the snm centralized ind & clinical trials network enabling implementation investigational &...
TRANSCRIPT
The SNM Centralized IND & Clinical Trials Network Enabling Implementation
Investigational & Approved PET Imaging in Multicenter Clinical Trials
George Q. Mills, MD, MBA
Vice President, Medical & Regulatory AffairsPerceptive Informatics, Inc.
June 13, 2009
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Initial development - October 2007 Washington, DC
Institute of Medicine (IOM) Meeting
FDA – NCI - Imaging & Therapeutic Developers
Presentations Advocating
Investigational & Approved
PET Imaging Biomarkers
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PET imaging for Multicenter Trials
Desired…but…numerous deficiencies…
lack of…
1. Supply of investigational PET agents
2. Standardized PET imaging acquisition protocols
3. Harmonized PET imaging report output
4. Qualified imaging centers large (200+ sites) multicenter clinical
trials
Industry could not effectively implement PET imaging in multicenter therapeutic clinical trials
Therapeutic Drug Developers Comments
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FDA IOM Meeting Assessment “Critical Path” Initiative…
Needs for Therapeutic Drug Development Enable the Development of
Diagnostic Investigational & Approved PET Imaging
r
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Assessment Efforts - SNM & FDA
Therapeutic Developers Participating PET Imaging Centers FDA – Pre-IND Process
Results – Solution Design Centralized Investigational PET Imaging IND
to Enable Therapeutic Developers’ Multicenter Therapeutic Clinical Trials
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Today’s topics• Overview – Key Elements – Centralized IND
• Delivered Timeline – First year - Centralized IND
• Clinical Trials Network
– Resources
– Sites Registry
– Phantom Program
– Education & Training Program
• F-18 FLT selection criteria
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Overview – Key Elements
SNM Centralized IND Concepts
– Demonstration Project - Future development INDs
– F-18 FLT – first choice – available – broad potential
1. Regulatory
2. CMC
3. Imaging Standardization
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Regulatory
facilitated PET use & improve administrative implementation
Letter of cross-reference to diagnostic IND
improve access for therapeutic
developers
Enable effective safety & efficacy reporting Diagnostic IND
Adverse events reports
Annual reporting
Final reports
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Regulatory – multicenter IND manufacturing
CMC – Investigational F-18 FLT
• Multiple production sites & multiple methods
• “Distributed manufacturing” = multiple end-product specs
• SNM Centralized IND F-18 FLT
FDA review – defining through review processes acceptable
ranges for end-product specifications
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Imaging standardization
1. Pre-clinical Imaging Standardization
SNM Imaging Phantom Program
Oncology – CNS - Cardiovascular
2. Clinical imaging - Standardized imaging acquisition protocol
3. International imaging clinical site registry (217 sites)
documentation of equipment & demonstrated capabilities
4. Clinical Trials Educational programs – Multicenter Trials
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Timeline - Achievements
Pre-IND – 3 FDA meetings & multiple t-con May – August 2008
Centralized IND submitted to FDA for F-18 FLT August 2008
SNM’s Clinical Trials Imaging Network August 2008
Centralized IND F-18 FLT FDA Approved September 2008
SNM Phantom imaging program implementation October 2008
Clinical Sites Registry October 2008
Clinical Trials Symposium – Mid-Winter Meeting February 2009
Standardized Phantom program – 4 – 10 – 10 centers March 2009
Network Education training programs June 2009
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SNM Clinical Trials NetworkEnabling
Multicenter Clinical Trials
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Investigator international site registry
Forming “Pick List” of available imaging centers for therapeutic
developers Enrollment & qualifications Location
• Geography
• Patient population access Equipment – hardware & software Personnel Access to investigational imaging agents Participation – phantom program – clinical trials
Clinical Trials Network - Registry
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Network Registries (Jun 09)
Imaging Registry (217 Sites)
77%
13%
10%U.S. Europe Rest of World
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World wide interest - imagers & manufacturers
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Four sites: U. Iowa, Mayo Clinic, U. Utah & U. Penn
– Separate, independent F-18 FLT INDs - Experienced – Participation - SNM’s imaging phantom program
Next thresholds
– Multicenter trial Imaging participation – Demonstration & implementation
Multicenter clinical trial protocol compliance Imaging acquisition standardization Harmonization of imaging output
Clinical Trials Sites - Centralized IND
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F-18 fillable phantoms– Qualitative & Quantitative (SUV)
– VA system
• Torso – Oncology • Head – CNS• Cardiac
SNM Imaging Phantom Program
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SNM Educational & Training ProgramsClinical Trials
February Mid-winter – Clearwater, Fl
1½-day symposium
June Annual Meeting – Toronto, Canada
Full-day categorical
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Selection - F-18 FLT
• Investigational PET imaging biomarker
• Literature reports of “potential” for
demonstrating tumor proliferation
• Potential as a surrogate marker for
evaluating investigational oncology
therapeutics as well as existing
therapeutics
• Broadly applicable to lung, breast,
esophageal, GI, brain, lymphoma
PRE-TX
22 days
113 days
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Therapeutic DevelopersCurrent Goals for Investigational F-18 FLT
Phase 1 – 2 Clinical Trials
Assess potential as imaging surrogate
Document & Report - safety & efficacy
“Promising vs. Not So Promising”
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Topics - Reviewed
• Overview – Key Elements – Centralized IND
• Deliverables Timeline – First year - Centralized IND
• Clinical Trials Network
– Resources
– Sites Registry
– Phantom Program
– Education & Training Program
• F-18 FLT selection
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Regulatory – multicenter IND manufacturing
CMC – Investigational F-18 FLT
• Multiple production sites & multiple methods
• “Distributed manufacturing” = multiple end-product specs
• SNM Centralized IND F-18 FLT
FDA review – acceptable ranges for end-product specifications
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Thank you
George Mills, MD, MBA
Vice President, Medical & Regulatory RelationsPerceptive Informatics
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