Development and regulation of gene and cell-based therapies in Europe: a quantification and reflection

Renske M T Ten Ham; Anke M Hövels; Olaf H Klungel; Hubert G M Leufkens; Andre W Broekmans; Jarno Hoekman

doi:10.1016/j.tips.2019.11.007

Development and regulation of gene and cell-based therapies in Europe: a quantification and reflection

Renske M T Ten Ham, Anke M Hövels, Olaf H Klungel, Hubert G M Leufkens, Andre W Broekmans, Jarno Hoekman

Lygature, Utrecht, The Netherlands.

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	67-71
Number of pages	5
Journal	Trends in Pharmacological Sciences
Volume	41
Issue number	2
DOIs	https://doi.org/10.1016/j.tips.2019.11.007
Publication status	Published - Feb 2020

Keywords

gene therapy
cell-based therapy
Advanced therapy medicinal products
clinical development
Drug approval

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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.",

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AU - Leufkens, Hubert G M

AU - Broekmans, Andre W

AU - Hoekman, Jarno

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KW - cell-based therapy

KW - Advanced therapy medicinal products

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Development and regulation of gene and cell-based therapies in Europe: a quantification and reflection

Abstract

Keywords

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