CBER chief Peter Marks to consider 'alternatives'
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Posted On: 05/19/2023 5:26:32 PM
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 two-week clock to review new INDs compared with how long it takes for each IND to get to the reviewers.
But Marks stressed that CBER will “help work with the sponsor to resolve them or present them with alternatives that are more attractive than being put on clinical hold…We know it can put shudders down investors’ spines when they see that. Especially for small companies.”
The comments come as Jefferies’ Michael Yee in Feb. 2022 detailed the sharp rise of FDA-imposed holds (RegenxBio even sued over a hold) following a decade of relatively little movement. The primary cause of the spike, Yee writes, is the vast increase in gene and cell therapy trials being conducted in recent years.
With more than 1,300 active INDs for gene therapies and over 1,200 active INDs for cell therapies, Marks and company have their work cut out for them, especially considering their past hiring woes, senior leader departures and backlog after the pandemic.
https://endpts.com/cber-chief-peter-marks-con...rs-spines/
What a novel idea: working WITH the sponsor.
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 two-week clock to review new INDs compared with how long it takes for each IND to get to the reviewers.
But Marks stressed that CBER will “help work with the sponsor to resolve them or present them with alternatives that are more attractive than being put on clinical hold…We know it can put shudders down investors’ spines when they see that. Especially for small companies.”
The comments come as Jefferies’ Michael Yee in Feb. 2022 detailed the sharp rise of FDA-imposed holds (RegenxBio even sued over a hold) following a decade of relatively little movement. The primary cause of the spike, Yee writes, is the vast increase in gene and cell therapy trials being conducted in recent years.
With more than 1,300 active INDs for gene therapies and over 1,200 active INDs for cell therapies, Marks and company have their work cut out for them, especially considering their past hiring woes, senior leader departures and backlog after the pandemic.
https://endpts.com/cber-chief-peter-marks-con...rs-spines/
What a novel idea: working WITH the sponsor.
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