Post on 25-May-2015
CCAFMARCH 3, 2008
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 investigators2
US TORI Oncology Research NetworkUS TORI Oncology Research Network
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
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.
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How to Increase Accrual?IS A COMMUNITY-BASED ONCOLOGY
RESEARCH NETWORK POSSIBLE?2002 - 2003
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Cancer Incidence by Ethnicity All Cancers
County White Black Hispanic Asian-Pacific IslanderAll RacesFresno 5,882 365 1319 335 8,143Kern 5,356 366 263 120 2,051Los Angeles 61,842 13,052 16,462 9,019 102,053Monterey 3,085 157 545 297 4,293Orange 25,062 318 2,642 2,070 30,981Riverside 15,673 824 1,802 332 19,328San Diego 26,735 1,276 3,047 1,720 33,490Ventura 6,969 135 959 294 8,585TOTALS 150,604 16493 27039 14187 208,924
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Cancer Incidence by Ethnicity All Cancers
County White Black Hispanic Asian-Pacific IslanderAll RacesLos Angeles 12,267 2,668 3,587 1,984 20,862Fresno 1,209 50 310 64 1,724Orange 5,139 49 595 448 6,466Riverside 3,240 182 416 76 4,043San Diego 5,281 243 665 360 6,780Ventura 1,473 10 205 54 1,803Kern 1,020 67 166 1,369TOTALS 28,609 3,202 5,778 2,986 41,678
UCLA-TORI Network HistoryPart 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
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Institutional Barriers to UCLA Community Network Research
Contracts and GrantsOne UCLA contract, negotiated on University
terms with UCLA PI
IRBOne 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
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Accrual to Trials Open in Both UCLA and Network
0
50
100
150
200
250
300Network
UCLA
UCLA-TORI Network HistoryPart 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
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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
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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-III TORI Phase I (UCLA/selected TORI sites), Phase II-III TORI and UCLAand 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 TORI Central drug distribution – separate UCLA TORI investigational pharmacyinvestigational pharmacy
Translational Oncology Translational Oncology Research International (TORI)Research International (TORI)
JCCC Internal Scientific Peer Review Committee JCCC Internal Scientific Peer Review Committee review of studiesreview of studies
JCCC Quality Assurance oversight/audit of studiesJCCC Quality Assurance oversight/audit of studies
JCCC/TORI central monitoring of Investigator JCCC/TORI central monitoring of Investigator Initiated studiesInitiated studies
Liaison coordinators/command center to review Liaison coordinators/command center to review eligibility requirements of ALL patientseligibility requirements of ALL patients
Translational Oncology Translational Oncology Research International (TORI)Research International (TORI)
Central site managementCentral site management
Central project managementCentral project management
Central regulatory submissions and file Central 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 JCCC Indirect rate/TORI funds = returned to JCCC to support research infrastructureto support research infrastructure
Translational Oncology Translational Oncology Research International (TORI)Research International (TORI)
TORI StudiesOver 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 includingHerceptin, Avastin, Gleevec, Tarceva,
Aranesp, Iressa, Zoledronate, Erbitux
Multiple FDA, QA, sponsor audits (because of high enrollment)
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TORI International SitesOpen 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 Centre17
JCCC Clinical Research UnitTORI Network Central Administration
SlamonDirector
GlaspyCo-Director
RybaAdministrative Director
McDonaldAssistant Director
TORI NETWORK
National Sites (25)International Sites (20)
Total Staff (55)
JCCC CRUREGULATORY &TORI CENTRAL
ADMIN
Total Staff (30)
TORI NetworkResearch Staff
-National Site Staff (54)-International Site Staff(37*)
* staff do not report toCRU
