The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?. Issue 2 (February 2019)

• Record Type: Journal Article
• Authors: Cathomen, Toni; Schüle, Silke; Schüßler-Lenz, Martina; Abou-El-Enein, Mohamed
• Is Part Of: Trends in biotechnology. Volume 37:Issue 2(2019)
• Page Start: 120
• Page End: 123
• Publication Date: 2019-02
• Subjects: clinical trials -- commercialization -- CRISPR -- ethics -- genome editing -- regulation; Biotechnology -- Periodicals; Biochemical engineering -- Periodicals; Genetic engineering -- Periodicals; Industrial microbiology -- Periodicals; 660.605
• DOI: 10.1016/j.tibtech.2018.06.005
• Languages: English
• ISSNs: 0167-7799

Abstract

Abstract : Medicinal products based on genome editing must undergo rigorous preclinical testing and are subject to regulatory oversight for proper risk assessment prior to first evaluation in humans. We give a European perspective on the regulatory expectations to translate genome editing to the clinic to ensure their timely progress to market.