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NIAAA Fosters Innovation Through Its Small Business Research Program – National Institute on Alcohol Abuse and Alcoholism

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) program supports the development and commercialization of innovative tools, technologies and strategies. the National Institute on Alcohol Abuse and Alcoholism (NIAAA) SBIR/STTR Program aims to improve the diagnosis, prevention and treatment, as well as the cure of alcohol-related problems. The SBIR/STTR program enhances NIAAA’s research portfolio across the spectrum of basic, translational, and clinical research. This portfolio includes drug development research, alcohol biosensors, screening and diagnostic tools, educational resources, mobile apps, and more.

“Established by Congress as part of a federal-wide effort, the SBIR/STTR program is an important part of NIAAA’s research portfolio, with funds earmarked to move innovative solutions from the lab to large-scale use. public,” says NIAAA Director George F. Koob, Ph.D.

What makes the SBIR/STTR program unique?

The SBIR/STTR program is also known as America’s Seed Fund. It provides support to small start-ups to meet the country’s research and development needs in a way that drives innovation, encourages entrepreneurship and contributes to the national economy. In turn, these research and development efforts increase the likelihood that the gains of publicly funded private sector research will be commercialized for the benefit of the American people.

“The SBIR/STTR program encourages researchers who have innovative ideas and who have successfully obtained R01 grants to embark on entrepreneurship. This reduces the risks associated with transitioning from academia to small business ownership,” adds Megan Ryan, MBA, who has served as NIAAA’s SBIR/STTR program coordinator since 2016.

Prioritizing project support is essential for the viability of small businesses at an early stage. Over the years, small businesses have taken advantage of the support provided by the SBIR/STTR program to advance products that show promise but are considered a lower priority given limited resources.

One example is the development of Vivitrol, a long-acting injectable form of naltrexone that has received US Food and Drug Administration (FDA) approval for the treatment of alcohol use disorder (AUD) in 2006. Alkermes, then a small biopharmaceutical company specializing in drug delivery technology, was awarded an NIAAA SBIR contract in 2000 to conduct proof-of-concept and efficacy clinical trials of Vivitrol. The SBIR award effectively eliminated development risk and helped Alkermes leverage the award to raise additional financial support and conduct larger clinical trials, ultimately providing the data needed for FDA approval.

Increase visibility of the NIAAA SBIR/STTR program

In recent years, the NIAAA has focused on improving its SBIR/STTR portfolio. This effort has largely focused on raising awareness of the NIAAA SBIR/STTR program and educating entrepreneurs on how to apply for an NIAAA SBIR/STTR award.

To do this, Ms. Ryan partnered with a science and healthcare marketing firm to expand NIAAA’s reach on its SBIR/STTR program. Together, they developed new outreach materials, expanded the NIAAA SBIR/STTR website, and hosted informational webinars with small business incubators and “state biographies.” State bios are organizations that bring together a state’s bioscience companies, universities, research institutes and others dedicated to advancing life science research and commercialization. These efforts contributed to a 33% increase in the total number of SBIR/STTR requests received by the NIAAA in one year. Despite common research setbacks in the COVID-19 pandemic, the NIAAA has continued to receive an increased number of SBIR/STTR requests.

“These findings demonstrate the importance of outreach to potential candidates, which will remain a focus of NIAAA’s SBIR/STTR program going forward,” said Jenica Patterson, Ph.D., new NIAAA SBIR/STTR Program Coordinator.

Highlights of NIAAA SBIR/STTR Program Priorities

One of the priorities of the NIAAA SBIR/STTR program is to develop wearable biosensors to detect the amount of alcohol consumed by an individual. Researchers are using innovative techniques to improve the accuracy of the devices as well as their portability. This work will allow researchers to better measure alcohol consumption in clinical research studies and treatment settings.

Another priority is the development of new drugs to treat alcohol-related consequences and conditions, such as AUD, alcohol-associated organ damage (AAOD), alcohol withdrawal, and alcohol overdose. An example of an SBIR project supported by the NIAAA, led by Felix Moser, Ph.D., at Synlife Bio, is the development of a new therapeutic injection to combat alcohol overdose. Billions of dollars are spent each year to treat cases of alcohol overdose, many of which result in death, but there are no FDA-approved pharmacological treatments. NIAAA’s Commitment to Developing New Drugs Highlighted by Recent SBIR/STTR Report funding announcementand is an important step in bridging the gap between basic research and clinical trials.

Improving diagnostics for AAOD is another area of ​​focus for NIAAA’s SBIR/STTR program. For example, InLighta BioSciences, a company founded by Jenny Yang, Ph.D., has developed a new magnetic resonance imaging (MRI) contrast agent that dramatically improves diagnostic ability for conditions such as liver. Unlike traditional contrast media, this agent is non-toxic and can detect the early stages of the disease. From the start, this technology was ready to provide a non-invasive early diagnostic tool for liver disease— a disease in which alcohol abuse is a major risk factor. In the United States, nearly half of liver disease deaths are associated with alcohol abuse.

NIAAA’s SBIR/STTR program also supports the development of alcohol prevention programs, educational services, behavioral treatment programs, and digital health technologies. In an ongoing clinical trial supported by the NIAAA, DynamiCare Health is testing a smartphone-based digital coaching program to support accessible and affordable long-term recovery from AUD. The program is based on behavioral techniques such as contingency management, recovery coaching and cognitive behavioral therapy.

Learn more

For more information on the NIAAA SBIR/STTR program, visit the NIAAA SBIR/STTR website.

References:
NIAAA SBIR/STTR Program. Available at https://www.niaaa.nih.gov/research/niaaa-sbir. Accessed March 16, 2022.

NIH. The invention relates to a liposomal enzyme system for the removal of ethanol from blood. Available at https://reporter.nih.gov/search/0u4ykZHaOkmWs3KG7egLHQ/project-details/10139179. Accessed March 16, 2022.

NIH. Investigational New Drug (IND) Activation and Early Stage Development of Drugs to Treat Alcohol Use Disorders and Alcohol-Related Organ Damage (Optional U43/U44 Clinical Trial). Available at https://grants.nih.gov/grants/guide/pa-files/PAR-22-102.html. Accessed March 16, 2022.

Salarian, M; Xue, S.; Ibhagui, OY; and Yang, JJ Design of calcium-binding proteins for molecular magnetic resonance imaging. Methods in molecular biology. 2019;1929:111–125. PMID: 30710270

NIH. Detection and staging of liver fibrosis by accurate MRI (pMRI). Available at https://reporter.nih.gov/search/-YBPOqtaA02LYdGGS9qccw/project-details/9971410. Accessed May 2, 2022.

National Library of Medicine. Tech-Enabled CM for AUD at Scale in Medicaid. Available at https://clinicaltrials.gov/ct2/show/NCT04581499. Accessed March 16, 2022.


This article first appeared in NIAAA Spectrum.

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