Document 2RrB8Gjjq6p1qjMpr8R6xabya

8127104 Draft BHRC Oversight Committee Meeting Minutes August 16 -19, 2004 San Francisco & Monterey Meeting Minutes Note: The BHRC OC met on four consecutive days: August 16, 17, 18, and 19. Since many topics were discussed on several days, the minutes are organized by topic, rather than date. To avoid confusion, only the final disposition of topics is presented in the minutes. A list of attendees by date is presented at the end of the minutes. L. Twerdok provided antitrust guidance and established that a quorum of voting members was present at all meetings. Consortium Agreement Amendment #2 Discussions were initiated on 8/16/04 and final approval on the amendment #2 language was given on 8/19/04. It was decided that members should have the signed amendment(s) returned to API by September 15, 2004. ACTION: J. Wagner will make all approved changes to the amendment and will obtain API signatures. Two copies of the API signed amendment will then be sent to OC members for signature. Additionally, for those companies that did not sign amendment #1 (which changed the payment schedule for payment in 2003/early 2004 of all initially committed funds), amendment #1 will be sent along with amendment #2 for signature. Technical Committee Update (P. Beattvon 8116) For information - NCI is updating their previous case-cohort study in Beijing; the contact, per federal register notice, is Richard Hayes SRP/ERP pre-annual meeting conference call went well o No new substantive issues o Discussions tended to be follow-ups from the 2003 Annual Meeting (SRP- urinary biomarkers) or revisiting issues (ERP - patienVcontrol compensation) Study Progress o Case-control study issue with controls resolved by only using inpatients as controls for NHL o Exposure assessments behind schedule o AML case accrual is faster than expected; NHL accrual numbers are lower than estimated but not expected to adversely impact study o Laboratory turnover/transition to Fudan University may come sooner than expected - see more detailed discussion below under PI/sponsor discussions Outreach Update Outreach contact matrix updated, see attached file, which will also be posted to the website Communications Committee is developing process for individual company outreach - discussions are still in committee ACTIONS: L. Twerdok will (1) follow up with H. Feldman to see if there will be a slot on the October 19 HESGC agenda for a SHS update, (2) seek opportunity for a SHS Page 1 of 6 SHELL-MCCLURG-056616 8127104 Draft update to the newly formed General Committee on Special Programs (GCSP), and (3) circulate roster for GCSP. Review of Action Item Table and 2004 vearlv plan Action item table was updated, see attached file, which will also be posted to the website Action item table & yearly plan to be updated on calls and at meetings. Both documents will be posted to the website ACTIONS: L. Twerdok will update update OC action item table, and coordinate posting to website M. Todd will tabulate list of additional professional organizations for potential outreach for OC discussion at the Nov. 3-4, 2004 meeting in Houston M. Johnston will work with J. Wagner to further investigate cost recovery potentials for the JCML; this activity could be a good way to initiate transition of laboratory to Fudan University M. Todd and B. Jarnot to fill in 2004 Plan for Communications, Technical and Budget committees M. Todd, B. Jarnot and L. Twerdok, in consultation with respective committees, will update yearly plan, and post updates to website New Funding Sponsor Privileges Agreed privileges are summarized in table below ACTIONS: L. Twerdok to communicate privileges to Marathon M. Todd to give Craig Parker of Marathon Ashland full access to website (with the exception of the SRP/ERP areas, which no sponsor has access to) OC members should use this chart in any updates presented at API, and other presentat'Ions as appropn.ate Approved Sponsorship Privileges for New Funding Sponsors Privileges Oversight Committee Technical Committee Budget Committee Communications Committee SRP/ERP Study Updates Website