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Vaccines, Blood & Biologics

Review Team Meeting Agenda Minutes, March 19 2009 - Laviv

Participants:  Donald Fink, John Thomas, Ashok Batra,  Gang Wang, Stephanie Simek, Bo Zhen, Ghanshyam Gupta, Michael Yao, Allen Ou,  Raj Puri, Lisa Stockbridge, Atm Hoque, Keith Wonnacott, Kimberly Benton, Robert  Wise, Lori Tull, Craig Zinderman, Janet White

Isolagen BLA 125348  First Committee Meeting

Introduction of  Review Team

Terrig Thomas  (Product)                                 
  Donald Fink                 (Product)                                 
  Atm Hoque                  (Pre-clinical)                            
  Michael Yao                 (Clinical)                                  
  Gang Wang                  (DMPQ)                                 
  Shiowjen Lee               (Statistics)                               
  Craig Zinderman           (Epidemiology)            
  Alan Ou                       (Epidemiology)                
  Janet White                  (Bioresearch Monitoring)         
  Lisa Stockbridge          (Labeling)                                
  Lori Tull                       (RPM)                                    

Outline of  Submission

Autologous  Fibroblasts (human, dermal, Isolagen Technologies, Inc.) Expanded ex vivo,  Administered Intradermally for the Treatment of Rhytids.

History Summary

Major Review  Milestones
  First committee meeting - 3/20/09
  Filing meeting - 4/17/09
  Filing action (letter) - due by 5/5/09
  Deficiencies identified (letter) - due by 5/19/09
  Labeling Target - due by 12/5/09
  PMC Study Target - due by 12/5/09
First action due - 1/4/10

Review  Expectations
  Good Review Management Principles (GRMP) Guidance

Sponsor  Communications
  How often – will schedule as needed, Mid cycle in August
  Who initiates?
  Who participates – as needed
  How are they documented – Lori drafts emails for comments from team

  Timing for DMPQ (June or August) and BiMo Inspections
  Product reviewer credentialing (Don and Terrig)

Need for  Advisory Committee Meeting - Yes

Overview of  upcoming Filing/Planning meeting – Lori to email checklist

Action Items
  Formal consult from CDRH and CDER
  PVP – possible REMS or PMR
  Set up eroom

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