Think ahead: preparing for challenges to accelerate your cell therapy commercialization

Dr Saba Ghassemi is an Assistant Professor in the Department of Pathology and Laboratory Medicine and serves as a Principal Investigator at the Center for Cellular Immunotherapies at the University of Pennsylvania. Her research focuses on developing novel CAR-T cells with enhanced potency through a multidisciplinary approach that integrates engineering with CAR-T cell immunology.

Dr Ghassemi pioneered the development of an abbreviated culture paradigm, resulting in less differentiated progeny with improved potency. This breakthrough led to a successful clinical trial at UPenn, utilizing a 3-day manufacturing process. Additionally, she has devised a novel method for delivering CAR transgenes into quiescent T cells, enabling the generation of highly potent CAR-T cells within 24 hours. Dr Ghassemi is currently spearheading efforts to transition this innovative platform into an upcoming clinical trial at Penn.

Her groundbreaking work has garnered recognition through several research grants and patent applications aimed at enhancing CAR-T cells' efficacy, expansion, and fitness for adoptive immunotherapy. Dr Ghassemi's ongoing research endeavors focus on optimizing, streamlining, and automating the manufacturing process of CAR-T cells, with the overarching goal of enhancing the translational applicability and accessibility of these novel therapies to a broader range of geographical locations and patient populations.

Kathryn Henckels is an Associate Director at Johnson & Johnson in the API Cell & Gene Therapy organization, where she leads a team focused on autologous and allogeneic process development for both early and late stage CAR-T cell therapy assets. She holds a PhD in Biological Sciences from Columbia University.

With 14 years of biopharmaceutical development experience, Kathryn has been working in the CAR-T field since 2018. Before joining Johnson & Johnson, she held positions in Inflammation Discovery Research, Cell Line Development, and Cell Therapy Process Development focusing on early stage autologous CAR-T and TCR-T programs.

Dr Hannah Song develops manufacturing processes for engineered T cell therapies for phase I/II clinical trials at the NIH Clinical Center in Bethesda, MD. She performs IND-enabling studies, drafts batch records, authors CMC sections for IND submissions, and routinely evaluates cutting-edge technologies for potential use in clinical manufacturing. She has a special research interest in understanding how to utilize advanced manufacturing techniques to optimally control T cell therapeutic profiles.

Prior to joining the NIH, Hannah earned her PhD in Chemical Engineering from the University of Wisconsin-Madison and trained as a post-doc at the Georgia Institute of Technology.