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Imaging Community Critical Need #1: Standardized and Harmonized Multisite Imaging

Imaging Community Critical Need #1: Standardized and Harmonized Multisite Imaging. George Q. Mills, MD, MBA Vice President, Medical & Regulatory Relations Perceptive Informatics. Enabling Investigational & Approved PET Imaging in Large Multicenter Clinical Trials.

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Imaging Community Critical Need #1: Standardized and Harmonized Multisite Imaging

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  1. Imaging Community Critical Need #1: Standardized and Harmonized Multisite Imaging George Q. Mills, MD, MBA Vice President, Medical & Regulatory Relations Perceptive Informatics

  2. Enabling Investigational & Approved PET Imaging in Large Multicenter Clinical Trials Discussion today will include comments and references to [F-18] FLT: an Investigational, non-FDA approved, PET Imaging Agent

  3. 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 can not effectively implement PET imaging in large multi-center therapeutic clinical trials

  4. SNM Assessment Efforts Results: • Multiple IND Design Solutions • Regulatory • CMC • Imaging Standardization

  5. Solution: SNM Centralized IND Solution Centralized Investigational PET Imaging IND: Oct. 2008 Will enable therapeutic developers’ multi-center therapeutic clinical trials

  6. Presentation - Solution Topics • Clinical Trials Network (CTN) Sites Registry • Distributed Manufacturing of PET agents – CMC • Imaging Standardization • [F-18] FLT selection

  7. Topic 1: Clinical Trials Sites - Registry International Registry - Investigators’ Sites • Industry necessity & reality • “Pick list” to match therapeutic sites • Registry criteria to enable industry review & site selection • Enrollment & qualifications • Location • Equipment – hardware & software • Personnel • Access to investigational imaging agents • Participation: phantom program – clinical trials

  8. International PET imaging sites & PET manufacturers

  9. Topic 2: Distributed Manufacturing of PET Agents Distributed Multi-center Manufacturing of PET Imaging • FDA – Anticipates - “single, GMP product” • PET production • Multi-center methods of production of the investigational PET product • Multiple “similar” PET products by end-product specifications

  10. Solution - Centralized IND Submission • 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” [F-18] FLT

  11. 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

  12. 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

  13. Key Point CMC information must be submitted in centralized IND • CMC may be directly submitted to IND submission or • CMC may be submitted through a letter of cross-reference to an existing DMF filed with FDA

  14. 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

  15. Topic 3: Imaging Standardization Solutions • Clinical imaging with a standardized protocol • hardware/software - International imaging clinical site registry • Clinical trials educational programs for multi-center trials • Pre-clinical imaging standardization - Phantom Program • Oncology / CNS / Cardiovascular

  16. SNM Imaging Phantom Program [F-18] FLT fillable phantoms • Qualitative & Quantitative (SUV) • VA system • Torso: Oncology • Head: CNS • Cardiac

  17. Presentation - Solution Topics • Clinical Trials Network (CTN) Sites Registry • Distributed Manufacturing of PET agents – CMC • Imaging Standardization

  18. Thank You George Mills, MD, MBA Vice President, Medical & Regulatory Relations Perceptive Informatics george.mills@perceptive.com Disclosures: • Consultant to SNM (Society of Nuclear Medicine) • Employee: PAREXEL/Perceptive Informatics - CRO

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