STTR_Straub_Steig

09/16/24

A research team at North Dakota State University has received an award of $295,876 from the National Institute of Health’s (NIH) Small Business Technology Transfer (STTR) program.

Led by principal investigator Jayme Steig, Assistant Professor of Practice at NDSU, and co-principal investigator Jeremy Straub, Associate Professor of Computer Science at NDSU, and in collaboration with pharmaceutical group company OpREMS, LLC, the opioid overdose data prevention project will research improving digital platforms and using AI to analyze data for the NDSU Opioid and Naloxone Education (ONE) program.

The STTR program is part of the NIH Small Business Programs, which are also known as America’s Seed Fund. STTR’s goal is to “foster technology transfer through cooperative R&D between small businesses and research institutions.” NDSU has received STTR awards in the past, dating back to 2002.

A team at NDSU including researchers from the pharmacy practice and computer science departments and staff from NDSU Office for Research and Creative Activity (RCA), worked with OpREMS, LLC to create the proposal. OpREMS then submitted the proposal -- the small business is the focus of the STTR award -- to the NIH and received the award.

NDSU researchers including Steig, Straub, Professor and CAP Center Director Elizabeth Skoy, and CAP Director of Operations Lisa Nagel and Senior Manager of Business Development & Analytics at MMB Healthcare (OpREMS' parent company) Nick Ferrarese will conduct the research .

The award will allow ONE to further develop and refine a digital platform incorporating current ONE Program tools to be used in select community pharmacies. Artificial intelligence will be utilized to analyze data to recognize the screening tools that have the most significant clinical impact. The results from the tools and interventions utilizing the digital platform will be compared to the existing ONE program.

“This STTR award and the public-private partnership between NDSU and OpREMS, LLC creates a great opportunity for the spread and sustainability of the ONE Program, creating a platform supporting widespread use of this proven screening tool to improve opioid misuse and overdose risk identification and the provision of education and interventions to address those risks,” Steig said. “In addition, it utilizes expertise across campus connecting pharmacy practice with computer science.”

Risk Evaluation and Mitigation Software (REMS) is a drug safety program from the U.S. Food and Drug Administration offers for certain medications that have major safety concerns and to ensure the medication benefits outweigh its risk. OpREMS LLC was formed by leading Risk Evaluation and Mitigation Software (REMS) and drug safety software and technology developers to improve the effectiveness and operability of REMS programs.

The grant proposal was originally submitted for review in 2023 with NDSU RCA Proposal Development Manager Cassie Johnson working with the pharmacy and computer science researchers. The responses to reviewers’ concerns were submitted in December and the award was announced this month.

“We in RCA were able to help with parsing application requirements, putting together a compliant application package, and supporting the small business through the process of getting registered in the various federal systems required to submit a proposal,” Johnson said. “On that front we also had a lot of support from the sponsored programs staff. It was great working with this team and I’m delighted all of their hard work paid off.”

ONE PROGRAM MAKES IMPACT

ONE has a focus on community pharmacy-based patient screening and interventions to improve population health by educating pharmacists to screen patient who receive opioid prescriptions to determine risks of misuse and accidental overdose. Phase I work is focusing on further developing and refining a digital platform incorporating existing ONE Program tools and pilots in a select group of community pharmacies.

“The ONE Program has impacted those in North Dakota receiving opioid prescriptions by improving their understanding of their risks for opioid misuse and overdose along with safe medication storage and disposal practices,” Steig said. “The program has resulted in naloxone, an opioid antidote, being provided to those at risk for overdose at rates significantly higher than national averages. This STTR award can help the screening reach more people and improve public safety.”

“The team is passionate about the translation of the work they’ve done inside of NDSU, benefitting American health by reducing the risk of opioid abuse, misuse and overdose,” said Heidi Grunwald, NDSU associate vice president for research and faculty development. “I’m happy they had the persistence because that’s what it takes.”

Steig was a member of the NDSU RCA Panel at the 2024 Bioscience Summit held in Fargo on Sept. 17. The panel, which discussed “Leveraging Higher Education Relationships,” was moderated by Alyssa Teubner, Director of Development at the NDSU Foundation.

Given the opportunity for non-profit research institutions such as universities to partner with small businesses to develop products and services that have commercial potential, NDSU RCA is interested in pursuing additional STTR grants and advancing industry partnerships more generally. As Director for Innovation and Economic Development, Cindy Graffeo can help in the development of these kinds of partnerships with NDSU, including early proposal development for possible STTR grants with NDSU faculty funded through the Economic Diversification Research Funds as the SBIR/STTR Phase 0 Funding Program.