(CASE STUDY) Establishing a Robust & Efficient Upfront Potency Assay Strategy to Prevent Setbacks Downstream
Time: 9:00 am
day: Day One
Details:
- 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
