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CCTSI Highlights 2023

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The vision of the CCTSI is to accelerate and catalyze thetranslation of innovative science into improved, equitablehealth and patient care for all.2023 HighlightsAdvancing Translational Science and Patient Care

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CU AnschutzMedical CampusUniversity ofColorado DenverNational JewishHealthUniversity ofColorado BoulderUniversity ofColorado HospitalDenver HealthThe Partnering Institutions of the CCTSIColorado StateUniversityChildren’sHospital ColoradoVA EasternColorado HealthCare System

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TABLE OFCONTENTS2 Focus on Long COVID4 Clinical Translational Research Centers (CTRCs)6 Funding Success7 Pilot Grant Update 8 CU - CSU Summit 9 National COVID Cohort Collaborative 10 Colorado Community Engagement Alliance Against Health Disparities (CO-CEAL)11 iHeard Colorado12 Awards & Honors 14 CCTSI in the News 15 Social Media 16 Workforce Development17 In Brief This report includes highlights of 2023 CCTSI activities that supported the researchenterprise on the Anschutz Medical Campus and our partner institutions, translatingresearch into life-changing treatments and care. 1 Prepared by CCTSI Marketing and Communications

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FOCUS on Lieutenant Governor of ColoradoDianne PrimaveraLong COVIDIn 2023, CCTSI researchers and clinicians caught the attention of federaland state elected officials and policymakers on the topic of Long COVID. Up to half a million Coloradans continue to experience long-termsymptoms after COVID-19. To address this issue, a group of healthcare providers, researchers and patient advocates came togetherfor a roundtable discussion on long COVID care on November 29,2023 with the Lieutenant Governor of Colorado Dianne Primavera.Her visit to the CU Anschutz Medical Campus started at the PostCOVID Multidisciplinary Clinic at UCHealth. The group also took amoment to celebrate a new grant that will be led by Sarah Jolley,MD, associate professor of pulmonary medicine in the CU School ofMedicine (SOM), and Donald Nease, MD, SOM professor of familymedicine and Director of Community Engagement and HealthEquity at the Colorado Clinical and Translational Sciences Institute.Read more here.2

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FOCUS on Long COVIDAdmiral Rachel Levine, MDAdmiral Rachel Levine, MD, who is leading the federalgovernment’s response to long COVID and working closelywith the National Institutes of Health on Researching COVID toEnhance Recovery (RECOVER) Initiative, met with CUAnschutz leaders, researchers, clinicians and patients during acampus visit on July 11, 2023. CCTSI research and clinicalleaders Kristine Erlandson, MD, and Sarah Jolley, MD, playedprominent roles, sharing information on Long COVID researchand patient care. Read more here.Pictured from left are CU Anschutz Chancellor Don Elliman; CU President ToddSaliman; Admiral Rachel Levine, MD, U.S. assistant secretary for health at theDepartment of Health and Human Services; and John J. Reilly, Jr., MD, dean ofthe CU School of Medicine and vice chancellor of health affairs. 3

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Clinical Translational ResearchCenters (CTRCs)At the CCTSI, we are focused on the unique needs of clinical and translationalinvestigators and their teams. Through our four CTRCs, we provide dedicated,research-only space and support for hundreds of clinical research studies andclinical trials. Our mission is disease agnostic, and we conduct manymechanistic studies in the CTRCs, including those with healthy controls. Take a moment to watch our new video that highlights our CTRCs.Adult CU Anschutz CTRC in 2023:156 PIs conducted their studies in theadult CTRC at UCHeath and in theAnschutz Health Sciences Building324 protocols took place in the adultCTRCParticipants completed 10,116 studyvisits Participants completed an additional4,089 exercise visitsPediatric CTRC in 2023:90 PIs conducted their studiesin the pediatric CTRC at CHCO186 protocols took place in thepediatric CTRC Participants completed 3,884study visits (inpatient,outpatient and mobile) in thepediatric CTRC4

