Transcript Document

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 Affairs
Perceptive Informatics, Inc.
June 13, 2009
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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Therapeutic Drug Developers Comments
PET imaging for Multicenter Trials
Desired…but…numerous deficiencies…
lack of…
1.
2.
3.
4.

Supply of investigational PET agents
Standardized PET imaging acquisition protocols
Harmonized PET imaging report output
Qualified imaging centers
large (200+ sites) multicenter clinical trials
Industry could not effectively implement PET imaging
in multicenter therapeutic clinical trials
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FDA IOM Meeting Assessment
“Critical Path” Initiative…
r
Needs for Therapeutic Drug Development
Enable the Development of
Diagnostic
Investigational & Approved PET Imaging
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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 Network
Enabling
Multicenter Clinical Trials
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Clinical Trials Network - Registry
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
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Network Registries (Jun 09)
Imaging Registry
(217 Sites)
U.S.
Europe
10%
Rest of World
13%
77%
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World wide interest - imagers & manufacturers
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Clinical Trials Sites - Centralized IND
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
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SNM Imaging Phantom Program
F-18 fillable phantoms
– Qualitative & Quantitative (SUV)
– VA system
• Torso – Oncology 
• Head – CNS
• Cardiac
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SNM Educational & Training Programs
Clinical 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
PRE-TX
• Potential as a surrogate marker for
evaluating investigational oncology
therapeutics as well as existing
therapeutics
22 days
• Broadly applicable to lung, breast,
esophageal, GI, brain, lymphoma
113 days
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Therapeutic Developers
Current 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 Relations
Perceptive Informatics
[email protected]
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