Donald C. Lo, PhD, Director, Division of Preclinical Innovation, NCATS, contributed to this Q&A.
What is the role of NCATS in helping researchers and entrepreneurs, and why is this so critical?
The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) is focused on transforming the translational research process so that new treatments and cures for disease can be delivered to patients faster. We believe that small businesses and researchers play an important role in translational research. NCATS programs are designed to help researchers and entrepreneurs accelerate and translate their science into novel products, services or technologies that can help improve disease prevention, detection and treatment. These programs, such as the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, serve as an engine of innovation, offering grants, contracts and technical assistance to small businesses and research organizations.
SBIR and STTR programs are one of the largest sources of funding for early-stage companies in the United States. They are especially helpful for entrepreneurial researchers who are launching small businesses and seeking to commercialize new products that will have public benefit.
In addition to funding through the SBIR and STTR programs, NCATS offers technical assistance to help companies with their research and infrastructure through the Therapeutics for Rare and Neglected Diseases (TRND) and Bridging Interventional Development Gaps (BrIDGs) programs.
How can life sciences companies, or researchers and entrepreneurs, take advantage of the NCATS SBIR and STTR programs?
Researchers and entrepreneurs can leverage NCATS’ SBIR and STTR programs to advance their early-stage research closer to commercialization. NCATS encourages companies and researchers to explore NCATS SBIR and STTR opportunities by visiting ncats.nih.gov/smallbusiness. To apply for funding, companies should review the NCATS research areas of interest and ensure that they meet the eligibility criteria for the programs. Interested researchers can review the opportunities and contact a program officer to discuss a research idea before application. Those who wish to apply are encouraged to get started early and get set up to submit an application.
Right now, there are a number of open funding opportunities that are accepting applications – each addressing different research priorities, such as drug discovery and development or biomedical, clinical and health research informatics.
There are many benefits to the NCATS SBIR and STTR programs. The funding is stable, predictable and not a loan. The capital is non-dilutive and the small businesses retain intellectual property rights. The next deadline to submit a funding application is September 5, 2018, at 5pm local time.
What are the future research priorities for NCATS SBIR and STTR Programs?
The NCATS SBIR and STTR programs are focused on helping to accelerate scientific discoveries that improve patient care, research, and the overall translation of research into practice. The research priorities that NCATS is focused on funding through the SBIR and STTR programs include:
Some of the additional targeted areas NCATS support include:
Development of Highly Innovative Tools and Technology for Analysis of Single Cells
Platform Delivery Technologies for Nucleic Acid Therapeutics
Tools for Cell Line Identification
Small Market Awards: SBIR Phase IIB Competing Renewals for Heart, Lung, Blood, and Sleep Technologies
NCATS encourages funding applications for projects that fall within these areas, and also supports the development of clinical technology, instruments, devices and related methodologies that may have broad application to clinical research and better patient care. Investigators may also propose novel research ideas through the annual SBIR/STTR Omnibus Solicitation.
What is the purpose of the TRND and BrIDGs programs? How do they help small businesses?
The BrIDGs program enables research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. Investigators do not receive grant funds through this program. Instead, selected researchers partner with NCATS experts to generate pre-clinical data and clinical-grade material through government contracts for use in Investigational New Drug (IND) applications to a regulatory authority such as the Food and Drug Administration (FDA). In general, BrIDGs provides synthesis, formulation, pharmacokinetic and toxicology expertise and resources to its collaborators.
The TRND program aims to encourage and speed the development of new treatments for rare and neglected diseases. The program is designed to advance the entire field of therapeutic development by encouraging scientific and technological innovations to improve success rates in the crucial pre-clinical stage of development.
TRND closes the gap that often exists between a basic research discovery and testing of new drugs in humans. That work includes the optimization and pre-clinical testing of therapies, with the goal to generate sufficient-quality data to support successful IND applications to the Food and Drug Administration and first-in-human studies in limited circumstances. Therapeutic clinical candidates that reach this stage should be attractive to biotechnology and pharmaceutical companies to take into clinical development.
To hear directly from Lili and Donald, and to schedule one-on-one meetings, register for our forum on May 8th!