CCAF MARCH 3, 2008 Translational Oncology

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CCAF MARCH 3, 2008 Translational Oncology

  1. 1. CCAF MARCH 3, 2008
  2. 2. Translational Oncology Research International (TORI) Developed out of original UCLA Oncology Network Not-for-profit 501(c)3 organization dedicated to early phase translational research TORI Research Network (US)  8 states: California, Nevada, Florida, Georgia, Indiana, Texas, Maryland, and New Mexico (Hawaii , Colorado, Illinois and Alaska pending)  25 sites, 57 offices, 149 investigators 2
  3. 3. US TORI Oncology Research NetworkUS TORI Oncology Research Network
  4. 4. Translational Oncology Research International (TORI) 501(c)3: Applies to corporations or foundations organized or operated exclusively for religious, charitable, scientific, literary, sports or educational purposes. Mission Statement Board of Directors Articles of Incorporation (TORI = Delaware, 2003) By-laws Budget , Record Keeping, Accounting System State and local tax exemption
  5. 5. Challenges for JCCC Division of Clinical Research: JCCC based at tertiary medical center. Market forces. Competitive practices. Opportunities for JCCC Division of Clinical Research: Institutional sparse. Population dense. 5 How to Increase Accrual? IS A COMMUNITY-BASED ONCOLOGY RESEARCH NETWORK POSSIBLE? 2002 - 2003
  6. 6. 6 Cancer Incidence by Ethnicity All Cancers County White Black Hispanic Asian-Pacific IslanderAll Races Fresno 5,882 365 1319 335 8,143 Kern 5,356 366 263 120 2,051 Los Angeles 61,842 13,052 16,462 9,019 102,053 Monterey 3,085 157 545 297 4,293 Orange 25,062 318 2,642 2,070 30,981 Riverside 15,673 824 1,802 332 19,328 San Diego 26,735 1,276 3,047 1,720 33,490 Ventura 6,969 135 959 294 8,585 TOTALS 150,604 16493 27039 14187 208,924
  7. 7. 7 Cancer Incidence by Ethnicity All Cancers County White Black Hispanic Asian-Pacific IslanderAll Races Los Angeles 12,267 2,668 3,587 1,984 20,862 Fresno 1,209 50 310 64 1,724 Orange 5,139 49 595 448 6,466 Riverside 3,240 182 416 76 4,043 San Diego 5,281 243 665 360 6,780 Ventura 1,473 10 205 54 1,803 Kern 1,020 67 166 1,369 TOTALS 28,609 3,202 5,778 2,986 41,678
  8. 8. UCLA-TORI Network History Part One 1976: UCLA receives “Comprehensive” status 1992: HER-2 trials: Slow accrual at UCLA 1993: Local Oncologists approached about UCLA affiliation 1995: First UCLA Oncology Network patient enrolled 2002: Network enrolling 60 to 80 patients a month 8
  9. 9. Institutional Barriers to UCLA Community Network Research Contracts and Grants One UCLA contract, negotiated on University terms with UCLA PI IRB One UCLA PI, Network investigators are sub- investigators Central Pharmacy Drug distribution to sites OK, indirect funds not used to increase pharmacy staff UCLA had to open before the Network could start = SLOW 9
  10. 10. 10 Accrual to Trials Open in Both UCLA and Network 0 50 100 150 200 250 300 ABX EGFNSCLC ABX-EGF09Colon BCIRG 006Breast BM STax/M enLung CDE Prostate CPT-11161Colon CPT-11Prostate FGN-012Prostate Filgrastim SD/01226 GSK EGF30003Breast Iressa040Prostate HER2-H0649g Herceptin98-012 LigandTargretinBreast NeoadjTxBreast NESP-980290Chemo NESP174Dosing OSI-2298gNSCLC SILVA 08971Lung SU101.009Ovarian SU101.032aProstate2 TAX 307Metastatic TAX 316Adjuvant VEGF2119gBreast VEGF2107gColonPh3 ZD6474-006NSCLC Zoledronate007-Ext Zoledronate011 Network UCLA
  11. 11. UCLA-TORI Network History Part Two 2002: UCLA Regents/Lawyers stopped new Network studies/contracts – enrollment < 8/month 2003: UCLA-TORI Memorandum of Agreement 2003: TORI - Translational Oncology Research International incorporated in Delaware, August 2003 2003: First TORI patient enrolled October 2003 2004: First ex-US TORI patient enrolled in Ireland, Canada, currently India pending To present: Over 4,000 enrolled on > 160 UCLA or TORI Network therapeutic trials 11
  12. 12. Translational Oncology Research International (TORI) US Sites Primarily single or multiple physician community practices – several hospital based practices Most can use central IRB, some have local IRB Most now conduct private research plus TORI studies Non-exclusivity contract with TORI – all practice physicians sign TORI has accrual goals per site, not per study TORI provides/trains research staff for TORI studies 12
