Karen Walker is Chief Technology Officer at Kyverna Therapeutics. Ms. Walker has broad and deep industry experience developing biopharmaceuticals and cell and gene therapy (CGT) products. She brings extensive and pioneering expertise in the product development, manufacturing, and supply of cell-based therapies and associated analytics.
Ms. Walker has several decades of biotech industry experience, holding positions in Technical Development, Regulatory Affairs, and Quality at a number of companies including Roche/Genentech, Seattle Genetics, Novartis, Amgen, Bayer, Bristol-Myers Squibb, and several other small to mid-sized biotech companies. She comes to Kyverna from Roche/Genentech where she was Senior Advisor, Cell and Gene Therapy Manufacturing. In this position, she was instrumental in developing and implementing the strategy for CGT manufacturing and controls into the Roche/Genentech organization.
Prior to Roche/Genentech, Ms. Walker was Vice President of Global Quality at Seagen Inc., formerly Seattle Genetics, where she oversaw and directed the Global Quality Organization in the U.S. and Europe. Previously, she was Vice President and Global Head of Cell and Gene Therapy Technical Development and Manufacturing for Novartis’ CGT Unit. There, she led the Chemistry, Manufacturing, and Controls (CMC) teams through the formation of the strategies and execution of those strategies to develop KYMRIAH® (tisagenlecleucel) through the pivotal trial stage and to filing of the first CAR-T Biologics License Application (BLA) in pediatric acute lymphoblastic leukemia (ALL). During her time at Novartis and continuing to the present, Ms. Walker has been a strong and leading voice in the establishment of industry standardization and contributed to influence emerging regulatory guidances in the area of CGT products globally.
Ms. Walker holds a bachelor’s degree from St. Olaf College. She is a member of numerous pharmaceutical industry trade organizations, including the Alliance for Regenerative Medicines (ARM) Cell Therapy Manufacturing Committee, DeLoitte Industry Working Group for Advanced Therapy Medicinal Products (ATMPs), Parenteral Drug Association (PDA), PDA Biologics Advisory Board, where she was vice chair from 2018 to 2020, and the PDA ATMP Working Group.