Translational Innovation Pilot (TIP) Program

The Utah CTSI’s TIP program will fund translational science projects aiming to identify and overcome barriers to the performance of translational research. Addressing critical barriers will allow subsequent translational research to accelerate the time from discovery to improved human health.

Leveraging CTSA funding, the Utah Clinical & Translational Science Institute (CTSI) will award pilots through its Translational Innovation Pilot (TIP) program. In alignment with NCATS, the Utah CTSI’s TIP program will support translational science projects that focus “on understanding a scientific or operational principle underlying a step of the translational process with the goal of developing generalizable principles to accelerate translational research.”

For additional information, please contact Breanne Johnson.

FOA FY’26 has closed.

Virtual Office Hours - closed for FY'26

Past Recipients

PI Name	PI Title	PI Dept	Pilot Title	TS Barrier	Project Abstract
Ann Bruno	Assistant Professor	OBGYN	A pilot study of rivaroxaban transfer into human milk	Development of a process for the study of medication excretion into human milk to allow medical research to safely be performed on lactating women	Venous thromboembolism (VTE) accounts for 9% of maternal deaths in the U.S. The risk is highest in the first two weeks postpartum. Therefore, national guidelines recommend hospitals implement a standardized approach to VTE risk assessment and thromboprophylaxis. While not currently recommended for obstetric populations, the use of direct oral anticoagulants (DOACs) may improve VTE thromboprophylaxis and help to reduce maternal mortality in the U.S. Heparin-based prophylaxis is the currently recommended pharmacologic agent based on known lack of transfer to human milk and safety profile. However, heparin-based prophylaxis requires daily or twice daily subcutaneous injection with self-administration after hospital discharge. The injections and associated discomfort and bruising, as well as self-administration, reduce medication adherence. DOACs offer an appealing alternative based on their oral administration. DOACs are widely used for treatment and prevention of VTE in non-obstetric populations. Before DOACs can be recommended for use in a postpartum population, the potential for DOAC transfer to human milk needs to be defined. Unlike other patient populations, postpartum individuals breastfeed. Understanding the potential for DOAC exposure among nursing infants is a key safety consideration. Case reports have identified the transfer of DOACs into human milk at low concentrations when administered at relatively higher therapeutic doses. Therapeutic doses of the DOAC, rivaroxaban, had the lowest transfer to human milk. The transfer of rivaroxaban into human milk when administered at a prophylactic dose (~1/3 of a therapeutic dose) has not been studied. These data could support DOAC use to prevent postpartum VTE. We are completing a single-center, observational study of 20 postpartum individuals to evaluate the excretion of rivaroxaban into human milk when administered at a prophylactic dose. Rivaroxaban concentrations from maternal blood and milk are collected to estimate the time and magnitude of transfer, as well as relative infant doses.
Tammy Stump	Visiting Instructor	Dermatology	STARS (Sun Protection and Tanning Awareness in Rural Schools)	Development of a process to integrate a health behavior intervention within state-mandated health education curricula	Melanoma is a significant public health problem, especially in rural areas that already experience significant health disparities. Melanoma incidence and mortality are higher in rural areas when compared to urban areas, and melanoma is diagnosed at later and harder to treat stages among individuals living in rural areas. Adolescents in rural areas are at particularly high risk for skin cancer because they do not use sufficient sun protection strategies, experience high levels of UVR exposure, and are at increased risk for sunburn occurrence. Although there are evidence-based interventions targeting adolescents’ sun exposure, translational research barriers reduced the potential impact of these interventions. These barriers include limited technology resources and differences in activity patterns sun protection attitudes compared to urban students. The overarching goal of the proposed project is to develop and pilot test a sustainable intervention targeting skin cancer prevention among high school students in Utah. To address the urgent need for skin cancer prevention programs for rural adolescents, this project has the two primary aims. First, we are evaluating barriers and facilitators to impactful and sustainable implementation of sun protection intervention in rural schools, through interviews with stakeholders. We are in the process of conducting interviews with 15 school staff, parents, and activity leaders to assess key constructs drawn from the Consolidated Framework for Implementation Research (e.g., relative advantage of the program) and have begun to use these interviews to guide refinements to plans for a school-based intervention. Second, we will conduct a pilot test of a ruraladapted skin cancer prevention intervention in rural high schools, evaluating effectiveness and implementation outcomes. The program will be co-implemented by the research team and school staff, with a focus on sustainability beyond the immediate study period. Interview and survey assessments following program implementation will evaluate both the program effectiveness and implementation outcomes (e.g., feasibility).
Anna L. Parks	Assistant Professor	Hematology	Anti-amyloid monoclonal antibodies for dementia and intracranial hemorrhage: elucidating underlying mechanisms	Development of a biomarker	Novel monoclonal antibodies targeting amyloid for Alzheimer’s disease and related dementias (ADRD) can slow the course of disease but at the expense of increased risk of intracranial hemorrhage. How to predict and prevent this complication remains unknown. Coagulation and platelet functional assays are promising candidate predictive biomarkers. In a cohort of 20 patients receiving anti-amyloid therapy, we will measure coagulation and platelet function both pre- and three months post-treatment. Using a control group for comparison, we will measure the association between functional hemostatic testing and development of intracranial hemorrhage. In doing so, we will accomplish three broader translational science goals: 1) Validate a broadly generalizable process to adapt for bleeding prediction biomarkers across disease states, 2) Address key unmet needs for research in vulnerable older adults, ADRD biomarkers and bleeding risk prediction, 3) Establish a new multidisciplinary scientific collaboration.
