Record of Telephone Conversation, May 9, 2014 - TRUMENBA

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA Submission ID: 125549/0 Office: OVRR

Product:
Meningococcal Group B Vaccine

Applicant:
Wyeth Pharmaceuticals Inc.

Telecon Date/Time: 09-May-2014 10:00 AM Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s):
1. Information Request

Author: Nancy Waites, Ramachandra Naik, and Theodore Garnett

Telecon Summary:
Requesting information about the buildings/rooms/equipment and manufacturing process used for MenB vaccine (or similar biotech product) production.

FDA Participants: 
Nancy Waites, Telecon Lead (OCBQ/DMPQ)
Donald Ertel (OCBBQ/DMPQ)
Carolyn Renshaw, Branch Chief (OCBQ/DMPQ)
John Eltermann, Jr., PharmD, MS, Division Director (OCBQ/DMPQ) Mark Schwartz, JD, Deputy Office 
Director (OCBQ)
Drusilla Burns, PhD, Deputy Director (OVRR/DBPAP) Theodore Garnett, PhD (OVRR/DVRPA)
Ramachandra S. Naik, PhD (OVRR/DVRPA)
Tina Rocklein, MS (OVRR/DBPAP)

Non-FDA Participants:

Carmel Devlin, Senior Director, Worldwide Safety & Regulatory
Katherine Arch-Douglas

---------------(b)(4)-------------------------
-----------------(b)(4)-------------------------
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-----(b)(4)----
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Trans-BLA Group: No

Related STNs: None
Related PMCs: None

Telecon Body:

Prior to beginning the telecon, --------------(b)(4)------------- confirmed that it was
acceptable for Pfizer representatives to be on the phone since we were going to discuss the other products that (b)(4) manufactures.

In addition, we were informed by Pfizer of the possibility of MenB vaccine being manufactured at (b)(4) either ----------------(b)(4)---------------.

During the telecon, we discussed the following:
We have been provided three possible dates for a pre-license inspection for the MenB BLA - June 16-18, July 7-10 and September 15-19. We have also been informed that the MenB product will not be manufactured during the proposed inspection dates. In order to help FDA schedule and plan for meaningful inspection, FDA asked (b)(4) to provide the following information as it relates to manufacturing during the proposed inspection dates:

1. Please specify the exact buildings/rooms/equipment used for MenB production and how it compares to the buildings/rooms/equipment for product being manufactured at the time of inspection.

(b)(4) stated that for both the upstream and downstream manufacturing processes, FDA will be able to inspect areas where MenB was manufactured. Manufacturing for (b)(4) other products will be performed during the July and September inspection dates. The manufacturing techniques are ---------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------- due to the fact that the manufactured product will not be MenB.

2. Please compare the MenB manufacturing process with the manufacturing process of the product being manufactured at the time of inspection.

(b)(4) stated that the manufacturing processes for the products being manufactured during the proposed inspection dates are very similar to the manufacturing process of MenB. The ---------------------------(b)(4)---------------------------------. Both products are considered Biotech products.

The product that will be manufactured in July is an approved US product and the product
that will be manufactured in September is not an approved US product due to the product

receiving ------------------------------------------------------------(b)(4)--------------------------------------------------------------. The area where the approved product is being manufactured has been the subject of an FDA inspection performed in ---(b)(4)---. The manufacturing area for product that received the ---(b)(4)--- was inspected by FDA in -----(b)(4)-----.

(b)(4) agreed to provide a chart to compare the manufacturing process of MenB with the products that will be manufactured during the proposed inspection dates. This comparison will also list the equipment used and indicate if the equipment is shared or dedicated.

(b)(4) stated that during the proposed inspection dates, the Quality Control laboratories such as the ---------------------------(b)(4)--------------------------- will be performing testing. In September, stability testing for MenB will be performed. QC testing during the other dates will not actually be testing MenB; however, the testing procedures are similar.

(b)(4) also stated that for pre-licensing inspection, during the short weeks (June 16-18 and July 7-10), they will be open for facility inspection, but not sure about manufacturing process inspection.

3. Please indicate if the product being manufactured during the proposed inspection dates are licensed or approved for the US market.

(b)(4) stated the product that will be manufactured in July is an approved product and has been inspected by FDA. The product that will be manufactured in September has been inspected by FDA; ------------------------------------------------(b)(4)-----------------------------------------------------------------.

Follow-up:
1. It was agreed that (b)(4) will provide a chart comparing the manufacturing process of
MenB to the manufacturing processes of the products scheduled to be manufactured during the proposed inspection dates. The comparison will also include equipment and room comparisons.

2. Based on the information provided, FDA will then determine the dates the facility will be inspected and notify Pfizer and (b)(4) as soon as possible after making the decision.

Pfizer indicated that in the rolling BLA, section 3.2.a.1 will have complete information
(rolled on May 27).

Call ended.
