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The Pressures in Developing Fast-Track Products

Frank Riske, Ph.D.
Presented at CHI, Bioprocessing Summit, Boston, MA, August 21-25th, 2017
In this presentation, the complications associated with accelerating process development are explored. Our industry is obsessed with speed to be first in human trials. This driver has caused companies to seek CDER’s Fast-Track designation for their development project. The continuing interest in seeking this designation is not surprising since such accelerated programs may reduce a typical development program from start to BLA from five to eight years to two and a half years. A focus on speed has also been supported by the emergence of advanced platform technologies. This presentation highlights some of the key factors, which lead to problem gaps in CMC development when accelerating development timelines.