Official Program

Day 1 - 25 September 2024

8:30-9:00
Registration
9:00-9:15

Welcome and opening by the Chair

Bernd-Wolfgang Igl

 

9:15-10:00
Annette Kopp-Schneider
DKFZ Heidelberg
Borrowing from external data in early clinical trials using Bayesian methods
10:00-10:15

Leonie Hezler

Boehringer Ingelheim

Experimental designs for preclinical dose response experiments

10:15-10:30
Anja Wiens
Boehringer Ingelheim

Less is more: Dose-response in preclinical xenograft experiments

10:30-10:45

Kristen Kohler

Johnson & Johnson

Comparing methods for averaging IC50s: can we forego complexity for a simpler approach?

10:45-11:00

Q&A

11:00-11:20
Coffee Break
11:20-11:45
My talk in 5 minutes
Sofia Prieto Leon
Hasselt University

Removal of unwanted variation in differential expression analysis of single-cell transcriptome sequencing data

Julia Christin Duda
Dortmund University

Bayesian Non-Linear Subspace Shrinkage using Horseshoe Priors

Dorothée Tamarelle
Sanofi

Author Guideline for Reporting Data Analysis and Statistical Methods in Pharmacology Reports

Jocelyn Sendecki
Johnson & Johnson

Supporting Novel High-Throughput Assay Development via a Flexible Shiny Dashboard

Alexandra Laugerotte
Sanofi

Desirability functions: a case study to select promising candidates for optimal cytokines release

11:45-12:00
Ivan Semeniuk
Chrestos Concept
Issues in reporting results of safety pharmacology studies according to new guidelines
12:00-12:15
Timur Tug
Dortmund University
Does interdisciplinary work between toxicologists and statisticians improve the understanding of the comet assay?
12:15-12:25
Q&A
12:25-13:45
Lunch
13:45-14:30
Silke Werz
Roche
Synergizing statisticians and scientists: the essential 'salt' in CMC process development
14:30-14:45
Jens Lamerz
Upcycling development data using Bayesian statistics to save experimental resources
14:45-15:00
Yang Cao
Johnson & Johnson
Leveraging Bayesian Techniques in DOE Model Prediction and Simulation to Enhance Decision-Making in the Context of Large Molecule Process Characterization in the Pharmaceutical Setting
15:00-15:15
Bernard G Francq
GSK
A New Interpretation To The Equivalence Test (TOST) By (Bayesian) Success Probabilities
15:15-15:30
Q&A
15:30-15:55
Coffee Break
15:55-16.20
My talk in 5 minutes
Christian Schmid
F. Hoffmann La Roche AG
Strategic Decision-Making in Drug Production: A Data-Driven Approach
Janine Burren
F. Hoffmann La Roche AG
Impact Ratio – An integral part of Roche’s synthetic molecule drug substance technical development
Tobias Eilert
Boehringer Ingelheim
An RShiny Application to guide the Planning and Evaluation of an Analytical Method Transfer
Martin Otava
Johnson & Johnson
Release testing strategies for dissolution for larger sample sizes
Jochen Giese
GSK
Statistical Tools for Continued Process Verification: Changepoint Control Charts
16:20-16:35
Philip Jarvis
Novartis
Use of Historical Controls in Non-Clinical
16:35-16.50
Max Menssen
Leibniz University
How to set historical control limits using the R package “predint”
16:50-17.00
Q&A

Day 2 - 26 September 2024

8:45-9:30
Liam Childs
Paul Ehrlich Institut
Current uses of AI in the medicinal product lifecycle
9:30-9:45
Jean-François Michiels
Cencora – PharmaLex
Reliably Assessing Comparability in Autologous Cell Therapy Change Protocols: A Compliance Perspective
9:45-10:00
Ying Chen
KU Leuven
Optimal Experimental Designs for Process Robustness Studies
10:00-10:15
Q&A
10:15-10:35
Coffee Break
10:35-10:50
Bernhard Schmelzer
Novartis
Stability analysis of censored and over-rounded data
10:50-11:05
Thomas Hoffelder
Boehringer Ingelheim
Equivalence of Dissolution Profiles: Time for the statistical dissolution (r)evolution?
11:05-11:20
Q&A
11:20-12:20
Moderator and Discussant: Stan Altan

Johnson & Johnson

Panel Session Patient-Centric Drug Product Quality Specifications: A Convergence of Clinical and Nonclinical Considerations
Hans Coppenolle

