Stephan O. Krause

Stephan O. Krause

Stephan O. Krause

AstraZeneca Biologics, USA

Stephan O. Krause, PhD, Director of QA Technical Support, AstraZeneca Biologics, USA

Dr. Stephan O. Krause is AstraZenca’s Director of QA Technology in clinical/commercial biologics operations. Prior to that, he was in MedImmune’s Regulatory Science group (headquarters). Other previous roles include Director of QC, Manager of QA/QC Technical Services and compendial liaison at Bayer Biologics. Stephan often chairs and/or provides talks at major conferences and is a frequent and recognized author. Most recently, he co-chaired the PDA/ FDA Biosimilar conference in 2017. Stephan won PDA’s Fred Simon award in 2017 for the best article published in 2016 and won PDA’s distinguished book award in 2008 for the best book published in 2007. He is the primary author and task force leader of PDA TR 57 (2012). He is co-author of PDA TR 65 for Technology Transfer (2014), PCMO’s task force leader for IMP Specifi cation Setting (2015), and the Biosimilars Initiative co-leader (since 2015). He is a member of PDA’s Biotechnology Advisory Board, Regulatory and Quality Advisory Board, Education Advisory Board, and a PDA/TRI trainer (since 2014). Stephan was nominated to PDA’s Board of Directors (2017-19). In recent years, he was invited by OBP/CDER/FDA and presented multiple times to the OBP CMC reviewers (at FDA headquarters) an industry perspective.