How Fast-Track Strategies Accelerate Time-To-Clinic

Pharmaceutical sponsors’ ambitious development timelines rarely align with the normal duration for biologics cell line, upstream process (USP), downstream process (DSP), and analytical methods development and scale-up. Typically, the timeline duration is based on providing material to support an investigational new drug (IND) filing with the FDA or its EU equivalent, a clinical trial application (CTA).

Sponsor timelines may reflect an attempt to beat competitors to first-in-clinic or a need for clinical data to drive additional funding. Whatever the reason, the application of various fast-track approaches can shave weeks or months off development timelines, trading increased risk for potentially extraordinary rewards. Fast-tracking pushes development teams forward with less data than would be available following a traditional timeline and is driven by two key strategies: decoupling activities and following a critical path.

Decoupling requires examining every development activity and determining what can be conducted in parallel, versus sequentially. Through this exercise, a critical path emerges that provides a logical baseline for decision-making (i.e., does this approach make sense for us in the context of our established critical path?).