System Info - 106076 SMITH, MICHAEL J 28-Sep-2009 15:19:27 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 24-SEP-2009 04:45 PM Initiated by FDA? Yes
Telephone Number: 845-536-3217
2. Information Request
Author: JULIENNE VAILLANCOURT
Follow-up on CMC items (9-1-2009 draft meeting minutes, Type –(b)(4)--- tightening of certain spec's for 6 new serotypes) and Postmarketing items ( Otitis Media Effectiveness study and phase 4 safety study).
FDA Participants: Julienne Vaillancourt and Mike Smith
Non-FDA Participants: Jack Love
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
I. CMC Issues
1) Tue 9/8/2009 e-mail (subject: Wyeth meeting minutes) from Jack Love to Julienne Vaillancourt and Michael Smith
2) Sat 9/19/2009 1:04 PM e-mail (subject: Follow-up on telephone call from Tina Roecklein and Willie Vann) from Jack Love to Julienne Vaillancourt and Michael Smith
3) Record of 9/9/2009 teleconference (CBER participant: Julienne Vaillancourt; sponsor participant: Jack Love).
- Minutes of September 1, 2009, Face-to-face Meeting on Outstanding CMC Issues:
- The Sponsor’s Minutes: The sponsor was informed that Dr. Vann had reviewed the sponsor’s minutes of the face-to-face meeting concerning outstanding CMC issues on September 1, 2009. CBER agreed to forward Dr. Vann’s tracked changes of these minutes to the sponsor immediately following the call. It was noted that Dr. Vann’s changes included some comments indicating need for additional internal CBER discussion on certain items. The sponsor was informed that in general CBER concurred with the sponsor’s minutes except for a few minor items as indicated by Dr. Vann and previously conveyed to Wyeth by Ms. Vaillancourt on September 9, 2009.
- CBER’s Minutes: The sponsor was informed that CBER’s minutes were similar in content to the sponsor’s minutes and CBER intended to share them with the sponsor soon. CBER acknowledged that both sets of comments contain language about pending feedback from CBER to the sponsor on certain issues, e.g., acceptability of proposed development and use of a mock sample for serotypes (b)(4) and (b)(4) conjugate in final DP for stability testing.
- Pending Information Request E-mail with Comment Concerning Type –(b)(4)--
- CBER informed the sponsor that an “information request” e-mail, with a number of CMC comments from Drs. Rajesh Gupta, John Cipollo and Willie Vann was pending, and would include a comment concerning the need for an assay and specification to measure ----(b)(4)--- in serotype (b)(4) conjugate. CBER commented that the lack of information in the BLA about ------(b)(4)--------- with serotype (b)(4) was identified by Dr. Cipollo during inspection of the -(b)(4)- facility. Dr. Love noted that he was not aware of this issue.
- New Pre-licensure Request to Revise Certain Specifications among Six New Serotypes
- In follow-up to Dr. Love’s September 19, 2009, e-mail, summarizing his September 17, 2009, teleconference with Dr. Willie Vann and Ms. Tina Roecklein, the sponsor was informed that CBER considered it important for the sponsor to formally revise certain specifications, recently identified by CBER as being too wide, for certain serotypes among the six new serotypes, pre-licensure. In response to this request to change (tighten) such specifications prior to licensure, the sponsor responded as follows:
- Please clarify which specifications for which serotypes you would like to see revised pre-licensure.
- Wyeth has tightened all previously discussed specifications except for -------(b)(4)------ which is currently being worked on.
- On September 1, 2009, during the face-to-face meeting, CBER agreed that there would be no new CMC requests, beyond those discussed at the meeting.
- Wyeth is willing to commit to operate with the tightened specs, but not formally establish them until sometime immediately following licensure, as this would require updating >200 documents in the BLA.
- As an interim measure, Wyeth has proposed to submit tables, which would summarize all such tightened specs, until these specs are formally revised post licensure. He expects to complete and submit these tables to us sometime early next week.
- Wyeth will release no lots outside of these “new” specifications; however, Wyeth will not update all pertinent documents in the BLA to reflect the new specifications until within the first three months of licensure.
- The sponsor reiterated that this request would involve an enormous amount of work as many different types of documents in the BLA would require being updated. The sponsor requested that CBER specify exactly which specifications for which serotypes the Agency would like updated in the BLA pre-licensure. The sponsor also requested CBER to reconsider accepting the tables, which are currently being prepared, pre-licensure, along with the sponsor’s commitment to operate within the revised specs until formal establishment of these revised specs via a supplement within the first three months post-licensure.
- CBER agreed to follow-up on this request with the CMC reviewers and if necessary arrange a teleconference with the sponsor to further discuss a solution, perhaps a compromise (e.g., perhaps Wyeth could provide updated documents for s subset of the specifications pre-licensure), that would be reasonable for both the sponsor and CBER.
II. Post Marketing Issues
- Pending Teleconference to Discuss Proposed Otitis Media Effectiveness Study
- CBER acknowledged the need for discussion on the sponsor’s proposed post marketing effectiveness study of otitis media and agreed to follow-up on arranging a teleconference.
- Follow-up on Recently Requested Changes to Phase 4 Safety Study
- CBER questioned the outcome of the sponsor’s recent discussion with Kaiser on CBER’s recently requested changes to the protocol for the proposed phase 4 safety study.
- The sponsor noted that Kaiser was okay with most of CBER’s requested changes, except for the request concerning timing of reports (i.e., CBER requested that the sponsor provide six-month cumulative tabulations within three months after the close of each six month period, starting with the first six months of data after study initiation.) The sponsor explained that Kaiser would need more time to generate the first report out, but thereafter should be able to generate subsequent reports in the time requested.
- The sponsor plans to submit a written response to CBER’s 9/11/2009 set of additional comments on the phase 4 safety study sometime early in the week of September 28, 2009.
End of telecon.