NC TraCS Impact Report April 2024 - March 2025

IMPACT REPORT NC TraCS APRIL 2024 — MARCH 2025 1 2 TABLE OF CONTENTS Perspectives from the TraCS Director .....................................................................3 Driving North Carolina’s Health Forward through Innovation ...........................4 Advancing Research & Translation: Data-Driven Insights .....................................5 Raising the Profile of Translational Science at UNC and Our Partners ...............6 Clinical and Translational Science Research Program ...................................................7 Ongoing i2i Award Highlight .............................................................................................8 Funding Your Science: Clinical and Translational (CTS) Pilot Program ........................9 Partners in Translational Science ...................................................................................10 Supporting the Research Journey from Inception to Innovation .......................13 Leveraging data to support Western NC after Hurricane Helene ...............................14 Partnering to screen newborns for rare genetic diseases ..........................................15 Ringing in innovation for women’s health .....................................................................16 Multi-faceted expertise enables landmark study of new food allergy drug .............17 Spotlight on Scholars ..............................................................................................18 Current K12 Scholars .......................................................................................................19 NC TraCS Services & Programs ..............................................................................21 Reaching Audiences within Academia and Beyond .............................................22 Join Us in Making an Impact ...................................................................................25 3 Dear Friends of NC TraCS, Thank you for taking the time to look over the work of the NC TraCS Institute—home of clinical and translational science at UNC-Chapel Hill. With our partners, North Carolina Agricultural and Technical State University and North Carolina State University, our mission is to accelerate high-impact research to improve human health. Our center is a hub of activity for all things clinical and translational research— from new projects providing breakthroughs in translational science, to the variety of services and training we offer daily to investigators and aspiring researchers at UNC and our partners. Now in our third year of this grant cycle, we are excited to see projects that began at the start of the cycle bearing fruit. On pages 7-8, learn about our Clinical & Translational Research Program and the Innovation to Impact (i2i) awards. These projects ask important, pragmatic questions—read about one project highlight where we hope to be able to predict who will suffer complications from cancer-related care, to make timely interventions and avert poor outcomes. NC TraCS is proud to sponsor innovative research and train the next generation of research professionals! Our pilot program (pages 9 and 12) supports innovative directions by creative scientists. The return on investment of these projects has been gratifying, with most projects spurring additional funding and scientific breakthroughs. Get to know our K12 Scholars (pages 19-20) to see the many faces of tomorrow’s leaders in research—and read up on our multitude of efforts to provide training and services to professionals at all levels. Now more than ever, research centers such as ours are called upon to demonstrate their value to human health. This report is both a testament to the many tangible ways in which NC TraCS benefits our community—and a promise to maintain a focus on the outcomes that matter to our patients. To another year of great translational science, Nick Shaheen, MD, MPH | PI & Director PERSPECTIVES FROM THE TRACS DIRECTOR 4 NC TraCS is a grant-funded institute founded as a service to the research community—a catalytic partner that educates, funds, connects, and supports researchers at UNC-Chapel Hill and across the U.S. We are part of the Clinical and Translational Science Awards (CTSA) consortium created by the NIH’s National Center for Advancing Translational Sciences (NCATS) with a common mission to accelerate discoveries into interventions that improve the health of individuals and the public. Together with our partners, we help advance the science of translation at UNC and beyond. We combine the research strengths, resources, and opportunities of the UNC-Chapel Hill campus and our partners: North Carolina State University in Raleigh