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The SNM Centralized IND

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Investigational & Approved PET Imaging. in Large Multicenter ... Torso Oncology. Head CNS. Cardiac. SNM Imaging Phantom Program. Selection - F-18 FLT ... – PowerPoint PPT presentation

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Title: The SNM Centralized IND


1
The SNM Centralized IND Clinical Trials
Network Enabling Implementation
Investigational Approved PET Imaging in Large
Multicenter Clinical Trials
George Q. Mills, MD, MBA September 9, 2009
2
Therapeutic Drug Developers Comments
  • PET imaging desired for Multicenter Therapeutic
    Trials
  • butnumerous deficiencies
  • Lack of
  • Limited supply of investigational PET agents
  • Standardized PET imaging acquisition protocols
  • Harmonized PET imaging report output
  • Qualified experienced imaging centers
    large (200 sites) multicenter clinical trials
  • Industry could not effectively implement PET
    imaging in multicenter therapeutic clinical
    trials

3
  • SNM Assessment Efforts
  • Therapeutic Developers
  • Participating PET Imaging Centers
  • FDA Pre-IND Process
  • Results - Design solutions
  • Centralized Investigational PET Imaging IND
  • to Enable Therapeutic Developers Multicenter
    Therapeutic Clinical Trials
  • Distributed Manufacturing
  • Investigational PET imaging Agents

4
  • SNM Centralized IND
  • Demonstration Project - Future development INDs
  • F-18 FLT first choice available broad
    potential
  • Regulatory
  • CMC
  • Imaging Standardization

5
Clinical Trials Sites Network - Registry
  • Investigator international site registry
  • Forming Pick List - therapeutic developers
  • Enrollment qualifications
  • Location
  • Geography
  • Patient population access
  • Equipment hardware software
  • Personnel
  • Access to investigational imaging agents
  • Participation phantom program clinical
    trials

6
  • World wide interest - imagers manufacturers

7
  • Regulatory multicenter IND manufacturing
  • Multicenter INDs - Single source
    investigational product
  • CMC Investigational F-18 FLT sources
  • Multiple production sites multiple methods
  • Distributed manufacturing multiple
    end-product specs
  • SNM Centralized IND F-18 FLT
    FDA CMC
    review of all sources acceptable ranges for
    end-product specifications

8
Review through submission to IND file directly or
through Drug Master File (DMF) a submission
tool of efficiency for manufacturers
  • Information concerning the Chemistry,
    Manufacturing and Controls (CMC) of a drug
    product or a component of a drug product to
    permit the FDA to review this information upon
    request in support of a submission

9
Types of DMFs
  • Five Types
  • I Plant information
  • II Drug substance, drug product, intermediates
    and material used in their manufacture
  • III Packaging
  • IV Excipients
  • V Other clinical, tox

10
Who must file a DMF?
  • CMC information must be available for IND review
  • CMC must be in an IND submission or in a DMF
  • There is no legal or regulatory requirement to
    file a DMF (submission by Holder,ref by
    applicant or authorized party)
  • Applicant submits a Letter of Authorization (LOA)
    from the Holder with their IND submission

11
Letter of Authorization (LOA) Enabling review
of DMF
  • The DMF will be reviewed ONLY when it is
    referenced in a submission or another DMF
    (initially receives an administrative review)
  • The Holder MUST submit an LOA (2 copies) to the
    DMF and send a copy to the Applicant
  • The Applicant submits LOA in their submission
    the mechanism to trigger review of the DMF by FDA
  • In Europe, the LOA is called a Letter of Access

12
DMF Advantages
  • Maintains proprietary information/trade secrets
    (e.g. manufacturing procedure) belonging to the
    Holder, from being revealed to the Applicant
    while permitting review by FDA
  • Permit review of information referenced by a
    number of applicants will be used to support
    submissions from many sponsors
  • Time efficient cost effective

13
  • Imaging standardization
  • Pre-clinical Imaging Standardization - Imaging
    Phantom Program
  • Oncology CNS - Cardiovascular
  • Clinical imaging - Standardized protocol
  • International imaging clinical site registry (217
    sites) documentation of equipment demonstrated
    capabilities
  • Clinical Trials Educational programs
    Multicenter Trials

14
SNM Imaging Phantom Program
  • F-18 fillable phantoms
  • Qualitative Quantitative (SUV)
  • VA system
  • Torso Oncology ?
  • Head CNS
  • Cardiac

15
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

16
  • Topics
  • Overview Key Elements Centralized IND
  • Clinical Trials Network
  • Resources
  • Sites Registry
  • Phantom Program
  • Education Training Program
  • F-18 FLT selection

17
Thank you
George Mills, MD, MBA Vice President, Medical
Regulatory Relations Perceptive
Informatics george.mills_at_perceptive.com
18
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