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From Latin Americato Colorado Clinical TranslationalResearch Centers(CTRCs)Physicians involved in the Human Trisome Project Latin America Network visitedColorado and the adult Clinical Translational Research Center (CTRC) in November2023. This group of eleven researchers and physicians traveled from Mexico,Colombia, Venezuela, Brazil, Bolivia, Chile and Argentina to CU Anschutz MedicalCampus, including the facilities of the Crnic Institute, the Anna and John J. Sie Centerfor Down Syndrome at Children’s Hospital Colorado, and the adult CTRC where theCrnic Institute conducts its clinical research. There, they received training on multipleaspects of the Crnic Institute Human Trisome Project research protocol, from obtainingconsent from research participants to processing blood samples and cloud-based dataanalysis.5

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6The CCTSI has been re-funded by NCATS/NIH for the fourth time! We obtained a $54 millionUM1 grant, which will extend for seven years. Longtime CCTSI Operations Director JanineHiggins, PhD, and CCTSI Director Ron Sokol, MD, will lead the CCTSI as Multiple PIs. Formore details, you may read our official grant announcement.Our T32 training grant awards are funded for five years at more than $3.6 million.We are now funded for both a pre-doctoral T32 and a post-doctoral T32 grant,(replacing our TL1 award). Kudos to Lisa Cicutto, PhD, APN, RN, on her fantasticwork as PI to secure this funding and oversee these two essential programs for ourcampus and partnering institutions.The K12 research scholar award (replacing our KL2 program) has been funded at$5.4 million over a 5-year period. Congratulations to Ellen Burnham, MD, PI on thissuccessful renewal. We are thrilled that Dr. Burnham will continue to direct thisfoundational work for launching careers of early-stage investigators.In 2023, the last year of our TL1 and KL2 grants, the CCTSI supported:6 research scholars2 Children’s Hospital Colorado research scholars8 pre-doctoral trainees; 3 post-doctoral traineesFUNDING SUCCESS Looking forward, the crucial support from the NIH will help us tackle new emphases in theUM1 grant, including increasing efficiency and reach, addressing health equity anddisparities, and maintaining deep partnerships with UCHealth University of ColoradoHospital, Children’s Hospital Colorado, National Jewish Health, Denver Health and HospitalAuthority, the Rocky Mountain Veterans Affairs Medical Center, CU Anschutz, CU Boulder,CU Denver and Colorado State University.

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Pilot Grant UpdateEach year, the CCTSI awards nearly $3 million in pilot grants and trainingawards. Since our launch in 2008, we have funded 502 projects, spanningthe spectrum of basic science to clinical trials and community-based research. In 2023, CCTSI awarded grants to 23 different pilot projects. Investigatorsfrom Colorado State University, CU Boulder, CU Anschutz, CU Denver,Children's Hospital Colorado, Denver Health and UCHealth University ofColorado Hospital were all awardees.For every $1 invested inCCTSI pilot grants, there isa return on investment(ROI) of $17 in follow-onextramural funding.*Impressive Return on Investment (ROI)*This data is from 2009 - 20227

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In August, the CCTSI hosted its 11th annual CU-CSU Summit on thetopic of Dissemination and Implementation (D&I) Science and Research.The conference was held at the new CSU Spur campus in Denver andattracted more than 100 highly engaged faculty, post docs and studentswho had an interest in learning more about D&I science and how tointegrate it into their research. You can read our story about the Summithere and find the agenda and presentations from the day here.I-CORPS@CCTSIScientists who want to learn how to translate their biomedical discovery or healthinnovation into a viable commercial product can participate in I-Corps@CCTSI. Theshort-course guides teams through the early stages of customer discovery where theycan test the business model hypotheses for their technology or idea. I-Corps is proudto work in partnership with CU Innovations and the Children’s Hospital ColoradoCenter for Innovation.Since the fall of 2016: I-Corps@CCTSI has trained 86 teams(256 participants) Teams have conducted 2,001 customerdiscovery interviews 31% of teams have successfullycompeted for Seed Grant fundingCU - CSU SummitEnhancing the Impact of Clinical and TranslationalResearch Through Dissemination and ImplementationScience8

