2nd Statistical and Data Management Approaches for Biotechnology Drug Development

29-30 September, 2015

Venue: US Pharmacopeia Conference Center, Rockville, Maryland
Organized by: IABS anad FDA

Scope and objective:

This meeting is to bring together regulators, scientists, academia and industry to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

 Among the challenges that will be explored :

  • Statistical Challenges with showing Comparability and Biosimilarity (Equivalence, small data sets, tolerance intervals etc.)
  • Using statistics for Assay Methods (Statistics for development, qualification, validation and transfer of methods)
  • The use of statistics and modelling when using Quality by Design (DoE, Bayesian, partial least squares, prior knowledge data sets)
  • Managing large and/or complex data sets (Large data sets for monitoring variation, complex analytical methods – Mass Spec, NMR, historical data sets)

 folderSlides and documents