Record of Telephone Conversation - June 19, 2009 - Prevnar 13

System Info - 120681  SMITH, MICHAEL J  21-Feb-2010 17:53:39  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:  19-JUN-2009 01:00 PM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  MICHAEL SMITH

Telecon Summary:
Drug product and drug substance issues discussed

FDA Participants:                     Mike Smith, John Cipollo, Willie Vann, Rajesh Gupta, Alfred Del Grosso and Julienne Vaillancourt

Non-FDA Participants:               Jack Love, Carmel Devlin, Barry Caplan, Kathy Kofsky, Rich Pelt, Kathrin Jansen, Dave Zisa, Bart Corsaro, David Vogt, Mildred Decker, Bounton Loun, Eric Finley and Joe Grillo

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
DEPARTMENT OF HEALTH & HUMAN SERVICES
FDA/CBER/OVRR/DVRPA

  Teleconference Memorandum

DATE:           June 19, 2009

TIME:            1:00 – 2:30 PM EASTERN

Sponsor:         Wyeth Pharmaceuticals, Inc.

Product:         13VPnC: Pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19a, 19F, and 23F conjugated to cross-reacting material (CRM 197).

Subject:          Clarification of drug product and drug substance issues

CBER Participants

John Cipollo, Willie Vann, Rajesh Gupta, Alfred Del-Grosso

Julienne Vaillancourt and Mike Smith

Wyeth Participants 

Jack Love, Carmel Devlin, Barry Caplan, Kathy Kofsky, Rich Pelt, Kathrin Jansen, Dave Zisa, Bart Corsaro, David Vogt, Mildred Decker, Bounton Loun, Eric Finley and Joe Grillo

Background:
On June 18, 2009, Jack Love and Carmel Devlin were E-mailed the talking points that Willie Vann generated for this meeting (see EDR).

Discussion:
CBER expressed concern after John Cipollo and Rajesh Gupta reviewed SOPP’s and validation reports for analytical methods for Prevnar 13.  CBER requested documentation on proof of conjugation and quantification of the amount of conjugation. CBER requested the sponsor review and modify several validation documents.  CBER requested the sponsor develop a test for conjugate in drug product that can be used as a stability indicating assay for individual conjugates.  Further discussion revolved around testing of free saccharide in drug product and the need for further documentation on the amount due to the problem of not being able to measure free saccharide in final product by ---------(b)(4)------ therefore the assessment must be indirect. Additionally, the linearity, accuracy and precision of measurement across the full working range were discussed.

Action:
Wyeth will submit an amendment to the BLA addressing the questions contained in the talking points sent to the sponsor on June 18, 2009, and those generated during the discussion at the June 19, 2009, teleconference.

Note: Amendments 22 and 31 were submitted in response to the June 19, 2009, teleconference.