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Progress of the SNM Clinical Trials Network

Progress of the SNM Clinical Trials Network. Michael Graham, PhD, MD Clinical Trials Network Co-Chair SNM President. CTN Organizational Chart. Mission. Promote “The Practice of Clinical Trials” through: Accelerated clinical trials for investigational therapeutics

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Progress of the SNM Clinical Trials Network

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  1. Progress of the SNM Clinical Trials Network Michael Graham, PhD, MD Clinical Trials Network Co-Chair SNM President

  2. CTN Organizational Chart

  3. Mission Promote “The Practice of Clinical Trials” through: • Accelerated clinical trials for investigational therapeutics • Improved availability and performance of imaging biomarkers • Increased number of imaging biomarkers available for clinical use • Faster, more cost-effective drug development to facilitate patient access

  4. Overall Goals • Provide an international registry of qualified and certified imaging centers through phantom utilization and ongoing assessment and monitoring • Organize a manufacturing registry for production of and access to imaging biomarkers • Provide site orientation and training programs to increase adherence to protocols; drive quality • Support multisite clinical trials to gather standardized imaging data that will lead to improved efficiency and validity of using imaging biomarkers for therapeutic trials • Collect safety and efficacy data of imaging biomarkers through a centralized IND

  5. Consistent Growth Network Registries (Dec 09)

  6. Imaging Biomarker Development Network • Pharma companies interested in using imaging technology in drug discovery and development • Focus on multicenter clinical trials ~ 1 per year • Credentialed academic institutions to conduct studies • Expertise • Technologies/applied standards • Site orientation and training programs • Certified technologists

  7. Site Qualification Process • Registration in the CTN site database: online completion of site-specific information (e.g., equipment, personnel, research experience) • Scanner Validation via the CTN Phantom Program • Site Qualification: meeting a minimum of pre-determined requirements related to research infrastructure, validated equipment and access to experimental imaging agents.

  8. Drugs without parentage • FDG • FLT • FDOPA • FAZA • FMISO • Ga-68 octreotide • FES • FHDT • C-11 acetate No company owns the rights No company will solely benefit No company will sponsor the trials • Centralized IND

  9. Benefits • Mechanism of access to radiopharmaceuticals without having to perform pre-clinical studies • Access to standardized imaging protocols • Decreased cost associated with pharmaceutical IND by not having to file a second tracer IND • Shared responsibility for reporting of safety and efficacy data • Centralized IND

  10. Centralized IND Selection Considerations • Community Needs • Therapeutic areas of interest • Current pharmaceutical development • Tracer Availability • Location of manufacturers • Agent viability • Access to Pre-clinical data

  11. Areas of Interest Dopaminergic Receptors Testosterone Receptors Hypoxia Estrogen Receptors Apoptosis Lipid Synthesis Protein Synthesis Amyloid Angiogenesis Centralized IND Selection 11

  12. F First Multicenter IND 3'-deoxy-3'-[18F] fluorothymidine (FLT)

  13. First Multicenter IND: [F-18] FLT Why FLT? • Community interest • Investigational PET imaging biomarker • Literature reports of “potential” for demonstrating tumor proliferation • Potential as a surrogate marker for evaluating investigational as well as existing oncology therapeutics • Broadly applicable to lung, breast, esophageal, GI, brain, lymphoma

  14. Second Multicenter IND F-MISO

  15. Second Multicenter IND Why F-MISO? • Community interest • Availability • Demonstrated ability to image and quantify hypoxia

  16. Accomplishments • First SNM multicenter IND for an investigational imaging biomarker • First three founding members from the pharmaceutical development community on board • 200+ members of both the imaging site and manufacturers registries • Over 25% participation from outside the U.S. • Development and launch of a clinical oncology phantom program • Many on-going educational activities to inform about the Network and advance the awareness and understanding of the “Practice of Clinical Trials” within the imaging community • Community Workshop to be held Feb 1-2, 2010 in Albuquerque

  17. Long-Term Vision • One new IND per year (next submission expected by mid-2010) • Expanded phantom program to include cardiac and brain qualifications • Reach beyond PET biomarkers • Assist with imaging protocol development, conduct, and integration with imaging CROs • Expand multicenter IND capability for imaging biomarkers • Non-proprietary • Proprietary • Individual academic-investigator driven • www.snm.org/clinicaltrials

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