Document EQkv4VJY0ZMdD066Z4VBVaQL

11126103 final BHRC Oversight Committee Meeting November 10/11, 2003 San Francisco, CA Partici pants: In person: Patrick Beatty, ChevronTexaco Don Burnett, BP Stuart Cagen, Shell Patsy Clegg, Shell Brian Doll, ExxonMobil Mike Johnston, ConocoPhillips Lorraine Twerdok, API By Phone (part-time) Lynn Russo, ExxonMobil Matt Todd, API Welcome, emergency review, antitrust and agenda review completed. Minutes from 8-20-03, 8-26/27-03, 8-27-03, 9-29-03, 10-7-03, 10-9-03, 10-28-03 meetings/conference call approved (motion Don, second Brian), pending revision of 10/7/03 minutes to include BPs agreement on project completion, without compromise to study integrity, on $21,084,000 budget. Minutes Action Items: 1. Minutes should reference completed work products in a manner that they can be accessed, as necessary. (Lorraine) 2. Going forward, minutes will be put out for 2-week comment period. Comments will be incorporated and finalized after the two week period, unless an item needs further consideration by OC. (Lorraine/Paula) Communications Committee Update& Budget Recommendation (Lynn) Media plan to Oversight Committee by end year - APCO China presentation to CC - October - Circulate/comment on/finalize plan - November - Update key messages and summary pages - October/November Stakeholder engagement process discussed with BHRC first half 2004 - Coordinate with Technical Committee on timeline - ongoing - CC discussion/alignment on approach - 4003 - Discussion within BHRC - 1004 - Revise/finalize process - 2004 Define budget and APCO contract commitments - 4003 - See Contract Review - Budget projection assumptions: + No extraordinary activity level requiring unanticipated effort + Results - oriented communication activity not addressed SH ELL-MCCLU RG-055996 11126103 final + Does not include launch costs ($1 0-15k) Actual expenditures thru 3003 Budget 4003 2004 2005 2006 2007 $ 263,178 $ 15,000 $ 60,000 $ 60,000 $ 60,000 $ 91,822 Total $ 550,000 OC Decision: Reduction in Communications budget from $1 M to $550k approved. 3Q03 Financial Report: Accepted by technical Committee 10/28/03 Accepted by OC Committee 11/10103 (move - Don, second - Patsy, approve - all) Financial Report Action Items: 1. Add a worksheet with case accrual projected, actual, and trailing 12 month avg. a. Develop worksheet (Lorraine) b. Work with PI's to populate worksheet (Patrick & Stuart) 2. Project cash flow worksheet out through 2007 (Lorraine) 3. Itemize UCHSC subcontractors for 4003 (Bruce) 4. Verify variances on program summary sheet (Lorraine) Budget (Stuart) See budget document "BHRC budget 11-10-03" Budget as described in spreadsheet approved unanimously (Mike motion, Patrick second). Assuming reductions: communications to $550K outside legal to $1 OOK OA/OC to $1 OOK Fudan to $230K SRP/ERP to $364K Cytopathology consultation to $0 (included in UCHSC grant) SH ELL-MCCLU RG-055997 11126103 final Starting budget + Irons Field Expenses + Urinary Biomarkers/HIV test controls + Program Launch in China (in API budget) + API additional expense (recruitment, program funding, financial report setup, annual meeting expenses) TOTAL - Reduction of 1000 ME cases - UCHSC Interest New Total Program Budget Contingency See spreadsheet for more exact figures $21,220,000 160,000 150,000 15,000 145,000 $21,690,000 (900,000) (100,000) $20,690,000 $21,084,000 $394,000 Budget Action Items: 1. Verify that current expense pf $52,435 is included in Fudan estimate of $230,000 (Bruce) 2. Contact AHS to discuss overspending - especially labor (Patrick) 3. Contact UCHSC to verify that interest on unspent grant funds go back into program funds, and that interest is accounted for and applied toward program costs. Agree via letter. Fallback position is to return interest income to consortium. (Bruce/Technical budget WG) 4. Request cost reduction amount for ME to reduction to 1000 cases (Bruce) 5. Task Irons to go to SRP with ME case reductions, urinary biomarkers, and HIV determination in controls for approval (Bruce) 6. Assuming SRP approval of #5, task Irons with IRB approval (Bruce) 7. Determine if IRB approval renewed as of May, 2003, and payment status (Bruce) 8. Contact SRP & ERP Chairs to inform that: (Patsy, Don) a. Requesting UCHSC to reduce ME to no less