7.1.1 As discussed previously, trials involving viral vectors have been steadily increasing for decades. Advanced therapies in general are complex products. The Wall Street Journal reports that, on average, 557 clinical holds were issued each year from 2012 through 2017, increasing to 664 from 2017 to 2021. In 2022 (through mid-December), 747 holds had been placed by the FDA.[104]
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7.2.1 The field of cell and gene therapies is rapidly advancing, with new strategies and technologies for the design, development, and manufacture of these novel and potentially life-changing medicines constantly leveraged. Such rapid evolution can be highly beneficial for patients seeking transformative therapies, but it also carries risk.
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7.3.1 The FDA is clearly aware of the issues and concerns surrounding cell and gene therapies. In 2021, it convened a two-day advisory committee meeting to look at questions of safety, including not only liver toxicity but also kidney damage and neuron loss.[111] The committee looked at various animal studies to see if any conclusions could be drawn about which animals and which assays are most predictive of potential safety issues. The question of whether standards are needed was also raised, as was the idea of conducting more formal risk assessments of potential recipients.
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7.4.1 In addition to the need for more communication between sponsors and regulatory authorities, there is a general recognition that standardization of global regulations covering cell and gene therapies is needed. Regulations in different regions have some similarities but also many differences, even when it comes to core GMP requirements, which create real challenges for cell and gene therapy developers and manufacturers, particularly when the requirements conflict.[120]
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