Johnson & Johnson

Proposed QbD statistical design to facilitate patient centricity
Trine Kvist
Novo Nordisk
Main basis for justification of specification – current state
Katharina Reckermann
Roche
Patient Centric Specifications: One of the most important and most challenging tasks in product development.
Sandra Suarez Sharp
Simulations Plus, formerly FDA
12:20-13:30
Lunch
13:30-14:15
Ulrich Dirnagl
Charité Berlin
Beyond the Bench: Bridging Biostatistics and Biomedical Research for Reproducibility and Translation
14:15-14:30
Frank Konietschke
Charité Berlin
Statistical Planning and Evaluation of Translational Trials
14:30-14:45
Juliane Wilcke
Munich University
Uncertain or biased input to sample size and power calculations in preclinical animal studies
14:45-15:00
Andreas Allgöwer
Ulm University
Many factors, few prior information – some thoughts, approaches and examples to consider for sample size calculation in preclinical animal trials
15:00-15:15
Q&A
15:15-15:40
My talk in 5 minutes
Ensoy-Musoro, Chellafe

Johnson & Johnson

Sampling Plan for Microbial Testing of Natural Origin Products

Eleonore Pablik

Boehringer Ingelheim
Which Design of Experiment is best for me? A comparison of different DoE strategies
José Núñez Ares
Effex
OMARS designs analysis, bridging the gap between screening and optimization experimental designs

Marion Berger

Sanofi
Scientists dreamt of it, OMARS made it

Clément Laloux

Cencora – PharmaLex

Bayesian framework for the determination of the confirmatory cut point during the immunogenicity assessment
15:40-16:00
Coffee Break
16:00 -16:15
Stijn Jaspers
Hasselt University
Covariate-adjusted generalized pairwise comparisons in small samples
16:15-16:30
Andreas Schulz
Sanofi-Aventis
Analyzing Zero-Inflated Continuous Data in Limited Sample Size
16:30:16:40
Q&A
16:40-17:00
Joe Watson
GSK
Anti-drug antibody immunogenicity studies in singlicate? Exploring some additional challenges faced and quantifying their impact
17:00-17:20
Traymon Beavers
Johnson & Johnson
Sorting Cytokines Using Regression Methods and Decision Trees in Immunology Studies

Day 3 - 27 September 2024

8:30-8:50
Koen Van den Berge

Johnson & Johnson

Assessing changes in cell composition between biological conditions in single-cell data
8:50-9:10
Fetene Tekle

Johnson & Johnson

Unraveling killing kinetics: insights from real-time cell analysis in oncology
9:10-9:30
Davit Sargsyan

Johnson & Johnson

Novel Differential Flow Cytometry Data Analyses Method Using Data Nuggets Compression and Projection Pursuit Algorithms
9:30-9:50

Jonathan Rathjens

Chrestos Concept GmbH & Co. KG

Multilevel mixed models for single-animal designs
9:50-10:10
Nicholas Hein

Johnson & Johnson

Unlocking synergy: Navigating Type I Error Control & Heterogeneous Variance in Simulation Studies
10:10-10:30
Thomas de Marchin
Cencora – PharmaLex
Unveiling Drug-Induced Liver Injury: Integrating Gene Expression Data and Target-Based Drug Families for an Advanced Predictive Model
10:30-10:45
Coffee Break
10:45-11:30
Tobias Verbeke
OpenAnalytics
Open Source: from Statistical Computing to Generative AI
11:30-11:45
Verena Nold
Boehringer Ingelheim
Influence of Process History on Models of Biodynamics
11:45-12:00
Deniz Akinc Abdulhayoglu
Cencora – PharmaLex
A Comparative Analysis of Bayesian Sampling Methodologies for Design Space Identification in Quality by Design (QbD) Approach
12:00-12:15
Yannick Van Haelst
Sanofi
A Comparative Analysis of Design Space Optimization Strategies for identifying High-Volume Hypercubes, including a novel algorithm
12:15-12:30
Q&A
12:30-12:55
My talk in 5 minutes
Arno Strouwen
JuliaHub
Bayesian non-linear mixed effects model for safer powder storage
Alexandre Mösching
F. Hoffmann La Roche AG
From Data to Impact: Yield Optimization in Biologics Manufacturing
Ben Wells
Bayezian
Temperature Excursion and Shelf-Life Estimation. Applications on vaccines
Thomas Weißschuh
Boehringer Ingelheim
Trending of (Ongoing) Stability Data
Armin Böhrer
Boehringer Ingelheim
Data Analysis of Accelerated Stability Data from Proteins for Shelf-Life Prediction
12:55-13:05

Kevin Lief

Beate Presser

GSK

Boehringer Ingelheim

Introduction of the new CMC SIG Group
13:05-13:15

Further activities and closing remarks by the Chair

Bernd-Wolfgang Igl

Further activities & Upcoming Events