


Dendreon PLI - Preliminary Report - Provenge, February 25, 2010



 
(System Info - 126208 Finn Thomas 04/16/2010 13:20:38 TULL)


Dendreon PLI - Preliminary ReportFrom: Finn, Thomas
 Sent: Thursday, February 25, 2010 10:41 AM
 To: 'Smith, Liz'
 Cc: Oh, Steven; Tull, Lori; Wang, Gang; Melhem, Randa
 Subject: RE: Dendreon PLI - Preliminary Report

Hi Liz a few quick follow-up questions:

a.. When was the product disposition faxed to the infusion site?
 b.. In response to our previous request you have implemented a process step 
time of -----(b)(4)---------- for packaging the product after formulation 
(Amendments 24 and 32). Please indicate how much of this step time was used for 
each of the lots generated during the PLI.
 c.. Could you please indicate how long total ---------(b)(4)----------- 
processing took for each lot?

Thanks,

 Tom

 

--------------------------------------------------------------------------------
 From: Smith, Liz [mailto:lsmith@Dendreon.com]
 Sent: Wednesday, February 17, 2010 7:06 PM
 To: Wang, Gang; Melhem, Randa
 Cc: Finn, Thomas; Oh, Steven; Tull, Lori
 Subject: RE: Dendreon PLI - Preliminary Report


Darnit! Here you go!

 

********************************************
 Elizabeth C. Smith
 Vice President of Regulatory Affairs
 Dendreon Corporation
 3005 First Ave
 Seattle, WA 98121
 t: 206.829.1556/ f: 206.219.1004/ m. 206.719.4366
 esmith@dendreon.com

*******************************************




--------------------------------------------------------------------------------

From: Wang, Gang [mailto:Gang.Wang@fda.hhs.gov]
 Sent: Wednesday, February 17, 2010 4:00 PM
 To: Smith, Liz; Melhem, Randa
 Cc: Finn, Thomas; Oh, Steven; Tull, Lori
 Subject: RE: Dendreon PLI - Preliminary Report

 

Liz, I didn?t see the attachment.

 

Gang




--------------------------------------------------------------------------------

From: Smith, Liz [mailto:lsmith@Dendreon.com]
 Sent: Wednesday, February 17, 2010 6:58 PM
 To: Melhem, Randa
 Cc: Wang, Gang; Finn, Thomas; Oh, Steven; Tull, Lori
 Subject: RE: Dendreon PLI - Preliminary Report

 

Hi Randa,

 

Please find attached the requested information. This information has been 
submitted as an amendment to the BLA (amendment 039) and this is a copy for your 
convenience.

 

Please let me know if you have any further questions.

 

Kind Regards,

 

Liz

 

********************************************
 Elizabeth C. Smith
 Vice President of Regulatory Affairs
 Dendreon Corporation
 3005 First Ave
 Seattle, WA 98121
 t: 206.829.1556/ f: 206.219.1004/ m. 206.719.4366
 esmith@dendreon.com

*******************************************




--------------------------------------------------------------------------------

From: Melhem, Randa [mailto:Randa.Melhem@fda.hhs.gov]
 Sent: Tuesday, February 16, 2010 8:57 AM
 To: Smith, Liz
 Cc: Wang, Gang; Finn, Thomas; Oh, Steven; Tull, Lori
 Subject: Dendreon PLI - Preliminary Report

 

 

Hi Liz,

Thank you for the preliminary report for the lots processed during the 
inspection.
 For each lot, please provide in a Table format the time for each of the 
following steps:

a.. Collection of APH at the Apheresis Site
 b.. Receipt of APH at Dendreon, NJ
 c.. Start of the manufacturing -b(4)- ? (b)(4)
 d.. Start of incubation
 e.. Start of manufacturing of Drug Product ? (b)(4)
 f.. Filling of Drug Product into Sipuleucel-T Primary container
 g.. Packaging of Drug Product in secondary shipping package
 h.. Collection of package by courier
 i.. Receipt of the Drug Product at the clinic
 j.. Infusion of the Drug product into the patient


Thanks again,

Randa Melhem, Ph.D.
 Consumer Safety Officer
 FDA/CBER/OCBQ/DMPQ
 Phone: 301-827-6999 Fax 301-827-3536

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