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

Autor: Ten Ham RMT; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Universiteitsweg 99, 3584, CG, Utrecht, The Netherlands., Hövels AM; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Universiteitsweg 99, 3584, CG, Utrecht, The Netherlands., Klungel OH; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Universiteitsweg 99, 3584, CG, Utrecht, The Netherlands., Leufkens HGM; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Universiteitsweg 99, 3584, CG, Utrecht, The Netherlands; Lygature, Utrecht, The Netherlands., Broekmans AW; Lygature, Utrecht, The Netherlands., Hoekman J; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Universiteitsweg 99, 3584, CG, Utrecht, The Netherlands; Innovation Studies Group, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands. Electronic address: j.hoekman@uu.nl.
Jazyk: angličtina
Zdroj: Trends in pharmacological sciences [Trends Pharmacol Sci] 2020 Feb; Vol. 41 (2), pp. 67-71. Date of Electronic Publication: 2020 Jan 13.
DOI: 10.1016/j.tips.2019.11.007
Abstrakt: 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.
(Copyright © 2019 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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