  13. 13. TORI Research Investigator network (US + ex-US)TORI Research Investigator network (US + ex-US) TORI Principal Investigator at each siteTORI Principal Investigator at each site UCLA scientists, researchers and laboratoriesUCLA scientists, researchers and laboratories Phase I (UCLA/selected TORI sites), Phase II-IIIPhase I (UCLA/selected TORI sites), Phase II-III TORI and UCLATORI and UCLA Central IRB (Western IRB) or local IRB (if needed)Central IRB (Western IRB) or local IRB (if needed) Central contracts , budgets and site paymentsCentral contracts , budgets and site payments Central drug distribution – separate UCLA TORICentral drug distribution – separate UCLA TORI investigational pharmacyinvestigational pharmacy Translational OncologyTranslational Oncology Research International (TORI)Research International (TORI)
  14. 14. JCCC Internal Scientific Peer ReviewJCCC Internal Scientific Peer Review Committee review of studiesCommittee review of studies JCCC Quality Assurance oversight/audit ofJCCC Quality Assurance oversight/audit of studiesstudies JCCC/TORI central monitoring ofJCCC/TORI central monitoring of Investigator Initiated studiesInvestigator Initiated studies Liaison coordinators/command center toLiaison coordinators/command center to review eligibility requirements of ALLreview eligibility requirements of ALL patientspatients Translational OncologyTranslational Oncology Research International (TORI)Research International (TORI)
  15. 15. Central site managementCentral site management Central project managementCentral project management Central regulatory submissions and fileCentral regulatory submissions and file maintenancemaintenance Central or local sponsor monitoringCentral or local sponsor monitoring eVelos system… coming sooneVelos system… coming soon Indirect rate/TORI funds = returned to JCCCIndirect rate/TORI funds = returned to JCCC to support research infrastructureto support research infrastructure Translational OncologyTranslational Oncology Research International (TORI)Research International (TORI)
  16. 16. TORI Studies Over 4,000 patients enrolled in more than 160 studies conducted across multiple tumor sites Breast , lung, colon, anemia of cancer, lymphoma, prostate, bladder, ovarian, melanoma, pancreatic, renal, bone mets. Participated in registrational studies including Herceptin, Avastin, Gleevec, Tarceva, Aranesp, Iressa, Zoledronate, Erbitux Multiple FDA, QA, sponsor audits (because of high enrollment) 16
  17. 17. TORI International Sites Open Sites:  Canada  Edmonton: Cross Cancer Institute  Montreal: McGill University  Ireland (Irish Clinical Oncology Research Group ICORG)  Belfast: Belfast City Hospital, Belvoir Park Hospital  Cork: Cork University Hospital, South Infirmary Victoria Hospital, Mercy Hospital, Bon Secours Hospital  Dublin: St. Vincent’s University Hospital, St. James Hospital, Mater Misericordiae University Hospital, Mater Private Hospital, Beaumont Hospital  Galway: University College Hospital  Limerick: Mid-Western Regional Hospital  Sligo: Sligo General Hospital  Waterford: Waterford General Hospital Pending Sites:  India:  Mumbai/Bombay: Tata Memorial Hospital, Jaslok Hospital and Research Centre  Hyderabad: Nizam’s Institute of Medical Sciences  New Delhi: Rajiv Gandhi Cancer Institute & Research Center, All India Institute of Medical Sciences, Jessa Ram Hospital  Pune: Deenanath Mangeshkar Hospital & Research Centre 17
  18. 18. UCLA CRU-TORI Organizational Chart
  19. 19. TORI Organizational Chart
  20. 20.  Trastuzumab (Herceptin) - breast **Trastuzumab (Herceptin) - breast **  Rituxamab (Rituxan) - lymphomaRituxamab (Rituxan) - lymphoma  Imatinib (Gleevec-STI-571) - cml, gist **Imatinib (Gleevec-STI-571) - cml, gist **  Erlotinib (Tarceva-OSI-774) - lung **Erlotinib (Tarceva-OSI-774) - lung **  Gefitinib (Iressa-ZD1839) - lung **Gefitinib (Iressa-ZD1839) - lung **  Cetuximab (Erbitux-C225) - colonCetuximab (Erbitux-C225) - colon  Bevacizumab (Avastin) - colon, lung **Bevacizumab (Avastin) - colon, lung **  Sorafenib (Nexavar-BAY43-9006) - hepatocellular, renalSorafenib (Nexavar-BAY43-9006) - hepatocellular, renal  Sunitinib (Sutent-SU11248) - renal **Sunitinib (Sutent-SU11248) - renal **  Dasatinib (Sprycel-BMS-354825) - cml, breast **Dasatinib (Sprycel-BMS-354825) - cml, breast **  Panitumumab (Vectibix-ABX-EGF) - colorectal **Panitumumab (Vectibix-ABX-EGF) - colorectal **  Lapatinib (Tykerb-GW572016) - breast **Lapatinib (Tykerb-GW572016) - breast **  Bortezomib (Velcade-PS-341) – multiple myeloma, mantle cell lymphomaBortezomib (Velcade-PS-341) – multiple myeloma, mantle cell lymphoma  Temsirolimus (Torisel-CCI-779) – renalTemsirolimus (Torisel-CCI-779) – renal  Pemetrexed (Alimta-LY231514) – lungPemetrexed (Alimta-LY231514) – lung  Telcyta (TLK-286) – lungTelcyta (TLK-286) – lung  Zoledronate (Zometa) – bone metastasis **Zoledronate (Zometa) – bone metastasis **  Aranesp (NESP) – anemia of cancer **Aranesp (NESP) – anemia of cancer **  Palifermin (Kepivance-KGF) – cancer treatment-induced mucositisPalifermin (Kepivance-KGF) – cancer treatment-induced mucositis  ** = number 1,2 or 3 accrual nationally or internationally** = number 1,2 or 3 accrual nationally or internationally UCLA-TORI Accrual SuccessesUCLA-TORI Accrual Successes
