Transcript Slide 1

Progress of the SNM Clinical Trials Network
Michael Graham, PhD, MD
Clinical Trials Network Co-Chair
SNM President
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CTN Organizational Chart
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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
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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
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Network Registries (Dec 09)
• Consistent Growth
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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
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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.
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Drugs without parentage
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FDG
FLT
FDOPA
FAZA
FMISO
Ga-68 octreotide
FES
FHDT
C-11 acetate
Centralized IND
No company owns the rights
No company will solely benefit
No company will sponsor the trials
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Centralized IND
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
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Centralized IND Selection
Considerations
• Community Needs
– Therapeutic areas of interest
– Current pharmaceutical development
• Tracer Availability
– Location of manufacturers
– Agent viability
1. Access to Pre-clinical data
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Centralized IND Selection
Areas of Interest
Dopaminergic
Receptors
Hypoxia
Lipid Synthesis
Estrogen
Receptors
Testosterone
Receptors
Apoptosis
Amyloid
Protein
Synthesis
Angiogenesis
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O
Me
HO
First Multicenter IND
NH
N
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O
F
3'-deoxy-3'-[18F] fluorothymidine (FLT)
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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
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Second Multicenter IND
F-MISO
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Second Multicenter IND
Why F-MISO?
• Community interest
• Availability
• Demonstrated ability to image and quantify hypoxia
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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
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Long-Term Vision
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One new IND per year (next submission expected by mid-2010)
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Expanded phantom program to include cardiac and brain
qualifications
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Reach beyond PET biomarkers
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Assist with imaging protocol development, conduct, and integration
with imaging CROs
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Expand multicenter IND capability for imaging biomarkers
– Non-proprietary
– Proprietary
– Individual academic-investigator driven
www.snm.org/clinicaltrials
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