@article{b320fa93d85a48b9999d68000a97860c,
title = "Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection",
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 = "advanced therapy medicinal products, cell-based therapy, clinical development, drug approval, gene therapy",
author = "{ten Ham}, RM and Anke Hovels and Olaf Klungel and Andr{\'e} Broekmans and Jarno Hoekman",
note = "Funding Information: This research has been performed within the context of the Escher platform for regulatory innovation that resides under the umbrella of the Dutch not-for-profit organization Lygature ( www.lygature.org ). Lygature has received funding from the European Federation of Pharmaceutical Industries and Associations (EFPIA) and its specialized group European Biopharmaceutical Enterprises (EBE). Publisher Copyright: {\textcopyright} 2019 Elsevier Ltd Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",
year = "2020",
month = feb,
doi = "10.1016/j.tips.2019.11.007",
language = "English",
volume = "41",
pages = "67--71",
journal = "Trends in Pharmacological Sciences",
issn = "0165-6147",
publisher = "Elsevier Limited",
number = "2",
}