Key priorities for cell & gene therapy manufacturing evolution in 2023 & beyond

David McCall, Commissioning Editor,BioInsights, spoke to David DiGiusto, Senior Vice President, Stem Cells and Regenerative Medicine, National Resilience

David DiGiusto is the Senior Vice President for Stem Cells and Regenerative Medicine at National Resilience. He has over 28 years of experience in the scientific, clinical and regulatory aspects of cells as therapeutic agents including the isolation, characterization and genetic modification of hematopoietic stem cells, T cells and regenerative medicine products for clinical applications. He has been instrumental in the creation of seven GMP compliant biologics manufacturing facilities and associated quality systems, production and QC testing programs. Under his direction, plasmid DNA, CAR-T cells, regulatory T cells, engineered stem cell grafts and gene modified hematopoietic stem cell products have been manufactured and released for use in Phase 1/2 clinical trials. David is a major contributor to first in human studies for Cancer and HIV Gene Therapy and has developed methods for assessing ex vivo stem cell manipulations using in vitro and in vivo models. David is a former member of the NIH recombinant DNA advisory committee (RAC) and an independent consultant to the Biotechnology industry.

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