Aliza Thompson

Company: FDA

Job title: Deputy Director

Seminars:

Panel Discussion | Replicating Precision-Based Approaches in Large-Scale Clinical Practice: What Will it Take to Get There? 4:00 pm

What must be done to bridge the gap between individual genetic tests or biomarker panels, to large scale clinical trials with thousands of CKD patients? How can we more efficiently identify which targets are more relevant for various populations of CKD? What will it take to bring forward a companion diagnostic biomarker into the clinic…Read more

day: Conference Day 1

FDA Perspective on the Evolution of Acceptable Endpoints for Both Broad & Specialized CKD 8:00 am

Looking beyond IgA Nephropathy for considerations of other accelerated approval paths that might be open to investigation using surrogate endpoints Navigating the differential relationship between proteinuria and eGFR across different indications, which poses a challenge when establishing proteinuria as a surrogate in other diseases Determining prerequisites for utilizing GFR decline for CKD studies in general…Read more

day: Conference Day 1

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