Transcript Slide 1
The Clinical Trials Network for European Manufacturers Sally Schwarz, MS, RPh, BCNP Chair, Manufacturer’s Registry Sub-Committee SNM Clinical Trials Network 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 So specifically, what’s 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 The Desired Solution An innovative molecular imaging program to accelerate clinical trials for investigational therapeutics through improved availability and performance of investigational imaging biomarkers. 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 Phase I Launch: August 2008 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 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 Global Engagement World wide interest from imagers and manufacturers Network Registries (Jun 09) • Consistent Growth Thank-you for your attention!