JCCC CRU Teams(Indirect Reporting)
-Team Leaders (2)-Coordinators (9)-Data Managers (6)-Clinic Coordinator (1)-Assistants (3)
TBNNetwork Field
Operations Manager
GrubbCRU-Network
Regulatory Manager
MuffTORI Chief Financial Officer
Business Director
BarkerCRU Financial Operations
Manager
CRU-TORI Admin &Financial Offices
-Fund Managers (4)
-TORI Financial Assistant(1)
CRU-TORI Assistants (3)
CRU-TORIADMINISTRATIVE &
FINANCIAL OPERATIONS
Total Staff (10)
JCCC OFFICE OFREGULATORYCOMPLIANCE
-Admin Director (1)-QA Monitor-ISPRC (1)-TORI Network Monitors (4)-Assistants (2)
UCLA PHARMACYDEPARTMENT
-UCLA InvestigationalPharmacist (3)-TORI InvestigationalPharmacist (1)
TORI-CIRG
Monitors TORIInvestigator-Initiated Studies
UCLA JCCC CLINICALRESEARCH UNIT
Total Staff (46)
JCCC CRU Teams(Direct Reporting)
-Team Leaders (4)-Coordinators (12)-Data Managers (8)
SpaargarenCRU Operations
Manager
JCCC CRU RegulatoryTORI Central
Administration Teams
-TORI Central AdminSupervisors (2)-TORI Clinical ResearchSpecialists (9)-Liaison Coordinators (2)-Database Coordinator (1)-CRU Direct Regulatory (8)-CRU Indirect Regulatory(7)
UCLA CRU-TORI Organizational
Chart
-UCLA TORI
Memorandum of UnderstandingMOU
-UCLA TORI
Director, Clinical Research Dennis Slamon
-Director, CRU TORI Nancy Ryba
TORI Board of Directors
Dennis Slamon John Mackey John Glaspy Fran Visco Carol Cass
TORI Officers
Chief Medical Officer Fairooz Kabbinavar
Chief Financial Officer Jim Muff
- CRU TORI Administration
Assistant Director Audrey McDonald
- - Operations Regulatory Financial Managers Andrea Barker
Chela Spaargaren Nikko Grubb
TBA
- TORI UCLA Network Sites and Staff
UCLA CRU Research Teams
TORI Central Administration Teams
TORI Liaison Coordinators Renee Robinson
Glaucia Vasquez
- TORI CRU Central Monitoring Senior Manager
- Lii Shin Lin
Central Monitoring Team (3)
TORI Admin Supervisors Gustavo Zetino
TBA
Clinical Research Specialists9( )
TORI Financial Assistant Kathy Farenbaugh
TORI Organizational Chart
Trastuzumab (Herceptin) - breast **Trastuzumab (Herceptin) - breast ** Rituxamab (Rituxan) - lymphoma Rituxamab (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
• 1995: First UCLA Oncology Network patient enrolled1995: First UCLA Oncology Network patient enrolled
• 1997: BCIRG founded in collaboration with Alberta Cancer 1997: BCIRG founded in collaboration with Alberta Cancer Board in EdmontonBoard in 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 studies HER2 studies
• 2000: CIRG Paris office opened2000: CIRG Paris office opened
• 2003: TORI - Translational Oncology Research 2003: TORI - Translational Oncology Research International formed in August 2003 – 1International formed in August 2003 – 1stst patient enrolled patient enrolled October 2003October 2003
• 2004: First ex-US patient enrolled on TORI studies2004: First ex-US patient enrolled on TORI studies
• 2004: TORI-CIRG enter into strategic alliance 2004: 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 FutureTRIO (TORI-CIRG) HistoryTRIO (TORI-CIRG) History
Cancer International Research GroupCIRG
Not-for-profit Canadian organizationAcademic LeadershipGlobal Investigator NetworkContract Research Organization Experienced Staff Flexible and DedicatedHigh quality data
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Worldwide Network of 2,000 Investigators Worldwide Network of 2,000 Investigators comprised of 500 centers in 45 countries comprised of 500 centers in 45 countries spanning 5 continents. spanning 5 continents.
Independent InvestigatorsIndependent Investigators
Cooperative groups: ANZ-BCTG, Cooperative groups: ANZ-BCTG, GERCOR, GEICAM, GBG, ICORG, US GERCOR, GEICAM, GBG, ICORG, US Oncology, TORI Oncology Research Oncology, TORI Oncology Research NetworkNetwork
CIRG Investigator NetworkCIRG Investigator Network
CIRG Enrolling RegionsCIRG Enrolling Regions
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
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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
TRIO – UCLA InfrastructureTRIO – UCLA Infrastructure
Data Management CIRG - 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
The Path ForwardClinical 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 infrastructure28