Document MX1wg72735jOwQ1dRMbLXmdj
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Cagen, Stuart Z SCC <szcagen@Shel1.Com>
Monday, August 6,2001 8:50 PM (GMT)
Cagen, Stuart Z SCC <szcagen@Shel1.Com>; 'Carol Fairbrother (E-mail)' <caro1.a.fairbrother@exxonmobi1.com>; 'Patrick Beatty (E-mail)' <pwbe@chevron.com>; 'Donald Burnett (E-mail).<burnetdm@bp.com>; 'Chris Roythorne (E-mail)' <roythorc@bp.com>; 'Shan Tsai (E-mail)' <sptsai@shellus.com>; 'William Broddle (E-mail).<bill.d.broddle@usa.conoco.com>
'Lorraine Twerdok' <twerdokl@api.org>; Clegg, Patsy M SCC-CHSE-PC <pmc1egg@Shel1.Com>; 'George Woodall' <Woodallg@api.org>
RE: Technical Review Committee Conference Call Summary
cv2.doc
CV of Dr. Li, provided by Shan Tsai: cv2.doc > -----Original Message----> From: Cagen, Stuart Z SCC > Sent: Monday, August 06, 2001 1: 18 PM > To: 'Carol Fairbrother (E-mail)'; 'Patrick Beatty (E-mail)'; 'Donald > Burnett (E-mail)'; 'Chris Roythorne (E-mail)'; 'Shan Tsai (E-mail)'; > 'William Broddle (E-mail)' > Cc: 'Lorraine Twerdok'; Clegg, Patsy M SCC-CHSE-PC; 'George Woodall' > Subject: RE: Technical Review Committee Conference Call Summary > > All: > > Although I have not heard much of a response regarding my other comments > regarding (not in any order of importance): the need for the entire > technical committee to move together on issues and plans (large and > small), relationship of technical committee to the communications > committee, participation of the technical committee (not just the chair) > in scientific review panel/investigator meetings - separate or > collective, timing, Albertini/Delzell in, Julian Preston in, etc...... , I > have a few additional and important suggestions to make regarding > potential members of the science review committee: >
> > Dr. Guilan Li, Chinese Academy of Preventive Medicine, Institute of > Occupational Medicine, Director of Toxicology, Beijing, China (we feel > very strongly about representation of a Chinese scientist in general and > Dr. Li , in particular). >
> Alternative scientists from Europe: We would not recommend Franz Oesch, > but alternatively would recommend: Dr. Richard Peto, Dr. Helmut Greim, or > Johannes Filser. > Please let me and Shan Tsai know how we can move these recommendations > further. >
>
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>
> Thanks
>
> Stuart
>
> -----Original Message----> From: Cagen, Stuart Z SCC > Sent: Wednesday, July 25, 2001 9:47 AM > To: 'George Woodall'; Cagen, Stuart Z SCC; Carol Fairbrother > (E-mail); Patrick Beatty (E-mail); Donald Burnett (E-mail); Chris > Roythorne (E-mail); Shan Tsai (E-mail); William Broddle (E-mail) > Cc: Lorraine Twerdok; Clegg, Patsy M SCC-CHSE-PC > Subject: RE: Technical Review Committee Conference Call > Summary
>
> All:
>
> George: Thanks for providing a quick summary of our call. You > correctly captured what was discussed. I would add my request that the > technical committee act as a whole for all questions - big or small, and > not the alternative model where day to day questions would be only brought > to Pat (the Chair). The main reason for this is for educational purposes; > that is, for me to be well informed to explain progress and problems of > the program to the folks back here. I think this will work as we only > have 5 sponsors.
>
> Some comments:
> >
> Regarding the relationship of the technical committee to the > oversight committee as well as the relationship of the technical committee > to the investigators: I would favor an active role, where the technical > committee should have an obligation to seek and recommend program issues > on behalf of the oversight committee. Although scientific issues will be > the purview of the investigators and the scientific peer reviewers, study > monitoring might be expected to raise programmatic implementation issues > (timing, protocol, other modifications) needing sponsor input. These > issues should be directed to the oversight committee via the technical > committee.
>
> Regarding reports or manuscripts: The investigators should have > full authority over publications with their option to consider sponsor > comments.
>
> Via the technical committee, the sponsors should participate in > discussions between the scientific review panel and the investigators,and > their role in meetings should be passive.
> >
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> Additional issues: the technical committee should also have some > sort of relationship with the communications committee to help with the > translation of study intent and findings.
>
> Regarding the scientific review panel: timing: do we think the > official scientific review panel will (functionally) be arriving a bit > late in the game if the current cadre of 4 or 5 reviewers (with some > overlap) will be the only ones technically commenting on the protocols > before IRB review. Can the university review wait until the full panel in > engaged or are there timing issues. Anticipating a yes to the timing > issues question: What are these timing issues.
>
> The scientific review panel: I would recommend Julian Preston as he > wou Id bring experience and knowledge in the area of genetic toxicology and > the relationship of biological markers of exposure to markers of potential > biologic activity. Would work well together with Albertini.
> >
> Other comments on the scientific review committee:
>
> I do not agree with the comment about Elizabeth Delzell and would > still keep her on the list of possibles. She is a fair and thoughtful > scientist.
>
> I am still working on possibles from Europe.
>
> I hope this helps.
>
> Thanks
>
> Stuart
> > > > > > > >
> -----Original Message----> From: George Woodall [SMTP:Woodallg@api.org] > Sent: Tuesday, July 24, 2001 10:28 AM > To: Stuart Cagen (E-mail); Carol Fairbrother (E-mail); > Patrick Beatty (E-mail); Donald Burnett (E-mail); Chris Roythorne > (E-mail); Shan Tsai (E-mail); William Broddle (E-mail) > Cc: Lorraine Twerdok > Subject: Technical Review Committee Conference Call > Summary > Importance: High
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>
> To all,
>
> Attached is the draft summary from yesterday's conference > call. Since then I have also done a little digging to come up with some > names for a Genetic Toxicologist and this is what I found.
>
> Julian Preston (EPA) He is the head of the Environmental > Carcinogenesis Division at EPA (Part of the National Health Effects and > Environmental Research Laboratory which is under ORO), and was formerly > head of a department at CIIT and previous to that, at Oak Ridge. He is a > world-class cytogeneticist.
>
> Ray Tice (Integrated Laboratory Systems) Also a world-class > cytogeneticist, he was formerly at Brookhaven. ILS is a contract lab > located in RTP, NC doing a lot of work for NIEHS.
>
> Regards,
>
> George > File: TechCommCaliSummary23July2001.doc
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