Steven Highfill | Director of Product Development, Center for Cellular Engineering, Clinical Center
National Institutes of Health

Dr. Steven L. Highfill is Director of Product Development at the Center for Cellular Engineering at the National Institutes of Health (NIH). He earned his Ph.D. in Immunology and Cancer Biology from the University of Minnesota and completed extensive postdoctoral training in cancer immunotherapy at the NIH, where he developed expertise in cellular therapies—particularly adoptive T-cell immunotherapy for cancer. Dr. Highfill has an established record of leading translational research in the development and clinical application of chimeric antigen receptor (CAR) T-cell therapies. At the NIH, he has completed CMC studies supporting more than 30 cell-therapy investigational new drug applications (INDs), including the development of CD22-directed CAR T-cell therapies for pediatric patients with cancer. His research has focused on overcoming the immunosuppressive tumor microenvironment, enhancing CAR T-cell efficacy through gene-editing technologies, and optimizing manufacturing strategies to produce safer and more effective cellular therapies. Dr. Highfill has co-authored more than 75 peer-reviewed publications and holds patents related to innovations in cellular therapy. His work has advanced cellular engineering approaches targeting both hematologic malignancies and solid tumors, with the ultimate goal of improving outcomes for patients with cancer.