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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Teleconference Memorandum- Summary of Conversation, March 8, 2007

 

March 8, 2007
12:00 pm

FDA participant:
Keith Wonnacott

Dendreon participants:
Lori Jones
Elizabeth Smith

Summary of conversation.

I asked several questions about the leukapheresis procedure.
Q. Does Dendreon have a custom setting for collecting MNC or do you use the manufacturers setting?
A. Dendreon uses the (b)(4) settings.

Q. What differences could there be between different types of leukapheresis machines?
A. Differences may include things such as flow rate, anti-coagulant ratio, and other minor parameters.

Q. How does the volume collected relate to a (b)(4) leukapheresis that is often used in (b)(4) to represent a 'large volume leukapheresis'?
A. The (b)(4) blood volume will be a range, but is often close to (b)(4). It depends on how big the patient is.

Q. So a larger patient would mean a larger blood volume and presumably more cells?
A. Yes.

Q. How do you determine if it is a (b4)(4) blood volume? How do you determine when to stop?
A. It is largely dependent on the patient. Factors that affect the stopping point include adverse reactions (patient tolerance), patient need to urinate, Dendreon pick-up time and other logistical issues.

The call lasted about 15 minutes.

(System Info - 127212 TULL LORI 04/28/2010 11:06:00 TULL)