Cheryl Rowe-Rendleman

Company: Omar Consulting Group

Job title: Owner, Chief Clinical Consultant & Managing Consultant

Seminars:

Building a Regulatory-Ready Preclinical Package in Dry AMD: Understanding the Evidence, Tools, and Models Required to De-Risk Early Development 9:00 am

Analyze lessons from recent approvals and rejections Outline preclinical evidence requirements that regulators expect to see Review the role of translational assays, imaging, and endpoints to de-risk translation How to align animal models with clinical endpoints to support IND submissionRead more

day: Day2

1:00 Structure Versus Function: Debating the Most Meaningful Endpoints to Drive Regulatory Confidence and Accelerate Dry AMD and Geographic Atrophy Trials 1:10 pm

As clinical development in dry AMD and geographic atrophy accelerates, the field remains divided on how best to define success. Should structural imaging biomarkers take precedence for their quantifiability, or do functional endpoints better capture what truly matters to patients? While OCT-based metrics like hypertransmission and EZ loss may offer precision, they are unable to reflect visual…Read more

day: Pre-Conf Workshop Day