From: Derr, Nancy E
Sent: Tuesday, February 10, 2004 9:19 AM
To: Dockets, FDA
Cc: Huang, Shiew Mei; Lesko, Lawrence J
Subject: FW: 2003D-0497; Pharmacogenomic Data Submissions, November 2003

This submission to the above guidance was sent to Dr. Lesko on 2/9/04.  Please include it in the public docket.  

Thanks in advance, Nancy 

-----Original Message-----
From: Lesko, Lawrence J 
Sent: Monday, February 09, 2004 5:52 PM
To: Derr, Nancy E; Huang, Shiew Mei
Subject: FW: Pharmacogenomic Data Submissions, November 2003


more fun

-----Original Message-----
From: michael.zuehlsdorf@bayerhealthcare.com [mailto:michael.zuehlsdorf@bayerhealthcare.com] 
Sent: Monday, February 09, 2004 10:40 AM
To: LeskoL@CDER.FDA.GOV
Cc: isabelle.stoeckert@bayerhealthcare.com; ronald.grobe-einsler@bayerhealthcare.com; jochen.kuhlmann.jk@bayer-ag.de; georg.wensing@bayerhealthcare.com
Subject: Re: Pharmacogenomic Data Submissions, November 2003






Dear Dr. Lesko,
first I want to thank you for the excellent draft guidance concerning
pharmacogenomic data submission. I think that this guidance is well balanced and
will facilitate the use and integration of this kind of data in drug
development.
Bayer in general welcomes and supports FDA's initiative to provide guidance on
PGx data submission. From our point of view we have just a few comments on this
guidance.
   The part "Recommended submission of exploratory data for a new or ongoing
   NDA/BLA" should be deleted - Question: Can exploratory data be supportive?
   (Chapter IV.B.4 page 9 lines 368-375, Appendix B.4. lines 715-719 and
   Appendix E). If yes then this should be stated and clarified.
   Who and on what basis will decide if a biomarker is classified as known or
   probable valid (chapter III.A. page 4 lines 128-155).
      A potential procedure could be that the IPRG updates annually/quarterly
   (?) a list of valid biomarkers after consultation of Pharma specialists.
   Are PGx data from existing exploratory preclinical studies conducted under
   non-GLP conditions acceptable if the biomarker is classified afterwards (may
   be after years) probable or known valid? (Chapter IV.D. lines 402-405).

Freundliche Grüße / Best Regards
Michael Zuehlsdorf
_________________________________________
Bayer HealthCare AG
PH-PD-GMD-GCP-Dyn
Biomarker and Pharmacogenetics
Elberfeld
Tel.: +49 202 36 4231
Fax: +49 202 36 4115
e-mail: michael.zuehlsdorf@bayerhealthcare.com
Internet :  http://www.bayerhealthcare.com


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