Jun Yang	Professor	Neurobiology	A pilot study on gene therapy for retinal degeneration	Development of a new gene editing therapy to correct genetic mutations which can be applied to multiple inherited diseases	Inherited diseases affect up to 5.9% of the population, equivalent to 446 million people worldwide. The pathogenic mechanisms of these diseases are mostly unclear, and there are few treatments or cures. Gene replacement therapy has shown promise, but it is more applicable to diseases caused by mutations in small genes due to the AAV packaging limit of 4.7 kb. This therapy also alters the physiological expression of target genes because it uses exogenous promoters in the viral vectors. Recently, CRISPR/Cas9-based gene editing technologies have emerged, which may address these limitations by precisely correcting mutations in the gene instead of replacing the entire gene and using exogenous promoters. In this project, we tested the efficacy of a HIER strategy (Fig. 1) to correct mutations in USH2A, a significantly large gene of 15.6 kb, with the goal of developing a therapeutic approach to rescue or slow down retinal phenotypes in USH2A patients. This approach could eventually be applied to other inherited diseases caused by mutations in large genes. Our findings demonstrated that the HIER strategy can replace mutant DNA fragments with a wild-type template and that the INDEL rate at the two ends of the replaced DNA template is acceptable when in introns. However, further improvements to the HIER strategy are necessary to increase gene editing efficacy for its potential translational application.
Hilary Coon	Professor	Psychiatry	Community Consultation on Research Use of Autopsy Blood Spots in Utah	Articulate practical guidelines and develop a template for community-informed engagement and design of a research study	This project will develop guidelines for conducting community-informed research. As a model for this development, we will explore and implement aspects of community perceptions and opinions regarding research uses of an archived resource of ~30,000 blood spots from decedents obtained from the Utah State Office of the Medical Examiner. Preliminary linking to longitudinal medical records data indicates the presence of many diagnoses among decedents in this resource, suggesting feasibility of genetic discovery across multiple areas of medical research. This study will explore optimal ways to conduct research using this resource through input from community leaders. Issues to be addressed will include risk perceptions, sample/data access, research design, limitations on sample use, and appropriate communication of results to community members. Community leaders will also help guide the development and editing of an initial proposal using the research resource that will include community-informed hypotheses, study design aspects, and return of results methods. Finally, our process of community engagement and community-informed proposal design will allow us to create more general guidelines for the implementation of community-based research. These guidelines will be disseminated, and will serve as a practical guide for designing future community-informed research studies.
Anne Thackeray	Assistant Professor	Physical Therapy/Athletic Training	Establishing a Functional Performance Index	Establishment of a common metric for functional performance – the functional performance index (FPI)	Functional performance (e.g., walking speed, ability to climb stairs, get in and out of a chair) is paramount for social participation, irrespective of health conditions. Self-reported measures of function are important measures that provide insight into an individual’s perception of function but are often confounded by pain and self-efficacy. Functional performance provides diagnostic and prognostic information beyond the patient’s perceptions and supports our understanding of the mechanisms associated with changes in function. The significant number of functional performance measures makes it challenging to compare studies and populations. Establishing a single functional performance index to which functional performance measures can be mapped would significantly improve the translation of research across populations and settings. We used secondary data to establish a functional performance index (FPI) as a proof of concept. We then examined FPI over time alongside patient-reported measures to determine the added value of the FPI. Mapping functional performance tests to a single measurement scale is feasible but requires further development of items and item discrimination. Functional performance changes over time are distinct from self-reported physical function and precede changes in self-reported function.
Louis R. Barrows & Philip J. Moos	Professor's	Pharmacology & Toxicology	Application of single cell RNA sequencing to infectious diseases	Apply scRNA sequencing to patients suffering Mtb and HIV infecton; with this proof of concept we are ready to tackle the truly central interactions that govern viral or bacterial control. Our discovery that bacterial pathogens are also detectable using this approach generalizes our work to other intracellular viral and bacterial infections.	People infected with HIV-1 (HIV)and Mycobacterium tuberculosis (Mtb) have up to 20 times higher risk of developing active tuberculosis (TB) than people without co-infection. TB is the global leading cause of death in HIV infected individuals, killing approximately 214,000 in 2020. We successfully employed a single cell RNA sequencing (scRNA-seq) approach to describe the cells and the communication networks characterizing granulomatous lymph nodes of TB patients by analyzing fine needle aspirates obtained from referred TB patients with enlarged peripheral lymph nodes. When mapping cells from individual patient samples, clustered based on their transcriptome similarities, we uniformly identify several cell types known to characterize human and non-human primate granulomas. We find the T cell cluster to be one of the most abundant. Many cells expressing T cell markers are clearly quantifiable within this CD3 expressing cluster. Other cell clusters that are uniformly detected, but that varied dramatically in abundance amongst the individual patient samples are the B cell, plasma cell, Natural Killer (NK) and macrophage/dendritic cell clusters. When we combine all our scRNA-seq data from our current 23 patients (in order to add power to cell cluster identification in patient samples with fewer cells), we distinguish T, macrophage, dendritic cell and plasma cell subclusters, each with distinct signaling activities. The sizes of these subclusters also varies amongst the individual patients. We will test whether the signaling pathways characterizing the cell type subclusters varies with HIV co-infection as compared to HIV uninfected Mtb granulomas. We discovered that the scRNA-seq pipeline, designed for quantification of human cell mRNA, detects HIV and Mtb RNA transcripts and associates them with their host cell’s transcriptome, thus identifying individual infected cells. Three patients from our cohort of patients accessed at a TB clinic, were serendipitously found to be HIV positive, with both T cells and macrophages infected. For this study, known HIV coinfected patients will be studied in parallel with Mtb infected patients. As for Mtb infected cells, we hypothesize that the number of detected bacterial transcript reads provides a measure of Mtb burden, as does the number of Mtb-infected cells. Our initial analysis suggests that human nodal granulomas mightstratify into high and low Mtb burden groups. By describing the granuloma cellular composition, the intracellular communication pathways within the granuloma and the impact of HIV-infection on these systems, and integrating this understanding with quantification of circulating virus, CD4 and inflammatory markers, we can demonstrate the translational power of this new approach.
