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

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PAR-28-072Grant

Response Deadline11/16/2029, 05:00:00 AM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The National Institutes of Health National Eye Institute is offering a bi-phasic, milestone-driven award through the Translational Research Program for Therapeutics (PAR-28-072) to accelerate the transition of laboratory research into biological, pharmaceutical, or medical device therapies for visual system diseases. The program is structured into two phases: an R61 phase of up to two years focusing on preliminary data and lead optimization, and an R33 phase of up to four years dedicated to final preclinical development and the filing of an Investigational New Drug or Investigational Device Exemption application with the FDA. The total combined duration of both phases cannot exceed five years. Transition to the R33 phase is contingent upon the administrative assessment of satisfactory completion of SMART milestones, which must include required pre-submission feedback from the FDA. Budgetary limits for direct costs are generally capped at 500,000 dollars per year for the R61 phase and 1,000,000 dollars per year for the R33 phase. Applicants must provide a Target Product Profile, a Gantt chart, and an Intellectual Property Strategy, while ensuring compliance with Good Manufacturing Practices and Good Laboratory Practice standards. Evaluation is based on the importance of the research, rigor and feasibility of the approach, and the expertise of the investigators and their environment. Eligible applicants, including small businesses and other for-profit organizations, must maintain active registrations in the System for Award Management and eRA Commons, and all principal investigators must have a linked ORCID ID. Awardees are also required to implement cybersecurity incident reporting procedures and an incident response plan in accordance with HHS guidelines.

General Info

NIH bi-phasic award for visual system disease therapies transitioning research to FDA application.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

(1)

PAR-28-072 NEI Translational Research Program for Therapeutics

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AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseSolicitation

PostedSep 25

Solicitation

Response DeadlineNov 16

Submission deadline

Response Deadline

11/16/2029, 05:00:00 AM UTCin about 3 years

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health

Contacts1 person available

OfficeUSA

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health

Office AddressUSA

Contacts

National Institutes of Health

contact@example.gov

+1 (555) 000-0000

Full Description

The purpose of NEI's Translational Research program (TRP) is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. The TRP will support the product development of biological, pharmaceutical, medical device, and/or combination therapies for any disease or disorder of the visual system.The TRP will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase can be up to two years and will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase can be up to four years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The total duration of both R61 and R33 cannot exceed five years. The R33 is to focus on advancing a single therapeutic candidate through Investigational New Drug or Investigational Device Exemption (IND/IDE) enabling studies, filing an IND/IDE package with the FDA, and designing future clinical trials. R33 recipients must submit or obtain an 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. Delineation of milestones by the applicant for the R61 and R33 phases is a key characteristic of this program. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. This program will support applications that propose a series of milestones including manufacturing and product development goals. Applications that address contingency plans to proactively confront potential delays in meeting the milestones are strongly encouraged. Milestones are required for both phases. Milestones must be specific, measurable, achievable, relevant, and time-bound (SMART). All projects will begin with a R61 phase regardless of therapeutic starting point.