Jie Li

Company: Vertex Pharmaceuticals

Job title: Director

Seminars:

PANEL: Partnering & Communicating Effectively with CROs – Finding a Company That Understands Your Specific Scientific Needs & Potency Assay Requirements 4:15 pm

Moderated by Shashwat Mishra, Principal Scientist – Analytical Development, Regeneron Overcoming the bottlenecks of lengthy GMP training periods and high CRO turnover rates Analysing the impact of limited CRO capabilities and the need to reduce assay complexity for a smoother tech transfer Balancing timelines between gene therapy developers and CROs to expedite development processesRead more

day: Day 1

(CASE STUDY) Can we Negotiate with Regulators? Outlining Lessons Learnt from Successful Regulatory Interactions to Help Facilitate Compromise 11:00 am

A real-world example of an end-end potency assay design strategy that resulted in a regulatory approval Discussing how feedback from regulators was incorporated into potency assay design as the drug product moved towards commercialization Outlining how interactions with regulatory authority can ultimately lead to compromise in potency assay expectationsRead more

day: Day 1