Workings of the SNM Clinical Trials Network Centralized IND for FLT
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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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George q mills md mba vice president medical regulatory relations perceptive informatics

Workings of the SNM Clinical Trials Network Centralized IND for FLT

George Q. Mills, MD, MBA

Vice President, Medical & Regulatory Relations

Perceptive Informatics


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

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

non-FDA approved, PET Imaging Agent


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

SNM Assessment Efforts

Multiple Discussions:

  • Therapeutic Developers

  • Participating PET Imaging Centers

  • FDA: Pre-IND Process

    Results:

  • Multiple IND Design Solutions

    • Regulatory

    • CMC

    • Imaging Standardization


George q mills md mba vice president medical regulatory relations perceptive informatics

Solution Topics

  • Clinical Trials Network (CTN) Sites Registry

  • Selection of IND biomarker – [F-18] FLT

  • Distributed Manufacturing of PET agents – CMC

  • Imaging Standardization


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

International PET imaging sites & PET manufacturers


George q mills md mba vice president medical regulatory relations perceptive informatics

Areas

of

Interest

  • Selection: [F-18] FLT (Oct. 2008)

Topic 2: Centralized IND Selection

8


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

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”


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

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


George q mills md mba vice president medical regulatory relations perceptive informatics

SNM Imaging Phantom Program

[F-18] FLT fillable phantoms

  • Qualitative & Quantitative (SUV)

  • VA system

    • Torso: Oncology

    • Head/Brain: CNS

    • Cardiac


George q mills md mba vice president medical regulatory relations perceptive informatics

Plans for Future Centralized IND

  • FDG

  • FLT

  • FDOPA

  • FAZA

  • FMISO

  • Ga-68 octreotide

  • FES

  • FHDT

  • C-11 acetate


George q mills md mba vice president medical regulatory relations perceptive informatics

Review: Solution Topics

  • Clinical Trials Network (CTN) Sites Registry

  • Selection of IND biomarker – [F-18] FLT

  • Distributed Manufacturing of PET agents – CMC

  • Imaging Standardization


George q mills md mba vice president medical regulatory relations perceptive informatics

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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