Purpose and Topics

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
  • Microbiome
  • Omics, target ID
  • Computational biology
  • Toxicology
  • Translational sciences
  • Applied Bayesian Statistics
  • Digitalization and automation
  • Data organization and standards (SEND)
  • Synergy
  • Causal inference

CMC

  • Process Performance & comparability
  • Stability, Dissolution, diffusion
  • Scale-up, scale-down
  • In-silico models of bioprocesses
  • QbD, aQbD, PAT
  • Continuous manufacturing
  • Bioassays, Analytical Procedures
  • Design of experiments
  • Analytical Biosimilarity
  • Regulatory trends
  • Applied Bayesian Statistics
  • Artificial Intelligence, Machine Learning and Digitalization

Methodology

  • Decision-making
  • Value of P-values in non-clinical research
  • Bayes factor
  • Bayesian statistics
  • Causal inference