Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.

Biopharma companies struggle with which trials, if any, to pause or delay. Lilly said it wants to ease the burden on health care facilities, while Galapagos said its choice is related to patient safety.

Clinical trials across the board are being impacted by coronavirus and Syncona, the investment powerhouse behind a number of UK cell and gene therapy biotechs, says that its portfolio companies are facing considerable delays.

Rather than expose patients and others to SARS-CoV-2, Provention opted to pause a Phase III type 1 diabetes trial. Addex and Iveric have since delayed trial initiations and more studies are likely to be impacted as coronavirus concerns mount.