CTSA REGULATORY KNOWLEDGE WORKGROUP
September 12, 2007
DTMI
representatives
Wesley Byerly, PharmD - Presenter
Bruce Burnett, PhD
Deborah Roth
Judith Kramer, MD
Jennifer Holcomb
Wajeeh Bajwa, PhD
Sue Avery
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Duke Translational
Medicine Institute
(DTMI)
Duke Translational
Organizational
Research Institute
Structure
(DTRI)
DTMI
Administration
Duke Clinical
Research Institute
(DCRI)
Duke Center for
Community Research
(DCCR)
Education and Training
Ethics
Pediatrics
Biomedical Informatics
Biostatistics
Nursing
Core Laboratories
Regulatory Affairs
Project Leaders and the Portal Office
Site Based Research (SBR)
Duke Clinical Research Unit (DCRU)
New molecule
First-in-human
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Preclinical development
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Application in the community
Phase II / III
Initiatives
 Site Based Research (SBR)
 DCRI Regulatory Services and QA/RC
 DTMI Regulatory Affairs
 Research Review Process
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Vehicle for Organizing Site Based Research (SBR)
 SBR Charters/Strategic Plan
Study evaluation and selection processes
Coordination of Site Initiation activities
Financial management and accountability/billing
activities
Personnel management
Communication activities
Annual reports
 Subject Registry
 QA (GCP and financial)
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DCRI Regulatory Services and
Quality Assurance and Regulatory Compliance
 DCRI Regulatory Services
Preparation, regulatory filing, and maintenance of
drug and device clinical trial applications
Regulations regarding submissions and clinical
trials
Resource for GMP testing, validation
Resource for CMC content and writing of CMC
sections for INDs as needed (e.g. when new dosage
forms or placebos are required)
 Fully developed Quality Assurance and
Regulatory Compliance function
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DTMI Regulatory Affairs
 Consulting and project planning throughout
full translational cycle
 IND/IDE Preparation, regulatory filing, and
maintenance of drug and device clinical trial
applications
 Draft Institutional Policy for IND/IDE
submissions
 Develop tools and resources for PIs
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Research Process Review
 Process Mapping
 Identify improvement opportunities
 Optimize operational and time efficiencies
 Implement identified process changes
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Additional Current Initiatives
 Centralized focus for Translational Pilot
Projects
 Outside consulting for key functions
Pilot Projects
Technology Cores (e.g. Cell Therapy)
 Regulatory support for technology core
initiatives (imaging, biorepository, genomics)
 Reshape Research Subject Advocacy function
 Multi-national project support
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Barriers and Challenges
 Culture change
 Streamlining business processes
 Determining scope of decentralized regulatory
support
 Pre-clinical development
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Thank You for Your Attention
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