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PET Tracer Coordination [ F-18] labeled

2010 ACRIN Annual Meeting Distribution of PET Radiopharmaceuticals for Clinical Trials – a GE Healthcare Perspective Ensuring delivery of required dose activity while acquiring Optimum Images for the Clinical Trials September 30, 2010. PET Tracer Coordination [ F-18] labeled.

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PET Tracer Coordination [ F-18] labeled

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  1. 2010 ACRIN Annual MeetingDistribution of PET Radiopharmaceuticals for Clinical Trials – a GE Healthcare PerspectiveEnsuring delivery of required dose activity while acquiring Optimum Images for the Clinical TrialsSeptember 30, 2010

  2. PET Tracer Coordination [F-18] labeled Patient Enrolment Patient Tracking Tracer Production Image Quality CMC-S PET Tracer Manufacturing (Synthesis Platform) Radiopharmacy Clinical cGMP Clinical /Imaging Sites Robust Image Quality Control GE Healthcare

  3. Global Compliance Mature/Maturing PET Markets EU Russia USA Japan Korea Brazil China

  4. PET Tracer Production & Delivery Manufacturing Facility cGMPCompliance Readiness Purchase and shipment of FASTlab and dispenser to PET Tracer Production Site Contracts TT Process Implementation including Training TT Documents Written & approved R&D CMC-S & QA Approval Application of Out-of-State Permits Tracer Production & Delivery to Clinical Trials Sites Transport Test Protocol Written & approved Transport Test completed External IND Approval Transfer Copy of Imaging Sites RAM License to Radiopharmacy Imaging Sites Ready with engineering controls to receive dose Method of Transport

  5. PET Tracer Production & Delivery cGMP / QA FASTlab GE135 & GE067 Dispenser GE135 & GE067 Radiopharmacy Clinical Materials For IMPs FASTlab GE148 Dispenser GE148 Hot Cells Technology Transfer

  6. Various Site Set-ups Scenarios Single Site CLIN1 A PET Production Site 3 PET CLIN/IMA 1 GE067 & GE148 IMA1 CLIN2 GE067 30 mins CLIN3 Multiple Sites CLIN/IMA 3 CLIN4 PET Production Site 1 CLIN/IMA 2 PET Production Site 2 B GE067 CLIN/IMA 1 IMA2 CLIN5 4.0 hrs Multiple Sites – A more complex combination CLIN/IMA 1 GE135 4.5 hrs CLIN/IMA 2 GE148 C 1.5 hrs

  7. PET Tracer Distribution for Clinical Trials Set-up C Challenges • Most complex Case: • PET Production Site distributing multiple tracers to multiple out-of-state clinical sites • Dose Capacity at production site • Delivery of requested doses in required volume • Coordination of multiple doses to multiple sites in a single day • Logistics Goal Accomplishments • Ensure delivery of required dose • activity while acquire optimum • Images for the Clinical Trials • Continuous monitoring to ensure dose delivery • Increased reliability of production with increase rate of dose requests • Faster recovery from production challenges

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