DATE:1./JJ,U ~

Case 3:12-md-02385-DRH-SCW Document 349-15 Filed 12/26/13 Page 1 of 4 Page ID
#7745
From:
Sent:
To:
Subject:
Attachments:
Clemens,Dr.,Andreas (CiinD&MedA) BIP-DE-1
Wednesday, October 31, 2012 4:21 PM
Friedman,Dr.,Jeffrey (CR) BIP-US-R
WG : Dabigatran Exposure-Response in AF Patients, a pharmacokinetic analysis of RE-LY
Concentration response ver 8 Oct 2012 pr_AC_TL.docx; Concentration response ver 14 June
2012 jf tl_Tables.docx; image001.png; image002.gif; image003.gif; image004.gif
Hi Jeff,
i have talked with Thorsten Lehr hoist he ,father/1 of the manuscript- Paul took it over and changed it significantly.
Thorsten wants to tailor the message according our ideas. I see value in this manuscript especially with regard to a
manuscript which will in the next step focus on lab levels (aPTI) to give the physicians an understanding what they have
to expect in specific situations regarding aPTI.
The world is crying for this information- but the tricky part is that we have to tailor the messages smart. Thorsten wants
to do that- so I think it would be worth if you and I would attend a TeiCon for alignment. This I see as a real opportunity
to not have a bad manuscript. Would be the last try to convince and guide Paul into an appropriate Bl conform direction.
So if you get an invite- would be great if you could join.
Mit freundlichen GruBen I Kind regards,
Dr. Andreas Clemens
Boehringer lngelheim Pharma GmbH & Co . KG
Clinical Development + Medical Affairs
Tel.: +49 (6132) 77-90606
Fax: +49 (6132) 72-90606
mailto:[email protected]
Boehringer Ingelheim Pharma GmbH & Co. KG, Sitz: Ingelheim am Rhein; Registergcricht Mainz: HR A 22206; Komplcmcntar
Boehringer Ingelheim Deutschland GmbH; Geschiiftsfiihmng: Dr. Engelbert Giinstcr (Vorsitzender), Ursula Fuggis-Hahn, Ralf
Gorniak, Michael Klein, Dr. Martin Wanning; Vorsitzender des Aufsichtsrates: Prof. Dr. Dr. Andreas Barner; Sitz: Ingelheim am
Rhein; Registergericht Mainz: HR B 23260
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•.? .~~ P..e!.~~~: ..~Y un~.u~o-~_zed !evie,~, use, di~~l?sure, -~<?P:Y~n& .?.r.~is~b~li~n i~ stricti~ P.~ohi~ite~ . ...... _ ........ ..
Von: Thorsten Lehr [mailto:[email protected]]
Gesendet: Mittwoch, 31. Oktober 2012 17:17
An: Reilly,Dr.,Paul (CR) BIP-US-R
Cc: Clemens,Dr.,Andreas (CiinD&MedA) BIP-DE-1
Betreff: AW: Dabigatran Exposure-Response in AF Patients, a pharmacokinetic analysis of RE-LY
Hi Paul,
Many thanks. Please find attached my comments on top of the comments from Andreas. In addition, you can find the
tables which are missing in the appendix.
I would propose, that after you have incorporated all the comments from all authors, we discuss (TC) the new (and close
to final version) in a small group (Paul, Andreas, Thorsten, Jeff?). I have the feeling that we are internally not 100%
aligned with our story.
1
EXHIBI.,.
WIT: -....,.....----.---
DATE:1./JJ,U~
MAUREEN 0. POLLARD
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Case 3:12-md-02385-DRH-SCW Document 349-15 Filed 12/26/13 Page 2 of 4 Page ID
#7746
Happy Halloween!
Thorsten
Von: [email protected] [mailto:[email protected]]
Gesendet: Montag, 15. Oktober 2012 17:31
An: [email protected]
Cc: [email protected]; [email protected]; [email protected]; [email protected]; [email protected];
[email protected]; [email protected]
Betreff: AW: Dabigatran Exposure-Response in AF Patients, a pharmacokinetic analysis of RE-LY
Dear Paul,
find my comments attached. The conclusions taken now I can support- but there are some places in the manuscript
where I think we need to be more Guidant ....
I have CC' d Klaus Dugi, that he is aware what is in the "Orbit" as he often has interactions with Salim Yusuf on other
things; but I think it is good that Yusuf feel that we are all well connected in Bl.
Mit freundlichen GrUBen I Kind regards,
Dr. Andreas Clemens
Boehringer lngelheim Pharma GmbH & Co. KG
TA Cardiology
Tel.: +49 (6132) 77-90606
Fax: +49 (6132) 72-90606
mailto:[email protected]
Boehringer Ingelheim Phanna GmbH & Co. KG, Sitz: Ingelheim am Rhein; Registergericht Mainz: HR A 22206; Komplementiir
Boehringer Ingelheim Deutschland GmbH: Geschaftsfiihrung: Dr. Engelbert Giinster (Vorsitzender), Ursula Fuggis-Hahn, Ralf
Gorniak, Michael Klein, Dr. Martin Wanning; Vorsitzender des Aufsichtsrates: Prof. Dr. Dr. Andreas Barner; Sitz: Ingelheim am
Rhein; Registergericht Mainz: HR B 23260
Diese E-Mail ist vertraulich zu behandeln. Sie kann besonderem rechtlichen Schutz unterliegen. Wenn Sie nicht der richtige Adressat
sind, senden Sie bitte diese E-Mail an den Absender zmiick, loschen die eingegangene E-Mail und geben den Inhalt der E-Mail nicht
weiter. Jegliche unbefugte Bearbeitung, Nutzung, Vervielfiiltigung oder Verbreitung ist verboten. I This e-mail is confidential and may
also be legally privileged. If you are not the intended recipient please reply to sender, delete the e-mail and do not disclose its contents
t? ~!!X p~r.sol!:..:.\nyunal1tl1orized_ r~view, use, disclosure, cop~·ing or distri~utign ,!.s..~tr,ic,tly }J~O-~~it~d.
