Tuesday, March 22, 2022 Daily Archives

Pharmaron’s cell and gene therapy webinar series

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Pharmaron has taken their platform beyond small molecules and are pleased to now offer a full array of services for biologics and cell and gene therapies (CGTs). Our new CGT webinar series focusses on identifying key cell and gene therapy questions that arise during drug discovery and development. Register here for the series. Our second webinar, entitled Downstream AAV Production: A Targeted Approach to Optimization takes place on Thursday, March 24 at 9.00am ET. Join us as we highlight our…

March 22, 2022

15 year follow-up for gene editing outlined in FDA draft guide

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The US FDA has set a 15 year follow-up period for therapeutic gene editing and edited products in new draft guidelines. The guidance – available here – covers therapeutic use of gene editing techniques like ZFN, and CRISPR, as well as gene therapy products made using those techniques. The aim, according to the FDA, is “to assist in the translation of these products from the bench to clinical trials, this guidance includes recommendations for how to assess the safety and…

March 22, 2022