Article | August 14, 2023

Staying On Top Of Changing FDA Regulations To Avoid Clinical Holds


According to the Alliance for Regenerative Medicine, 2022 was a breakthrough year for biopharma approvals. Not surprisingly, the COVID-19 pandemic created a large influx in related cell-and-gene-based therapeutic INDs, but even without the pandemic, biopharma technology has exploded in recent years. Meanwhile, the FDA recently eliminated the animal testing requirement for bringing new drugs to market. Although animal studies might be the safest option for some therapeutics, this sweeping change affects how sponsors create their IND applications. Now sponsors can choose whether to use animal testing or other methods, such as computer modeling, artificial intelligence, or patient cells.

Before beginning Phase I clinical trials, sponsors must prove their drug has a safe starting dose for patient trials. Sponsors rely on in vitro proof of concept studies to demonstrate efficacy and in vivo studies that show the product’s benefit. In a perfect world, these precautions would lead to foolproof INDs and perfectly executed clinical trials. However, the exponential growth in experimental cell and gene therapies and the shifting FDA landscape creates more room for error, leading to increased clinical holds.

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