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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Team Meeting Agenda, February 15, 2013 - ALLOCORD

 

 

Sponsor:          SSM Cardinal Glennon Children’s Medical Center
BLA #:            BLA 125413
Product:          Hematopoietic Progenitor Cells
Date:               February 15, 2013
Time:              11:30 AM-12:30PM
 
 
1.         Discipline Reviews of Application/Issues Needing Resolution  
 
·                 CMC – Brent, Joydeep, Safa, Brian
Comment on residual antibodies needs to be in PI.
Need shipping container label, SOP for labeling process
Stability testing acceptance criteria for expiration not acceptable
Need to sign off lot release
           
·                 DMPQ –Nancy
            Just an update on my progress from the SLCBB CR review.  I’m moving along, but I’m      at a waiting period right now.
 
            I have sent my CR response review to my Branch Chief for review.  I am recommending            approval as long as the Product Office doesn’t have any issues.
 
            For the 483 response review, I sent my draft review to Brent to get Product Office input.  Once I get that, I will be able to finalize my review.  At that time, the inspection will be        endorsed in FACTS which means that I can then do a compliance check for the             application whenever it is needed.  In order to do a compliance check for a BLA, a copy    of the endorsement is needed.  So, the final part, the compliance check is contingent upon    getting the 483 review done and the endorsement signed by my Branch Chief.
 
·                 Pharm/tox – Shamsul – some PI comments
·                 Clinical – Lei
·                 Stats – Renee
·                 Labeling – Loan – working on PI
                       
2.         Timeline
      (Assuming a May 15 target approval date)
 
            March 4
            PNR letter due (RPM to draft letter by Feb. 25)
 
            March 20
            Draft Review Memos Due to TL/BC (Review Committee)
 
            April 3
            Draft Review Memos Due to DD (Review Committee)
            Draft SBRA memo (Review committee)
            Draft Approval Letter (RPM)
 
            April 17
            Final Review Memos Due to Office Director (Review Committee)
            PMC Study Target (tcon with applicant)
            Labeling Target (tcon with applicant)
 
3.         Labeling
            Attachment 19 in amendment 12 located in the EDR. 
            Inform Vada Perkins about ISBT
             
 
4.         PMC
            Need to enter email to make target date
 
Participants: Stephanie Simek, Shamsul Hoque, Loan Nguyen, Kim Benton, Safa Karandish, Brent McCright, Nancy Waites, Joydeep Ghosh, Brian Niland, Keith Wonnacott, Ilan Irony, Lei Xu, Lori Tull