Regulatory Aspects of Gene Therapy and Cell Therapy Products

This text discusses the global regulation of increasingly popular gene therapy (GT) and cell therapy (CT) products by national and international bodies, focusing on ones in Japan, Brazil, and the United States, as well as the International Conference on Harmonisation and the Regulators Forum Cell Th [...]
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This text discusses the global regulation of increasingly popular gene therapy (GT) and cell therapy (CT) products by national and international bodies, focusing on ones in Japan, Brazil, and the United States, as well as the International Conference on Harmonisation and the Regulators Forum Cell Therapy Group. More specifically, it analyzes regulatory frameworks; lends insight into the applicable regulatory pathways; and provides an overview of specific considerations in product manufacturing, pharmacology, toxicology, and clinical trial design. Each chapter walks the reader through the applications of nonclinical research to translational clinical research to licensure for these revolutionary products. Global perspectives from regulators with experience in GT and CT product oversight lends real-world context to the book. Regulatory Aspects of Gene Therapy and Cell Therapy Products: a Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series.It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.