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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Planning Meeting Minutes, May 24, 2011 - HPC Cord Blood

 

21 Day Planning Meeting Minutes
 
DATE:            May 24, 2011
Time:              12 -1 PM EST
Sponsor:         ClinImmune
BLA #:            BLA 125391
Product:          Hematopoietic stem/progenitor cells, cord (HPC-C)
 
Attendees:      Simek, Stephanie; Ramani V; Przepiorka, Donna; Witten, Rachel, Fan, Yong; Nguyen, Loan; Heidaran, Mohammad; Hoque, Atm S.; Wonnacott, Keith; Cato, Dennis; Karandish, Safa; Bi, Lilia; Riggins, Patrick; Benton, Kimberly; Cheng, Chunrong; Waites, Nancy;
 
1.         Introduction of Review Team
 
  • Product Team stated that each member will review a particular area of the       CMC section.
    • Yong Fan -Manufacture
    • Lilia Bi-Assays and validations (except Sterility and Flow)
    • Safa Karandish-Donor eligibility(DE) and labeling relevant to DE
    • Steve Bauer-Flow cytometry (CD34 enumeration and validation)
    • Joydeep Ghosh Sterility tests and validation
 
2.         Official Milestones and Monthly Goals
 
            A draft timeline was agreed upon. Please see Appendix 1 (Page 3)
 
All reviewers will check for filing issues using the BLA filing check list. The filling issues will be discussed at the filing meeting.
 
Reviewers should also identify major deficiencies and missing information.
 
All communications with the sponsor will be initiated through and documented by Ramani.
 
Reviewers should bring major issues to the review committee and management for potential AC meeting items.
 
  3.                  Action Items
 
The following action items were identified:
 
Task
Responsible Party
Due Date
Coordinate Facility Inspection dates to include 2 OCTGT participants.
Mohammad Heidaran
Yong Fan and Lilia Bi
Soon
Contact Sponsor regarding data listings and data dictionary
Rachel Witten\Donna P.
Chunrong Cheng
Ramani Sista
Before filing
Send E-Room link to team
 
Ramani Sista
ASAP
Schedule a post inspection meeting
Ramani Sista
When Inspections scheduled
Post marketing registry – Speak with Rachel Anatol
Rachel Witten
Soon
Add filing checklists to eroom
 
Ramani Sista
ASAP
Prepare presentations for Filing Meeting
 
Review Team
6/21/11
Draft Reviews to Celia by Midcycle
Review Team
10/06/2011
 
 
4.                  Next Steps
 
  • Filing Decision Meeting scheduled for 6/21/2011
 
 Appendix 1. GRMP timeline for BLA 125391


 

 
Timeline
Activity
Comments/Meeting Dates
Day 0
Application Receipt
May 04, 2011
Days 0 – 14
Assign RPM
 
Begin Regulatory Filing Review (RPM)
 
By Day 14
05/18/2011
Acknowledge application receipt in writing
 
Assign Review Team- Team Leaders
Product Chair &: Yong Fan  
 Reviewers: Lilia Bi
                    Safa Karandish                  
MO:            Rachel Witten
P/T:            Shamsul Hoque
Facilities:   Mo H. & Marion M.
Stats:          Chunrong Cheng
BiMO:       Dennis Cato
APLB:       Loan Nguyen
PM:            Ramani Sista
Schedule Filing Meeting (RPM)
 
Days 0 – 45(30)*
21 Day Meeting
Request Consults , schedule PeRC
05/24/2011
21 Day Meeting
 
Identify Inspection Actions (DMPQ\BiMO)
Designate Priority or Standard Review Status
Identify Signatory Authority
Determine if PeRC Meeting necessary
Proprietary Name
By Day 45 (30)*
June 18, 2011
 
Hold Filing/Planning Meeting
June 21, 2011
Conduct Filing Review- decide if AC necessary
 
By Day 60
July 3, 2011
Inform Applicant of a Priority Designation in Writing
60 day letter out on or before July 1, 2011
Communicate Filing Determination to Applicant, if RTF
By Day 74
July 17, 2011
Communicate Filing Review Issues to Applicant
Letter out on or before July 17.
Convey Potential RTF Issues to Applicant
 
 
Team Meeting
August 10, 2011
 
By End of
Month 5(3)*
October 4, 2011
 
Mid-Cycle Meeting
October 6 , 2011
 
Update on reviews, consults, and inspections,
Notify SWG if PMRs
Notify OCC if REMS
PeRC forms and scheduling
 
 
Define need for additional interaction with applicant related to labeling, risk management, PMCs
 
 
Draft reviews to Celia
Due 10/06/2011
 
Revise review plan, if needed ie, internal consults
 
 
 
Team Meeting
November 16, 2011
By End of
Month 8(5)*
January 4, 2012
Completed Review DUE DATES
 
Signed off reviews in EDR\RMS-BLA
 January 4, 2012  
 
January 5, 2012
 
Integrate outcomes of reviews, consults, inspection reports, and AC input
 
6 (4-6)* weeks before action
Labeling Meetings
 
 
5-6 weeks before action fax proposed labeling
 
Compile Action Package
Draft action letter
 
4 weeks before Approval action
Lot release clearance
Submit final Product Testing Plan to Office Director for signoff
 
February 3, 2012
 
 
 
4 (3-4)* weeks
before action
Circulate and Review Action Package and Letter
February 3, 2012
Begin 3 weeks before Division sign-off
Finalized Action Package to Office Director
February 10, 2012
 
 
3(2-3)*weeks before action
Labeling telecom/discussion with applicant, Negotiation of PMC, Risk Mgmt
February 10, 2012
By PDUFA Goal Date
Action
March 2, 2012
 
 
 
 
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