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How genetically modified organism (GMO) regulations impact on the development of genetically modified cell-based therapies in Europe, the U.S. and Japan

      Somatic cell therapy products (whether autologous, allogeneic or xenogeneic) that have been subjected to an ex vivo gene transfer procedure will normally be classified as GMOs (not just the gene transfer vectors used in their construction or used as gene therapy medicinal products in their own right). These products will therefore fall under the applicable environmental regulatory framework. This results in significant implications for approval of clinical trials, as will be explained in this presentation.
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