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8h00-8h30 : Registration
Pre Conference Workshop:
8h30 – 12h15 : Course – Fang Chen, SAS Institute:
Bayesian non clinical applications using Proc MCMC
Including coffee break: 10h15-10h45
12:15 – 13:30 Lunch
13:30 – 13:45 Welcome – Main Conference
Session 1 Chair: tbd
Session Theme: Process performance and comparability
13:45 – 14:30 Thomas Lang, EMA expert
What if comparative statistical analysis of “non clinical“ data gets highly relevant
for regulatory decision making?
14:30 – 14:50 Bill Pikounis, Johnson&Johnson:
Out of Specification Evaluations for Biopharmaceuticals
14:50 – 15:10 Jens Lamerz, La Roche AG:
Two years on Assessing practical significance of a process parameter in pharmaceutical technical development using the “Impact Ratio”
15:10 – 15:30 Timothy Mutsvari, Arlenda:
Process Performance Qualification: Optimized Sampling Plan that controls for Producer and Consumer Risks using a Bayesian approach.
15:30 – 16:00 Coffee Break
Session 2 Chair: Bruno Boulanger
Session Theme: Process performance and comparability
16:00 – 16:45 Bruno Boulanger, Pharmalex:
Analytical Similarity and comparability – a point of view of industry
16:45 – 17:05 Jos Weusten, MSD:
Process performance qualification using two-sided intervals – balancing coverage and confidence, and a bayesian approach
17:05 – 17:25 Luwis Diya, Janssen:
Process Performance Qualification Sample Size Determination using Bayesian simulation
17:25 – 17:45 Bernard Francq, GSK:
Equivalence approach for multi-factor robustness evaluation with application in vaccines development.
17:45 – 18:00 My Poster in 180 seconds: Bioassays
Anja Bertsche, Boehringer Ingelheim:
Quantitative quality assessment during the pharmaceutical process design stage taking into account prior expert knowledge
Establishing statistical similarity for an insulin biosimilar based on equivalence and interval approaches
Maxim Nazarov, Open Analytics:
Drug Interaction Modeling and Visualization in R with drugCombo
08:15 – 08:45 Registration (continued)
Session 3 Chair: tbd
Session Theme: Process
08:45 – 09:30 Bradley Jones, SAS JMP:
Modern Design of Experiments for Rapid and Active Learning
09:30 – 09:50 Gregory Chen, Novartis:
On Constructing a Control Limit at Release for Stability Risk
09:50 – 10:10 Olga Yee, Bristol-Myers Squibb:
Holistic risk assessment for biologic compounds to meet target product profile throughout the planned shelf-life, using limited development data and multiple stability segments
10:10 – 10:30 My Poster in 180 seconds: Bioassays
Be confident, predictable or tolerable in method comparison studies. Correlated-error-in-variables regressions in XY and MD plots
Alice Raillard, Sanofi-Pasteur:
Toward an extensive characterization of analytical method performances of analytical methods
Evaluation of alternative robust methods for anti-drug antibodies cut-point determination
10:30 – 11:00 Coffee Break
Session 4a Chair: tbd
Session Theme: High dimension data
11:00 – 11:45 Rudradev Sengupta, Janssen 4-NCS HMyers:
High Dimensional Surrogacy: A Joint Modeling Approach
11:45 – 12:05 Philippe Bastien, L’oréal:
Use of sparse methods in cosmetics
12:05 – 12:25 Philippe Bastien, L’oréal:
Different approaches for summarizing Comet data per slide and their impact on the final statistical outcome
12:25 – 12:45 Hadley Myers, JMP :
Using Functional Data Analysis for time-dependent optimization of batch processes
Session 4b Chair: tbd
Session Theme: Bioassays
11:00 – 11:45 Wilson Tendong, Arlenda:
Assay Reproducibility versus Compound Precision using Bayesian Statistics
11:45 – 12:05 Charles Tan, Pfizer:
New paradigm to assess and derive ADA cut points
12:05 – 12:25 Bernard Francq, GSK:
