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Vaccines

Record of Telephone Conversation - August 5, 2009 - Prevnar 13

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  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:                                                                       
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  05-AUG-2009 03:45 PM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Other

Author:  JULIENNE VAILLANCOURT

Telecon Summary:
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

Telecon Body:
e-mail:

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:

Dial-in Information:
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

Jack D. Love, Ph.D.
Assistant Vice President
Vaccine Regulatory Affairs
Wyeth Pharmaceuticals, Inc.
One Blue Hill Plaza BH 21125
Pearl River, NY 10965
845-602-1283

Attachment:

13 pages determined not to be releasable: (b)(4)

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002