NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44)

Purpose

NINDS is committed to advancing diagnostics and treatments for people burdened by neurological diseases and the NINDS Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies and therapeutics for the diagnosis and treatment of neurological diseases. The SBIR/STTR Programs are structured in three phases. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the SBC will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III.

Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death,” between the end of the SBIR/STTR Phase II award and the commercialization stage. In particular, the development of therapeutics and medical devices often requires several years and substantial capital investments, due in part to the costs associated with conducting clinical trials. Traditionally, large pharmaceutical and biotechnology companies, as well as venture capital firms, have provided the resources needed to fully develop and commercialize biomedical products and technologies initiated with SBIR/STTR funding. More recently, however, many investors in life science technologies have shown a bias toward financing the continued development of relatively mature technologies at established companies, rather than the higher-risk, emerging technologies under development at many small businesses.

The goal of this FOA is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product/technology that requires Federal regulatory approval or to bring a complex research tool to market. To achieve this goal, the FOA aims to facilitate the transition of previously funded SBIR or STTR Phase II projects to the commercialization stage by encouraging business relationships between NIH’s SBIR/STTR awardees and third-party investors and/or strategic partners. In particular, this FOA will give competitive preference and funding priority to applications deemed likely to result in a commercial product as indicated by an applicant's ability to secure substantial independent third-party funds (i.e. third-party funds that equal or exceed the NINDS funds being requested throughout the Phase IIB project period).

These funds can come from a variety of sources and a number of public and private organizations are taking steps to provide additional resources to advance a greater number of early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but also establishing programs to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds focused on supporting projects in the pre-clinical stages of development, and some of these firms have established technology incubators to provide regulatory guidance. In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and numerous state-sponsored technology funds have also been created across the U.S. to support start-up companies. Taken together, these programs can provide additional financing and commercialization support for awardees that have received initial seed funding and a rigorous technical evaluation through the NIH peer review process. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR/STTR awardees and a broad range of potential third-party investors.

Specific Objectives

Independent Third-Party Investor Funds

This FOA is specifically intended to encourage business relationships between applicant SBCs and third-party investors/strategic partners who can provide substantial financing to help accelerate the commercialization of promising new products and technologies initiated with NIH SBIR or STTR funding. In particular, applicants are expected to leverage their previous NIH SBIR or STTR support, as well as the opportunity to compete for additional NINDS funding under this FOA, to negotiate and attract third-party financing needed to advance a product or technology toward commercialization. The applicant’s ability to secure independent third-party investor funds that equal or exceed the total amount of the NINDS funds being requested over the entire Phase IIB project period will provide a measure of the commercial potential that is essential for the SBIR applications submitted to this FOA. This potential will be strongly considered in making funding decisions. It is anticipated that many of the partnerships between applicant SBCs and third-party investors will involve a considerable level of project due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects. In light of these goals, the NINDS strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in the commercialization of emerging biomedical technologies.

Scientific/Technical Scope

This FOA is specifically designed to provide additional support for products/technologies that require ultimate approval by a Federal regulatory agency or complex research tools. Such products include, but are not limited to:

• Therapeutics or diagnostics that require FDA approval, including medical implants, drugs, biologics, biomarkers, and new treatment or diagnostic tools.
• Complex research tools: This is instrumentation comprising several distinct parts that must work together. Very often the goal of such projects is to deliver turnkey products for researchers. For example, high density electroencephalography instrumentation includes electrode arrays, amplifiers, data analytic and data visualization software, etc. Another example is non-invasive near infrared imaging instrumentation, which might include photon sources and detectors, timing devices for delivering photons, amplifiers, and software. Some high throughput assay systems may fall into this category.
• Clinical research tools: Such tools would include those that are developed for clinical research use that do not require any federal regulatory approval, but still require extensive development in order to demonstrate validity in a diverse population.

The technical and commercial objectives described in the SBIR Phase IIB application must represent an extension of the development efforts that were pursued in a previously funded NIH SBIR/STTR Phase II grant or contract. Applicants are encouraged to read the NINDS Notice NOT-NS-11-023 on Improving the Quality of NINDS-Supported Preclinical and Clinical Research through Rigorous Study Design and Transparent Reporting.

Renewal applications of SBIR Phase II awards (i.e. SBIR Phase IIB) to conduct clinical trials are not included in this FOA and should be submitted to PAR-17-479. A clinical trial, as defined by the NIH, is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Please read Notice NOT-OD-15-015 for more details.

See Section VIII. Other Information for award authorities and regulations.