Transcript Slide 1

North Carolina TraCS Institute
Wednesday, February 4, 2009
presented by
The NC TraCS Institute
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
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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
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CTSA Network 2008 (38)
38 CTSAs in place, will grow to 60 by 2010
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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
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TraCS Institute Overreaching Goals
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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
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Schematic for Type II Translational
Research
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
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Governance
Erskine Bowles, President
Holden Thorp, Chancellor
External Advisory Board
Internal Advisory Board
William Roper, VC Medical Affairs
Etta Pisano, CTSA PI Director
Community Advisory Board
Steering Committee
Translational Research
Advisory Board
TraCS Study Section
PI Extenders:
Richard Boucher, Translational Research
John Buse, Clinical Research
Tim Carey, Population Sciences
William Marzluff, Basic Research
Rosemary Simpson, Chief Operating Officer
Deputy Directors:
Giselle Corbie-Smith, Community
..José-Marie Griffiths, Informatics
..Lisa LaVange, Analytics
David Peden, Child Health
Core Directors:
Janee Smith, Evaluation
Michael Fried, Participant Clinical Interaction Resources
Gail Henderson, Ethics
Michael Kosorok, Biostatistics
Eugene Orringer, Education
David Peden, Child Health
TBN, Communication
Michael Fried, Clinical Science
Rudolph Juliano, Basic Science
Eugene Orringer, Education
Giselle Corbie-Smith, Community Engagement
José-Marie Griffiths, Bioinformatics
Rudolph Juliano, Novel Methodology
Cathy Melvin, Community Translation
William Marzluff, Translational Technology
David Weber, Regulatory
Etta Pisano, Strategic Opportunities
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North Carolina TraCS Institute
Community
Clinical
Bench
Faculty
&
Ideas
North Carolina
TraCS Institute
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North Carolina TraCS Institute
Services and Resources
Providing the infrastructure to increase the safety, speed, and
rigor of patient-oriented research
NC TraCS Central Desk
Education
Clinical Data Mgmt
Research Navigators
Laboratory Assay
Development
Commercialization
Biomedical Informatics
Biostatistics
Clinical and
Translational Research
Center (CTRC)
Clinical and Community
Research Ethics
Clinical Dental and
Inflammation Research
Bionutrition
Community Engagement
Personalized Medicine
Consultation
Grant Proposal
Assistance
Regulatory
Carolina Data
Warehouse-Health
Core Facilities and
Translational Technologies
Pilot Program
Biobanking
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North Carolina TraCS Institute
TraCS Institute
Ideas Heading to
External Funding
Ideas Heading to
Dissemination to
North Carolina
Ideas Heading to
Commercialization
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North Carolina TraCS Institute
TraCS Institute
Ideas Heading to
External Funding
Ideas Heading to
Dissemination to
North Carolina
Ideas Heading to
Commercialization
Study Section
And Pilot Project
Program
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North Carolina TraCS Institute
Pilot Projects
$2K
$10K
Core Technology
Commercialization
Large Pilot
TOTAL
$
$
$
TraCS
100,000
200,000
200,000
200,000
1,600,000
2,300,000
Match
$
200,000
200,000
1,600,000
$
2,000,000
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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
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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.
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North Carolina TraCS Institute
TraCS Institute
Ideas Heading to
External Funding
Ideas Heading to
Dissemination to
North Carolina
Ideas Heading to
Commercialization
Community Engagement
And Dissemination Cores
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North Carolina TraCS Institute
TraCS Institute
Ideas Heading to
External Funding
Ideas Heading to
Dissemination to
North Carolina
Ideas Heading to
Commercialization
North Carolina
Center for Biotechnology
Innovation Translation
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North Carolina Center for Biomedical
Innovation Translation (NC-CBIT)
NC-CBIT
Office of Technology
Transfer
Bioentrepreneurial Board
Spinoff
Companies
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North Carolina TraCS Institute
Pilot Projects
Commercialization $
TraCS
200,000
Match
$
200,000
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North Carolina TraCS Institute
Pilot Projects
Community
Additional Pilot
Funding
Commercialization
External
Funding
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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
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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
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Strategic Planning Major Projects – Year One
Community Engagement Core
Giselle Corbie-Smith
• Community Initiatives
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»
»
»
»
Community Connection Portal & Webmap
Listening sessions
Greensboro AHEC
Practice based research network
Dissemination – statewide network
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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
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Champions
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Community Engagement Core
Giselle Corbie-Smith, MD, MSc Deputy Director of the TraCS Institute
Director of the CEC
Malika 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
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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 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
Community
Wake
CRU
Area L
CRU
Clinical
Community
Clinical
Community
Clinical
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ECHO-Ethnicity, Culture & Health Outcomes, PBRN-Practice-based Rsh Networks, CRU-Community Rsh
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
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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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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
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Strategic Planning Major Projects – Year One
Education Core
Eugene Orringer
• Education, Training and Career Development Initiatives
» Trainee Programs - TL1, KL2, K30, Howard Hughes Medinto-Grad, Doris Duke, Birch
» K trainees to R01 grants Program
» Masters of Science in Clinical Research, enrolling 2009
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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
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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
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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
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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
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To contact the NC TraCS Institute
Website
www.tracs.unc.edu
Telephone
919-966-6022
Email address
[email protected]
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Questions? Comments?
Etta D. Pisano, MD
[email protected]
919-966-6932