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Vaccines, Blood & Biologics

Review Committee Meeting Summary, November 12, 2009 - Menveo

BLA 125300_0
Novartis ACYW-135 Mening Vaccine

November Review Committee Meeting Agenda

Date

Time

Location

US
Call in

Password

International Call in - Toll

Thursday
November 12, 2009

3:00 – 4:00 EST PM

Room 300 N, in Building WOC 1

---b(4)------------------

Participant Passcode --b(4)------

Leader pass code --b(4)---

---b(4)---------------

  1. Attendees

    Al-Humadi, Nabil
    Bash, Margaret
    Campbell, Karen
    Fiore, Cara
    Freedberg, Daron
    Gupta, Rajesh
    Krasnicka, Barbara
    Lee, Martha
    Stewart-Bennett, Daphne
    Sutkowski, Elizabeth
    Vann, Willie
    Valenti, Elizabeth

  2. Recent Amendments
    1. Running list
      1. optimizing CRM 197 innocula (0.1)
      2. Extractables and Leachables (0.2)
      3. Partial DI response (0.3)
      4. Partial DI response and additional info (0.4)
      5. Response to IRs. (0.5)
      6. HPV V59P18 (0.6)
      7. Pharmacovigilance Response (0.7)
      8. Correction to LIMS and updated product list (0.8)
      9. PerC Deferral Information (0.9)
      10. 483 response (.10)
      11. Batch records and product samples (.11)
      12. Stability Data for 24 months and packaging mock ups
      13. Specifications and validation of specs, manufacturing data
      14. Pharmacovigilance plan, ---b(4)---------------, updated 483 responses, Comparability Protocol
      15. Complete Response (Aug 21, 2009)
      16. Pre-licensure testing – selection of batches (Oct 8, 2009)
      17. Stability data to 36 months, batch data for pre-licensure testing, PVP
  3. Team Reports
    1. Clinical – the IND continues to dominate the majority of the review time. Last week the sponsor was told that focus needed to be put on the BLA, not the IND; however, they then submitted more amendments to the IND. The sponsor wants answers on retesting in the infant P14 study and toddler P21 study . Dr. Bash agreed to draft language, for review by OVRR management, to gain support for only reviewing the BLA at this time.
    2. Statistical – the P14 submission for the IND was also reviewed and a new analysis plan was (for an assessment of agreement of the original test and re-test procedures) proposed. Review of the BLA will continue next week.
    3. CMC – Daron Freedberg – the sponsor wanted --b(4)----------------- however, rational for ---b(4)------------------ was not satisfactory. The review is in draft form and the ----b(4)------------------------------------. An IR will be sent to the sponsor asking -----b(4)----------------------------------------------
    4. Lot Release – Problems should be identified and comments should be sent to the sponsor by mid-December. The final review memo should be completed by January 15, 2010.
    5. Labeling – APLB review finished. The first labeling meeting is November 17, 2009. OBE, APLB, DE, and Repro Tox have sent comments. Dr. Vann will review the drug description prior to the labeling meeting.
  4. Major Due Dates are on Table below
    Milestones Date
    Lot release protocol asap
    Lot release testing (consist and launch) 10/20/09
    Labeling - start Oct/Nov
    Further BIMO/CMC inspection?
    Another facility inspection?
    Deficiencies Identified 11/03/09
    Midcycle Review 11/04/09
    Prep of product testing plan 11/04/09
    Final Prop name review 11/19/09
    Final Reviews Due 12/19/09
    PMC to FDAAA Safety WG
    Action Package routing 1/13/09
    Lot release clearance 01/18/10
    Approval letter draft 1/19/09
    Action Package to Branch Chiefs 1/20/10
    Final Action Due Date 2/20/10
    Action Package Posting 2/20/09
    Monthly Meetings (Team report) monthly
    IOD Monthly Update monthly
  5. Next Meeting –
    1. December 9, 2009
  6. Questions/Comments/Concerns?
    1. Please continue to include Cara and Betsy on emails.
  7. Action Items
    1. Dr. Bash to draft language, for review by OVRR management, to gain support for only reviewing the BLA at this time.
    2. Dr. Freedburg to draft an IR asking that the tests be added back to the plan.

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