Development and regulation of gene and cell-based therapies in Europe: a quantification and reflection
Publication date
2020-02
Authors
ten Ham, R.M.T.
Hövels, Anke
Klungel, Olaf H.
Leufkens, H.G.
Broekmans, Andre W
Hoekman, Jarno
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Advisors
Supervisors
Document Type
Article
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Abstract
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.
Keywords
gene therapy, cell-based therapy, Advanced therapy medicinal products, clinical development, Drug approval, Taverne
Citation
Ten Ham, R M T, Hövels, A M, Klungel, O H, Leufkens, H G M, Broekmans, A W & Hoekman, J 2020, 'Development and regulation of gene and cell-based therapies in Europe : a quantification and reflection', Trends in Pharmacological Sciences, vol. 41, no. 2, pp. 67-71. https://doi.org/10.1016/j.tips.2019.11.007