Jie Li

Company: Vertex Pharmaceuticals

Job title: Director

Seminars:

Panel Discussion: Developing a Phase-Appropriate CMC Analytical Strategy 4:20 pm

What should a specification list look like for release material into the clinic? How do assay qualification requirements vary depending on the stage of development? Ensuring phase-appropriate potency assay testingRead more

day: Conference Day One

Fireside Chat: Robust Potency Assay Strategies – Lessons Learned from Clinical Development 3:50 pm

Defining a potency assay approach based on the disease mechanism-of-action Learning from a successful potency assay strategy for IND clearance Sharing a case study of adapting a potency assay matrix strategy through early- to late-stage developmentRead more

day: Conference Day One