Document nkw453QwoMXyR3a3gzJEGL8j8

Shanghai Health Study Sponsor: Benzene Health Research Consortium November 2003 SH ELL-MCCLU RG-068038 Shanghai Health Study Program Program Management Accomplishments Events and Path Forward Shell Activities SH ELL-MCCLU RG-068039 Health Effect Study of Benzene in Shanghai AML/NHL Case Control Study I AA/MDS/AML/BP Disease Progress Study Molecular Epidemiological Study of Benzene Exposure I Joint Sino-US Clinical and Molecular Laboratory CJCML) SH ELL-MCCLU RG-068040 Referral Hospitals Outside Benzene Cases Factories Clinical Laboratory Support L I JCML Laboratory Consultation Exposure SMCDPC SMIPHS Case Control Disease Progression Molecular Epidemiolog~ SH ELL-MCCLU RG-068041 Occupational Disease Society Hematolog ical 1+-......~.... Society .. .~. Cancer Pathological Society Fudan University School of Public Health Shanghai Municipal Center for Disease ....- .... Prevention and Control Shanghai Municipal Institute for Public Health Supervision SH ELL-MCCLU RG-068042 Occupational Disease Society benzene poisoning, Hematolog ical Soc ty Cancer Pathological Society Cases of aplastic anemia, myelodysplastic syndrome, and acute myelogenous leukemia non-Hodgkin's lymphoma Analysis of exposure sample, medical examinations Exposure assessment, factories organizing Shanghai Municipal Center for Disease - ........ Prevention and Control Shanghai Municipal Institute for Public Health Supervision SH ELL-MCCLU RG-068043 Ministry of Health Ministry of Science and Technology Ministry of Education I- - - - - - - - - - - , ,Shanghai I ~, Bureau of - - - ... Fudan University Health ---------------l-~------f---------i ......-------~---. SMCDPC SMIPHS Huashan H SPH Cancer H Lab Database -- ... JCML Factories Hospitals SH ELL-MCCLU RG-068044 Shanghai Health Study Program Management Budget planning - Budget revised to meet new funding level, $21.08M - Working with investigators for protocol revisions, with scientific review, to meet new budget. - Quarterly financial report format finalized. Contract reviews - Process in place External Stakeholders Engagement - Process beginning SH ELL-MCCLU RG-068045 Budget Revision Approved Unapproved Approved Original Cost Revised Cost Cha nges API not Estimate (Jan. Estimate (Dec. approved (June 11 NOV 03 OC Item 2001) 2001) 2003) mtg AHSciences Case-Control Study $1,595,000 $2,283,095 $2,283,095 $2,283,095 DP & ME Studies (UCHSC) $13,665,017 $15,258,017 $15,258,000 $14,508,000 Irons(T & E) $1,253,428 $1,253,428 $1,597,273 $1,413,428 Fudan University $165,700 $190,555 $661,000 $230,000 Total Research Costs $16,679,145 $18,985,095 $19,799,368 $18,434,523 Scientific Review Panel $648,000 $551,736 $300,000 Ethics Review Panel $216,000 $192,000 $64,000 External Pathology & Cytogenetics Workgroups(Cc $130,000 $0 $0 Total Panel Costs $450,000 $994,000 $743,736 $364,000 AP I Seed Monies $500,000 $0 $0 $0 Outside Counsel $500,000 $100,576 $100,000 Public Affairs $1,000,000 $1,000,000 $960,600 $550,000 QA/QC Activities $225,000 $100,000 $100,000 UCHSC Interest ($100,000) contingency $190,855 $0 $0 $390,272 Miscellaneous Costs $1,690,855 $1,725,000 $1,161,176 $1,040,272 Subtotal $18,820,000 $21,704,095 $21,704,280 $19,838,795 API Admin. $941,000 $1,085,205 $1,085,019 $1,245,205 GRAND TOTAL $19,761,000 $22,789,300 $22,789,299 $21,084,000 SH ELL-MCCLU RG-068046 Shanghai Health Study Accomplishments SH ELL-MCCLU RG-068047 Participating Organizations University of Colorado Health Sciences Center Fudan University University of Cincinnati Shanghai Hematology Society Shanghai Pathology Society Shanghai Occupational Medicine Society Shanghai Municipal Center for Disease Prevention Institute for Public Health