access Financial Reports Identified as sponsor on publications, posters and meeting presentations Annual Meeting $200,000 X Observer X Invite to participate X ~ ~ ~ Second tier acknowledgement: 'With additional funding by ..." Observer $500,000 1 share Participant Participant Participant Participant X ~ ~ ~ Full Participant Page 2 of 6 SHELL-MCCLURG-056617 8127104 Draft 2Q04 Financial Report 2Q04 report reviewed and approved 8/17/04, pending (1) receipt of UCHSC financial report and insertion of UCHSC subcontractor cost breakout, and (2) updating of case accrual worksheet OC approved leaving contingency expense projection in 2005 Sponsor invoicing of remaining committed funds to be done on an as needed basis ACTIONS: B. Jarnot to update/verify case accrual numbers for 2Q04, and add case referral numbers (total number of diagnosis performed at JCML) to 3Q04 financial report Technical Budget Committee to develop recommendations to OC for sponsor invoicing as funds are required L. Twerdok to add invoice dates to yearly plan as they are adopted L. Twerdok and B. Jarnot to adjust UCHSC EMBSI subcontractor projected expenses to first half of calendar year. EMBSI is paid once per year, rather than the current biannual projections 0 Discussions between OC and PIs Clinicallaboratorv transition and turnover after the SHS is completed (8116 & 18) It is not too soon to begin developing plan, with the goal of initiating discussion in 1Q05 and presenting formal plan to Chinese at the 2005 Annual Meeting in Shanghai Brainstorming ideas: o Commercialization of lab to make it self-supporting/profitable could be a part of the transition plan o Identification of a Chinese Clinical Director to manage the transition o Joint venture opportunities with Chinese & biotech industry to conduct fee-for-service, while maintaining diagnostic and research functions of the lab R. Irons informed OC on 8/18 that Fudan University is already having internal discussions on the disposition of the laboratory once the SHS is complete. ACTIONS: M. Johnston to take lead on lab transition/turnover plan development. M. Johnston to work with S. Tsai and J. Wagner on issue OC members to research in-house experience on sustainability transitions, e.g. health clinics in E&P areas R. Irons to keep OC informed of progress/decisions by Fudan University on disposition of laboratory Outreach & Publications L. Russo explained BHRC plans for outreach to a broader circle of stakeholders (in addition to PI traditional outreach via scientific publications and presentations) Investigators concurred with sharing with Technical Committee pre-submission publications for suggestions to improve quality of manuscripts (as with the SRP/ERP, acceptance/rejection of comments totally at discretion of Pis) BHRC may enlist PI aid and knowledge of Chinese cultural differences for outreach in China ACTION Investigators will keep SRP, ERP, Technical Committee and OC updated on upcoming scientific meeting presentations and papers, and circulate draft manuscripts to SRP/ERP and Technical Committee prior to submission to journals Page 3 of 6 SHELL-MCCLURG-056618 8127104 Draft Exposure Assessment Issues Exposure assessment behind case accrual ACTIONS P. Clegg work with R. Irons to explore use to Shell's access to Shanghai Mayor's Office to request that IPHS devote more experienced IH resources to the study QAIQC Issues for Case Control study and Exposure Assessment ACTION: Technical Committee to evaluate existing QA/QC resources to see if they can be deployed to address IH and QA/QC issues. Program Budget: Exposure assessment and QA/QC issues will have budgetary impact ACTIONS: R. Irons and O. Wong will develop revised study proposals to align funding to address exposure assessment and QA/AC issues. Technical Committee will work with the investigators in development of proposals, and appropriate review by OC and SRP/ERP. Technical Committee will update OC on investigators' proposals at the November OC meeting in Houston. M. Bird will explore funding opportunities with American Leukemia Society, Health Effects Institute (HEI), and International Life Sciences Institute/Health Effects Sciences Institute (ILSI/HESI), and report back on progress at the November OC meeting. 