NCS 2018

Day 1 – Wednesday, 3 October 2018

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

Birgit Niederhaus, Sanofi:

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

Day 2 – Thursday, 4 October 2018

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

Bernard Francq, GSK :

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

Valérie Martin, Sanofi:

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”

Day 3 – Friday, 5 October 2018

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

Lea Vaas, Bayer AG:

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