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North Carolina TraCS Institute

North Carolina TraCS Institute. Wednesday, February 4, 2009 presented by The NC TraCS Institute. NIH CTSA Mission Statement.

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North Carolina TraCS Institute

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  1. North Carolina TraCS Institute Wednesday, February 4, 2009 presented by The NC TraCS Institute

  2. NIH CTSA Mission Statement The Goal of the Clinical and Translational Science Award (CTSA) program is to transform the local, regional and national environment for clinical and translational science, thereby increasing the efficiency, quality and speed of clinical and translational research

  3. National CTSA Goals • To improve how biomedical research is conducted across the country • To reduce the time it takes for laboratory discoveries to become treatments for patients • To engage communities in clinical research efforts • To train the next generation of clinical and translational researchers

  4. CTSA Network 2008 (38) 38 CTSAs in place, will grow to 60 by 2010

  5. UNC PI VISION “TRANSFORMATION” To transform all activities relating to clinical and translational research by creating new programs and pathways that make it easier for research to be performed at UNC and throughout the State of North Carolina

  6. TraCS Institute Overreaching Goals • Enable teams of interdisciplinary researchers to create, innovate, and translate discoveries into advancements in the health of both individual patients (T1) and populations (T2) • Develop innovative programs for education, training and career development • Participate in targeted faculty recruitment • Provide $4.3 million per year in pilot project funding with a particular focus on building new interdisciplinary research teams, supporting the efforts of junior faculty members, spreading new technologies to the community through outreach and commercialization • Collaborate with and increase partnership activities across the State

  7. Schematic for Type II Translational Research

  8. TraCS Continuous Cycle of Activity Continuous Cycle Discovery Clinical Practice Disseminated to Community Improved Health Community benefits from best practices and helps establish research agenda

  9. Governance Erskine Bowles, President Holden Thorp, Chancellor William Roper, VC Medical Affairs External Advisory Board Internal Advisory Board Etta Pisano, CTSA PI Director Community Advisory Board Steering Committee PI Extenders: Richard Boucher, Translational Research John Buse, Clinical Research Tim Carey, Population Sciences William Marzluff, Basic Research Rosemary Simpson, Chief Operating Officer Translational Research Advisory Board Deputy Directors: Giselle Corbie-Smith, Community Michael Fried, Clinical Science ..José-Marie Griffiths, Informatics Rudolph Juliano, Basic Science ..Lisa LaVange, Analytics Eugene Orringer, Education David Peden, Child Health TraCS Study Section Core Directors: Janee Smith, Evaluation Giselle Corbie-Smith, Community Engagement Michael Fried, Participant Clinical Interaction Resources José-Marie Griffiths, Bioinformatics Gail Henderson, Ethics Rudolph Juliano, Novel Methodology Michael Kosorok, Biostatistics Cathy Melvin, Community Translation Eugene Orringer, Education William Marzluff, Translational Technology David Peden, Child Health David Weber, Regulatory TBN, Communication Etta Pisano, Strategic Opportunities

  10. North Carolina TraCS Institute Community Clinical Bench Faculty & Ideas North Carolina TraCS Institute

  11. North Carolina TraCS InstituteServices and Resources Providing the infrastructure to increase the safety, speed, and rigor of patient-oriented research NC TraCS Central Desk Research Navigators Biomedical Informatics Bionutrition Biostatistics Clinical and Community Research Ethics Community Engagement Personalized Medicine Consultation Clinical Data Mgmt Commercialization Regulatory Carolina Data Warehouse-Health Core Facilities and Translational Technologies Pilot Program Biobanking Education Laboratory Assay Development Clinical and Translational Research Center (CTRC) Clinical Dental and Inflammation Research Grant Proposal Assistance

  12. North Carolina TraCS Institute TraCS Institute Ideas Heading to Dissemination to North Carolina Ideas Heading to External Funding Ideas Heading to Commercialization

