Charles Lee

Company: AstraZeneca

Job title: Executive Director - Regulatory Affairs, Cardiovascular, Renal & Metabolism

Seminars:

Panel Discussion | Translating Learnings from IgA Nephropathy to Strive for Acceptable Surrogate Endpoints in Broader CKD 9:00 am

Debating whether hard outcome studies are needed to demonstrate meaningful changes in renal function Extending the emerging learnings from IgA Nephropathy to other orphan kidney diseases Debating the validity of surrogate endpoints for demonstrating renal functionRead more

day: Conference Day 1

Implications for Clinical Trial Design Following Introduction of New Endpoints That are Accepted for Registration 1:30 pm

Exploring how the introduction of new endpoints will affect patient selection and trial execution Outlining what introducing new endpoints means for broad CKD vs specific indications and factors to consider, such as clinical relevance, feasibility and trial logistics Ensuring clear explanations are laid out for the clinical implementation of novel endpoints in CKD trialsRead more

day: Day 1 Track 3 PM