| Literature DB >> 31948797 |
Renske M T Ten Ham1, Anke M Hövels1, Olaf H Klungel1, Hubert G M Leufkens2, Andre W Broekmans3, Jarno Hoekman4.
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
Year: 2020 PMID： 31948797 DOI： 10.1016/j.tips.2019.11.007
Source DB: PubMed Journal: Trends Pharmacol Sci ISSN： 0165-6147 Impact factor: 14.819