  21. 21. • 1995: First UCLA Oncology Network patient enrolled1995: First UCLA Oncology Network patient enrolled • 1997: BCIRG founded in collaboration with Alberta Cancer Board1997: BCIRG founded in collaboration with Alberta Cancer Board in Edmontonin Edmonton • 1999: CIRG incorporated – BCIRG first Oncology division1999: CIRG incorporated – BCIRG first Oncology division • 1999: BCIRG – UCLA collaborate on 11999: BCIRG – UCLA collaborate on 1stst HER2 studiesHER2 studies • 2000: CIRG Paris office opened2000: CIRG Paris office opened • 2003: TORI - Translational Oncology Research International2003: TORI - Translational Oncology Research International formed in August 2003 – 1formed in August 2003 – 1stst patient enrolled October 2003patient enrolled October 2003 • 2004: First ex-US patient enrolled on TORI studies2004: First ex-US patient enrolled on TORI studies • 2004: TORI-CIRG enter into strategic alliance2004: TORI-CIRG enter into strategic alliance • 2006: TRIO (Translational Research in Oncology) developed2006: TRIO (Translational Research in Oncology) developed The Past (Part Three) and the FutureThe Past (Part Three) and the Future TRIO (TORI-CIRG) HistoryTRIO (TORI-CIRG) History
  22. 22. Cancer International Research Group CIRG Not-for-profit Canadian organization Academic Leadership Global Investigator Network Contract Research Organization Experienced Staff Flexible and Dedicated High quality data 22
  23. 23. Worldwide Network of 2,000Worldwide Network of 2,000 Investigators comprised of 500 centers inInvestigators comprised of 500 centers in 45 countries spanning 5 continents.45 countries spanning 5 continents.  Independent InvestigatorsIndependent Investigators  Cooperative groups: ANZ-BCTG,Cooperative groups: ANZ-BCTG, GERCOR, GEICAM, GBG, ICORG, USGERCOR, GEICAM, GBG, ICORG, US Oncology, TORI Oncology ResearchOncology, TORI Oncology Research NetworkNetwork CIRG Investigator NetworkCIRG Investigator Network
  24. 24. CIRG Enrolling RegionsCIRG Enrolling Regions
  25. 25. CIRG Study Successes  BCIRG 001: Adjuvant Ph 3, Node +, 1491 patients – 118 sites in 20 countries – TAC regimen approved by FDA August 2004  BCIRG 005: Adjuvant Ph 3, Node +/HER2- 3301 patients in 320 sites in 38 countries  BCIRG 006: Adjuvant Ph 3, Node +, HER2+ 3200 patients in 393 sites in 40 countries  BCIRG 101: Metastatic Ph2, 1st line HER2+ pilot study for TCH combination – 62 patients in 10 sites  BCIRG 007: Metastatic Ph3, 1st line HER2+ 263 patients – 80 sites  BCIRG 103: Neoadjuvant presurgical treatment, tissue collection – 59 patients in 21 sites in 7 countries 25
  26. 26.  Scientific Development (UCLA)Scientific Development (UCLA)  Medical Supervision (UCLA)Medical Supervision (UCLA)  BiostatisticsBiostatistics  Information TechnologyInformation Technology  Data ManagementData Management  Project ManagementProject Management  Monitoring ResourcesMonitoring Resources  Drug Safety and PharmacovigilanceDrug Safety and Pharmacovigilance  Quality AssuranceQuality Assurance  Finance and Administration (CIRG-TORI)Finance and Administration (CIRG-TORI) TRIO Clinical OperationsTRIO Clinical Operations
  27. 27. TRIO – UCLA InfrastructureTRIO – UCLA Infrastructure Data ManagementCIRG - Edmonton Office • Data Management • Information Technology • Finance • Scientific Development • Logistics CIRG - Paris Office • Project Management • Monitoring Resources • Drug Safety and Pharmacovigilance • Quality Assurance • Finance UCLA-TORI Office •University Laboratories and Clinics •Scientific Development - Medical Mgmt •Site Management •Regulatory Affairs – Project Management •Finance
  28. 28. The Path Forward Clinical Research Translate preclinical findings into clinical research Conduct innovative clinical research across all phases of drug development and multiple indications. Develop and implement clinical operation models for registration and non registration trials Consolidate the existing infrastructure 28

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