(CASE STUDY) Establishing a Robust & Efficient Upfront Potency Assay Strategy to Prevent Setbacks Downstream

Time: 9:00 am
day: Day One


  • Establishing a lean matrix approach to phase I/II, keeping in mind a regulatory strategy for late and commercial phase readiness
  • Discussing contemporary tools for early potency assay development to increase the likelihood of meeting potency CQAs
  • Navigating regulatory hurdles to maximise the chance of approval success