Development and regulation of gene and cell-based therapies in Europe : a quantification and reflection
- Ten Ham, Renske M T
- Hövels, Anke M
- Klungel, Olaf H
- Leufkens, Hubert G M
- Broekmans, Andre W
- Hoekman, Jarno
DOIAbstract
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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