North Carolina TraCS Institute

North Carolina TraCS InstituteNorth Carolina TraCS Institute

Wednesday, February 4, 2009

presented by

The NC TraCS Institute

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NIH CTSA Mission StatementNIH 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

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National CTSA GoalsNational 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

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CTSA Network 2008 (38)

38 CTSAs in place, will grow to 60 by 2010

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UNC PI VISIONUNC 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

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TraCS Institute Overreaching GoalsTraCS 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

Schematic for Type II Translational Schematic for Type II Translational ResearchResearch

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TraCS Continuous Cycle of ActivityTraCS Continuous Cycle of Activity

Continuous CycleDiscovery Clinical Practice Disseminated to Community Improved Health

Community benefits from best practices and helps establish research agenda

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GovernanceGovernance

Etta Pisano, CTSA PI Director

PI Extenders: Richard Boucher, Translational Research John Buse, Clinical Research Tim Carey, Population Sciences William Marzluff, Basic Research Rosemary Simpson, Chief Operating Officer

External Advisory Board

Internal Advisory Board

Community Advisory Board

Holden Thorp, Chancellor

Erskine Bowles, President

William Roper, VC Medical Affairs

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

Translational Research Advisory Board

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

Steering Committee

TraCS Study Section

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North Carolina TraCS Institute

Faculty&

Ideas

Clinical

Community

Bench

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North Carolina TraCS InstituteNorth Carolina TraCS InstituteServices and ResourcesServices 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

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TraCS Institute

Ideas Heading toExternal Funding

Ideas Heading to Dissemination toNorth Carolina

Ideas Heading toCommercialization

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Study SectionAnd Pilot Project

Program

TraCS Institute




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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$

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TraCS Pilot Program 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

Role of external partners in pilot programsRole 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.

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Community Engagement And Dissemination Cores

TraCS Institute




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North CarolinaCenter for Biotechnology

Innovation Translation

TraCS Institute




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North Carolina Center for Biomedical North Carolina Center for Biomedical Innovation Translation (NC-CBIT)Innovation Translation (NC-CBIT)

Bioentrepreneurial Board

SpinoffCompanies

Office of TechnologyTransfer

NC-CBIT

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Pilot Projects TraCS Match

Commercialization 200,000$ 200,000$

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Pilot Projects

ExternalFunding

Community

Additional PilotFunding

Commercialization

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Strategic Planning Major Projects – Year OneStrategic 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

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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

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Community Engagement Core

Giselle Corbie-Smith

• Community Initiatives» Community Connection Portal & Webmap

» Listening sessions

» Greensboro AHEC

» Practice based research network

» Dissemination – statewide network

External PartnersExternal 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

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26Champions

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Community Engagement Core Community Engagement Core Giselle Corbie-Smith, MD, MSc Deputy Director of the TraCS InstituteGiselle Corbie-Smith, MD, MSc Deputy Director of the TraCS Institute

Director of the CEC Director of the CECMalika Roman-Isler, PhDMalika Roman-Isler, PhD Deputy Director of the CEC 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

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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.

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NC TraCS InstituteChampions

Program Manager – TraCS/ECHO

WakeCRU

WakeCRU

Area L CRU

Area L CRU

ClinicalCommunityCommunityClinical

Community Clinical

GreensboroCRU

GreensboroCRU

Community Engagement Core

PBRNs P. Sloane

TraCS/ECHO CRUs P. Godley

Research Management S. Cykert

Activities: NC State-wide Infrastructure

ECHO-Ethnicity, Culture & Health Outcomes, PBRN-Practice-based Rsh Networks, CRU-Community Rsh Unit

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Clinical and Community Translation Core Clinical and Community Translation Core

Cathy L. Melvin, PhD, MPH – Director Cathy L. Melvin, PhD, MPH – Director Catherine Rohweder, DrPH – Director, NC Catherine Rohweder, DrPH – Director, NC SPEEDSPEED

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

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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.

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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.

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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

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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

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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

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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

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ChallengesChallenges

• 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

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CTSA SupplementsCTSA 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

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To contact the NC TraCS InstituteTo contact the NC TraCS Institute

Website www.tracs.unc.edu

Telephone 919-966-6022

Email address [email protected]

Questions? Comments?Questions? Comments?

Etta D. Pisano, MD

[email protected]

919-966-6932

mailto:[email protected]

Documents

North Carolina TraCS Institute