NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)

The mission of the National Eye Institute (NEI) is to eliminate vision loss and improve quality of life through vision research. The NEI invites applications for research that aligns with our strategic plan. The purpose of this program is to accelerate the development of biological, pharmacological, medical device, and/or combination product interventions for clinicians to use in the treatment of visual system diseases and disorders. In the context of this program, the PD/PI assembles a multi-disciplinary research team that employs an integrative approach to the rapid and efficient translation of laboratory research findings into IND or IDE applications to the FDA for testing new therapeutic approaches. The collaborative teams must include as appropriate, non-clinical and clinical scientists, disease experts, regulatory experts, bioethics specialists, experts in manufacturing under Quality Systems and Design Controls, and other relevant academic, clinical, and/or industry experts.

This program is not intended to support solely basic science, platform technologies or isolated technology development. The goal is to produce preclinical data that will support an IND or IDE application to the FDA. Each project must have a well-defined end point, of developing a new device or treatment for a specific ocular disease that is achievable within a five-year time frame. The steps towards this goal should be clearly delineated in a series of milestones that support the development of a therapeutic or device that can be tested in a clinical trial.

Structure

This NOFO will utilize a bi-phasic, milestone-driven R61/R33 mechanism consisting of an Exploratory phase (R61) and a Developmental phase (R33). Applicants must address objectives for both a R61 and a R33 phase and are strongly encouraged to use project management principles as appropriate.

Phases of Award

Applicants are strongly encouraged to consult with relevant agency staff prior to developing and submitting an application (see Agency Contacts, Section VII). Early contact with NEI Staff (at least 12 weeks prior to submission) is encouraged. This period of time provides an opportunity for NEI staff to discuss the scope and goals, and to provide information and guidance to the applicants.