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SPEED TO IND: RISKS TO ACHIEVING AGGRESSIVE BREAKTHROUGH/FAST-TRACK PRODUCT TIMELINES

By: Susan Dana Jones

Presented at: KNect365 BioProcess International West Conference, February 27-March 2, 2017.

The pharmaceutical industry is highly motivated by financial incentives to advance product candidates into first-in-human trials quickly. The drive to get biopharmaceuticals into the clinic quickly often leads companies to use platform manufacturing processes that are sufficient to make material for early clinical development but are not robust enough to meet commercial supply requirements. This strategy works when companies plan to follow a normal development path and seek commercial authorization 5 or more years after initiation of clinical trials. However, it can backfire if a rapid approval pathway such as FDA’s Breakthrough designation is obtained. Accelerated approval pathways can shorten the typical timeline from IND to BLA from 5-8 years to less than 3 years and will put significant pressure on the CMC activities which were not designed to meet commercial requirements . The points addressed in this presentation include:

 

  • Platform upstream and downstream process development approaches
  • Significant clone to clone variations in shortened cell line programs
  • Compressed timelines for process validation to meet regulatory expectations