When aggressive timelines are a “must,” it’s critical that companies don’t gloss over early-phase scale-up throughout the development process. The time and effort spent on risk assessments and thinking about scalability early on will pay dividends in the long run as the path toward regulatory approval is smoother.
Download "The Race to Phase III: A Cautionary Tale of Scalability" to follow the paths of two companies facing this challenge as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.