than 1000 cases b. Add urinary biomarkers c. Add HIV determination in controls d. (other deep admin cuts to meet new budget) 9. Circulate new, approved budget, and add to financial report (Lorraine) 10. Communicate to UC new approved Grant amount so Irons can pay subcontractors. Other Budget Action Items: 1. Follow up on BP payment of 10103 invoice (Don) 2. Follow up on application of clinical laboratory profit to research funding (John Wagner & Mark Fitzsimmons) 3. QA/QC requirements and contracting (Michael Bird) 4. Review and arrange for completion of action items from Tarita's report. (Patsy) 5. Add Contingency fund worksheet to financial spreadsheet (Lorraine) SH ELL-MCCLU RG-055998 11126103 final Sponsor Funding Schedule: Table development of invoicing schedule until have updated budget based on newly approved budget. Action Items: a. Update budget based on newly approved budget (API) b. Update Cash Flow and project out thru 2007 (Lorraine) c. Determine when run out of $ from current $16.5M (from b.) (Lorraine) d. A-C due mid-December. Status of Marathon Payment: Have been contacted by Don, and confirmed $200K amount. Expect MAP to get back to Don in a few weeks with preferred payment method, and benefits they expect. Annual Report to Sponsors: Summary of Annual Research meeting fulfills this obligation. Contract Review: Sponsor Agreement Action Items: a. Reassemble ad hoc legal group for agreement review and amendment (John Wagner) b. Circulate list of issues for review and comment, then give to ad hoc legal committee to assist agreement review. (Patsy) UCHSC: All recommendations accepted except for #2 (oversight of subcontractors). Action Items: a. Contact Irons on data access and final report; amend grant appropriately (Stuart & Patrick). b. Contact Irons for expense needs, write amendment and disperse funds by Dec 15 (Bruce) APCO: All recommendations accepted. Action Item - get contract amendment started ASAP (Matt). Irons Field Expenses Action Items: a. Amend contract to pay $1 OOK under existing terms (Bruce) b. Request "daily ledgers" to date, to determine if sufficient detail (Bruce) c. Redo contract by end of 1003 (Bruce) AHS: Recommendations accepted. SH ELL-MCCLU RG-055999 11126103 final Acknowledgements - "BHRC consisting of ChevronTexaco, ConocoPhillips, ExxonMobil and Shell, with additional support by Marathon Ashland Petroleum." Action Item - see if BP wants to be named, also. (Don) Fudan University: Recommendations accepted for incorporation into new contract. Action Item - check back on invoices for taxi charges - they seem too high (Bruce) Information - Benzene International Symposium is scheduled for October 11-13,2004, in Munich. Stakeholder Recruitment - Action Items: a. Provide strawman on logistics to approach various categories of stakeholder to present at Dec 15 conference call. (Lynn) b. Circulate ORO contact that requested information on program; supply information (Matt & Patrick) c. Review basic information documents, and arrange for update as appropriate (Matt, TC, CC) 2004 Annual Meeting Planning Decision - Asilomar, August 16 -19 (3 nights). Hold BHRC meetings Aug. 15/16 in San Francisco. Annual Meeting Action Items: a. Have Madeleine check Asilomar availability for dates (3 nights). See if can book everyone into one building that has a "living room." Book outside BBQ area for Monday night social. (Lorraine) b. Inform OC, TC, CC, Pis, SRP, ERP of dates ("details to follow"). (Lorraine) c. Develop strawman attendance list from 2003 attendance. (Lorraine) d. Make companies responsible for paying for company no-shows - commitment is for entire meeting; less than full-time attendees make their own accommodations arrangements Decision - do not translate 2003 Annual Meeting slides into Chinese. Other Action Items: a. Circulate API accounting procedures presentation and explanation of API expenses to OC. (Lorraine) b. Circulate new budget (Lorraine) Next Conference Calls: SH ELL-MCCLU RG-056000 11126103 final Monday, December 15, 2003 3-5 PM (EST) OC and Communications Committee - stakeholder recruitment discussion Wednesday, December 17, 2003 2-5 PM (EST) OC - Update on contract progress, review new budget distributions, ~C, CC, TC committee chair rotations (2 year terms are up). SHELL-MCCLURG-056001