Workshop Co-organized by IABS and FDA


Scientific Committee

Richard K. Burdick
Arizona State University
Robert Capen
Merck & Co., Inc.
Kristi Griffiths
Eli Lilly and Company
Ruojia Li
Bristol-Myers Squibb
Tsai-Lien Lin
FDA
Anthony Lonardo
Eli Lilly and Company
Tony Mire-Sluis
AstraZeneca
Dan Obeng
Sanofi Genzyme
Laura Pack
Seattle Genetics
Bill Pikounis
Centocor
Andrew Rugaiganisa
Pfizer
Volker Schnaible
Roche
Tim Schofield
GlaxoSmithKline
Meiyu Shen
CDER/FDA
Harry Yang
Medimmune LLC
Yi Tsong
CDER / FDA
Lanju Zhang
AbbVie


Meeting management:

IABS
Geneva, Switzerland




Objectives of the Workshop

This meeting is to bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, 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 will be provided by the speakers and panel members. 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.