A 101 in First-in-Human CRISPR Trials
Time: 1:00 pm
day: Pre-Conference Workshop Day
Details:
- Setting out a framework for deciding on trial design, outcome measures, and eligibility criteria
- Especially in a competitive field, how can we ensure enrollment is attractive for patients?
- Considerations for preparing an onsite team to protect the quality of the treatment
- Understanding the key regulatory requirements surrounding CRISPR personalized medicine programs and strategies to meet these
- Developing inexpensive, fast, and robust safety and efficacy testing platforms
- Laying out a pathway for manufacturing guides, nucleases, and vectors to the required scale for the clinical stage
