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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Review Committee Assignment, July 25, 2011 - MenHibrix

 

Date: July 25, 2011
To: 125363/12 File
Review Committee
From: Kirk Prutzman, Ph.D.
Thru: Joseph Temenak, Ph.D. Chair, MenHibrix Review Committee Assignment Memo
Subject: Addition of Lucia Lee, M.D. to Review Committee Assignment
 
Lucia Lee, M.D. has been assigned to GSK’s CR response for MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) as a Clinical Reviewer.
The action due date for this application is October 15, 2011
 
Review Assignment               Committee Member                           Supervisor
Chair                                        Joseph Temenak                                   Elizabeth Sutkowski
RPM                                        David Staten                                         Elizabeth Sutkowski
RPM                                        Kirk Prutzman                                       Elizabeth Sutkowski
Clinical Reviewer                      Meghan Ferris                                       Lucia Lee
Clinical Reviewer                      Lucia Lee                                             Douglas Pratt
Product CMC/Serology              Mustafa Akkoyunlu                               Willie Vann
Product CMC                           Willie Vann                                           Jay Slater
Product CMC                           Daron Freedberg                                   Willie Vann
Product CMC                           Drusilla L Burns                                    Jay Slater
Product CMC                           Annisa Cheung
Product CMC                           James E Keller                                      Drusilla Burns
Product CMC                           Majid Laassri                                        Konstantin Chumakov
Product CMC                           Steven A Rubin                                     Konstantin Chumakov
Product CMC                           Michael Schmitt
Product CMC                           Shuang Tang                                         Philip Krause
Product CMC                           Iryna Zubkova                                        
Toxicology                               Steven C Kunder                                   David Green
Product CMC                           Tina Roecklein                                      Jay Slater
Facilities/DMPQ                       Sean Byrd                                             Carolyn Renshaw
Advertising/
Promotional Labeling                 Maryann Gallagher                                Lisa Stockbridge
Clinical Statistical Reviewer       Barbara Kransnicka                              Dale Horne
Assays Statistical Reviewer       Tsai-Lien Lin                                        Dale Horne
Epidemiology                             Manette Niu                                          Thomas Buttolph
DPQ/Lot Testing Plan               Rajesh Gupta                                        Bill McCormick
DPQ/Lot Testing Plan               Karen Campbell                                    Bill McCormick
Lot Release                              Joe Quander                                               Jay Elterman
BiMo                                        Soloman Yimam                                    Patricia Holobaugh
Electronic Integrity Review        David Schwab                                       Laraine Henchal