1. The Clinical Trials Network for European Manufacturers Sally Schwarz, MS, RPh, BCNP Chair, Manufacturer’s Registry Sub-Committee SNM Clinical Trials Network

2. Common needs for pharma and the imaging community 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 Clinical Trial Challenges Exist

3. 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 So specifically, what’s not working…..?

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

5. 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 Early 2008

6. Major Programs Defined Imaging Site Registry Imaging Site Qualification (Phantom Program) Imaging Site Validation & Monitoring Manufacturer’s Registry Safety and Efficacy Reporting Database Multicenter IND Demonstration Project: FLT Pathway for Proprietary Biomarkers Phase I Launch: August 2008

7. 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

8. World wide interest from imagers and manufacturers Global Engagement

9. Consistent Growth Network Registries (Jun 09)

10. Thank-you for your attention!