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DTMI

CTSA REGULATORY KNOWLEDGE WORKGROUP September 12, 2007. DTMI. representatives. Wesley Byerly, PharmD - Presenter. Deborah Roth Jennifer Holcomb Sue Avery. Bruce Burnett, PhD Judith Kramer, MD Wajeeh Bajwa, PhD. Duke Translational Medicine Institute (DTMI)

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DTMI

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  1. CTSA REGULATORY KNOWLEDGE WORKGROUPSeptember 12, 2007 DTMI representatives Wesley Byerly, PharmD - Presenter Deborah Roth Jennifer Holcomb Sue Avery Bruce Burnett, PhDJudith Kramer, MD Wajeeh Bajwa, PhD

  2. Duke Translational Medicine Institute (DTMI) Organizational Structure DTMI Administration Duke Translational Research Institute (DTRI) 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 Application in the community Preclinical development Phase II / III

  3. Initiatives • Site Based Research (SBR) • DCRI Regulatory Services and QA/RC • DTMI Regulatory Affairs • Research Review Process

  4. 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)

  5. 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

  6. 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

  7. Research Process Review • Process Mapping • Identify improvement opportunities • Optimize operational and time efficiencies • Implement identified process changes

  8. 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

  9. Barriers and Challenges • Culture change • Streamlining business processes • Determining scope of decentralized regulatory support • Pre-clinical development

  10. Thank You for Your Attention

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