Could Automation Rescue CAR-T Manufacturing?
Manufacturing constraints have prevented even the most pioneering cell therapy companies from meeting patient demand for their life-saving treatments. They are still in the works, but could fully automated, closed manufacturing platforms be potential game changers?
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The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.
Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms.