Karen M. Walker BioAB Vice-Chair

Prior to joining Roche/GNE, she served as Global Quality Head for Seattle Genetics (2017-2020). Her experience with Cell and Gene Therapies includes serving in the role of VP and Global Head of Technical Development and Manufacturing for Novartis’ Cell and Gene Therapy Unit where she led the CMC teams through the formation of the strategies and the execution of those strategies to develop Kymriah through the pivotal trial stage and to filing of the first CAR-T BLA in Pediatric ALL.

Karen’s years of experience in Biopharma Technical Development, Quality, Regulatory CMC, and Manufacturing (including Cell and Gene Therapy), both within the US and Europe have contributed to honing a mind-set and approach that is strategic, forward looking and adaptive. The challenges that are here in the Drug Development space, including shortened development time (4 years faster), complex supply chains, implementation of new and enabling technology and changes to the way we work, are all inspiring and energizing to Karen as the Pharma/BioPharm Industry evolves in the 21st Century.

Karen has been an active member of PDA since 1996 and most recently served as Vice Chair of the Bio Advisory Board.