The top official at the US Food and Drug Association’s Center for Biologics Evaluation and Research has proposed that the biopharmaceutical industry partner with academia to facilitate the development of vectors for gene therapies for ultra-rare diseases. Although the plan is still in the preliminary phase, the idea is these vectors could be developed by academic investigators and then transferred to manufacturers once they show promise in early clinical trials.
The idea was floated by CBER director Peter Marks at two recent industry meetings, at the Drug Information Association annual...