Supervision Shanghai Public Health Bureau ExxonMobil Biomedical Sciences, Inc. Twenty One Shanghai Referral Hospitals Chinese National Committee on Occupational Standards SH ELL-MCCLU RG-068048 Milestones Feasibility Analysis Shanghai DP/ME Proposals (Prospective) Final SAP Approval Training of clinical and laboratory personnel Laboratory construction begins in Shanghai IntI. Ethics Committee Approves Protocols Contractual Arrangements Completed Laboratory construction completed Aug, 1999 Nov, 1999 Jan, 2001 Feb, 2001 Feb, 2001 Mar, 2001 Aug, 2001 Aug, 2002 SH ELL-MCCLU RG-068049 Milestones Equipment installation and training Jan 2002- Mar, 2003 COMIRB Approval of Protocols (Provisional) May, 2002 Fudan IRB Approval of Protocols Aug, 2002 COMIRB Approval of Protocols (Final) Nov, 2002 Bilingual database system, installed Jan, 2003 Chinese licensing and approval Feb, 2003 US training of Chinese personnel completed Mar, 2003 Clinical Laboratory Start-up Jun,2003 Case Accrual CC, DP Jul,2003 SH ELL-MCCLU RG-068050 SHELL-MCCLURG-068051 Shanghai Health Study Events and Path Forward First Annual Meeting was a success Launch event celebrating completion and start up of the laboratory - December 2003 Stakeholder Engagement discussions to begin- December 2003 Next annual meeting - August 2004 SH ELL-MCCLU RG-0680S2 Shanghai Health Study Shell Activities Shell Communication Quarterly updates Other? SH ELL-MCCLU RG-068053 Shanghai Health Study Sponsor: Benzene Health Research Consortium Shell Steering Team Update September 2004 SH ELL-MCCLU RG-0680S4 Shanghai Health Study Agenda Study Briefing - Program - Program Management - Accomplishments - Shell Activities Shell Business Sponsor Transfer Issues SH ELL-MCCLU RG-068055 Health Effect Study of Benzene in Shanghai AML/NHL Case Control Study I AA/MDS/AML/BP Disease Progress Study Molecular Epidemiological Study of Benzene Exposure I Joint Sino-US Clinical and Molecular Laboratory CJCML) SH ELL-MCCLU RG-068056 Shanghai Health Study Program 6 Sponsors (Shell, ChevronTexaco, ExxonMobil, ConocoPhillips, BP, Marathon) Three studies Benzene and leukemia/lymphoma epidemiology Benzene exposure estimation in Shanghai community - a challenge. Leukemia/lymphoma epidemiology - a science based approach to understanding disease progression of a complex family of diseases: - The older concept that leukemias are fundamentally different from solid tumors of the same cell type, is replaced in the new WHO classification in which lymphoid tumors of a given cell type are a single entity that may present either as leukemia or lymphoma. SH ELL-MCCLU RG-0680S7 Referral Hospitals Outside Benzene Cases Factories Clinical Laboratory Support L I JCML Laboratory Consultation Exposure SMCDPC SMIPHS Case Control Disease Progression Molecular Epidemiolog~ SH ELL-MCCLU RG-068058 Occupational Disease Society Hematolog ical ~........~.. Society .... .~.. Cancer Pathological Society Fudan University School of Public Health Shanghai Municipal Center for Disease ....- .... Prevention and Control Shanghai Municipal Institute for Public Health Supervision SH ELL-MCCLU RG-068059 Shanghai Health Study Program Management Budget planning - Funding level: $21.08M Shell's contribution: $ 4.12M External Stakeholders Engagement - Process beginning SH ELL-MCCLU RG-068060 Budget Revision Approved Unapproved Approved Original Cost Revised Cost Cha nges API not Estimate (Jan. Estimate (Dec. approved (June 11 NOV 03 OC Item 2001) 2001) 2003) mtg AHSciences Case-Control Study $1,595,000 $2,283,095 $2,283,095 $2,283,095 DP & ME Studies (UCHSC) $13,665,017 $15,258,017 $15,258,000 $14,508,000 Irons(T & E) $1,253,428 $1,253,428 $1,597,273 $1,413,428 Fudan