Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection

Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection

Gene and cell-based therapies (GCTs) are said to hold great promise as treatments for previously untreatable and high-burden diseases. Here, we provide insight into GCT development and regulation activities in Europe, quantify clinical and regulatory success, and compare these with other medicinal p...

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Veröffentlicht in:Trends in pharmacological sciences (Regular ed.) 2020-02, Vol.41 (2), p.67-71
Hauptverfasser: ten Ham, Renske M.T., Hövels, Anke M., Klungel, Olaf H., Leufkens, Hubert G.M., Broekmans, Andre W., Hoekman, Jarno
Format: Artikel
Sprache:eng
Schlagworte:
advanced therapy medicinal products
cell-based therapy
clinical development
drug approval
gene therapy
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Zusammenfassung:Gene and cell-based therapies (GCTs) are said to hold great promise as treatments for previously untreatable and high-burden diseases. Here, we provide insight into GCT development and regulation activities in Europe, quantify clinical and regulatory success, and compare these with other medicinal products in order to reflect on regulatory changes and challenges.
ISSN:0165-6147
1873-3735
DOI:10.1016/j.tips.2019.11.007