Document nkNO1dvD8yxyGaXrX6XY4YXz6

To: 'George Woodall' <Woodallg@api.org> From: Cagen, Stuart Z SCC <szcagen@SheII.Com> Cc: Lorraine Twerdok <twerdokl@api.org>; Paula Podhasky <podhaskyp@api.org>; John Wagner <Wagner@api.org>; Bill Frick <frick@api.org>; 'burnetdm@bp.com' <burnetdm@bp.com>; 'burnetdm@bp.com' <burnetdm@bp.com>; 'bondtj @bp.com' <bondtj @bp.com>; 'michael.d.johnston@usa.conoco.com' <michael.d.johnston@usa.conoco.com>; 'carol.a.fairbrother@exxonmobil.com' <carol.a.fairbrother@exxonmobil.com>; 'Iynn.b.russo@exxon.com' <lynn. b. russo@exxon.com>; 'pwbe@chevron.com' <pwbe@chevron.com>; 'twerdokl @api.org' <twerdokl @api.org>; 'pmclegg@shellus.com' <pmclegg@shellus.com>; 'woodallg@api.org' <woodallg@api.org>; 'roythorc@bp.com' <roythorc@bp.com>; 'burnetdm@bp.com' <burnetdm@bp.com>; 'bondtj@bp.com' <bondtj@bp.com>; 'bill.d.broddle@usa.conoco.com' <bill.d.broddle@usa.conoco.com>; 'carol.a.fairbrother@exxonmobil.com' <carol.a.fairbrother@exxonmobil.com>; 'pwbe@chevron.com' <pwbe@chevron.com>; 'roythorc@ bp. com' <roythorc@ bp. com>; 'sptsai @shellus.com' <sptsai @shellus.com>; 'woodallg@api.org' <woodallg@api.org>; 'szcagen@SheIlUS.Com' <szcagen@SheIlUS.Com> Bcc: Received Date: 2001-08-24 10:56:40 GMT Subject: RE: Benzene Consortium Status Update George: A note to confirm what we discussed yesterday: I am comfortable and quite excited about the depth of the peer review that is expected prior to and during the Scientific Review Panel meeting, which includes at least one individual from each discipline, with the exception, so far, of a biostatisician. As we discussed, I would highly recommend a formalized process for the peer review whereby there is designated a chair of the Scientific Review Panel (perhaps Dr. Larson ?) and that a product of the meeting on the 27th of September should be a report from the Scientific Review Panel to the investigators (cc: the technical review committee). The chair would author the report but all of the members of the Scientific Review Panel should review and approve draft(s). I suppose that most of the members of the Scientific Review Panel would resist taking on the role of the chair because of a perceived extra load of work, but you could possibly reassure them that you can help with the compiling of individual review comments, possibly, but not necessarily, as a rappatour for the Panel (I hope you would agree to this). Regardless, this should not be a role of any of the industry members - neither oversight nor technical committees. I would ask, however, that the technical committee be included in the correspondence between the Scientific Review Panel and the investigators so there is sponsor understanding of the review as well as investigator responses or recommended program adjustments. Finally, as mentioned before, I would like to included in discussions regarding the implementation of this program, and hope that my willingness to be an active member of the technical committee is viewed as an asset. Regardless, it is an expectation on my end. Thanks SHELL-MCCLURG-055179 Best wishes Stuart > -----Original Message----- > From: George Woodall [SMTP:Woodallg@api.org] > Sent: Thursday, August 23, 2001 5:50 PM > To: BenzConsort@listserve.api.org > Cc: Lorraine Twerdok; Paula Podhasky; John Wagner; Bill Frick; Stuart > Cagen Ph.D. (E-mail) > Subject: Benzene Consortium Status Update > > To all interested parties; > > Please forward this message to anyone not on the attached list that should > be included. > > This e-mail is being sent to foster better communications. Much has > happened in the past few weeks and more will need to happen in order to > make this consortium work. > > * List of Committees - I have attached a Word document that lists all > the members and ex-officio members of the consortium committees, and a > separate list of "interested parties" that should include everyone on the > other three lists along with others. This document also includes the list > server e-mail addresses for each group, along with the e-mail addresses > for each individual. > * Legal Workgroup - A Legal Workgroup