In­di­vid­u­al­ized ther­a­pies: CBER di­rec­tor dis­cuss­es chal­lenges, reg­u­la­to­ry ap­proach

The FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER) is look­ing for ways to fa­cil­i­tate the de­vel­op­ment of more prod­ucts in­tend­ed to treat in­di­vid­ual or small groups of pa­tients, in­clud­ing cell and gene ther­a­pies, an­ti­sense oligonu­cleotides and phage ther­a­pies.

At a work­shop at the FDA’s head­quar­ters in Sil­ver Spring, MD on Tues­day, CBER Di­rec­tor Pe­ter Marks ad­dressed some of the bar­ri­ers to de­vel­op­ing in­di­vid­u­al­ized ther­a­pies such as “cus­tomized prod­ucts” with a sin­gle in­di­ca­tion and a mode of ac­tion that are tai­lored to in­di­vid­ual pa­tients, or “cre­at­ed prod­ucts” that could tar­get dif­fer­ent in­di­ca­tions via dif­fer­ent modes of ac­tion.

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