Workshop Co-organized by IABS and FDA


Scientific Committee

Rick Burdick,
Arizona State University
Robert Capen,
Merck & Co., Inc.
Kedar Dave,
Bristol-Myers Squibb
Abe Germansderfer,
Novartis
Kristi Griffiths,
Lilly
Walter Hauck,
Sycamore Consulting LLC
Tsai-Lien Lin,
FDA
Anthony Lonardo,
Lilly
Tony Mire-Sluis,
Amgen Inc.
Thomas Parish,
AbbVie
Bill Pikounis,
Centocor
Tim Schofield,
Medimmune LLC
Volker Schnaible,
Roche
Meiyu Shen,
FDA
Andrew Rugaiganisa,
Pfizer
Yi Tsong,
FDA
Harry Yang,
Medimmune
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.