Program Lead/Presenter: Tony D. Gover, Ph.D., Program Director
Council Date: October 11, 2024
Goal:
The goal of NEI’s Translational Research 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. A critical hurdle in realizing this goal is the regulatory approval process and requirements. The proposed Eye Product Assistance Center created through an Indefinite Delivery, Indefinite Quantity (IDIQ) contract with NEI will provide investigators from academic, industry, and other eligible organizations consultant assistance for product development and regulatory related issues prior to NEI supported translational research efforts.
Rationale:
Although NEI supports several translation opportunities (e.g., NEI Translational Research Program (TRP) R61/R33, Blueprint Neurotherapeutics Network Programs, Bioengineering Research Grants, Bioengineering Partnerships with Industry, and SBIR/STTR programs), there is a critical need to support investigators with regulatory consulting advice, intellectual property, manufacturing, identification of appropriate contract research organizations and consultants, commercialization, strategic partnership issues, and other product development issues prior to submitting applications to our translational research opportunities. NEI receives very few translational research applications despite supporting hundreds of applied research grants every year. Although NEI has a robust Small Business Program, the high success rates, and wide-ranging impact scores every year suggest there is room to make this program more competitive. Additionally, most of the translational applications we receive score poorly at study section. There are several reasons for the number of applications and poor quality of translational research applications. Some of the hurdles that limit the number of translational applications and quality are the lack of knowledge of product development and regulatory requirements, lack of appropriate facilities/services (e.g. GLP, GMP, etc.) or the ability to identify these services, and lack of funds to support these types of efforts prior to grant applications.
Objectives and Scope:
Objective: To provide direct preclinical consultation support to investigators to increase the number and quality of applications and subsequent product development efforts.
Scope: The IDIQ contractor will provide direct preclinical consultation support to investigators to increase the number and quality of applications and subsequent product development efforts.
Investigators may request consultant support for, but not limited to, the following:
- Regulatory
- Chemistry Manufacturing and Controls (CMC)
- Identification of appropriate contract research organizations (CROs) and consultants
- Intellectual property
- Commercialization
- Strategic partnership issues
- IDIQ contractor support may not be used to assist in the development, writing, or editing of research applications to be submitted to the federal government
- The contractor is expected to support up to 30 investigators per year
- Investigators could request up to 20 hours of support
Impact:
The Eye Product Assistance Center will provide resources that are critical for investigators to submit successful translational research applications and subsequent product development efforts.