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9The past year has been a testament to collaborative team science and realizing accessiblereal-world data that defines the National Cohort COVID Collaborative (N3C). The N3Ccommunity has made terrific progress in planning for the future. During 2023, the N3C community grew to 4,953 (+1,597 new) registered users from369 institutions. N3C has over 29 billion rows of data and 234 sites contributing data.N3C is expanding beyond COVID and has launched a pilot project to evaluate thefeasibility of conducting non-COVID research using the existing secure N3C Enclaveinfrastructure. Three medical conditions were part of a pilot to determine if theinfrastructure could be expanded for use beyond COVID: Alzheimer's, renal, andpulmonary diseases. The purpose of the pilot, which was called Tenant, was to provideresearchers with a secure computing platform to conduct analysis to address local andnational questions and to advance scalable research.The Tenant pilot looking at all three medical conditions was successful. All 10 data -contributing sites completed the IRB processes, 9 of the 10 successfully submitteddata, and 11 sites successfully participated in the clinical projects. CCTSI DirectorRonald Sokol, MD, and Sara Deakyne Davies, MPH, from CU Anschutz and Children'sHospital Colorado were members of the Tenant Governance committee.National COVID Cohort COLLABORATIVE (N3C)

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ColoradoCommunityEngagementAllianceAgainst HealthDisparities(CO-CEAL)In 2023, the Colorado Community EngagementAlliance Against Health Disparities (CO-CEAL)wrapped up its work in five Coloradocommunities, providing accurate, science-basedinformation on COVID-19 treatments andvaccines. The five Colorado communities were:urban and rural Latino/a/x, urban Black/AfricanAmerican, rural African immigrant, and urbanAmerican Indian/Alaska Native (AI/AN)communities.During 2023, Alliance members participated in aspecial publication in the American Public HealthAssociation Journal and authored, “RapidCommunity Translation in the Colorado CEAL(CO-CEAL) Program: Transcreating Messaging toPromote COVID-19 Vaccination.” The publicationwas released in January 2024.In its third year of funding, CO-CEAL movedbeyond COVID-19 to address health disparitiesaround other chronic conditions experienced byparticipating communities.10

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The iHeard Colorado interactivedashboard is updated weekly withthe survey data, reflecting whatpeople are hearing—and providingtimely, scientifically vettedinformation in response. iHeard ColoradoThis innovative program, launched in June 2023, gathers information on healthtopics Coloradans are talking about in real time, and then provides them withtrusted and clear information. Each week, over 130 residents from 3 distinctColorado communities answer a brief survey on their phone, asking what theyhave heard, seen or read about COVID-19 and other health-related information inthe last seven days. Weekly response rates have ranged from 90-100%. Community Engagement and Health Equity 11

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AWARDS & HONORSTeri Hernandez, PhD, RNDirector of Early Life Exposures Research ProgramIn 2023, the American Academy of Nursing inducted TeriHernandez, PhD, RN, into its 2023 Class of New Fellows. Weare particularly proud of her accomplishments as a homegrownresearcher and leader: 20 years ago, Dr. Hernandez was aresearch nurse in the adult CTRC. Today, Dr. Hernandez leadsthe CCTSI’s Early Life Exposures Program, is Associate Deanof Research and Scholarship in the CU College of Nursing andis a national leader in life course research. Congratulations Teri! Cathy Bodine, PhDDirector of Innovation Ecosystem Congratulations are also in order for Cathy Bodine, PhD, forreceiving the 2023 Faculty Excellence Award from CU Denver,acknowledging her outstanding performance in the category ofExcellence in Leadership and Service. Dr. Bodine leads theCCTSI’s Innovation Ecosystem, which features the short courseI-Corps@CCTSI. She is also Professor of Engineering, Designand Computing at CU Denver. She says, “The favorite part ofmy work is helping to create the next generation ofbioengineers. Today’s students are compassionate, incrediblycommitted to improving the world, and they are focused on howthey can contribute.” Well done, Dr. Bodine! Donald Nease, MDDirector of Community Engagement and Health Equity The Colorado Trust appointed Donald Nease as Trustee in2023. Dr. Nease is Professor of Family Medicine and Directorof Community Engagement and Health Equity for the CCTSI.Dr. Nease focuses on partnerships at the community level tomove the needle on health outcomes in the state. His vastexperience with population-based health initiatives will beessential to The Colorado Trust’s work to advance the healthand well-being of all Coloradans.12

