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
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 19-JUN-2009 01:00 PM Initiated by FDA? Yes
Author: MICHAEL SMITH
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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
John Cipollo, Willie Vann, Rajesh Gupta, Alfred Del-Grosso
Julienne Vaillancourt and Mike Smith
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
On June 18, 2009, Jack Love and Carmel Devlin were E-mailed the talking points that Willie Vann generated for this meeting (see EDR).
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.
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.