AmplifybioHorizontal WhiteV1.RGB

Dr. Victoria Best's Safety Summit 2022 Q&A

Dr. Victoria Best's Safety Summit 2022 Q&A

Download the slides from Dr. Victoria Best’s talk at Optimizing AAV Safety 2022 about assessing preclinical safety signals derived from AAV gene therapies.  

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

  • 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 into preclinical data to inform the design and monitoring protocols that occur in the clinic

  • Overlooked opportunities for collaboration in the community, particularly amongst industry partners (data mining/sharing)