CTSA Administrator Meeting

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CTSA Administrator Meeting

• October 2, 2007

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Seamless Integration
Clinical Research
Translation and Adoption
Global Health
Translation
Discovery
Clinical Development Phase II, III
FDA Approval Evidence Based Medicine
Proof of Concept in Man
Practice Adoption, Practice Guidelines, Cost
Effective

• Community
• Assessment
• Care delivery
• Outcomes
• Economics

Basic Discovery
Preclinical Research In Vivo Analysis
Improve Community Health Status
Global Health Service/ Research, Population/ Pu
blication
PK,PD, Toxicology
Current State Entities
AHS/Industry/ Biotech
Industry/Biotech
Clinical Research Organizations/AHS
HCS/Hospitals/ Practices/FQHC/AHS
Government NGOs
AMC/AHS
AMC/AHS
AMC/AHS
AMC/AHS
AMC/AHS
AMC/AHS
Basic Discovery
Preclinical Research
PD/PK/ Toxicology
Proof of Concept In Man
Phase II, III and IV
Health Service and Outcomes Research
Guidelines And Adoption
Community Health Trends
Global Health Research and Service
DCRI
DGHI
DTRI
DCCR
New Timeline 1012 years
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CTSA Governance and Leadership

• DTMI Board
• Chancellor for Health Affairs, CEO of Acute Care
  Services and CFO of Health System, Dean of SOM,
  Head of MD Practice Plan, Vice Chancellor for
  Corporate Research Development
• DTMI Leadership Group
• Faculty and Operational Leaders of Pillars and
  Core Resources
• Key institutional officials (Director of Cancer
  Center, Director of Center for Genomic Medicine,
  CIO for Duke Medicine, Vice Chancellor for
  Corporate Research Development, Vice Dean for
  Research, Associate Vice Dean for Research
  Support Services, etc.)

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DTMI Governance and Leadership Guiding
Principles

• Small, lean core senior leadership group
• High level of integration between CTSA leadership
  roles and institutional leadership roles. Key
  examples
• Exec Committee of DCCR is chaired by the SON Dean
  and includes the Director of Global Health
  Institute, Associate VP of Community Relations
  for Health System, etc.
• Director of DTMI Biostatistics Core is also the
  Director of Biostatistics for the Cancer Center
• Associate CIO for Clinical and Translational
  Medicine services is also DTMI Director of IT
• Pilot Project Selection Committee overseen by
  School of Engineering Senior Associate Dean for
  Industrial Partnerships and Research
  Commercialization

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Barriers

• Lack of transparency of other institutional
  commitments and risk of duplicating efforts
• Concerns about who gets credit
• Conflicts with departments regarding faculty
  effort and sharing of indirects
• Silos

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Key Strategies

• Co-investment in institutional strategic
  priorities with other entities (departments,
  centers and institutes)
• Create federations to develop and adopt
  harmonized data standards
• Financial transparency
• Project management

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DTRI - Central Role of Project Management
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Successes

• Key Hires/Appointments
• Director and COO
• New DCRI Leadership team
• Director, Finance Business Strategy, Financial
  Analyst, Senior Grants Manager
• Director, Regulatory Affairs
• Manager, Regulatory Education and Training
• 6 Project Leaders
• Associate Director of Biomedical Informatics
• Director of Operations and Research Manager for
  DCRU
• 2 Senior Nurse Scientists for DCRU
• Key leaders of Community Health Research Liaison
  Center, Training Center and Virtual Library

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Successes (continued)

• Received 35M gift to fund MURDOCK Study in
  conjunction with North Carolina Research Campus
• Roundtable meetings with key faculty in cell
  therapy and immune monitoring
• Strategy sessions for each pillar and core
  resource to identify 4 year goals and investment
  plan for institutional commitment funds
• Launched digital image management system for
  image-based clinical trials
• Launched CRF library
• Launched regulatory strategy consultation service
• Launched statistical consultation service
• Initiated centralized inventory of IND/IDEs

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The M.U.R.D.O.C.K. StudyThe Measurement to
Understand Reclassification of Disease Of
Cabarrus/Kannapolis Study
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Success (continued)

• Implemented new structure for site-based research
  (organized investigators and study coordinators
  into formal groups by therapeutic area)
• Operational restructuring of GCRC (integration of
  review process with eIRB, streamlined review
  process, creation of subject confinement area,
  etc.)
• Implementing web-based system for pilot project
  application submission and review
• Executed Memorandum of Understanding with FDA to
  host Public Private Partnership for Streamlined
  and Effective Clinical Trials

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Organizational Structure for Site-Based Research
Group
Chancellor/Dean
Chairs/CSU Directors/Center Directors
Department Administration
SBR Director
Faculty Advisory Board
Financial Manager
Principal Investigators
Lead Study Coordinator
Study Coordinators and Other Research Support
Personnel
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