and North Carolina Agricultural and Technical State University (N.C. A&T) in Greensboro. DRIVING NORTH CAROLINA’S HEALTH FORWARD THROUGH INNOVATION DRIVING RESEARCH FORWARD BUILDING THE FUTURE OF TRANSLATIONAL SCIENTISTS FUELING RESEARCH INNOVATION STRENGTHENING COMMUNITY PARTNERSHIPS EXPANDING ACCESS TO RESEARCH OPPORTUNITIES: RESEARCH FOR ME EMPOWERING RESEARCHERS WITH DATA ADVANCING CLINICAL RESEARCH INFRASTRUCTURE 2,685 + research requests supported 1,042 researchers across 14 UNC Schools and over 20 + external institutions 46% of PIs return for additional support, reflecting long-term research partnerships Nearly 300 data requests supported from the Carolina Data Warehouse for Health (CDW-H) with our EHR Data Service 13 early-career scholars trained in our K12 Junior Faculty Development Program, preparing them to lead innovations in therapeutics, clinical interventions, and behavioral health Our Clinical and Translational Science (CTS) Pilot Program is accelerating breakthroughs, funding 9 projects across 11 UNC departments, 4 schools, and 2 institutions to drive real-world health solutions • 48,000 + people expressed interest in joining research studies that began recruiting between April 2023 to March 2025 • 8,300 + are registered on our study listing and clinical research education site, Research for Me—an increase of nearly 1,800 from the previous two years • Representation from 95 of North Carolina’s 100 counties, highlighting broad statewide engagement • Formed a 300-member community and patient network informing all aspects of research at UNC, with our partners, and across North Carolina • Facilitated 38 meetings with 312 community/patient partners to integrate patient and community voices into research • Trained 348 researchers across 37 institutions in our Engagement in Research Training Series Our Clinical and Translational Research Center (CTRC) supported 6,887 participant visits across 255 studies led by 99 investigators, providing 15,000 + hours of research support Supported 611 + scientific publications, expanding the impact of our work Offered over 200 training events with more than 6,000 participants Advancing Research & Translation: Data-Driven Insights DATA: APRIL 2023 – MARCH 2025 6 RAISING THE PROFILE OF TRANSLATIONAL SCIENCE AT UNC AND OUR PARTNERS 7 CLINICAL AND TRANSLATIONAL SCIENCE RESEARCH PROGRAM The CTS-RP supports innovative research addressing barriers in the translational research pipeline. Its three goals are to: 1. Enhance the effectiveness and efficiency of translational research 2. Expand CTS by integrating translational science with translational research 3. Address high-priority questions for rapid implementation within UNC Health and beyond To achieve these goals, CTS-RP funds Innovation to Impact (i2i) awards of $125,000-250,000 annually for up to three years, with additional support from TraCS services to boost collaboration. Over the past two years, we supported two i2i projects (projected end date: March 2026) focusing on their dissemination and implementation efforts. These projects are distinctly innovative, tackling critical scientific and operational challenges. Each project must address a translational research (TR) question in a specific disease or condition, paired with a new method or process that resolves a relevant translational science (TS) barrier. The developed TS method should not only solve the TR question, but also be broadly applicable across various diseases and conditions. These projects contribute to NCATS’ initiative of accelerating the development of treatments for all people. The next round of projects will start in fall 2025. (CTS-RP) To learn more about the Innovation to Impact (i2i) awards, visit tracs.unc. edu/services/cts-research-program 8 ONGOING i2i AWARD HIGHLIGHT Transforming Cancer Care with Personalized Risk Prediction Jennifer Elston Lafata, PhD, and Jacob Stein, MD, MPH, lead a project to transform cancer treatment through predictive modeling. Their team developed the Oncology Risk-Stratified Intervention System (OR-SIS) to personalize patient care by predicting risk of hospitalization in cancer patients using health records and clinical insights. Supported by a Clinical Advisory Panel, the system integrates the panel’s feedback to refine its approach. This approach also enables the joint development of model building and intervention planning—two processes which have been historically disconnected—with the goal of offering patient care that is more tailored and effective. Since the start of the project in 2023, the team has created two models: a baseline risk model, as well as a dynamic model that adjusts based on current factors and therapies. The team secured buy-in from oncology leadership and are