Opportunities to Expand AAV Safety Data, Benchmarking, and Harmonization at the Preclinical phase

Time: 9:15 am
day: Day One


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)