Preclinical trends in developing genetically altered cell therapies

There are many scientific and regulatory considerations to be made when planning for the development of genetically altered cell therapy products. These products include different cell types (for example both T cells and B-cells) and for the treatment of diseases in different therapeutic areas (oncology, inflammation, enzyme, or protein replacement constructs). This article will present a framework for approaching these projects from a preclinical perspective and share trends in common feedback from regulatory agencies, most notably the US FDA. The intent is to share this information with other product developers at an earlier point to make planning easier.

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