Sihem Boudina	Professor	Nutrition and Integrative Physiology	Validate the therapeutic potential for BMPER in improving vascular remodeling in arteriovenous fistula (AVF) maturation	People with end stage kidney disease need to undergo dialysis which requires the establishment of an arteryveinous access. Unfortunately, more than half of these patients face a problem with this access as it does not mature appropriately and will require another access. The factors that mediate the maturation of the arteriovenous access are not understood and we propose to study a new factor called BMPER to see if it is involved in the maturation of these vessels.	Hemodialysis vascular access failure is the primary cause of morbidity in patients with end-stage kidney disease. Vascular access complications account for nearly 30% of the hospitalization of hemodialysis patients in the United States. A major cause for AVF failure is the development of neointimal thickening at the venous anastomosis. The native arteriovenous fistula (AVF) is the preferred form of dialysis access but is associated with a high early failure rate. Indeed, up to 60% of AVFs do not mature and of the remainder that do mature, 35% fail after 2 years of their creation. Therefore, the identification of novel factors that can enhance AVF maturation is of unmet need. BMP binding endothelial regulator or BMPER. BMPER has recently emerged as a bona-fide marker of several stem/progenitor cells in different tissues including the vasculature, adipose tissue and liver and BMPER+ cells are detected in the adventitia of arteries. The goal of this proposal is to validate BMPER as a therapeutic target for the treatment of maturation failure. In this initial seed proposal, we plan to (1) define the contribution of BMPER+ stem cells to adventitial progenitors and (2) examine the role of BMPER in vascular remodeling post-AVF creation.
Yizhe Xu			An Efficient, high-Quality, Unbiased, Interpretable Pipeline for Overcoming Barriers in the Translational Research using Real-World Data	This project will deliver a unified, generalizable solution, EQUIP, that leverages the TTE framework and advanced causal inference methods to address critical barriers in observational studies. By providing three comprehensive research schemas and public deployment tools, EQUIP will enhance the rigorous and efficiency of translational research, ultimately driving advancements in human health.	Randomized controlled trials (RCTs) are the gold standard for evaluating medical interventions, but they are often impractical, slow, or costly. Modern causal inference methods, coupled with real-world data (RWD), provide a faster, well-powered alternative for estimating treatment effects across various patient populations. Despite this potential, several barriers hinder their effective use in translational research. A key challenge is aligning "time zero," the point at which a patient cohort is defined, eligibility, and treatment assignment, which leads to intractable bias. Other barriers include biases induced from data preprocessing, confounding, or strong modeling assumptions. Target trial emulation (TTE) is a major innovation that addresses these barriers by emulating RCT protocols using RWD. The TTE framework has proven especially useful in fostering improved communication between statisticians and clinicians to align sound study design, incisive data analysis and clinical insight to improve the quality of research. Currently, the Translational Research: Implementation, Analysis, & Design (TRIAD) team supports multiple research groups in evaluation of causal inferences using RWD, but the work is piecemeal and we must frequently “reinvent the wheel”. In addition, resource constraints often prevent us from using the most effective methods. Our proposal aims to develop innovative solutions to overcome these barriers using TTE and rigorous causal inference methods as the foundation, systematizing and expanding the workflow to enhance the efficiency, quality, and impact of the translational research process. The specific aims are to build on TRIAD’s ongoing work on causal inference and TTE to stand up the Efficient, high-Quality, Unbiased, Interpretable Pipeline (EQUIP) and develop a research tool for unbiased and robust estimation of average causal effects (Aim 1). To support precision medicine, we will expand EQUIP by developing two additional research tools for estimating heterogeneous treatment effects and optimal dynamic treatment regimens (Aim 2). We will also create a public, user-friendly code hub to provide off-the-shelf implementations for the three research schemas in EQUIP (Aim 3). By providing three comprehensive, scalable, and reproducible research tools, EQUIP will empower clinicians and researchers across multiple disciplines and institutions to conduct high-quality observational studies, bridging the gap between methodology and broader applications. We will collaborate with TRIAD’s survey design core to continuously collect user feedback via surveys on the clarity, usability, and reproducibility of these tools and improve them accordingly. EQUIP will be a unified, generalized solution to streamline workflow in observational studies, enable us to answer relevant and rigorous research questions, and facilitate external collaborations.
Molly Conroy			PASO A PASO: Tailored Diabetes Prevention Program for Spanish-Speaking Communities Feasibility Study	Using the RE-AIM Framework, this project will assess the adapted program's impact on participant health and program effectiveness.	Hispanic/Latino (H/L) Americans face nearly double the risk of Type 2 Diabetes (T2D) compared to non-Hispanic Whites, with one in three having pre-diabetes. The National Diabetes Prevention Program (NDPP) has been less effective for H/L participants due to differences in program alignment with community needs. To address this, our collaborative research partnership has adapted the NDPP to better serve Spanish-speaking H/L residents in Salt Lake City. This project will finalize the "Paso a Paso" intervention, train instructors, and test its feasibility with 30 participants. Using the RE-AIM Framework, we will evaluate its impact on participant health and program implementation to guide future sustainability and reduce T2D disparities in H/L communities.

