Progress of the SNM Clinical Trials Network

Michael Graham, PhD, MDClinical Trials Network Co-Chair

SNM President

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CTN Organizational Chart

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

Mission

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• 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

Overall Goals

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• Consistent Growth

Network Registries (Dec 09)

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• 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

Imaging Biomarker Development Network

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• 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.

Site Qualification Process

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• 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 INDDrugs without parentage

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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

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Considerations• Community Needs

– Therapeutic areas of interest– Current pharmaceutical development

• Tracer Availability– Location of manufacturers– Agent viability

1. Access to Pre-clinical data

Centralized IND Selection

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Centralized IND Selection

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Areas of Interest

Hypoxia

Amyloid

Lipid Synthesis

Protein Synthesis

Dopaminergic Receptors

Estrogen Receptors

Angiogenesis

Apoptosis

Testosterone Receptors

First Multicenter IND

3'-deoxy-3'-[18F] fluorothymidine (FLT) 12

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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

First Multicenter IND: [F-18] FLT

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F-MISO

Second Multicenter IND

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Why F-MISO?

• Community interest

• Availability

• Demonstrated ability to image and quantify hypoxia

Second Multicenter IND

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• 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

Accomplishments

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• 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

Long-Term Vision

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www.snm.org/clinicaltrials