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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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Pros and cons of point of care manufacture of cellular cancer immunotherapies

Decentralized Manufacture

Linda Kelley

Dr Linda Kelley, Cell Therapy Facility Director, is a Senior Member at Moffitt Cancer Center and Professor at the University of South Florida. Dr Kelley has provided leadership for cellular therapy facilities for over 20 years at three institutions, University of Utah, Dana Farber Cancer Institute and Moffitt Cancer Center. She received graduate and post-doctoral training in immunology and hematology from Vanderbilt University, Nashville, TN. Her scientific career evolved from a fundamental interest in immunological mechanisms of T-lymphocyte function, growth mechanisms of hematopoietic stem and progenitor cells and molecular changes associated with malignant transformation. Knowledge of the hematopoietic system led to an interest in stem cell biology and therapies. As director of the Cell Therapy Facility at the University of Utah from 1994 to 2011, she was responsible for developing and expanding a Cell Therapy and Regenerative Medicine Laboratory. During her tenure she was responsible for pre-clinical and clinical cell therapy product development to support IND applications for the production of allogeneic mesenchymal stromal cells (MSC), autologous bone marrow-derived mononuclear cells and allogeneic fetal-derived oligodendrocytes. As director of the Cell Manipulation Core Facility at the Dana Farber Cancer Institute at Harvard from 2011 to 2012, she oversaw management of 20 FDA-approved INDs for the manufacture of gene-modified CD34+ cells, tumor cell vaccines, dendritic cells, MSCs and others. As director of the Cell Therapy Facility at Moffitt Cancer Center, she oversees 22 active INDs for a variety of cell therapy products largely to support immunotherapy for adult and pediatric patients. She currently serves as the Principal Investigator for Production Assistance for Cellular Therapies (PACT) – Cell Processing Facilities to perform pre-clinical cell therapy product development in collaboration with NHLBI and other PACT Centers and as Core Laboratory Technical Director for the Moffitt Cancer Center Support Grant. Dr Kelley excels at bridging the gap between laboratory-based discoveries and new therapies for patients.

DOI: 10.18609/cgti.2019.118
Citation: Cell & Gene Therapy Insights 2019; 5(10), 1109-1114.
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