Ting He

Ting He

Company: Ultragenyx Pharmaceutical

Job title: Senior Scientist, AAV Pharmaceutical Development


(CASE STUDY) (NEW DATA) Bridging Potency Assays in Gene Therapy Clinical Development: Methods for Adjusting the Potency Matrix Between Clinical Phases 10:00 am

Presenting case-study examples of both, a protein expression and viral entry assay to determine their relative importance across developmental phases Highlighting the increasing expectations from regulators for potency assessment at all phases of clinical development to determine acceptable differences in assay readouts between clinical phases How should you adapt your potency matrix approach through the…Read more

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