Workshop Co-organized by IABS, NIST and FDA


Scientific Committee

Tony Mire-Suis
AstraZeneca; Chair, IABS Biotherapeutics Scientific Committee
John Schiel
NIST
Michael Tarlov
NIST
Rohini Deshpande
Amgen
Patrick Swann
Biogen
Ingrid Markovic
CBER FDA
Emanuela Lacana
CDER FDA
Gary Takle
Merck and Co
Dieter Schmalzing
Genentech


Meeting management:


IABS
Geneva, Switzerland




Objectives of the Workshop

This meeting is to bring together regulators, and scientists, or those interested in analytics from 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 current and novel analytics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability and process development and execution 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.