was formed to try to iron out > the issues associated with developing the consortium agreement. This is a > very time-sensitive issue since many of the contributing companies have > tied having a finalized and signed contract in place prior to honoring any > invoices for the consortium. As it now stands, we have had communication > from 4 of the 5 companies indicating that they prefer the bilateral > contract arrangement over the option for the consortium to incorporate > separately. The attached e-mail from John Wagner includes the latest > draft of the agreement document. > * Scientific Review Panel - The candidates for the SRP that have > accepted include: Jerry Rice (IARC - General Toxicolgy), Helmut Greim > (University of Munich - General Toxicolgy), Li Guilan (Chinese Academy of > Preventative Medicine - Genetic Toxicolgy), Richard Larson (Univ. of > Chicago - Hematology), Robert Herrick (Harvard - Industrial Hygiene), John > Cherrie (University of Aberdeen- Industrial Hygiene), and Nancy Mueller > (Harvard - Epidemiology). The following have been invited to participate > but have not yet indicated acceptance: Martha Linet (NCI - Epidemiology), > Mark Minden (Ontario Cancer Center - Hematology), Richard Brunning > (University of Minnesota - Hematopatholgy), and Kenneth Kopecky > (University of Washington - Statistics and Study Design). > * Protocol Review Meeting - Scheduled for September 27 in Chicago. > The panel that will review the protocols include all of the SRP members > that have accepted, as well as Elizabeth Delzell (University of Alabama at > Birmingham - Epidemiologist) and Richard Albertini (University of Vermont > - Genetic Toxicology), both of whom were retained prior to the development > of the SRP. Not all of the members of the SRP will be able to attend, but > have promised to at least provide written comments prior to the meeting. SHELL-MCCLURG-055180 > * Contracts with the Researchers - API is in the process of developing > separate contracts with American Health Sciences (Dr. Otto Wong) and Fudan > University (Dr. Fu Hua) for the Case-Control portion of the project. A > larger grant to the University of Colorado Health Sciences Center (Dr. > Richard Irons) is also in process which will include the funding for the > parts of the Molecular Epidmiology and Disease Progression studies being > done at Fudan University, and the other Chinese agencies in Shanghai. A > separate contract with Dr. Richard Irons' consulting company is being > drafted to cover project-related expenses that could not be included in an > agreement with the University of Colorado (travel for UCHSC staff, housing > in China, etc.). At present, much of this can only go to the draft stage > until the funding to support the contract/grant is on the ledger at API. > > I hope this helps to keep you updated. If there is additional information > that you feel needs to be communicated, please send me an e-mail or give > me a call. > > Best regards, > > George M. Woodall, Ph.D. > Senior Scientist > American Petroleum Institute > 1220 L Street, NW > Washington, DC 20005 > > Tel. (202)682-8067 > Fax. (202)682-8031 > ----------------------------------------------- File: > BenzeneConsortiumCommittee.doc Message: Benzene Consortium > Agreement SHELL-MCCLURG-055181 To: From: Cc: Bcc: Received Date: Subject: szcagen@shell.com <szcagen@shell.com> lynn. b. russo@exxonmobil.com <lynn. b. russo@exxonmobil.com> 2001-08-24 12: 16:24 GMT RE: Benzene Consortium Status Update this didn't get to you on the first attempt so I'll try again. ----- Forwarded by Lynn B Russo/FairfaxlExxonMobil on 08/24/01 08: 12 AM Lynn B Russo To: "Cagen, Stuart Z SCC" <szcagen@SheII.Com>@SMTP@Exchange1 cc: bill.d.broddle@usa.conoco.com, bondtj@bp.com, 08/24/01 08: 10 burnetdm@bp.com, Carol A Fairbrother/FairfaxiMobil-Notes@xom, Bill AM Frick <frick@api.org>, L.B. (Lynn) Russo/lbrusso/Americas/Exxon@c-Americas2, michael.d.johnston@usa.conoco.com, pmclegg@shellus.com, Paula Podhasky <podhaskyp@api.org>, pwbe@chevron.com, roythorc@bp.com, sptsai@shellus.com, szcagen@SheIlUS.Com, Lorraine