Senior Scientist Evonik Canada Inc. Burnaby, British Columbia, Canada
There has been explosive growth in gene therapy products in the last 30 years! The regulatory expectations from health authorities are still evolving regarding nonclinical safety considerations. This presentation will briefly cover regulatory expectations, species selection, study design requirements, biodistribution, viral shedding, reproductive and developmental safety for AAV-based gene therapies.
Learning Objectives:
Upon completion, participants will be able to know the nonclinical safety aspects for the development of AAV-based gene therapy.
Upon completion, participants will know species and dose selection for nonclinical studies and study design requirements
Upon completion, participants will know regulatory consideration for the nonclinical safety assessment of gene therapies
