Ashley Shay

Senior Manager of Regulatory Affairs

Ashley joined Luminary Therapeutics in 2025. She is an experienced regulatory affairs leader with a proven track record in utilizing regulatory intelligence and strategy to advance the global development of early phase cell and gene therapy programs. Prior to joining Luminary, Ashley worked at Forge Biologics where she supported multiple IND and accelerated pathway applications across varied therapeutic areas including pediatric and rare disease. Ashley is inspired to serve patients and their families by leveraging efficient regulatory strategies to accelerate patient access to safe and effective therapies.

• Holds a B.S. in Molecular Genetics from The Ohio State University and a M.S. in Regenerative Medicine and Entrepreneurship from Case Western Reserve University
• 7 years of experience with drug development
• Guest lecturer, Master’s of Science in Regenerative Medicine and Entrepreneurship Program, National Center for Regenerative Medicine, Case Western Reserve University