
Monthly Meeting Summary, January 18, 2012 - MenHibrix


 
 
MenHibrix 
 

125363/12 
 

Monthly Meeting Summary – January

Date: January 18, 2012

Members Present 
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

Discussion 
1.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.
2.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.
3.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.
4.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.
5.GSK provided clarification on the Final Container samples. CBER will request lot release protocols for these samples.

 

ACTION 
CBER will respond to GSK information requests via email