Confidence and Prediction intervals in Linear Mixed Models, Trueness and Accuracy (Trueness + Precision) in Assay Qualification
12:25 – 12:45 Marion Berger, Sanofi:
BivRegBLS: a one year-anniversary R package in method comparison studies with tolerance intervals and errors-in-variables regressions
12:45 – 14:00 Lunch
Session 5 Chair: tbd
Session Theme: Process Analytical Technology
14:00 – 14:45 Martin Otava, Janssen-Cilag:
Homonegeity within an individual tablet: leveraging NIR technology to study within tablet location effects
14:45 – 15:05 Tatsiana Khamiakova, Janssen:
Model averaging to determine reaction process endpoint using infrared spectroscopy as process analytical technology
15:05 – 15:25 Michel Thiel, Janssen:
Comparison of chemometrics methods for the spectroscopic monitoring of active pharmaceutical ingredients in chemical reactions
15:25 – 15:45 Nicolas Sauwen, Open Ananlytics:
Analysis of NIR spectroscopy data for blend uniformity using semi-Nonnegative Matrix Factorization
15:45 – 16:05 Caroline Leveder, Sanofi-Pasteur:
Process Analytical Technology (PAT): Raman spectroscopy for real-time monitoring of antigen production during the fermentation process
16:05 – 16:35 Coffee Break
Session 6a Chair: tbd
Session Theme: Microbiome
16:35 – 16:55 Dea Putri, Janssen:
Detection of high dimensional biomarkers in non-clinical and clinical microbiome studies
16:55 – 17:15 Thierry Van Effelterre, Janssen:
The challenges of estimating the interactions between bacterial species from longitudinal data
17:15 – 17:35 Stijn Hawinkel, University of Ghent:
Log-linear models for the explorative visualization of microbiome read count data
17:35 – 17:55 Davit Sargsyan, Janssen:
Matched Analysis of Differences of Microbiomes in Japanese vs. Non-Japanese Patients from an Ulcerative Colitis Study
Session 6b Chair: tbd
Session Theme: Bioassays
16:35 – 16:55 Eva Adriaensen, Open Analytics:
Risk-Based Decision Making in Discovery using Quantigene Plex Assay
16:55 – 17:15 Francisca Galindo, Janssen Vaccines
Can the Capillary Electrophoresis (CE) method replace the quantitative Polymerase Chain Reaction (qPCR) method for the direct quantification of intact adenovirus particles?
17:15 – 17:35 Md Abu Manju, Eindhoven University of Technology:
Non-inferiority testing under generalized Poisson distribution
17:35 – 17:55 Graham Healey, Oncimmune:
The use of sensitivity analysis to set acceptance criteria in the validation of biomarker assays
20:00 Conference Dinner at “Le Bistro Parisien”
Session 7 Chair: tbd
Session Theme: Pharmacology
08:30 – 09:15 Leonard Held, University of Zurich:
Bayesian statistics and Reproducibility
09:15 – 09:35 Hannes-Friedrich Ulbrich, Bayer AG:
Mouse clinical trials of N=1: Do we reduce too much?
09:35- 09:55 Milana Filatenkova, Arlenda
Optimal study formats for preclinical studies: leveraging manufacturing experience to overcome the reproducibility crisis.
09:55 – 10:00 My Poster in 180 seconds: Pharmacology
Noception and pain in animal models: von Frey and its difficulties
10:00 – 10:30 Coffee Break
Session 8 Chair: tbd
Session Theme: Pharmacology
10:30 – 11:15 Ludwig Hothorn, University of Hannover:
Statistics in animal studies
11:15 – 11:35 David R Willé, GSK:
What drives your analysis? Investigating the links between data, interventions and design
11:35 – 11:55 Laurent Andrieu, Sanofi:
Frailty Cox model applied to Maze test data
11:55 – 12:15 Antoine Pissort, Arlenda
Electric signals classification in a model of epilepsy: Methods Comparison for a three-class problem
12:15 – 12:35 Helen Barnett, Lancaster University:
Methods for Non-Compartmental Pharmacokinetic Analysis with Observations below the Limit of Quantification
12:35 Closing and Concluding Remarks