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

The National Eye Institute has established the Translational Research Program for Therapeutics. This grant program aims to quickly and efficiently transfer the outcomes of innovative lab research into practical treatments for visual diseases or disorders. This work is to be performed by multi-disciplinary teams of scientists and clinicians who will generate evidence in a preclinical setting. This could lead to the inception of interventions like biological, pharmacological, or medical device combinations.

The ultimate objective of the program is to broaden the resource pool available to clinicians and patients with new technology, biological, and pharmaceutical offerings. A set of outlined steps or milestones should support the development of these therapeutics or devices. This will subsequently pave the way for applications to the U.S. Food and Drug Administration for Investigational New Drug (IND) or Investigational Device Exception (IDE) approvals or even for clinical trial testing.

The grant operates on a two-step, milestone-centric award system. The initial phase (R61) backs research projects that show crucial preliminary data but haven’t yet reached the clinical translation stage. The latter phase (R33) aids research that is on the brink of finishing preclinical development and possesses potential for quick clinical advancement. However, if a single phased award that doesn’t require the R61 exploratory stage is needed, support is available through the accompanying R33, PAR-23-205.