The following is an op-ed excerpt from MassBio CEO & President Kendalle Burlin O’Connell in BioSpace:
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
I can’t help but think: the FDA was built for a different time.
I recently sat in a room of 10 biotech executives, and none are doing first-in-human clinical trials in the U.S. That should stop us in our tracks.
As CEO and president of MassBio, I have watched this shift firsthand. Not long ago, running a first-in-human trial in the United States was simply the default. It did not require a decision or justification. For a growing number of biotechs, that is no longer true.