Stephan O. Krause, PhD

Results-driven leader with technical, managerial, and executive experience. Proven background in leading quality and technical functions within global operations. Recognized leader of industry working groups to improve and standardize best practices for analytical and quality-focused processes. Breadth of experience includes mAbs, ADCs, ATMPs, Vaccines, Coagulation Factors, Small Molecules, Biosimilars. Highlights: • Over 20 years of management experience in the development, manufacture, and testing of commercial and clinical products. • Expert in analytical method development, qualification, validation, transfer, standardization and automation, platform analytical procedure development/use, reference standards, stability programs, and specification and limit setting. • Highly experienced in phase-appropriate quality systems, global QC method monitoring programs and standardization, comparability protocols, continuous process verification, technology transfer, OOS investigations, statistical analysis, lean implementation, and risk-based decision-making. • Experienced in QRM, accelerated CMC development, IND/BLA writing and reviews, managing regulatory inspections. Accomplished PDA Task Force Leader for: • Analytical Method Validation and Transfers for Biologics (TR 57, 2010-15) • PCMO L01 for Biological Product IMP Specification Setting (2012-15) • Biosimilars Initiative (2015-19) • ANS-007 Analytical Standard Development (since 2021) • Phase-appropriate GMP/QS (since 2021) Current PDA Leadership: • Board of Directors member (since 2019) • Immediate Past-Chair ATMP AB (since 2020), BioAB member (since 2014), RAQAB (2017-22) • Chair of ANS-007 Analytical Standard Development (since 2021) • Chair of TR56-R1 ATMP Annex (since 2024) Industry Awards and Recognition: • PDA´s Distinguished Book Author Award (2008) • PDA Technical Report No. 57 Award (2012) • PDA Technical Report No. 65 Award (2014) • Fred Simon Award (2017) • Distinguished Service Award (2018) • Service Appreciation Award (2019) • Service Appreciation Award (2020) • PDA Letter Article of the Year Award (2021) [Only recipient of all three PDA publication awards] • Service Appreciation Award (April 2025) • Invited by FDA to present an industry perspective to FDA staff for analytical method lifecycle steps (2012), and, for use of platform processes/conditions to support accelerated product development and approval (2015). • Invited by Health Canada to present an industry perspective to HC staff to support the implementation of ICH Q2(R2), Q12 and Q14 (2021).