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Progress of SNM Clinical Trials Network: Enhancing Imaging Biomarker Development

The SNM Clinical Trials Network aims to accelerate clinical trials, improve imaging biomarker availability, and support drug development. It provides site qualification, scanner validation, and centralized IND benefits for biomarker studies.

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Progress of SNM Clinical Trials Network: Enhancing Imaging Biomarker Development

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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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