Opportunities to Expand AAV Safety Data, Benchmarking, and Harmonization at the Preclinical phase
Time: 9:15 am
day: Day One
Details:
Issues the FDA is going to pay more attention to soon. Lab developed test validation, identifying correlates and biomarkers of safety
- Opportunities within the preclinical and clinical community to harmonize their methods for analytical testing
- Overlooked Opportunities for gaining insight in preclinical data to inform design and monitoring protocols that occur in the clinic
- Overlooked opportunities for collaboration in the community, particularly amongst industry partners (data mining/sharing)
