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Answer to Questions Email, September 17, 2012 - Ducord

From: Joanne Kurtzberg, M.D. [joanne.kurtzberg@duke.edu]
Sent: Monday, September 17, 2012 6:17 PM
To: Gavin, Denise K; Rebecca Durham
Cc: Bruce Burnett, Ph.D.
Subject: Re: answers to some of your questions

Follow Up Flag: Follow up
Flag Status: Red
Sorry. I meant (b)(4). J


From: Gavin, Denise K [mailto:Denise.Gavin@fda.hhs.gov]
Sent: Monday, September 17, 2012 06:14 PM
To: Rebecca Durham
Cc: Joanne Kurtzberg, M.D.; Bruce Burnett, Ph.D.
Subject: RE: answers to some of your questions
 

previously you said STCL-SOP-036 will be used for pt (b)(4), here you say
(b)(4)....please clarify.

thanks, Denise
 


From: Rebecca Durham [mailto:rebecca.durham@duke.edu]
Sent: Monday, September 17, 2012 5:10 PM
To: Gavin, Denise K
Cc: Joanne Kurtzberg, M.D.; Bruce Burnett, Ph.D.
Subject: FW: answers to some of your questions
 

Denise,
This email bounced for some reason.
Becky

Rebecca J. Durham
Project Leader
Robertson Clinical & Translational Cell Therapy Program-CT2- DTRI
Room 9022, North Pavilion
2400 Pratt Street
Durham, NC 27710
919-668-7145 Office
919-407-0859 Cell
919-668-7161 Fax
Rebecca.Durham@Duke.edu


From: Joanne Kurtzberg, M.D.
Sent: Monday, September 17, 2012 4:58 PM
To: Denise.Gavin@fda.hhs.gov
Cc: Rebecca Durham; Bruce Burnett, Ph.D.
Subject: answers to some of your questions

Dear Denise:

We thought it was important to get these answers to you by email. Your questions are in blue, our answers are in black.

When did you start using STCL-PROC-036 as the procedure to wash thawed CBU?

The effective date for STCL-PROC-036 was 24AUG2012. This is ---(b)(4)--- wash protocol and is used to wash units that will be infused into patients who weigh (b)(4) or more. Units for smaller patients are processed by the --(b)(4)-- procedure (028). .

Was this protocol used for any of the units in the stability data analysis submitted in amendment 013?

STCL-036 was not used for any of the units in the stability data analysis submitted in amendment 0123.

Comment: the validation report for comparison of the ---(b)(4)--- wash method and --(b)(4)-- wash method will be forwarded to you tomorrow 18SEPT2012.

Sincerely,
JK and the Duke CCBB Team

Joanne Kurtzberg, MD
Director, Carolinas Cord Blood Bank
Chief Scientific Officer, Robertson Clinical and Translational Cell Therapy
Program
Director, Pediatric Blood and Marrow Transplant Program
DUMC Box 3350
2400 Pratt Street Room #9026
Durham, NC 27705
919-668-1119 (phone)
919-668-1183 (fax)
kurtz001@mc.duke.edu