2005 Annual Meeting Planning (discussions on 8116, 8118 with PIs, and 8119) Possible Shanghai venues suggested by Pis o Ritz Carlton o Four Seasons o Hilton o Howard Johnson P. Clegg contacted first three hotels via internet for preliminary information/rates. It appears to be feasible to arrange meeting by phone and email. API to take lead on meeting planning; do not want to divert laboratory resources for meeting planning purposes Should plan one hour rest period after lunch, in the Chinese custom Dr. Irons volunteered his assistant to arrange the banquet Laboratory tours in small groups (6-8); should be able to move guests through in 1.5- 2 hrs, reserve a half day on the agenda for tours Need to reserve time on agenda for Q&A during plenary sessions Attendees to include Pis, SRP/ERP, sponsors, API staff (as directed by OC), and invite sponsor in-country representative attendance (first day plenary) Preliminary 2005 agenda: Day 1 Day 2 -AM PM Day 3 -AM Full Day Plenary Include time for Q&A Close with panel discussion Laboratory tour Closed SRP/ERP meetings SRP/ERP/PI meetings Evening banquet Page 4 of 6 SHELL-MCCLURG-056619 8127104 Draft PM I Closing Plenary I Logistics: Begin meetings at 9 AM noon - 1 PM Lunch provided at meeting 1 - 2 PM rest period, in the Chinese custom TBD - provide group breakfasts I I ACTION: L. Russo and C. Roythorne to check if they have corporate discounts with any of the potential hotels for the meeting M. Sellouk to research hotel options for 2005 Annual Meeting in Shanghai and report to OC at November OC meeting O. Wong to provide L. Twerdok detailed map of Shanghai, noting locations of hotels and Fudan University 8120104 "Lessons Learned" debrief of 2004 Annual Meeting Include attendee roster with full contact information in meeting packages next year. Reserve plenty of time for Q&A during opening plenary session Pis should be invited to give closing remarks, in addition to SRP/ERP Chairs and Sponsors OC/PI informal discussion session worked well, repeat in 2005 Next Meeting: WednesdayfThursday November 3-4, 2004 November 3; 1 - 5 PM November 4; 8 - noon ConocoPhillips to host in Houston ACTION: M. Johnston to provide logistical information to L. Twerdok for distribution to OC Agenda to include: Review professional organizations identified for outreach by L. Russo and M. Todd Update on International Benzene Symposium Lab transition - OC members to report out on company experience with similar sustainability transitions (e.g. health clinics) Update action item table and 2004 Plan Update on 2005 Annual Meeting hotel options (M. Sellouk) Contract status review M. Bird update on funding solicitation progress Technical Committee report on PI proposals Technical Budget Committee recommendation for timing of 2005 sponsor invoicing Page 5 of 6 SH ELL-MCCLU RG-056620 8127104 Draft BHRC Oversight Committee Meeting Attendees by Date MondaY,August16,2004: In person: Patrick Beatty, ChevronTexaco Don Burnett, BP Patsy Clegg, Shell Brian Doll, ExxonMobil Mike Johnston, ConocoPhillips Lynn Russo, ExxonMobil Lorraine Twerdok, API By phone: Mark Fitzsimmons, Steptoe & Johnson (PIT) John Wagner, API TuesdaY,August17,2004: In person: Patrick Beatty, ChevronTexaco Don Burnett, BP Stuart Cagen, Shell Patsy Clegg, Shell Brian Doll, ExxonMobil Mike Johnston, ConocoPhillips Lynn Russo, ExxonMobil Lorraine Twerdok, API By phone: Mark Fitzsimmons, Steptoe & Johnson (PIT) John Wagner, API WednesdaY,August18,2004: Patrick Beatty, ChevronTexaco Michael Bird, ExxonMobil Don Burnett, BP Patsy Clegg, Shell Brian Doll, ExxonMobil Mike Johnston, ConocoPhillips Chris Roythorne, BP Lynn Russo, ExxonMobil Lorraine Twerdok, API Guests: Richard Irons, UCHSC Robert Schnatter, EMBSI Otto Wong, Applied Health Sciences Thursday, August 19, 2004: Patrick Beatty, ChevronTexaco Don Burnett, BP Stuart Cagen, Shell (PIT) Patsy Clegg, Shell Brian Doll, ExxonMobil Lorraine Twerdok, API Guest Michael Bird, ExxonMobil (PIT) Page 6 of 6 SHELL-MCCLURG-056621