'Pull every lev­er': Marks dou­bles down on ur­gency to im­prove gene ther­a­py man­u­fac­tur­ing

FDA’s bi­o­log­ics leader Pe­ter Marks has a warn­ing for gene ther­a­py man­u­fac­tur­ers and the health­care pay­ers that cov­er them: If they can’t stream­line man­u­fac­tur­ing in the next 10 years, gene ther­a­pies could be­come in­creas­ing­ly in­ac­ces­si­ble to the pa­tients that could re­ly on them.

Speak­ing on a pan­el at the Milken In­sti­tute Fu­ture of Health Sum­mit on Mon­day, Marks high­light­ed the chal­lenges fac­ing gene ther­a­py man­u­fac­tur­ing and re­it­er­at­ed his call to dras­ti­cal­ly ramp up gene ther­a­py de­vel­op­ment.

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