Genome editing is becoming a popular tool to create novel gene therapy medicinal products (GTMP). As these technologies are developed, stakeholders in academia, industry and government agencies grapple with testing, approving and regulating these products for use in medicine. The authors of The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage? discuss how the regulatory field must evolve with innovative gene therapy technologies to address questions in how to move forward with clinical testing of GTMPs. The authors point out that each treatment design is different and therefore should be assessed on a case-by-case basis taking into account the quality of preclinical data and the need for the particular treatment. Furthermore, the authors discuss how China and the United States are taking the lead in clinical testing while Europe lags behind. It may be that European researchers are more risk-averse than their Chinese and American counterparts or Chinese and American researchers are hastier in their approach to medical progress.
Scientific Advice Interactions on GTMPs Conducted by the Paul-Ehrlich-Institute between 2013 and the First Half of 2018
Elaine Miller – Potluck 3/10/2020
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