Karen Walker, Chief Technology Officer, Kyverna Therapeutics. Karen brings >30 years’ experience in the biotech industry, holding positions in Technical Development, Regulatory Affairs and Quality. She has worked in a number of companies including Roche/Genentech, Seattle Genetics, Novartis, Amgen, Bayer, and several other small to mid-sized biotech companies.
Her experience with Cell and Gene Therapies includes the role of Senior Advisor for Cell and Gene Therapy at RGNE, focused on aspects of development and industrialization of ATMPs. Topics include patient engagement, supply management, control strategy development and data and analytics that incluse research, clinical development and CMC to gain insight into how the products perform with respect to safety, efficacy and durability of benefit. Prior experience included VP 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 rusulting in the filing of the first CAR-T BLA. A strong focus for Karen has been active external engagement with industry/trade organizations and dialogue with Health Authorities to influence the regulatory framework for these products and advocating for stronger harmonization across regions.