Da­ta sug­gest gene, cell ther­a­py tri­al ini­ti­a­tions in Eu­rope lag be­hind North Amer­i­ca — here's why

Med­ical sci­ence has moved on from the one-size-fits-all ap­proach to the era of per­son­al­ized med­i­cine. Eu­ro­pean au­thor­i­ties ap­proved the world’s first-ever gene ther­a­py — GSK’s Strimvelis, a treat­ment for an in­or­di­nate­ly rare in­her­it­ed dis­or­der char­ac­ter­ized by a rav­aged im­mune sys­tem, in 2016. So far, the EMA has grant­ed the great­est num­ber of mar­ket­ing au­tho­riza­tions for ad­vanced ther­a­py med­i­c­i­nal prod­ucts (ATMPs) —or med­i­cines based on genes, tis­sues or cells — glob­al­ly. But da­ta sug­gest that the num­ber of ATMP clin­i­cal tri­als ini­ti­at­ed in Eu­rope has been eclipsed by ini­ti­a­tions in North Amer­i­ca in re­cent years.

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