Record of Telephone Conversation, June 19, 2013 - ALPROLIX

Submission Type: Original BLA    Submission ID: 125444/0    Office: OBRR
 Product:          Coagulation Factor IX (Recombinant), Fc Fusion Protein, [rFIXFc]
 Applicant:       Biogen Idec, Inc.
 Telecon Date/Time: 19-Jun-2013 01:30 PM        Initiated by FDA? Yes
 Communication Category:                 1. Advice
 Author: Edward Thompson
 Revisions: Nancy Kirschbaum
 Telecon Objective:  To discuss Biogen Idec plans for incorporation of a -------(b)(4)------- step into the manufacture of rFIXFc
 FDA Participants: 
 Mahmood Farshid, PhD, Deputy Director, CBER/OBRR/DH
 Nancy Kirschbaum, PhD, CBER/OBRR/DH/LH
 Timothy Lee, PhD, Acting Branch Chief,  CBER/OBRR/DH/LH
 Ze Peng, PhD, CBER/OBRR/DH/LH
 Edward Thompson, CBER/OBRR/DBA/RPMB

Non-FDA Participants:
Biogen Idec
 Amin Abujoub          VP, Global Quality Control
 Aoife Brennan           Senior Director, Medical Research
 Doug Cecchini          Director, Technical Development
 Paula Cobb                VP, Program Management
 Nadine Cohen            Senior VP, Regulatory Affairs
 Lynda Cristiano        Director, Drug Safety and Risk Management
 Ann Dodds-Frerichs  VP, CMC Regulatory Affairs
 Kim Hocknell            Director, CMC
 Alison Innes              Associate Director, Biostatistics
 Clive Patience           VP, Global Quality Assurance
 Glenn Pierce              Senior VP, Global Medical Affairs 
 Heidi Reichert           Director, CMC
 Paula Sandler            VP, Regulatory Affairs
 Denise Schultz          Associate Director, CMC Regulatory Affairs
 Debra Segal               Director, Regulatory Affairs
 Daniel Soroko           Associate Director, Regulatory Affairs 
 Suzanne Stella           Director, CMC Regulatory Affairs

Telecon Body:
 FDA initiated this meeting to discuss Biogen Idec’s plans for incorporation of a (b)(4)

One (1) Page Determined to be Non-Releasable:  (b)(4)
