Stephan O. Krause
Stephan O. Krause, PhD, is the head of the Product Quality Group for AstraZeneca Biologics in Maryland, USA. Stephan has a PhD in analytical biochemistry from the University of Southern California and has fulfilled leading roles in QA/QC and RA for clinical and commercial manufacturers for the last 18 years. His many publications/ presentations reflect his broad experience in risk management, validation, tech transfer, and control strategies. He won the 2008 PDA Distinguished Author Award, PDA’s Fred Simon Award in 2017, and the Distinguished Service Award in 2018.
Stephan has numerous publications in the PDA Letter and PDA Journal, has co-authored several PDA technical reports, and was the former PCMO’s Task Force leader for IMP Specification Setting (2015). He holds many volunteer positions for PDA, including serving as the leader for the Biosimilars IG, as a member of PDA’s BioAB, EAB, RAQAB, PDA Letter Editorial Team, and the Program Advisory Group, and as a course instructor at PDA’s Training and Research Institute in Bethesda, USA.
Stephan often serves as chair and lecturer at major conferences worldwide. In 2012 and 2015, Stephan was recognized for his work with PDA and was invited by the FDA to present and discuss industry perspectives with OBP/CDER staff at FDA’s headquarters.