The Road to Approval: Gene Therapy Analytical Package From Early IND to Approval
Time: 9:00 am
day: Day One AM
Details:
- Lean release analytical package for the initiation of Phase 1/2 clinical trials: minimum requirements and common challenges
- Evolution of the analytical package through different stages until filing for marketing approval: extended vs characterization vs release
- Regulatory expectations at the time, of BLA/MAA approval: first hand, learnings from parallel filing in the US, and EU