integrating OR-SIS into Epic. They are also exploring factors such as insurance status and rural residency with the goal of identifying patients who benefit more from OR-SIS. This work is expected to extend beyond oncology, offering valuable insights for enhancing care across other healthcare systems and chronic diseases. See: Charting a new path to help cancer patients Jennifer Lafata, PhD Jacob Stein, MD, MPH 9 The CTS Pilot Program supports the field of translational science with one-year $50,000 pilot grants to assist investigators in collecting data to support larger investigations—so that advances can be applied to research on any target or disease. In Grant Year 2, we funded 4 projects: Integrated Digital Health platform to assess and respond to mental health crises in children and adolescents Illuminating the Prognostic Potential: Predicting the Drug Effects on Cancer Tumors with Deep Neural Network Developing an Efficient Translational Pipeline for Biospecimen Collection Alper Bozkurt, PhD, MSc Ning Sui, PhD Aysenil Belger, PHD Zhishan Guo, PhD Tessa Andermann, MD, MPH Psychiatry, UNC School of Medicine Electrical & Computer Engineering, NC State University Computer Science, NC State University Molecular & Structural Biochemistry, NC State University Infectious Diseases — Department of Medicine, UNC School of Medicine Kevin Friede, MD Developing Methods for Gene Expression Analysis of Antiplatelet Drug Exposure Cardiology — Department of Medicine, UNC School of Medicine FUNDING YOUR SCIENCE: CLINICAL AND TRANSLATIONAL (CTS) PILOT PROGRAM Our CTS Pilot Program is accepting applications through July 8, 2025. Learn more at tracs.unc.edu/services/ pilot-program/cts. Read CTS Pilot Program stories at tracs.unc.edu/component/tags/tag/ cts-pilot. 16 RINGING IN INNOVATION FOR WOMEN’S HEALTH Imagine a world where cutting-edge technology meets women’s health, revolutionizing treatments and empowering women globally— this is the vision driving Rahima Benhabbour, PhD, and her groundbreaking research. Benhabbour is a biomedical engineer at UNC whose work focuses on developing advanced, patient-centered solutions for improving women’s health. Her lab has explored various innovations including ultra-long-acting injectable formulations for HIV prevention, thin-film technologies for treating chronic vulvar pain, and biodegradable implants capable of releasing multiple drugs simultaneously. One of her most notable achievements is the development of the first 3D-printed intravaginal ring, which could transform how women receive treatments for infertility, HIV, menopause, and more. She hopes to create systems that will empower women around the world, giving them more control over their reproductive health. To commercialize the intravaginal ring, Benhabbour founded the start-up company AnelleO with the motto: “Where 3D printing meets women’s health.” NC TraCS has been pivotal in advancing Benhabbour’s innovative research on 3D-printed intravaginal rings as a customizable drug-delivery platform. Through comprehensive services, including Career Development, Pilot Funding, and Regulatory assistance, NC TraCS enabled the early stages of this groundbreaking work. Pilot funding was crucial for initial research and development, while regulatory support helped navigate the uncharted territory of FDA approval for 3D-printed intravaginal rings. As a TraCS KL2 scholar, Benhabbour received crucial training and development, which she describes as a springboard for her career. These combined efforts underscore our commitment to fostering pioneering scientific endeavors. Benhabbour’s development of a 3D-printed intravaginal ring exemplifies translational science by introducing innovative drug delivery methods to address unmet needs in women’s health across a vast number of health conditions. It advances a customizable, patient-centered platform that could transform how women’s health is delivered across multiple care settings. View the video featuring Benhabbour at: tracs.unc.edu/about 17 FDA APPROVAL: MULTI-FACETED EXPERTISE ENABLES LANDMARK STUDY OF NEW FOOD ALLERGY DRUG What if children with severe food allergies could finally eat without fear? The OUtMATCH trial has made this possible. OUtMATCH, a multi-center clinical trial funded by the National Institute of Allergy and Infectious Diseases, tested a monoclonal antibody, omalizumab, for reducing allergic reactions in multi-food allergic children. Previously, oral immunotherapy was the only approved treatment for food allergies. In February 2024, the FDA approved omalizumab for the reduction of allergic reactions, including anaphylaxis. This approval offers a new treatment option that allows multi-food allergic children to consume an increased amount of