Record of Telephone Conversation - April 27, 2009 - Prevnar 13

System Info - 101572  SHONE, DEANNA   06-Aug-2009 15:48:19  SHONEDE

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:  27-APR-2009 05:49 PM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  MICHAEL SMITH

Telecon Summary:
Email: IR request for OPA VAL RPTs and ---(b)(4)---- doc's

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
From: Smith, Michael (CBER)
To: "DEVLINC@wyeth.com";
cc: Vaillancourt, Julienne;
Subject: RE: BLA
Date: Monday, April 27, 2009 5:49:22 PM
Attachments: BLA 125324 requested documents as of 27APR09.doc

Carmel, I attached a MS Word file that has a list of documents requested from a reviewer. Although it is unclear to me at this time if these documents are required to file the BLA, I wanted to let you know about this request as soon as possible. Please let me know when you could get these documents uploaded into Global Submit Review.

Thanks,
Mike
301-827-9047

4.2.3.1. 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (13vPnC): 5-CYCLE (1 DOSE/3 WEEK CYCLE) INTRAMUSCULAR TOXICITY STUDY WITH A 4-WEEK OBSERVATION PERIOD IN RABBITS RPT-72055

The following ---(b)(4)--- assay documents are needed.

- Conjugation of PS to ------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------- Document VR-SOP-LC-10010.

- -----------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------ Document LM-1224.

- Evaluation of the efficiency and ---(b)(4)----- of PS --------(b)(4)-----------------  Document OP-1148.

- ----------------------(b)(4)-------------------------------- 13-valent lot and qualification.  Document OP-1147.

- -----------------(b)(4)--------------- Determination of Antibodies to PnPS in ---(b)(4)--- Sera.   Document TM-1019.

- Procedure for Secondary Review, Approval and Data Flow for ------(b)(4)----- Data packages. Document OP-1274.

-  Data review procedures for the testing carried out to evaluate IgG specific for the 13 serotypes of 13vPnC.

Documents OP-1274 and RPT-73543.

-  Qualification of the -------------(b)(4)----------------------------------for the  evaluation of serotype-specific IgG in--(b)(4)--- sera.  Document RPT-73286.

5.3.1.4.1. Bioanalytical and Analytical Methods for Human Studies 13V Pn OPA HL-60

The following opsanophagocytic assay related documents are needed. 

- SOP for OPA assay. SOP TM-3030.

- Validation of OPA assay. MVP-1001.

- Study to validate precision, linearity, and accuracy associated with the PnOPA for serotypes Pn1, Pn6A and Pn23F in this lower range of titers of ---(b)(4)---. MVP-10182.

Validation reports for individual PS 

- Yu X. Pn1 Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008;  RPT-71821.

- Yu X. Pn3 Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71748.

- Yu X. Pn4 Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71822.

- Yu X. Pn5 Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71823.

- Yu X. Pn6A Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71824.

- Yu X. Pn6B Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71825.

- Yu X. Pn7F Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71826.

- Yu X. Pn9V Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71827.

- Yu X. Pn14 Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71828.

- Yu X. Pn18C Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71829.

- Yu X. Pn19A Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71830.

- Yu X. Pn19F Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71831.

- Yu X. Pn23F Validation Report of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-71833.

-Yu X. Pn1 Validation Report of Range Extension of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-73343.

- Yu X. Pn6A Validation Report of Range Extension of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-73344.

- Yu X. Pn23F Validation Report of Range Extension of Opsonophagocytic Assay for Detection of Functional Antibodies to Streptococcus pneumoniae in Human Serum. Wyeth Research Reports. 2008; RPT-73345.