Twerdok <twerdokl@api.org>, John Wagner <Wagner@api.org>, George Woodall <W oodallg @api.org> Subject: RE: Benzene Consortium Status Update(Document link: Lynn B Russo) thank you; good note. In regard to one your points below, the Operations Committee discussed at its last meeting the need for complete independence of the Scientific Review Panel. In that discussion, it was agreed the panel should have available the necessary staff support to conduct its work--call meetings, write reports, assemble comments, etc. It was further agreed that while the API/George could perform that function, the consortium companies were willing to provide the needed fundings to retain support outside the companieS/API if the Panel felt it preferred such independence. It sounds like that offer/option should be discussed with the Panel now. (And it may help in recruiting a chair.) Lynn Lynn B. Russo Phone: 703-846-2500 Fax: 703-846-4169 Email: Iynn.b.russo@exxonmobil.com "Cagen, Stuart Z SCC" To: George Woodall <Woodallg@api.org>@SMTP@Exchange1 <szcagen@Shell. cc: Lorraine Twerdok <twerdokl@api.org>@SMTP@Exchange1, Paula Com> Podhasky <podhaskyp@api.org>@SMTP@Exchange1, John Wagner <Wagner@api.org>@SMTP@Exchange1, Bill Frick <frick@api.org> SHELL-MCCLURG-055182 @SMTP@Exchange1, burnetdm@bp.com@SMTP@Exchange1, 08/24/01 06:56 burnetdm@bp.com@SMTP@Exchange1 , bondtj @bp.com@SMTP@Exchange1 , AM michael.d.johnston@usa.conoco.com@SMTP@Exchange1, Carol A Fairbrother/FairiaxiMobil-Notes@xom, L. B. (Lynn) Russo/lbrussolAmericas/Exxon@c-Americas2, pwbe@chevron.com@SMTP@Exchange1, twerdokl @api.org@SMTP@ Exchange1 , pmclegg@shellus.com @SMTP@ Exchange1 , woodallg@api.org@SMTP@Exchange1, roythorc@bp.com@SMTP@Exchange1, burnetdm@bp.com@SMTP@Exchange1, bondtj @bp.com@SMTP@Exchange1 , bill.d.broddle@usa.conoco.com@SMTP@Exchange1, Carol A Fairbrother/FairiaxiMobil-Notes@xom, pwbe@chevron.com@SMTP@Exchange1, roythorc@bp.com @SMTP@ Exchange1 , sptsai@shellus.com@SMTP@Exchange1, woodallg@api.org@SMTP@Exchange1, szcagen@SheIlUS.Com @SMTP@ Exchange1 Subject: RE: Benzene Consortium Status Update George: A note to confirm what we discussed yesterday: I am comfortable and quite excited about the depth of the peer review that is expected prior to and during the Scientific Review Panel meeting, which includes at least one individual from each discipline, with the exception, so far, of a biostatisician. As we discussed, I would highly recommend a formalized process for the peer review whereby there is designated a chair of the Scientific Review Panel (perhaps Dr. Larson ?) and that a product of the meeting on the 27th of September should be a report from the Scientific Review Panel to the investigators (cc: the technical review committee). The chair would author the report but all of the members of the Scientific Review Panel should review and approve draft(s). I suppose that most of the members of the Scientific Review Panel would resist taking on the role of the chair because of a perceived extra load of work, but you could possibly reassure them that you can help with the compiling of individual review comments, possibly, but not necessarily, as a rappatour for the Panel (I hope you would agree to this). Regardless, this should not be a role of any of the industry members - neither oversight nor technical committees. I would ask, however, that the technical committee be included in the correspondence between the Scientific Review Panel and the investigators so there is sponsor understanding of the review as well as investigator responses or recommended program adjustments. SHELL-MCCLURG-055183 Finally. as mentioned before, I would like to included in discussions regarding the implementation of this program, and hope that my willingness to be an active member of the technical committee is viewed as an asset. Regardless, it is an expectation on my end. Thanks Best wishes Stuart > -----Original Message----> From: George Woodall [SMTP:Woodallg@api.org] > Sent: Thursday, August 23, 2001 5:50 PM > To: BenzConsort@listserve.api.org > Cc: Lorraine Twerdok; Paula Podhasky; John Wagner; Bill