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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