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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. PET imaging desired for Multicenter Therapeutic Trials …but…numerous deficiencies… Lack of…

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The SNM Centralized IND & Clinical Trials NetworkEnabling Implementation Investigational & Approved PET Imaging in Large Multicenter Clinical Trials

George Q. Mills, MD, MBA

September 9, 2009

therapeutic drug developers comments
PET imaging desired for Multicenter Therapeutic Trials

…but…numerous 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

Therapeutic Drug Developers Comments
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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

slide4
SNM Centralized IND

Demonstration Project - Future development INDs

F-18 FLT – first choice – available – broad potential

Regulatory

CMC

Imaging Standardization

slide5
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

Clinical Trials Sites Network - Registry

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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

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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

types of dmfs
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

who must file a dmf
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

letter of authorization loa enabling review of dmf
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

dmf advantages
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

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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

snm imaging phantom program
SNM Imaging Phantom Program

F-18 fillable phantoms

  • Qualitative & Quantitative (SUV)
  • VA system
    • Torso – Oncology 
    • Head – CNS
    • Cardiac
selection f 18 flt
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

slide16
Topics

Overview – Key Elements – Centralized IND

Clinical Trials Network

Resources

Sites Registry

Phantom Program

Education & Training Program

F-18 FLT selection

thank you
Thank you

George Mills, MD, MBA

Vice President, Medical & Regulatory Relations

Perceptive Informatics

george.mills@perceptive.com