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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Monthly Meeting Summary, October 13, 2009 - MenHibrix

MenHibrix
125363/0
Monthly Meeting Summary – October

Date:   October 13, 2009

As required by OVRR, the review team for MenHibrix met via e-mail to present review issues to the Chair and indicate to the BLA RPMs whether any of these issues require communication to GSK.

 

Members Present 
ChairJoseph Temenak, Ph.D.     
Clinical Reviewer/Labeling Meghan Ferris, M.D.
Product CMC/Serology            Mustafa Akkoyunlu, M.D. Ph.D, 

Product CMC                                    

Willie Vann, Ph.D.

Product CMC                                    

Daron Freedberg, Ph.D

Product CMC                                 

Tina Roecklein, MS

Product/CMC                                   

Milan Blake, Ph.D.

Product/CMC                                    

James E. Keller, Ph.D.

Product/CMC                                    

Michael Schmitt, Ph.D

Facilities/DMPQ                                

Joseph George
Facilities/DMPQ                              Sean Byrd

Advertising/ Promotional Labeling    

Maryann Gallagher

Clinical Statistical Reviewer               .

Barbara Krasnicka, Ph.D

Assays Statistical Reviewer               

Tsai-Lien Lin, Ph.D.
Epidemiology  David Menschik, M.D., MPH

Epidemiology                                     

David Martin, M.D.

DPQ/Lot Testing Plan                                   

Rajesh Gupta, Ph.D.

DPQ/Lot Testing Plan                                   

Karen Campbell 

Lot Release                                        

Joe Quander III

BiMo                                                  

Robert Wesley  
DVRPA Regulatory Project Manager                       David Staten, MPH

DVRPA Regulatory Project Manager                     

   Jason Humbert   

DBPAP Regulatory Coordinator                   

Jennifer Bridgewater, MPH

Discussion:

1. The Clinical Reviewer has identified issues to be included in an Information Request letter. These items will be forthcoming.

2. APLB is currently reviewing the proposed proprietary name MenHibrix and the product labeling.

3. The main outstanding issue thus far from an epidemiological standpoint is that they did not submit a draft synopsis or protocol for a phase 4 study which was requested at the pre-BLA stage. The epidemiology reviewers are working on what they would like to see in such a study and anticipate generating some comments that will need internal (DE/VSB) concurrence before forwarding to others on the BLA committee and ultimately conveying to the sponsor. GSK has indicated that they would like to discuss the topic with CBER, but that strategy will be to formulate our position first and convey comments in advance of a possible teleconference.

4. No other issues were presented. The committee will meet again in November.

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