Yu-Chih Hsu

Company: University of Pennsylvania

Job title: Director of potency assay and automation at Gene Therapy Program

Seminars:

PANEL DISCUSSION: Getting to Grips With Potency Assay Regulatory Guidance & Guidelines 10:00 am

• Current potency guidance is largely designed to address challenges for biologics, thus what trends or shifts are we likely to observe (which may not be stated in any kind of guidance) • What is currently driving the trends of potency assay development and regulatory communications? • Are we any closer to an industry wide…Read more

day: Day One AM

(CASE STUDY) Relative Infectivity Assay Method 3:30 pm

• Overview of current infectivity approaches • REGENXBIO case study of relative infectivity approach, challenges and opportunities Read more

day: Day Two PM