The conference is aimed at statisticians with an interest in the application of statistics to non-clinical areas of the drug development and production process.
Discovery and preclinical research
Reproducibility / Replicability
Omics, target ID
Computational biology
Toxicology
Translational sciences
Data organization and standards (SEND)
Historical or virtual controls
Experimental design
Visualization
Biomarker analysis
CMC
Process development and process performance qualification
Specification settings
Stability
Transfers, equlivalence, post approval changes and comparability
Scale-up, scale-down
In-silico models of bioprocesses and digital twins
QbD, aQbD, PAT
Continuous manufacturing
Bioassays, Analytical Procedures
Design of experiments
Analytical Biosimilarity
Methodology & General Topics
Quantitative Decision-making
Applied Bayesian statistics
Causal inference
Artificial Intelligence, Machine Learning and Digitalization
Collaboration & Knowledge Sharing
FDA Modernization Act 2023 propose in-vitro bioassays: statistical consequences
