Sarah Tuller

Company: Opus Genetics

Job title: Chief Regulatory Officer

Seminars:

Navigating Novel Ophthalmic Endpoint Development & Regulatory Validation to Accelerate Disease Therapeutic Approvals 10:00 am

Novel endpoint development and validation are major challenges in ophthalmic gene therapy, with regulatory acceptance crucial for approval. Traditional vision measures often fall short in rare, slow-progressing diseases, while patient-reported outcomes add variability. Join us in this workshop to identify effective endpoints and regulatory strategies to increase regulatory approval. Key Discussion Points: Navigating FDA’s RDEA…Read more

day: Pre-Conference Workshop Day