Topics

The Non-Clinical Statistics conference addresses statisticians and data scientists focusing on quantitative decision-making and statistical methodology with applications to all non-clinical areas of pharmaceutical research, development and manufacturing.

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, equivalence, 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: statistical consequences
  • Regulatory trends
  • Synergy