Program Lead/Presenter: Tony D. Gover, Ph.D., Program Director
Council Date: February 3, 2023
This concept clearance is for the NEI Translational Research Program for Therapeutics. The goal of the National Eye Institute (NEI) Translational Research Program (TRP) for Therapeutics is to accelerate the development of biological, pharmacological, medical device, and/or combination product therapeutics to use in the treatment of visual system diseases and disorders. Specifically, the TRP supports product-oriented projects and the preclinical activities that are required for an Investigational New Drug (IND) or Investigational Device Exception (IDE) application to the U.S. Food and Drug Administration (FDA). Recipients of TRP awards are expected to submit or obtain an IND or IDE application to FDA within the period of performance of the award.
The purpose of the TRP is to encourage investigators to pursue translational activities to advance the development of biological, pharmacological, medical device, and/or combination product therapeutics for diseases and disorders that affect the visual systems. To this end, the TRP is designed to support high-risk product development activities that are not typically supported by R01 mechanisms. The proposed bi-phasic, milestone driven mechanism will allow NEI to de-risk less mature efforts and support IND/IDE enabling studies for more mature products. The TRP study sections will be organized by NEI’s Scientific Review Officers and will include expertise in product development, regulatory science, and ophthalmology.
Objectives and Scope:
The proposed Funding Opportunity Announcement (FOA) will utilize a bi-phasic, milestone driven mechanism consisting of an Exploratory phase (R61) and a Developmental (R33) phase. Applicants that meet specific entry criteria may submit directly to the Developmental phase. The Exploratory phase will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The Developmental phase will support research that is in the final states of preclinical development with potential for near-term clinical development. The Developmental phase is to focus on advancing a single therapeutic candidate through IND/IDE -enabling studies, filing an IND/IDE package with the FDA, and designing future clinical trials. Delineation of milestones by the applicant for the Exploratory phase and the Developmental phase is a key characteristic of this FOA. Satisfactory completion of the Exploratory phase milestones will be assessed administratively by NEI to determine eligibility to transition to the Developmental phase.