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

Overview

Journal Trends Pharmacol Sci

Specialty Pharmacology

Date 2020 Jan 18

PMID 31948797

Citations 2

Authors

Renske M T Ten Ham

Anke M Hovels

Olaf H Klungel

Hubert G M Leufkens

Andre W Broekmans

Jarno Hoekman

Affiliations

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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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