Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
The SNM Centralized IND & Clinical Trials Network Enabling Implementation Investigational & Approved PET Imaging in Multicenter Clinical Trials George Q. Mills, MD, MBA Vice President, Medical & Regulatory Affairs Perceptive Informatics, Inc. June 13, 2009 Initial development - October 2007 Washington, DC Institute of Medicine (IOM) Meeting FDA – NCI - Imaging & Therapeutic Developers Presentations Advocating Investigational & Approved PET Imaging Biomarkers Page ‹#› Therapeutic Drug Developers Comments PET imaging for Multicenter Trials Desired…but…numerous deficiencies… lack of… 1. 2. 3. 4. Supply of investigational PET agents Standardized PET imaging acquisition protocols Harmonized PET imaging report output Qualified imaging centers large (200+ sites) multicenter clinical trials Industry could not effectively implement PET imaging in multicenter therapeutic clinical trials Page ‹#› FDA IOM Meeting Assessment “Critical Path” Initiative… r Needs for Therapeutic Drug Development Enable the Development of Diagnostic Investigational & Approved PET Imaging Page ‹#› Assessment Efforts - SNM & FDA Therapeutic Developers Participating PET Imaging Centers FDA – Pre-IND Process Results – Solution Design Centralized Investigational PET Imaging IND to Enable Therapeutic Developers’ Multicenter Therapeutic Clinical Trials Page ‹#› Today’s topics • Overview – Key Elements – Centralized IND • Delivered Timeline – First year - Centralized IND • Clinical Trials Network – Resources – Sites Registry – Phantom Program – Education & Training Program • F-18 FLT selection criteria Page ‹#› Overview – Key Elements SNM Centralized IND Concepts – Demonstration Project - Future development INDs – F-18 FLT – first choice – available – broad potential 1. Regulatory 2. CMC 3. Imaging Standardization Page ‹#› Regulatory facilitated PET use & improve administrative implementation Letter of cross-reference to diagnostic IND improve access for therapeutic developers Enable effective safety & efficacy reporting Diagnostic IND Adverse events reports Annual reporting Final reports Page ‹#› Regulatory – multicenter IND manufacturing CMC – Investigational F-18 FLT • Multiple production sites & multiple methods • “Distributed manufacturing” = multiple end-product specs • SNM Centralized IND F-18 FLT FDA review – defining through review processes acceptable ranges for end-product specifications Page ‹#› Imaging standardization 1. Pre-clinical Imaging Standardization SNM Imaging Phantom Program Oncology – CNS - Cardiovascular 2. Clinical imaging - Standardized imaging acquisition protocol 3. International imaging clinical site registry (217 sites) documentation of equipment & demonstrated capabilities 4. Clinical Trials Educational programs – Multicenter Trials Page ‹#› Timeline - Achievements Pre-IND – 3 FDA meetings & multiple t-con May – August 2008 Centralized IND submitted to FDA for F-18 FLT August 2008 SNM’s Clinical Trials Imaging Network August 2008 Centralized IND F-18 FLT FDA Approved September 2008 SNM Phantom imaging program implementation October 2008 Clinical Sites Registry October 2008 Clinical Trials Symposium – Mid-Winter Meeting February 2009 Standardized Phantom program – 4 – 10 – 10 centers March 2009 Network Education training programs June 2009 Page ‹#› SNM Clinical Trials Network Enabling Multicenter Clinical Trials Page ‹#› Clinical Trials Network - Registry Investigator international site registry Forming “Pick List” of available imaging centers for therapeutic developers Enrollment & qualifications Location • Geography • Patient population access Equipment – hardware & software Personnel Access to investigational imaging agents Participation – phantom program – clinical trials Page ‹#› Network Registries (Jun 09) Imaging Registry (217 Sites) U.S. Europe 10% Rest of World 13% 77% Page ‹#› World wide interest - imagers & manufacturers Page ‹#› Clinical Trials Sites - Centralized IND Four sites: U. Iowa, Mayo Clinic, U. Utah & U. Penn – Separate, independent F-18 FLT INDs - Experienced – Participation - SNM’s imaging phantom program Next thresholds – Multicenter trial Imaging participation – Demonstration & implementation Multicenter clinical trial protocol compliance Imaging acquisition standardization Harmonization of imaging output Page ‹#› SNM Imaging Phantom Program F-18 fillable phantoms – Qualitative & Quantitative (SUV) – VA system • Torso – Oncology • Head – CNS • Cardiac Page ‹#› SNM Educational & Training Programs Clinical Trials February Mid-winter – Clearwater, Fl 1½-day symposium June Annual Meeting – Toronto, Canada Full-day categorical Page ‹#› Selection - F-18 FLT • Investigational PET imaging biomarker • Literature reports of “potential” for demonstrating tumor proliferation PRE-TX • Potential as a surrogate marker for evaluating investigational oncology therapeutics as well as existing therapeutics 22 days • Broadly applicable to lung, breast, esophageal, GI, brain, lymphoma 113 days Page ‹#› Therapeutic Developers Current Goals for Investigational F-18 FLT Phase 1 – 2 Clinical Trials Assess potential as imaging surrogate Document & Report - safety & efficacy “Promising vs. Not So Promising” Page ‹#› Topics - Reviewed • Overview – Key Elements – Centralized IND • Deliverables Timeline – First year - Centralized IND • Clinical Trials Network – Resources – Sites Registry – Phantom Program – Education & Training Program • F-18 FLT selection Page ‹#› Regulatory – multicenter IND manufacturing CMC – Investigational F-18 FLT • Multiple production sites & multiple methods • “Distributed manufacturing” = multiple end-product specs • SNM Centralized IND F-18 FLT FDA review – acceptable ranges for end-product specifications Page ‹#› Thank you George Mills, MD, MBA Vice President, Medical & Regulatory Relations Perceptive Informatics [email protected] Page ‹#› Page ‹#› Page ‹#›