Von: Reilly,Dr.,Paul (CR) BIP-US-R
Gesendet: Freitag, 12. Oktober 2012 21:04
An: Friedman,Dr.,Jeffrey (CR) BIP-US-R; Haertter,Dr.,Sebastian (MED) BIP-US-R; Clemens,Dr.,Andreas (CiinD&MedA)
BIP-DE-1
Cc: Desch,Dr.,Marc (CiinD&MedA) BIP-DE-1; Brueckmann,Prof.Dr.,Martina (CiinD&MedA) BIP-DE-1; Thorsten Lehr,PhD
Betreff: FW: Dabigatran Exposure-Response in AF Patients, a pharmacokinetic analysis of RE-LY
Dear All,
Here is a revised version of the exposure-response manuscript. I have tried to incorporate all changes suggested on the
last version. It has been simultaneously sent to the RE-LY OC for review. I think it has significantly improved and would
be grateful for your feedback.
(Thorsten, in the interests of space limitations, I simplified some of your changes but we can discuss)
Kind regards
Paul
2
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Case 3:12-md-02385-DRH-SCW Document 349-15 Filed 12/26/13 Page 3 of 4 Page ID
#7747
7F' K::ot>hbger
~~!II1V bgelilelm
Paul A. Reilly, PhD
Executive Director
Team Leader Clinical Program
Clinical Development & Medical Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, Connecticut
P: 203 798 4125 ::Cell: 203 685 9712
pau l.rei lly@boeh ringer- i ngelhei m .com
•.•'·liD~
From: Reilly,Dr.,Paul (CR) BIP-US-R
Sent: Friday, October 12, 2012 2:58 PM
To: '[email protected]'; Connolly, Stuart; Yusuf, Salim; Brueckmann,Prof.Dr.,Martina (CiinD&MedA) BIP-DE-1;
[email protected]; Themeles, Ellison'; Lehr,Dr.,Thorsten (TransMed) BIP-DE-8; 'Thorsten Lehr,PhD'
Cc: Lindeman, Judy; Levesque, Tammy; Pogue, Janice; '[email protected]'; '[email protected]'; John
Eikelboom; Hill Lynda; Warth,Caroline (CiinD&MedA) BIP-DE-1; Healey, Jeff; Maystrenko, Natalie
Subject: Dabigatran Exposure-Response in AF Patients, a pharmacokinetic analysis of RE-LY
Dear Group,
Please find attached a revised version of the exposure-response paper. I have incorporated almost all the comments
that have been sent on the last version (Lars, Stuart, John, Mike, Salim), including Bl internal comments in an attempt to
satisfy all the different points of view. There are a couple of analyses that we will do in the background (demographic
characteristics of sampled patients compared to RE-LY population, add amiodarone and verapamil to the regression
model) but these are not expected to impact the text very much. At the same time I will get feedback from Bl internal
partners. From my point of view, the paper is improved again and ready for submission.
If we have time, perhaps we can discuss briefly on our next OC call on Wed Oct 17. The paper is currently formatted for
submission to JACC.
Kind regards
Paul
(:,•:".., B,~·ehrlllgH
\<1hiJ
11 fngdhemi
Paul A. Reilly, PhD
Executive Director
Team Leader Clinical Program
Clinical Development & Medical Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, Connecticut
P: 203 798 4125 ::Cell: 203 685 9712
R<:I_YL.x.eUiy.@b_9.§hri.na_~.r~.i!l_ggJ.hgi.r:n,_c;:_Q_m
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From: Themeles, Ellison [mailto:[email protected]]
Sent: Friday, September 28, 2012 4:14PM
To: '[email protected]'; Connolly, Stuart; Reilly,Dr.,Paul (CR) BIP-US-R; Yusuf, Salim;
Brueckmann,Prof.Dr.,Martina (CiinD&MedA) BIP-DE-1; [email protected]
Cc: Lindeman, Judy; Levesque, Tammy; Pogue, Janice; '[email protected]'; '[email protected]';
John Eikelboom; Hill Lynda; Warth,Caroline (CiinD&MedA) BIP-DE-1; Healey, Jeff; Maystrenko, Natalie
Subject: RE: RELY Operations Committee Teleconference: October 1, 2012 9:00am. - 10:00 am (EDT)
Importance: High
Dear group:
3
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Case 3:12-md-02385-DRH-SCW Document 349-15 Filed 12/26/13 Page 4 of 4 Page ID
#7748
Please find enclosed the preliminary agenda for Mondays update call. Dr. Connolly plans to circulate the
updated RELY-ABLE manuscript by tomorrow for discussion on our call.
With kind regards,
Ellison
Dial in details are as follows:
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McMaster University and Hamilton Health Sciences Centre
David Braley Cardiac, Vascular and Stroke Research Institute (DBCVSRI)
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Telephone:905-527-4322 Ext. 40488
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