System Info - 120678 SMITH, MICHAEL J 21-Feb-2010 16:13:07 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 05-AUG-2009 03:45 PM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
Plans for evaluating serotype 5 ---(b)(4)----
FDA Participants: Julienne Vaillancourt and Mike Smith
Non-FDA Participants: Jack Love, Emilio Emini and Kathrin Jansen
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Jack Love [mailto:LOVEJ@wyeth.com]
Sent: Wednesday, August 05, 2009 3:45 PM
To: Vaillancourt, Julienne; Smith, Michael (CBER)
Cc: Dr. Emilio Emini; Kathrin Jansen
Subject: Plans for evaluating Serotype 5 ---(b)(4)----
Julie and Mike,
Attached is the experimental plan that the scientific team here at Wyeth developed following our meeting last week to further evaluate type 5 ---(b)(4)----. This plan will be the basis of the discussion tomorrow at 10:30 am. Please forward it to the appropriate people at CBER. We appreciate the follow-up meeting to be sure that we are in alignment on the approach, so that it will satisfy the CBER scientific group.
The information for the telephone call is shown below:
Toll Free Dial In Number: ----(b)(4)----
Int'l Access/Caller Paid Dial In Number: ----(b)(4)----
Host: Jack Love
Participant Code: ----(b)(4)----
Thanks and talk to you tomorrow,
Jack D. Love, Ph.D.
Assistant Vice President
Vaccine Regulatory Affairs
Wyeth Pharmaceuticals, Inc.
One Blue Hill Plaza BH 21125
Pearl River, NY 10965
13 pages determined not to be releasable: (b)(4)