Expertise: Biotherapeutics (antibodies, antibody drug conjugates, proteins) – analytical development, CMC Quality systems, and CMC Compliance. Auditing and FDA/EMA inspection preparation/training. Method development, transfer, bridging, and validation. Stability study strategy and management. Defining, characterizing, and managing/bridging reference materials. CMO selection and oversite. Setting specifications for IND through BLA. E-CTD Module 3 strategy and writing for IND/ IMPD and BLA/MAA. Risk management approaches and strategies.
Experience: 15 years analytical development working on protein analytical characterization and method development at various companies from start-up through large biopharma and 14 years heading up Quality Control at Seattle Genetics. Worked on numerous products from pre-IND through commercial including proteins, mAbs and ADCs. Multiple successful interactions with FDA and EU regulators.
Other: Co-Chair of IABS Biotherapeutics sub-group. Member ASQ, PDA, ECA, CASSS. Previous co-chair WCBP conference (2017), Workshop lead at World ADC (2019).