NJIT Implementation of Recent Executive Orders
NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
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 three-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 milestone-driven R33 mechanism. Applicants are strongly encouraged to use project management principles to help facilitate achievement of performance milestones as appropriate.
The R33 phase can be up to three years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The R33 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. R33 recipients must submit or obtain an Investigational New Drug/Investigational Device Exemption (IND/IDE) application to FDA, or must transition the product to clinical practice, within the period of performance. The specific activities appropriate for the R33 phase will depend on the product under study and available preliminary data on the product.Examples of activities that can be supported during the Developmental (R33) stage include, but are not limited to:
- cGMP manufacturing of material for IND-enabling and/or Phase I clinical testing
- IND/IDE-enabling safety pharmacology and toxicology studies to determine a basis for clinical dose extrapolation using a relevant animal model
- IND/IDE document preparation and filing with the FDA
Evidence of a pre-IND/IDE meeting with the FDA is required to submit an R33 application. Applicants that have not achieved this requirement or are not ready for this late stage of product development should consider the companion (R61/R33) NOFO PAR-23-200.
Application budgets for the R33 should not exceed $1,000,000 in direct costs per year.
February 16, 2025
Tony Gover, Ph.D.
National Eye Institute (NEI)
Telephone: 301-529-7320
Email: tony.gover@nih.gov