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From 2019 - 2023, the CCTSI operated with support of grants UL1 TR002535, KL2 TR002535 and TL1 TR002533 from NCATS/NIH.Over the course of the five-year period, the CCTSI was cited in academicpapers 1,101 times In 2023, the CCTSI was cited 274 timesNicole Carlson, PhDDirector of Biostatistics, Epidemiology and ResearchDesign (BERD)In 2023, the American Statistical Association (ASA) electedNicole Carlson, PhD, as a Fellow. This prestigious status is onlygiven to three percent of the current ASA membership at anypoint in time. Dr. Carlson is a longtime leader of CCTSI’s BERDprogram and a professor in the Department of Biostatistics andInformatics. ASA recognized Dr. Carlson for her contributions toBayesian statistics and spatial and time series data analysis,team science, and training and mentoring of students. CCTSI staff members who support the Clinical TranslationalResearch Centers (our clinical research units) emergedtriumphant in the CU Innovation and Efficiency awards! Theaward recognizes initiatives developed to improve operations,enhance cost savings and improve customer service. Congratulations to Christopher Caldwell, Archana Mande, JanineHiggins, Thomas Yaeger, Jennifer Cathcart, Diane Branham andMelanie Tsosie who developed the new electronic visit statusdashboard to manage and coordinate research visits andimprove team collaboration at our CTRC. Their award brings positive attention to our institute across theCU System and confirms what we already knew—they are aninnovative and talented team!CCTSI Citations13

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CCTSI IN THE Five questions for Ron Sokol andJanine HigginsNEWSCU Connections featured leaders of theCCTSI on how its $54 million grant willhelp power innovation, health equity. CU Boulder center supports humanbiomedical researchThe Daily Camera featured Holden Hemingway,of the CU Boulder Clinical TranslationalResearch Center (CTRC), and his passive heattherapy research on cardiovascular health. National Institutes of Health awards$54 million to CU AnschutzThe Denver Gazette highlighted theannouncement of our grant that will spread overseven years, helping boost research efforts. A 15-year, multicenter study (TODAY 2) haschanged the course of care for youth with type 2diabetes, enhancing treatments for this growingpopulation. Type 2 Youth Diabetes Study ChangesStandard of Care Worldwide14

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Social MediaThe CCTSI consistently leverages “X” (formerly Twitter) and LinkedIn as channels todisseminate information regarding funding opportunities, news updates, training andresources. When comparing the CCTSI to the other 60+ CTSA hubs on “X”, theCCTSI ranks in the top 5 in terms of number of followers and activity. In 2023, CCTSI sought to raise awareness of the CTRCs among PIs and researchstaff. This promotional campaign featured engaging videos and graphics toeffectively highlight and promote the CTRCs. Watch Video!15

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WORKFORCEDEVELOPMENTT R A I N I N G T H ER E S E A R C H L E A D E R SO F T H E F U T U R E162023 Participants82Clinical Science Graduate Program54CO-Mentor31Pre K Grant Review18K to R Transition Program12K12 Scholars10T32 Pre- and Post-Doctoral Train ees207*207 individuals joined this community, whichincludes trainings and coursesClinical Research Professionals*

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In Brief: 2023Colorado PROFILES102,600 users238,100 pageviewsREDCap6,356 active users20,000 total projectsI-Corps@CCTSI31% of teams successfullycompeted for seed grantfunding after the courseCommunicating YourScience to the Public98 participants trainedResearch Studio9 Studio sessions11 participatingresearch experts Resources & ProgramsCommunityEngagement andHealth Equity Forum4 sessions203 attendees17

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CONTACT UScctsi.cuanschutz.edu303-724-1222 1890 N. Revere Ct. Campus Box B141 Aurora, CO 80045