University $165,700 $190,555 $661,000 $230,000 Total Research Costs $16,679,145 $18,985,095 $19,799,368 $18,434,523 Scientific Review Panel $648,000 $551,736 $300,000 Ethics Review Panel $216,000 $192,000 $64,000 External Pathology & Cytogenetics Workgroups(Cc $130,000 $0 $0 Total Panel Costs $450,000 $994,000 $743,736 $364,000 AP I Seed Monies $500,000 $0 $0 $0 Outside Counsel $500,000 $100,576 $100,000 Public Affairs $1,000,000 $1,000,000 $960,600 $550,000 QA/QC Activities $225,000 $100,000 $100,000 UCHSC Interest ($100,000) contingency $190,855 $0 $0 $390,272 Miscellaneous Costs $1,690,855 $1,725,000 $1,161,176 $1,040,272 Subtotal $18,820,000 $21,704,095 $21,704,280 $19,838,795 API Admin. $941,000 $1,085,205 $1,085,019 $1,245,205 GRAND TOTAL $19,761,000 $22,789,300 $22,789,299 $21,084,000 SHELL-MCCLURG-068061 Participating Organizations University of Colorado Health Sciences Center Fudan University University of Cincinnati Shanghai Hematology Society Shanghai Pathology Society Shanghai Occupational Medicine Society Shanghai Municipal Center for Disease Prevention Institute for Public Health Supervision Shanghai Public Health Bureau ExxonMobil Biomedical Sciences, Inc. Thirty Shanghai Referral Hospitals Chinese National Committee on Occupational Standards SH ELL-MCCLU RG-068062 Milestones Feasibility Analysis Shanghai DP/ME Proposals (Prospective) Final Scientific review Panel Approval Training of clinical and laboratory personnel Laboratory construction begins in Shanghai Ethics Review Panel Approves Protocols Contractual Arrangements Completed Laboratory construction completed Aug, 1999 Nov, 1999 Jan, 2001 Feb, 2001 Feb, 2001 Mar, 2001 Aug, 2001 Aug, 2002 SH ELL-MCCLU RG-068063 Milestones Equipment installation and training Jan 2002- Mar, 2003 COMIRB Approval of Protocols (Provisional) May, 2002 Fudan IRB Approval of Protocols Aug, 2002 COMIRB Approval of Protocols (Final) Nov, 2002 Bilingual database system, installed Jan, 2003 Chinese licensing and approval Feb, 2003 US training of Chinese personnel completed Mar, 2003 Clinical Laboratory Start-up Jun,2003 Case Accrual CC, DP Jul,2003 SH ELL-MCCLU RG-068064 SH ELL-MCCLU RG-068065 Shanghai Health Study Events and Path Forward First and Second Annual Meetings successfully provided engagement environment for investigators and sponsors to discuss progress and challenges. Launch event celebrating completion and start up of the laboratory - December 2003 - Shell participation Stakeholder Engagement discussions underway Next annual meeting - November 2005 in Shanghai SH ELL-MCCLU RG-068066 Shanghai Health Study (SHS) Shell Activities SHS sponsors are leading petrochemical industry in science based approach to leukemia/lymphoma and relationships to benzene exposure, and Shell is leading the consortium. Global Shell communication continuing Chemicals & RDS Issue Sustainable Development Opportunities being discussed. SH ELL-MCCLU RG-068067 Shanghai Health Study Shell Steering Team Team: Nancy Sullivan, Business sponsor Susan Tholstrup, HSE sponsor Patsy Clegg, Oversight Committee Stuart Cagen, Technical & Budget Committees Shan Tsai, Technical Committee Sarah Colletti, External Affairs Lauren Iannarone, Issues Management John Schmid, Legal Tarita Samuel, Finance Business Sponsor Transition: Contract & Financial Support - Business Sponsor - SH ELL-MCCLU RG-068068 Shanghai Health Study Issues Laboratory sustainability after conclusion of study ~ Sustainable Development Opportunity Chinese support for exposure assessment ~ Malcolm Brinded letter to/meeting with Shanghai mayor Budget ~ Need for prioritization of work ~ Additional funding being sought from industry & associations SH ELL-MCCLU RG-068069