  13. North Carolina TraCS Institute TraCS Institute Ideas Heading to Dissemination to North Carolina Ideas Heading to External Funding Ideas Heading to Commercialization Study Section And Pilot Project Program

  14. Pilot Projects TraCS Match $2K $ 100,000 $ - $10K 200,000 - Core Technology 200,000 200,000 Commercialization $ 200,000 200,000 Large Pilot 1,600,000 1,600,000 TOTAL $ 2,300,000 $ 2,000,000 North Carolina TraCS Institute

  15. TraCS Pilot Program • TraC$2K $100,000 (no match) • 1st cycle deadline 11/21/08 • Over 40 received, 16 funded • 2nd cycle deadline 2/16/09 • TraC$10K $200,000 (no match) • 1st cycle due date 12/5/08 • 55 received, still under review • 2nd cycle deadline 3/4/09 • TraCS Large Pilots $1.8 million plus match • 1st cycle due date 1/9/09 • 64 received • 2nd cycle - June

  16. Role of external partners in pilot programs • Investigator at external partner has an idea, contacts colleague at UNC as a collaborator. • Product is grant submission, UNC may be either prime or sub, but should be involved. • Investigator at UNC has an idea, contacts colleague at external partner as a collaborator • Product is grant submission, UNC may be either prime or sub, but should be involved. • Investigator at UNC collaborates with partner around issues of data collection, information gathering, priority setting, specimen collection, dissemination.

  17. North Carolina TraCS Institute TraCS Institute Ideas Heading to Dissemination to North Carolina Ideas Heading to External Funding Ideas Heading to Commercialization Community Engagement And Dissemination Cores

  18. North Carolina TraCS Institute TraCS Institute Ideas Heading to Dissemination to North Carolina Ideas Heading to External Funding Ideas Heading to Commercialization North Carolina Center for Biotechnology Innovation Translation

  19. North Carolina Center for Biomedical Innovation Translation (NC-CBIT) NC-CBIT Office of Technology Transfer Bioentrepreneurial Board Spinoff Companies

  20. North Carolina TraCS Institute

  21. North Carolina TraCS Institute Pilot Projects Community External Funding Additional Pilot Funding Commercialization

  22. Strategic Planning Major Projects – Year One Clinical Data Management/Biostatistics Lisa LaVange • Clinical Data Management Initiatives • Data Management Service • TraCS Clinical Research Data Management System (TCR-DMS) • Flexible and mobile data collection tools • Biostatistics services • Statistical Methods Development

  23. Strategic Planning Major Projects – Year One Biomedical Informatics Core José-Marie Griffiths • Biomedical Informatics Initiatives • Carolina Data Warehouse for Health (CDW-H) • Research Portal • Interdisciplinary Master's degree program in Health Informatics

  24. Strategic Planning Major Projects – Year One Community Engagement Core Giselle Corbie-Smith • Community Initiatives • Community Connection Portal & Webmap • Listening sessions • Greensboro AHEC • Practice based research network • Dissemination – statewide network

  25. External Partners • Community-based organizations • HBCU’s • Other members of the UNC system • ECU, NCSU, NCCU • Practice-Based Research Networks (PBRN’s) • AHEC clinical research units (new!) • State of NC agencies

  26. Champions

  27. Community Engagement Core Giselle Corbie-Smith, MD, MSc Deputy Director of the TraCS InstituteDirector of the CECMalika Roman-Isler, PhD Deputy Director of the CEC • CEC Purpose: Create permanent research structures-community research units (CRUs)-local community boards, single connection portal and core resources with stable research staff so that population research dictated by community needs can proceed rapidly and successfully. • Guiding Principles • Two-way Exchange – bi-directional between university and community • Participatory Approaches – co-learning , shared decision making, mutual ownership of products and processes • Education and Training – specific capacity building for all partners – community, investigators and health care providers

  28. Connection Portal • What’s in a name? Suggestions Welcomed • Two components to the Portal • Person-to-Person • Web-based System • Links to UNC research navigators • Networking-use statewide infrastructure of AHEC-CRUs, SPEED, • CBPR projects-to build person-to-person structure. • Biomedical Informatics Core –build and link electronic data bases and web-system to support the connection portal and other CTSA function and activities.