peanut, tree nut, egg, milk, and wheat products without an allergic reaction, thus reducing potentially life-threatening reactions to accidental exposures. National Geographic included this research in their Seven Medical Breakthroughs that Changed Medicine in 2024. This work reflects translational science by exploring a single therapeutic approach with the potential to treat multiple food allergies, moving beyond the traditional model of allergen-specific treatments. Additionally, if the drug proves effective without requiring desensitization therapy—a major barrier of traditional oral immunotherapy—it could help establish a more efficient, patient-centered treatment model, exemplifying an innovation in the translational process itself. At UNC-Chapel Hill, this trial was led by Edwin Kim, MD, and conducted at the NC TraCS Clinical and Translational Research Center (CTRC). The CTRC provided essential space, skilled staff, and logistical support to facilitate treatment visits and ensure smooth protocol implementation throughout the study. NC TraCS Informatics and Data Science also supported OUtMATCH by using the Carolina Data Warehouse for Health (a central data repository containing clinical, research, and administrative data sourced from the UNC Health System) for identifying potential patients for recruitment into the trial. 18 Gene Orringer Junior Faculty Career Development Program (TraCS K12) The NC TraCS K12 Program trains and develops earlystage investigators to conduct translational science. The scholars conduct TS projects and receive training to develop leadership and mentoring skills in the principles of TS with input and support from their mentors, the program co-PIs, and affiliated faculty and staff. Meet the scholars from Grant Year 2 (pages 19-20). SPOTLIGHT ON SCHOLARS Scholars since 2008 in funding support have attained subsequent funding 106 $28.7M 90% Michelle Hernandez, MD Professor of Pediatrics UNC School of Medicine Jon Juliano, MD, MSPH, DTM&H Professor of Medicine UNC School of Medicine K12 Co-PIs K Scholars Read profiles about some of our scholars at tracs.unc.edu/ component/tags/tag/tracs-scholarprofiles. 19 CURRENT K12 SCHOLARS Department of Pediatrics, School of Medicine Primary Mentor: Samantha Schilling, MD Bianca Allison, MD Department of Health Policy & Management, Gillings School of Global Public Health Primary Mentor: Kristen Hassmiller-Lich, PhD Samuel Baxter, PhD Department of Psychiatry, School of Medicine Primary Mentor: Brian Boyd, PhD Kelly Caravella, PhD Department of Pediatrics, Division of Pediatric Gastroenterology Primary Mentor: Shehzad Sheikh, MD, PhD Matthew Egberg, MD Pharmacoengineering and Molecular Pharmaceutics UNC Eshelman School of Pharmacy Primary Mentor: Jeff Aube, PhD Owen Fenton, PhD 20 CURRENT K12 SCHOLARS cont. Eshelman Institute of Innovation, Eshelman School of Pharmacy Primary Mentor: Albert Baldwin, PhD Department of Medicine, Division of Endocrinology Primary Mentor: Jenny Flythe, MD, MPH Andrew Satterlee, PhD Klara Klein, MD, PhD Department of Medicine, School of Medicine Primary Mentor: Richard Boucher, MD Stephen Schworer, MD, PhD Department of Medicine, School of Medicine Primary Mentor: Alex Duncan, MD, PhD Andreea Waltmann, PhD Clinical Research Operations and Conduct A healthier North Carolina through innovation •Clinical & Translational Research Center (CTRC) •Regulatory Support •Research Coordination and Management Unit (RCMU) Clinical Informatics and Electronic Health Record Data •Informatics and Data Science (IDSci) •Translational Science Application Development (AppDev) Engagement, Recruitment, and Demographic Support in Research •Patient and Community Engagement (PaCER) •Assessment, Design, & Analysis for Population validiTy (ADAPT) •Recruitment & Retention •Qualitative Research Service •Practice-based Research (NCNC) Proposal Development, Funding, and Team Science •Funding Opportunities •Proposal Development •Team Science Education, Training, and Workforce Development Support •K12 Program •R Writing Groups •Mock Reviews •Career Development Award (K) Writing Groups •Mentor Identification/Training Research Analytics, Design, and Data Management •Biostatistics Service •FastTraCS •Integrated Methods and Research Design 21 To promote our mission of accelerating high-impact research to improve human health, NC TraCS organizes our collective activities into six categories. NC TraCS SERVICES & PROGRAMS TraCS Service Navigation Get an overview of TraCS services and learn how we can support your project with personalized, one-on-one guidance. Request a Service Consultation tracs.unc.edu/request 22 Top 10 Most-popular subject areas published by NC TraCS-supported researchers Data April 1, 2023 - March 31, 2025 | by subject area (numbers indicate count of publications citing our Institute during this period) EXPLORING THE RESEARCH: REACHING AUDIENCES WITHIN ACADEMIA AND BEYOND scientific publications times in academic journals Cited Featured in Mentioned in Referenced in policy documents news stories and blogs patents awarded 611 24,435 6 2,449 6 2,677 posts on by 19,706 unique users across 152 countries These metrics reflect both academic influence and broader reach—showing how research shapes scholarly work, public health policy, clinical guidelines, and conversations in the media and online. 