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The COVID-19 vaccine effort was the most rapid global response to a health crisis in history. The challenge of managing unparalleled volumes of safety information provided unique opportunities to evaluate the robustness of current pharmaceutical industry pharmacovigilance practices and test novel approaches to strengthen safety signal detection, evaluation and communication.
The Assay Guidance Manual programme, a translational science education and training initiative at the US National Center for Advancing Translational Sciences (NCATS), aims to help bridge the gap between research discoveries and the delivery of new therapies by creating and disseminating experimental protocols and standards for rigour in preclinical translational research.
Bluebird bio has now secured FDA approvals for two lentiviral vector gene therapies for rare diseases. Melissa Bonner, the company’s head of research, discusses the rocky road to success and future applications.