Frick; Stuart > Cagen Ph.D. (E-mail) > Subject: Benzene Consortium Status Update > > To all interested parties; > > Please forward this message to anyone not on the attached list that should > be included. > > This e-mail is being sent to foster better communications. Much has > happened in the past few weeks and more will need to happen in order to > make this consortium work. > > * List of Committees - I have attached a Word document that lists all > the members and ex-officio members of the consortium committees, and a > separate list of "interested parties" that should include everyone on the > other three lists along with others. This document also includes the list > server e-mail addresses for each group, along with the e-mail addresses > for each individual. > * Legal Workgroup - A Legal Workgroup was formed to try to iron out > the issues associated with developing the consortium agreement. This is a > very time-sensitive issue since many of the contributing companies have > tied having a finalized and signed contract in place prior to honoring any > invoices for the consortium. As it now stands, we have had communication > from 4 of the 5 companies indicating that they prefer the bilateral > contract arrangement over the option for the consortium to incorporate > separately. The attached e-mail from John Wagner includes the latest > draft of the agreement document. > * Scientific Review Panel - The candidates for the SRP that have > accepted include: Jerry Rice (IARC - General Toxicolgy), Helmut Greim > (University of Munich - General Toxicolgy), Li Guilan (Chinese Academy of > Preventative Medicine - Genetic Toxicolgy), Richard Larson (Univ. of > Chicago - Hematology), Robert Herrick (Harvard - Industrial Hygiene), SHELL-MCCLURG-055184 John > Cherrie (University of Aberdeen- Industrial Hygiene), and Nancy Mueller > (Harvard - Epidemiology). The following have been invited to participate > but have not yet indicated acceptance: Martha Linet (NCI - Epidemiology), > Mark Minden (Ontario Cancer Center - Hematology), Richard Brunning > (University of Minnesota - Hematopatholgy), and Kenneth Kopecky > (University of Washington - Statistics and Study Design). > * Protocol Review Meeting - Scheduled for September 27 in Chicago. > The panel that will review the protocols include all of the SRP members > that have accepted, as well as Elizabeth Delzell (University of Alabama at > Birmingham - Epidemiologist) and Richard Albertini (University of Vermont > - Genetic Toxicology), both of whom were retained prior to the development > of the SRP. Not all of the members of the SRP will be able to attend, but > have promised to at least provide written comments prior to the meeting. > * Contracts with the Researchers - API is in the process of developing > separate contracts with American Health Sciences (Dr. Otto Wong) and Fudan > University (Dr. Fu Hua) for the Case-Control portion of the project. A > larger grant to the University of Colorado Health Sciences Center (Dr. > Richard Irons) is also in process which will include the funding for the > parts of the Molecular Epidmiology and Disease Progression studies being > done at Fudan University, and the other Chinese agencies in Shanghai. A > separate contract with Dr. Richard Irons' consulting company is being > drafted to cover project-related expenses that could not be included in an > agreement with the University of Colorado (travel for UCHSC staff, housing > in China, etc.). At present, much of this can only go to the draft stage > until the funding to support the contract/grant is on the ledger at API. > > I hope this helps to keep you updated. If there is additional information > that you feel needs to be communicated, please send me an e-mail or give > me a call. > > Best regards, > > George M. Woodall, Ph.D. > Senior Scientist > American Petroleum Institute > 1220 L Street, NW > Washington, DC 20005 > > Tel. (202)682-8067 > Fax. (202)682-8031 > ----------------------------------------------- File: > BenzeneConsortiumCommittee.doc Message: Benzene Consortium > Agreement SHELL-MCCLURG-055185