23 High Impact Publications (April 2024 to March 2025) “Favorable antiviral effect of metformin on SARS-CoV-2 viral load in a randomized, placebo-controlled clinical trial of COVID-19” — Clinical Infectious Diseases, 2024. John Buse (UNC-affiliated co-author). Read at academic.oup.com/cid/article/79/2/354/7660393. This manuscript presents the finding of a clinical trial examining the antiviral effects of metformin, a widely used diabetes medication, on SARS-CoV-2 viral load. The clinical trial, which was supported by the NC TraCS Clinical & Translational Research Center (CTRC), found that metformin significantly reduced viral load in individuals with COVID-19 compared to a placebo, suggesting a potential therapeutic benefit. These findings support further investigation into repurposing metformin as a treatment for COVID-19. In the top 5% of all research products scored by Altmetrics. Attention Score is in the top 1% compared to products of the same age. “Once-weekly semaglutide in adults with alcohol use disorder” — JAMA Psychiatry, 2025. Christian Hendershot, Michael Bremmer, Michael Paladino, Georgios Kostantinis, Thomas Gilmore, Neil Sullivan, Amanda Tow, Robyn Jordan, Klara Klein (UNC-affiliated co-authors). Read at jamanetwork.com/journals/jamapsychiatry/fullarticle/2829811. This publication reports the findings of an investigation into the effects of once-weekly semaglutide in adults with alcohol use disorder. Researchers found that semaglutide significantly reduced alcohol consumption compared to a control group, suggesting its potential as a pharmacological treatment for alcohol use disorder. These findings highlight the need for further research on GLP-1 receptor agonists in addiction treatment. In the top 5% of all research products scored by Altmetrics. Attention Score is in the top 1% compared to products of the same age. EXPLORING THE RESEARCH cont. Altmetric Attention Score Reflects how much attention a research publication has received across sources like news media, policy documents, and social media platforms. 24 View altmetrics report for publications since 2008 View our April 2023 to March 2025-supported publications in PubMed “Endometrial thickness as diagnostic triage for endometrial cancer among Black individuals” — JAMA Oncology, 2024. Erin Carey and Til Stürmer (UNCaffiliated co-authors). Read at jamanetwork.com/journals/jamaoncology/fullarticle/2820528. This publication, supported by NC TraCS services including Informatics and Data Science (IDSci), evaluates the potential of using endometrial thickness as a diagnostic triage tool for endometrial cancer in Black individuals. The research highlights how measuring endometrial thickness could improve early detection and diagnosis of endometrial cancer, particularly in populations with historically lower screening rates. These findings suggest that endometrial thickness could serve as a cost-effective and accessible screening approach. In the top 5% of all research products scored by Altmetrics. Attention Score is in the top 1% compared to products of the same age. EXPLORING THE RESEARCH cont. 25 Thank you for taking the time to read our Impact Report. We are incredibly proud of what we’ve achieved together in the last year and are excited about the opportunities ahead. Explore the multitude of opportunities to collaborate with us across our diverse array of services, resources, and programs. Whether you’re seeking support for research projects, access to specialized training, or pathways to develop and commercialize a product, NC TraCS is here to facilitate collaboration and foster innovation. Our team provides solutions and fosters partnerships that drive translational science forward. Let’s work together to achieve your research goals and make meaningful contributions to advancing healthcare and improving patient outcomes. Explore opportunities with us Learn more about our services, resources, and programs: tracs.unc.edu/services Stay connected and learn more about our institute by attending our events: tracs.unc.edu/calendar Contact us JOIN US IN MAKING AN IMPACT TRACS.UNC.EDU [email protected] FACEBOOK.COM/NCTRACS 919.966.6022