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Vaccines, Blood & Biologics

First Committee Meeting, May 2, 2008 - Flublok


Date:                           May 2, 2008,
To:                              The File of STN 125285.0
From:                         Rakesh Pandey, Ph.D., Chair, Review Committee
                                    Katherine L. Matrakas, MS, RN, CAPT, USPHS;
                                    Regulatory Coordinator
Sponsor:                     Protein Sciences Corporation (Meriden, CT)
Product:                     Influenza Vaccine, FluBlok (Purified Recombinant Influenza Hemagglutinin)
Subject:                      Summary of theFirst Committee meeting for theBLA
Location and Time:  5/2/08, 3:00 –4:30 PM, WOC 1 Room 300N (Call-in number: -----------------(b)(4)------------------------
Attendees:                 Rakesh Pandey, Maryna Eichelberger, Matthew Sandbulte, Cynthia Nolletti, Andrea James, Joseph Toerner, Barbara Krasnicka, Rajesh Gupta, Arifa Khan, Jonathon McInnis, Deborah Trout, Loris McVittie, Katherine Matrakas
The purpose of this meeting was to ensure that the committee assignment was completed and that we had routed the relevant parts of the BLA to the review team. We made sure that we had reviewers in the committee to review every aspect of the data that was submitted in the BLA. We familiarized the committee with the regulatory milestones for the BLA that are listed here:
            Application received:             April 18, 2008
            Committee assignment:         May 2, 2008
            First committee meeting:       May 9, 2008
            Filing meeting:                       June 2, 2008
            Filing action:                          June 17, 2008
                                                SOPP at
            Deficiencies identified:          July 1, 2008  
                                                SOPP at
Letter template at
            First action due:                     October 18, 2008 (Saturday so Friday, October 17, 2008)
            Committee members and review responsibility:
            Rakesh Pandey                       Chairperson and overall review of the BLA
            Katherine Matrakas                Regulatory Project management
            Cynthia Nolletti                      Clinical Data
            Barbara Krasnicka                  Biostatistics Review
            Maryna Eichelberger              Product Review
            Matthew Sandbulte                Product Review
            Arifa Khan                              Cell Substrate Review
            Jonathon McInnis                   Facilities Review related to upstream processing
            Deborah Trout                                    Facilities Review related to downstream processing
Andrea James                         Pharmacovigilance
            Jean Makie                             Promotional Labeling Review
            Robert Wesley                                    Bioresearch Monitoring
            Marion Gruber                        Reproductive-toxicology Review
Rajesh Gupta                          Testing Methods and Analytical Chemistry Review
            Lev Sirota                               Assay Validation Review
            Joe Quander                            Lot Release Protocol
Discussion Items:
·       It was discussed that we needed to carefully look for any Refuse to File issues as the filing action milestone will be due on June 2, 2008. If we decide to file the BLA, a combined filing/ no major deficiencies identified letter may be issued.
·       The BLA has been submitted as paper submission in CTD format. However, the final action package will be an electronic approval package. Therefore all telecon memos, reviews etc need to have approval stamp and certification by author of the document for submission into EDR. Authors of telecon or review memos will be responsible for uploading these files into EDR. Committee was advised to attach word documents to the signed PDF format documents to assist OCTMA with the FDAAA requirements and redaction. Reviewers were advised to notify the Chair & RPM and the review team on uploading any memos to the BLA in EDR.
·       6 month priority review cycle. First action due 10/17/08 since 10/18 falls on Saturday. Sponsor desires for the 2008/2009 flu season.
·       Hard copy- complete set of paper CTD submission would be available to reviewers to borrow as not everybody was routed a full set of the BLA. Some BLA information was available in an electronic format in the EDR, and will be available to everyone on the review team. The BLA in Paper CTD was organized in the following modules:
1.     Module 1 Administrative Information and Prescribing Information
2.     Module 2 Common Technical Document Summaries
3.     Module 3 Quality
4.     Module 4 Nonclinical Study Reports
5.     Module 5  Clinical Study Reports
  • The BLA wouldl be discussed at the September VRBPAC to be scheduled sometime towards the last week. Since we would need about one month to prepare and provide briefing materials for the VRBPAC, it would be important to have all reviews completed by July 2008. Christine Walsh will assist with VRBPAC planning and deadlines.
  • The committee needs to keep in mind PeRC and PREA requirements and deadlines- usually requested to have reviews by mid-cycle. We would contact Rosemary Addy to get on the calendar for PeRC.
  • Need to see how new FDAAA Title IX: Section 901 regulations apply regarding PMR- post-marketing requirements and REMS- risk evaluation and mitigation strategies. Follow-up on possible allergies regarding novel insect cell master seed with possible post-marketing studies. 
  • It will be important to get the facility inspections completed in a timely fashion and all issues resolved for final action.
  • Mid-cycle review meeting with upper management to discuss how review work is going-would be held around July 16-17, 2008.
  • The contact person for PSC for this BLA is Dr. Manon Cox. Review team to communicate with Chair and RPM in order to have communications with sponsor and document electronically and in EDR and clarify any issues. Topics should be grouped for monthly committee meetings to allow for efficient use of review time.
  • Monthly BLA review meetings would be set up based on the availability of the committee members. Status of the BLA review will also be provided at monthly OVRR Update meetings to update the Office Director on BLA review progress and issues.
  • Assay validation information would be routed to Lev Sirota and the product, clinical and statistics reviewers would consult with him regarding any issues related to assay validation. 
  • Statistician expressed difficulty in accessing data submitted in the statistical databases, so we were to contact PSC to resolve these issues. The necessary definitions etc. were not provided.
  • DMPQ reviewers requested additional copies of BLA Modules 1 & 2. and agreed to share the rest. We also made sure that any of the volumes that were not needed by people who got them, will share with others who would need those volumes. We were going to send one consolidated request for extra copies.
  • Dr. McVittie discussed the requirements for the final action package which would include review memos using formal, clear, appropriate language. It is important to site clearly what you have reviewed, site the submission date or the section of the document and the specific parts involved. All issues covered in the responses to the sponsor and what has been accepted by the review team. This will be the Documentation Review document that will show the historical progression of the submissions and the work done as well as how issues were resolved. Issues should be grouped to be able to communicate to the sponsor and document clearly in the telecon in a coherent cumulative request to send back to the sponsor.
  • DPQ reviewer discussed briefly about the testing plan that should be available in draft around mid-cycle and agreed to work with the CMC reviewers in support of the testing for the BLA. They would coordinate with Joe Quander in support of lot release and receipt of the samples for testing.
  • The sponsor would submit strain change information for the 2008-2009 formulation as an amendment to the BLA and may need some advice on how to provide the sequencing information on the strains.  
  • Clinical reviewer will coordinate with BiMo reviewer regarding possible sites to inspect for evaluation of investigator and clinical sites.
  • Facility reviewers indicated that the facility inspection for the Connecticut site would likely be in the week of June 16th and for filling at the Hospira site in first week of July, depending on the production schedule. It was possible that based on previous inspection of contract filling site, Hospira site inspection might be waived.
  • The draft approval letter for the BLA will be reviewed by OCC and there will be further draft template language for safety studies required in light of the new FDAAA requirements.


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