
Record of Telephone Conversation, Potency Assay Issues, September 3, 2014 - BEXSERO

 

 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR 

Product:
 Meningococcal Group B Vaccine 

Applicant:
 Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 03-Sep-2014 01:00 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: Follow up IR regarding potency assay issues

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK, MARGARET BASH, ELIZABETH SUTKOWSKI, FREYJA LYNN, TSAI-LIEN LIN

Non-FDA Participants: DUCCIO MATTII, LEONARDO GHERARDINI, MICHELE BURRINI, FEDERICA BAFFETTA, JOE CROWELL, JANNE ULDAL, PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 

CBER and Novartis (NVD) met to discuss issues regarding information requests from CBER dated July 15, 2014, August 14, 2014, and August 20, 2014. 

CBER explained that the goal of the ongoing review of the data for potency assays is to understand how the assays are performing and how reproducible the results are. We expressed concern that the assay validations may not be sufficient at this point and that the raw data may help demonstrate that the assays are performing adequately based on the reliability of those underlying data. Further, we indicated that the annotations submitted in the August 19, 2014, amendment for the potency assay validation data were unclear. NVD said that they will submit the updated, annotated data soon. CBER asked NVD to submit the individual animal titer data from the potency assay used for the release of the lots for clinical study V72_41. NVD agreed. Novartis also clarified that the reference vaccine used for the validation was one of the lots used in study V72_41. 

Regarding the issue of the raw OD values, CBER asked NVD to clarify which data are available in an electronic format and which data are available in paper format only. NVD explained that (b)(4) data collected in 2012 or earlier are stored in paper copies only. (b)(4) data collected after 2012 has -(b)(4)- data stored electronically but in a format readable only by the data reduction program. NVD confirmed that the -(b)(4)- have not changed and are being performed the same as they have been in the past. CBER requested that NVD provide additional information as to the size of the archived paper data files from the validation to determine if some of the paper files might be submitted. CBER also requested a description of the software used to generate the programs used to reduce the raw OD data to reportable values, and then to relative potency values. NVD agreed. CBER and NVD discussed the possibility of submitting the potency data from the (b)(4) lots of final drug product that have already been released.

Call ended.