Year of Award	Investigators	Investigator Departments	Project Titles
2022	M. Mateo Paz Soldan, MD, PhD	Neurology	Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis
2022	Guillaume Horeau, PhD, DVM	Emergency Medicine	Validation of a novel noninvasive monitor of renal hypoxia in a pig model of hemorrhagic shock
2022	Jungkyu (Jay) Kim, PhD	Mechanical Engineering	A Biomimetic Cornea Chip for studying Fuchs' dystrophy
2022	Kevin Watt, MD, PhD	Pediatrics	Optimizing Drug Exposure in Patients Supported with Extracorporeal Membrane Oxygenation
2022	Yue Zhang, PhD	Internal Medicine	Biomechanical Data Analysis using Statistical Parametric Mapping Approach in the Presence of Nested Observations
2021	Rebecca Simmons, PhD, MPH	OB/GYN	Understanding barriers and facilitators of implementing the LNG IUD as emergency contraception in varied clinical settings: a pilot study
2021	Tuan Pham, MD	Internal Medicine	Inflammation in Fatty Liver Disease
2021	Anna Ibele, MD	Surgery	Loss to Follow Up after Bariatric Surgery: Contributors and Consequences
2021	Sunjin Park, PhD	Neurobiology & Anatomy	A single-step assay determining the role of disease-associated genes in neuronal activity
2021	Hediyeh Baradaran, MD	Radiology & Imaging Services	MRI Evaluation of Vascular Aging and Vulnerable Plaque
2020	Alexander Pastuszak, MD, PhD	Surgery	Genetic Basis of Peyronie's and Dupuytren's Diseases
2020	Joseph Kim, PhD	Psychiatry	Affect Control Functions of the Prefrontal Cortex
2020	Vikas Sharma, MD	Surgery	Human Amniotic Membrane as Pericardial Substitute in Cardiac Surgery Patients
2020	Sihem Boudina, PhD	Nutrition & Integrative Physiology	Establishing the Function of a Novel Human Genetic Mutation in PRDM16 using Patient-Derived iPSC-CMs and In Vivo Model Systems
2020	Mary Playdon, PhD, MPH, MPhil	Nutrition & Integrative Physiology	Feasibility and Acceptability of Time Restricted Feeding (TRF) among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer