Letter from the Editor: FIH data — is now the time for change?

In the game of risk that is biotech, few events are as important for de-risking a program as testing it in humans for the first time. That test doesn’t always tell you if it will work, or how well, or how it will stack up against the competition. But it will tell you if it has a fighting chance of becoming a drug.

While that’s been a critical issue for years, the topic of expediting the path to first-in-human data has become THE big talking point in biopharma this year. In this environment, it sits at a nexus of geopolitics, regulatory change, clinical trial reform and the broadening scope of innovation. ...