With Dan Stanton via BioProcess International:
Planning, patient, and payer problems hurting gene therapy rollouts
Cell and gene therapies (CGTs) have finally come of age and are making a mark on the regulatory landscape. At the time of writing, the US Food and Administration (FDA) has approved 28 such products (excluding hospital-specific cord blood and scaffold products).
With four more action dates potentially before the year’s end (Autolus’s obe-cel; Humacyte’s Acellular Tissue-Engineered Vessel; Abeona’s pz-cel; Rocket Pharma’s marne-cel), 2024 could see nine FDA-approved therapies, realizing the predictions made five years ago by former FDA commissioner Scott Gottlieb, who stated that there could be ten or more approvals per year by 2025.
With his firm Dark Horse Consulting having supported most of these approvals and submissions, CEO Anthony Davies said at a bespoke summit in Milan, Italy earlier this month that the regulatory future is rosy.
Read the full article here.
