The Clinical Trials Network for European Manufacturers

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The Clinical Trials Networkfor European
Manufacturers
Sally Schwarz, MS, RPh, BCNP Chair,
Manufacturers Registry Sub-Committee SNM
Clinical Trials Network
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• Clinical Trial Challenges Exist

• Prove the clinical utility of BOTH therapeutic
  and imaging agents
• Need more use of imaging biomarkers in existing
  therapy trials as surrogate endpoints
• Need funding of multicenter clinical trials for
  imaging biomarkers
• Need a framework for timely development
  approval of each

Common needs for pharma and the imaging community
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• So specifically, whats not working..?

• Each company is developing (or re-developing)
  their own biomarkers no standardization
• Ad hoc application of Molecular Imaging (MI)
  technologies in drug development
• Lack of consensus on the regulatory
  process/pathway for biomarker development
• Too much talk, too little action

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• An innovative molecular imaging program to
  accelerate clinical trials for investigational
  therapeutics through improved availability and
  performance of investigational imaging
  biomarkers.

• The Desired Solution

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• Early 2008

• Established A Vision for the Network
• Facilitate the use of investigational imaging
  biomarkers in multicenter clinical trials of new
  therapeutics
• Focus on multicenter INDs for imaging biomarkers
  of interest to the therapeutic pharmaceutical
  community
• Coordinate standardized imaging protocols across
  qualified clinical trial sites via phantom
  utilization
• Maintain active engagement with the FDA
• Span drug development, molecular imaging and the
  adherence to good manufacturing practices (GMP)
  of radio-labeled probes

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• Phase I Launch August 2008

• Major Programs Defined
• Imaging Site Registry
• Imaging Site Qualification (Phantom Program)
• Imaging Site Validation Monitoring
• Manufacturers Registry
• Safety and Efficacy Reporting Database
• Multicenter IND Demonstration Project FLT
• Pathway for Proprietary Biomarkers

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• Organization

Committee Chairs Mike Graham Sandy McEwan Peter
Conti Ramsey Badawi Toni Shields George
Segall John Sunderland Sally Schwarz Paul
Christian John Hoffman Denise Harbora
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• Global Engagement

• World wide interest from imagers and manufacturers

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• Network Registries (Jun 09)

• Consistent Growth

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• Thank-you for your attention!