Employee/Officer List - TRUMENBA

EMPLOYEE/OFFICER LIST MEMO

To: The File
Date: October 23, 2014

BLA: STN 125549/0
Sponsor: Wyeth Pharmaceuticals, Inc.
Product: Trumenba™, Meningococcal Group B Vaccine

From: Theodore Garnett, Ph.D. (RPM)

Through: Drusilla Burns, Ph.D. (Chair)

Section 916 of the Food and Drug Administration Amendments Act (FDAAA) requires that the identity of each employee or officer who participated in the decision to approve an original application be listed and filed as part of the Action Package for that file.

The following employees and officers have consented to have their names published publicly as being a participant in the approval decision for this file.

 Drusilla Burns, Ph.D. - Chair
 Michael Smith, Ph.D. - Lead Regulatory Project Manager
 Theodore Garnett, Ph.D. - Regulatory Project Manager
 Ramachandra S. Naik, Ph.D. - Regulatory Project Manager
 Lucia Lee, M.D. - Clinical reviewer
 Tina Roecklein, M.S. - Product, product test methodologies, and Regulatory Coordinator
 Freyja Lynn, B.S. - Bioassay (clinical serology and product test methodologies)
 Margaret Bash, M.D., M.P.H. - Bioassay (hSBA) consult 
 Alfred Del-Grosso, Ph.D. - Product test methodologies reviewer
 Anil Choudhary, Ph.D. - Product test methodologies reviewer
 Cheryl Hulme, M.L.T., - A.S.C.P. Coordination of lot release 
 Barbara Krasnicka, Ph.D. - Biostatistics reviewer
 Tsai-Lien Lin, Ph.D. - Statistical reviewer
 Nancy Waites, M.S. - Facilities, CCIT reviewer
 Lillian Ortega, M.P.H. - Bioresearch Monitoring reviewer
 Michael Brony, Pharm.D. - Advertising/Promotional Labeling
 Leigh Bernardino, R.N., B.S.N. - Regulatory Project Manager
