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Vaccines

Email Response to Sponsor, October 27, 2010 - MenHibrix

Date:October 27, 2010
From:David C. Staten, Jr., MPH, CDR, USPHS
Subject:Email Response to Sponsor in Reference to October 6, 2010 teleconference and to GSK October 12, 2010 meeting minutes
To:Ad ministrative File STN 125363

Summary:

FDA r eceived DRAFT meeting minutes via email from Norris P y le of GSK on October 12, 2010. After the review team reviewed the minutes in was apparent misunderstand our comments concerning free pol ysaccharide in the vaccine. The following clarification email was sent to GSK on October 15, 2010.

From:
Staten, David

To:
"Norri s Pyle"; Temenak, Joseph;

cc:
Jody Gould; Bridgewater, Jennifer; Smith, Herbert; Sutkowski, Elizabeth M.;

Subject:
RE : MenHibrix: GSK"s minutes of teleconference held October 6, 2010

Date:
Friday, October 15, 2010 2:46:00 PM

This is to clarify further our discussion via teleconference on October 6th, 2010, and your DRAFT meeting minutes from Norris Pyle submitted to us by email October 12, 2010.

Please be advised that as we indicated in o ur teleconference, while we agree to review data for any experiments you have performed thus far, these data alone will not be sufficient to address the CR question(s). CBER does not agree at this time that sufficient studies have been performed to prove that free polysaccharide content cannot be measured. CBER still expects that GSK will perform additional developmental work to address the CR question, as free polysaccharide content is a critical quality attribute. In order to assist you further, we have t he following questions: One of your main issues with the free saccharide assay appears to be -------------------(b)(4)---------------------. You should present data on adsorption techniques including but not limited to (a) -------------------------------(b)(4)----------------------------------------------.

You have not presented data on the free Hib polysaccharide in the vaccine. Can free Men C and Men Y be measured accurately as an aggregate?

Have you attempted to -----------------------------------(b)(4)--------------------------------------------------------------------?

Have you tried to develop -------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------? Have you performed ----------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------.

Have you thoroughly reviewed the scientific literature for assistance with potential methods development?

After further discussion, we have determined that at this time it would be advisable to submit data on experiments you have performed thus far to IND (b)(4) for our initial review.

From: Norris Pyle [mailto:norris.h.pyle@gsk.com] Sent: Wednesday, October 13, 2010 10:06 AM To: Temenak, Joseph Cc: Jody Gould; Staten, David; Bridgewater, Jennifer Subject: RE: MenHibrix: GSK's minutes of teleconference held October 6, 2010

H i Joe,

Ok – that is why I always will send GSK’s draft minutes to ensure agreement/alignment. We w i ll look forward to receiving CBER’s minutes w i th “comments/qu estions/concerns” outlined. Hopefully we are not too far apart in our details.

Thanks - Norris

From: Temenak, Joseph [mailto:Joseph.Temenak@fda.hhs.gov] Sent: Wednesday, October 13, 2010 9:32 AM To: Norris Pyle Cc: Jody Gould; Staten, David; Bridgewat er, Jennifer Subject: RE: MenHibrix: GSK's minutes of teleconference held October 6, 2010

Norris,

We have looked over your draft MenHibrix meeting minutes for the telecon we conducted on Oct. 6, 2010. We do not agree with your 'action' items to follow re lated to a CR response. There must have been either a misunderstanding or miscommunication on one or both of our parts.

We plan to send you our comments/questions/concerns within the next 2 days, as we want to make sure things are cleared up prior to the submission of your CR response.

Thank you,

Joe

From: Norris Pyle [mailto:norris.h.pyle@gsk.com] Sent: Tuesday, October 12, 2010 8:43 AM To: Staten, David; Temenak, Joseph Cc: Jody Gould Subject: MenHibrix: GSK's minutes of teleconference held October 6, 2010

Hi Commanders Staten and Temenak,
Her e are GSK’s minutes of the above teleconference. As promised, the m i nutes provide a list of the GSK participants.
Let me know if you need anything else or have any questions. Thank you - Norris