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Vaccines

GSK MenHiberix BLA Committee Email, August 05, 2011 - MenHibrix

 

From:                     Bridgewater, Jennifer
Sent:                      Friday, August 05, 2011 3:50 PM
To:                         Prutzman, Kirk C; Temenak, Joseph; Staten, David; Dickerson, David
Cc:                         Lynn, Freyja; Slater, Jay; Bridgewater, Jennifer
Subject:                 GSK MenHiberix BLA Committee, STN125363
Hi all -
 
Freyja has returned to DBPAP after a time at a NIH. Her speciality is serology and we want her on board this file to work on serology. So we are asking you to please add her formally as a committee member, job type, CMC, serology.
 
David D - is there anything you need to do to make sure she can physically access the file in the EDR? She is able to be added to any committees as we filled out the DCC-101. If you need to do anything special so the BLA shows up in her workload and she can access it please do.
 
Thanks very much everyone -
 
Jen
 
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                           
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
Product CMC                           Freyja Lynn
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