Demonstrating drug potency early in cell therapy development: Why it’s challenging and why it matters

After decades of anticipation, cell and gene therapies are proving that human DNA can, indeed, be used to treat complex chronic diseases in truly transformative ways. The United States Food and Drug Administration (FDA) recently announced that it anticipates approving 10 to 20 cell and gene therapies by 2025. Since inception in 2017, the Center for Biologics Evaluation and Research has granted 40 out of the 108 requests it has received for Regenerative Medicine Advanced Therapy
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