Monthly Meeting Summary – January
Date: January 18, 2012
Chair Joe Temenak
RPM David Staten
RPM Kirk Prutzman
Product/CMC Mustafa Akkoyunlu
Product/CMC Daron Freedberg
Product/CMC Drusilla Burns
Product/CMC Michael Schmitt
Product/CMC Tina Roecklein
Product/CMC Jennifer Bridgewater
Promotional Labeling Maryann Gallagher
Clinical Stats Barbara Kransnicka
DPQ/Lot Testing Plan Rajesh Gupta
DPQ/Lot Testing Plan Karen Campbell
CMC3 Supervisor Elizabeth Sutkowski
CMC Supervisor Jay Slater
CMC Supervisor Willie Vann
Lot Release Joe Quander
- The team reviewed upcoming milestones. Emphases on the February 27, 2012 Mid-Cycle Review meeting. Reviewers were instructed to present any issues related to the approval of the BLA. There may be unresolved assay issues. Mustafa stated comments for the sponsor should be finalized before the Mid-Cycle meeting.
- Prior to this meeting CBER receive two information requests from GSK. GSK (b)(4) month stability data being generated for the January 30th deadline submission did not meet specifications. No data on what failed was submitted. GSK requested to submit a real-time stability protocol which includes a (b)(4) month time point in the January 30th submission. They also requested to submit these data via the next annual report. For BLA approval GSK will need to maintain ---(b)(4)--- expiration.
- The review team agreed that any stability data beyond 24 months must be submitted as a PAS to the licensed BLA. Stability data can not be submitted via annual report.
- GSK is implementing a revised persistence sample hSBA MenC assay. During the November 15, 2011 Type B meeting CBER advised against this revision. GSK stated they understand implementing this revision is at their own risk since CBER cannot agree with the assays and validation package yet given the outstanding questions regarding the assays in the context of the MenHibrix BLA. GSK gave no indication for the change. CBER will acknowledge GSK risk.
- GSK provided clarification on the Final Container samples. CBER will request lot release protocols for these samples.
CBER will respond to GSK information requests via email