CBER chief Pe­ter Marks to con­sid­er 'al­ter­na­tives' to clin­i­cal holds as they 'put shud­ders down in­vestors' spines'

As mem­bers of the House ex­pressed con­cerns with the num­ber of clin­i­cal holds at Pe­ter Marks’ Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, Marks said at a con­fer­ence on Wednes­day that there is a way to man­age the holds “that’s more user friend­ly,” not­ing CBER will work more in ad­vance with spon­sors.

Marks ac­knowl­edged an uptick in clin­i­cal holds for cell and gene ther­a­pies dur­ing the height of the pan­dem­ic, “where we got re­al­ly re­source con­strained,” es­pe­cial­ly tak­ing in­to ac­count the short­ened re­view clock for new INDs, es­pe­cial­ly con­sid­er­ing how long it takes for each IND to ac­tu­al­ly get to the re­view­ers.

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