Karen Thudium Mueller

Karen is the Vice President of Translational Science and Global Program Lead for GentiBio’s lead program. Prior to joining, Karen led the clinical pharmacology and translational sciences team for cellular and gene therapies at Novartis Pharmaceuticals including both early and stage late development programs. Karen was instrumental in leading the clinical pharmacology and biopharmaceutics strategy for the first cellular therapy (CAR-T) approved in the United States, Europe, and Rest of World, supporting the program from IND through regulatory approvals including an Oncology Drug Advisory Committee. She has authored and co-authored numerous seminal papers in the field of cellular therapy. In addition, to cellular therapies, Karen has led the early development of several ADCs and supported the clinical pharmacology strategies for Kisqali, Afinitor and other established products. Karen received her Doctor of Pharmacy and Master of Science in Pharmaceutical Sciences with a focus on Clinical Pharmacology, from Rhode Island University and completed post-doctoral fellowships at the Roswell Park Cancer Institute in Buffalo and at Novartis.