
Team Meeting 4, November 26, 2012 - HPC, Cord Blood BLA 125432

 
 
 

DATE:                November 26, 2012

Time:                 12:00 -1:00 PM EST

Sponsor:          LifeSouth

BLA #:                              BLA 125432

Product:           HPC, Cord Blood

 

FDA Attendees:          Candace Jarvis, Mohammed Heidaran, Juanita Williams-Gould, CHad Burger, Atm S.Hoque, , Stan Lin, , Karoll Cortez, Keith Wonnacott, Lisa Stockbridge, , Joydeep Ghosh, Wilson Bryan, Kimberly Benton, Lillian Ortega, , Fatima Abassi, Eric Dollins, Stephanie Simek, Celia Witten, Mark Borigini, Changting Haudenschild, Raj Puri,

 

 

Call in information:  -------------(b)(4)------------------------

 

Agenda:

 

1.           Administrative Updates
•None at this time

 

2.           Review Updates

 

a.                CMC:

Outstanding issues: 
•Donor screening SOPs need to be revised to provide detail information regarding review of the medical and physical examination records
•Collection validation information not adequate. The applicant has not provided all the data; doable in a short period of time
•The applicant must provide information regarding the assignment of unique donor identification and maintaining linkage between the collected unit and the birth mother; doable in a short period of time
•The applicant must provide analytical specificity and analytical sensitivity for CD34 and nRBC enumeration laboratory validated tests; (higher limit of detection need to be shown); doable in a short period of time
•In regard to ---(b)(4)--- sterility test method validation, the adequacy of the sampling plan for the final product has not been adequately established; sponsor to submit validation plans for preview/comments; need to determine if the sponsor plans to exclude birth mothers on antibiotics.
•Package label is not in compliance with ISBT requiring bar codes

Update: Sponsor plan to fully implement ISBT 128 by 12/30/12
•Request for proprietary name is outstanding

Update: Sponsor plan to submit proprietary name request after approval.
•Revalidation of the Emergency recovery remains to be performed.

 

b.               DMPQ : 
•Sponsor states that they are planning renovation of clean rooms on 11/27/12. Not too sure of flooring they are going to use as it is listed as industrial grade clean room flooring from a tile company; however, the owness for their choice of flooring belongs to them. Once renovations are complete, they will need to re-qualify the room. 
•Main issue: seems to be executing the qualifying of the cleaning and identifying organisms and growth promotion; they also need to qualify new equipment. 
•End of January beginning of February seems to the target for resolving the facility issue

 

c.                PHARM/TOX:
•No new updates

 

d.               CLINICAL: 
•Sponsor submitted the appropriate HLA matching data, appears to be adequate.

 

e.                STATS:
•Created a table showing the number of subjects achieving ANC>500 by day 42 cross classified by HLA match and TNC Dose (X107/kg).

 

f.                 LABELING:
•No new updates

 

3.           Upcoming Dates:

 

Next team Mtg: January 7, 2013

Completed Review Due: January 17, 2013

Wrap-Up Mtg: February 19, 2013 (Date subject to change)

Labeling Mtg: TBD

 

4.           Other Issues
•Timelines submitted by sponsor-Upper Mgmt discussion needed
•Determination of Major Amendment for outstanding items submitted by sponsor and clock extension option
•Determination of CR letter issuance.

5.           Issues/Questions for sponsor discussion
•Inform sponsor that when submitting amendments to the BLA, inspectional findings need to be separated from review related issues.

Update: sponsor informed in 11/28/12 t-con