belgium Pharmacology
14:00 – 14:45 T. Jaki, Lancaster University, UK Statistical approaches for Anti-Drug-Antibody (ADA) identification
Contributed papers 14:45 – 15:05 J. Bright, AstraZeneca, UK Reduce & Repeat – a way of obtaining more precise XC50s using fewer wells (in vitro) and fewer animals (in vivo)
15:05 – 15:25 S. Janssen, J. Talpos, T. Jacobs, L. Fellini, T. Steckler, Janssen Pharma, Belgium Statistical Aspects for the Quantification of Learning Behaviour
15:25 – 15:45 E. Rozet, L. Natalis, B. Matthee, J. Swildens, T. Ritsema, W. Beumer, B. Boulanger, Arlenda, Belgium Piecewise nonlinear mixed-effects model for modelling Nasal Potential Difference (NPD)
15:45 – 16:05 L. Muchene, M. Otava, Z. Shkedy, T. Jacobs, Hasselt University, Belgium Determination of the minimum effective dose for correlated dose-response data using Bayesian variable selection (BVS) models
16:05 – 16:25 L. Bijnens, Janssen Pharma, Belgium Closing and Concluding Remark