In the drug development ecosystem, a long-standing “valley of death” exists between basic research discoveries and approved therapies, where many potential candidates stall due to translational barr...
Ophthalmology stands at the forefront of gene therapy translation. The retina’s immune-privileged status, anatomically confined structure, and objectively quantifiable visual endpoints have made the ...
This article examines three critical operational challenges in clinical trials for chronic ophthalmic diseases such as age-related macular degeneration (AMD) and diabetic retinopathy (DR): patient rec...
I. Overview of Clinical Trial Endpoints for Common Ophthalmic DiseasesThe appropriate selection of endpoints in ophthalmic drug clinical trials directly determines the scientific validity of a study a...
IntroductionCell and Gene Therapy (CGT) is transforming the treatment landscape for difficult-to-treat diseases, particularly cancers and rare disorders. However, the path from lab to market remains s...
As Cell and Gene Therapy (CGT) products transition from the laboratory to the clinic, the design of the clinical trial protocol is not only the starting point for scientific exploration but also the c...