  29. NC TraCS Institute Champions Activities: NC State-wide Infrastructure Community Engagement Core Research Management S. Cykert TraCS/ECHO CRUs P. Godley PBRNs P. Sloane Program Manager – TraCS/ECHO Greensboro CRU Wake CRU Area L CRU Clinical Community Community Community Clinical Clinical ECHO-Ethnicity, Culture & Health Outcomes, PBRN-Practice-based Rsh Networks, CRU-Community Rsh Unit

  30. Clinical and Community Translation Core Cathy L. Melvin, PhD, MPH – Director Catherine Rohweder, DrPH – Director, NC SPEED • Goal: Assure that more proven strategies to improve health and health care reach more people, in more places, in less time. • Guiding Principles • Build the science base for dissemination and implementation research • Enhance system capacity to conduct translational and community-based research • Create demand among communities, providers and researchers for translational research and dissemination of evidence-based interventions

  31. Transformative Elements • Create, biannually, a priority list of dissemination and implementation research and practice areas for the TraCS Institute. • Guarantee access to experts who can support interdisciplinary teams as they prepare proposals for pilot projects by ensuring their use of appropriate models and preliminary data and their consideration of health policy issues relevant to their proposal. • Provide unique services to facilitate, design and execute funded projects focused on dissemination and implementation research or practice. • Hold statewide and regional academies of evidence to share priorities and activities with community stakeholders.

  32. Transformative Elements • Establish a statewide network of research associates based in communities to assist TraCS investigators in planning and conducting their dissemination and implementation projects • NC SPEED: Statewide Push for Excellence, Engagement and Delivery • Develop a report card to assess the impact of all TraCS dissemination and implementation projects.

  33. Strategic Planning Major Projects – Year One Clinical Science Core (former GCRC) Michael Fried • Clinical Research Initiatives • GCRC/CCCT merger • Improve process and user- friendliness • Establish on-campus mobile unit • Increase clinical trials and subject recruitment at UNC • Greensboro Community Research Unit

  34. Strategic Planning Major Projects – Year One Education Core Eugene Orringer • Education, Training and Career Development Initiatives • Trainee Programs - TL1, KL2, K30, Howard Hughes Med-into-Grad, Doris Duke, Birch • K trainees to R01 grants Program • Masters of Science in Clinical Research, enrolling 2009

  35. Strategic Planning Major Projects – Year One Novel Methodologies Core Rudy Juliano • Novel Methodology Initiatives • Develop faculty profiling and resources database to enable team collaboration and sharing of resources • Biobanking Service • Diagnostic Test Development Service • Personalized Medicine Consultation Service

  36. Strategic Planning Major Projects – Year One Child Health Core David Peden • Child Health Initiatives • Establish a child health unit in the CTRC • Increase child health clinical trials and subject registry at UNC • Develop a state-wide registry of children with chronic disease

  37. Challenges • Break down research silos • Increase collaborations across schools, other universities and the community • Find ways to partner with UNC Hospitals and other sites to increase research within clinical settings • Reduce administrative burdens for Investigators - streamline and shorten processes

  38. CTSA Supplements • CTSA Institutions will be eligible to apply for supplemental funding from the NIH and Partners to further specific goals of the CTSA program • Individual researchers will be eligible to apply for funding such as R01s which require that they be affiliated with a CTSA Institution

  39. To contact the NC TraCS Institute Website www.tracs.unc.edu Telephone 919-966-6022 Email address nctracs@unc.edu

  40. Questions? Comments? Etta D. Pisano, MD etpisano@med.unc.edu 919-966-6932

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