Translational Research Core

National Eye Institute

Investigators

Linked publications & trials

Abstract

The mission of Translational Research CORE (TRC) is to offer up-to-date instrumentation, technical and scientific expertise to investigators translating eye function findings into the Clinic. In our CORE, we established and maintained a set of animal models accepted by the FDA and can be used to provide validation data for IND submissions. We also maintain CORE staff with a unique expertise: Surgeon, Veterinarian, Anesthesiologist, Husbandry specialists who have extensive research background and understanding of FDA requirements needed to help, advise and support all translational/clinical efforts. Apart from the help in collecting data, we are also actively engaged in modifying and adjusting techniques, tools, methodologies, and all other components necessary to satisfy FDA standards for IND submission and use in human clinical trials; help in evaluating FDA compliant product use in a surgery room environment and serve as an unbiased evaluator of preclinical findings; assist in the preparation of a preclinical proposal to include critical elements needed for successful IND approval. TRC actively participates in several ongoing projects to bring the most promising research findings into the Clinic based on our ongoing and planned efforts. We are currently engaged in preclinical data collection for potential tyrosinase-deficient albinism treatment in the eye using gene therapy, Stargardts, and iPS-RPE tissue replacement Clinical trial. Last year we also joined a group of several other investigators to restore vision caused by combat eye injuries in soldiers under project Outer Retina Reconstruction for Combat Afflictions. Preclinical data have been generated in all projects to support translational efforts and therapies.