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Workings of the SNM Clinical Trials Network Centralized IND for FLT. George Q. Mills, MD, MBA Vice President, Medical & Regulatory Relations Perceptive Informatics. Discussion today includes background information, comments and references to the SNM Clinical Trials Network Centralized IND

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slide1

Workings of the SNM Clinical Trials Network Centralized IND for FLT

George Q. Mills, MD, MBA

Vice President, Medical & Regulatory Relations

Perceptive Informatics

slide2

Discussion today includes

background information, comments and references to the SNM Clinical Trials Network Centralized IND

Selection of [F-18] FLT: an Investigational,

non-FDA approved, PET Imaging Agent

slide3

FDA / IOM Meeting – October 2007

Therapeutic Drug Developers Comments

  • PET imaging desired for Multi-center Therapeutic Trials …but ... numerous deficiencies with PET imaging

ISSUES

    • Lack of qualified & experienced imaging centers for large (200+ sites) multi-center Phase 3 clinical trials
    • Limited supply of known/desired investigational PET agents
    • No standardized PET imaging acquisition protocols
    • No harmonized PET imaging report output
  • Industry could not effectively implement PET imaging in multi-center therapeutic clinical trials
slide4

SNM Assessment Efforts

Multiple Discussions:

  • Therapeutic Developers
  • Participating PET Imaging Centers
  • FDA: Pre-IND Process

Results:

  • Multiple IND Design Solutions
      • Regulatory
      • CMC
      • Imaging Standardization
slide5

Solution Topics

  • Clinical Trials Network (CTN) Sites Registry
  • Selection of IND biomarker – [F-18] FLT
  • Distributed Manufacturing of PET agents – CMC
  • Imaging Standardization
slide6

Topic 1: Clinical Trials Sites Registry

  • International Registry - Investigators’ Sites
    • Industry necessity & reality
    • “Pick list” to match therapeutic sites
  • Criteria to enable industry review & site selection
    • Enrollment & qualifications
    • Location
    • Equipment – hardware & software
    • Personnel
    • Access to investigational imaging agents
    • Participation: phantom program – clinical trials
slide8

Areas

of

Interest

  • Selection: [F-18] FLT (Oct. 2008)

Topic 2: Centralized IND Selection

8

slide9

Selection Criteria for [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 for lung, breast, esophageal, GI, brain, lymphoma

PRE-TX

22 days

113 days

slide10

Topic 3: Distributed Manufacturing of PET Agents

Distributed Multicenter Manufacturing of PET Imaging

  • FDA: Anticipates “single GMP product”
      • PET production
        • Multicenter methods of production of the investigational PET product
        • Multiple “similar” PET products by end-product specifications
slide11

Using the SNM Centralized IND for [F-18] FLT

  • FDA must review CMC for all manufacturing sources & methods
  • CMC from all manufacturers supplying [F-18] FLT to trials must be submitted directly to IND or through letter of cross-reference to a filed DMF
  • FDA defines acceptable ranges for [F-18] FLT by end-product specifications
  • FDA accepted [F-18] FLT products = “single IND GMP product”
slide12

Drug Master File (DMF)

DMF = Efficient CMC submission tool for manufacturers

Drug Manufacturer’s Submits Information –

Chemistry, Manufacturing and Controls (CMC) of a drug product or a component of a drug product to FDA file room to permit the FDA to review this information upon request only and in support of a specific submission

slide13

FDA Regulatory DMF Background

Five Types

  • I: Plant information
  • II: Drug substance, drug product, intermediates and material used in their manufacture
  • III: Packaging
  • IV: Excipients
  • V: Other clinical, toxicology
slide14

Key Point

CMC information must be submitted in centralized IND

  • CMC may be directly submitted in IND submission

or

  • CMC may be submitted through a letter of cross-reference to an existing DMF filed with FDA
slide15

Letter of Authorization (LOA) - Enables FDA review of DMF

  • The DMF Holder (manufacturer) MUST submit an LOA (2 copies) to the DMF and route a separate copy to the IND Applicant
  • The Applicant submits LOA in their IND submission… the mechanism to enable review of the DMF by FDA
  • The DMF will be reviewed ONLY when it is referenced in an IND submission
  • In Europe, the LOA is called a Letter of Access
slide16

Topic 4: Imaging Standardization

Solutions

  • Clinical imaging with a standardized protocol
  • International imaging clinical site registry – hardware/software
  • Clinical trials educational programs for multicenter trials
  • Pre-clinical imaging standardization - Phantom Program
    • Oncology / CNS / Cardiovascular
slide17

SNM Imaging Phantom Program

[F-18] FLT fillable phantoms

  • Qualitative & Quantitative (SUV)
  • VA system
    • Torso: Oncology
    • Head/Brain: CNS
    • Cardiac
slide18

Plans for Future Centralized IND

  • FDG
  • FLT
  • FDOPA
  • FAZA
  • FMISO
  • Ga-68 octreotide
  • FES
  • FHDT
  • C-11 acetate
slide19

Review: Solution Topics

  • Clinical Trials Network (CTN) Sites Registry
  • Selection of IND biomarker – [F-18] FLT
  • Distributed Manufacturing of PET agents – CMC
  • Imaging Standardization
slide20

Thank You

George Mills, MD, MBA

Vice President, Medical & Regulatory Relations

Perceptive Informatics

[email protected]

Disclosures:

  • Consultant to SNM (Society of Nuclear Medicine)
  • Employee: PAREXEL/Perceptive Informatics - CRO
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