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Vaccines, Blood & Biologics

Meeting Summary, January 7, 2013 - Q-Pan

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service


Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

MEETING SUMMARY

Date and Time: January 7, 2013 12:30 am – 1:30 pm
Location: WOC2 – Room 2330
STN #: 125419/0
Sponsor: ID Biomedical Corporation of Quebec (dba GlaxoSmithKline Biologicals)
Product: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

CBER/FDA Invitees

Attended Committee MemberReview AssignmentSupervisor
Carmen Collazo-CustodioChairElizabeth Sutkowski
Jeremy WallyLead RPMElizabeth Sutkowski
Kirk PrutzmanCo-RPMElizabeth Sutkowski
Andrea JamesClinicalLewis Schrager
Hana GoldingProduct CMCJerry Weir
Surender KhuranaProduct CMCHana Golding
Nabil Al-HumadiToxicologyDavid Green
Tsai-Lien LinClinical/Assay StatsDale Horne
Tielin QinAssays StatsDale Horne
Maryann GallagherAdvertising/Promotional LabelingLisa Stockbridge
Cheryl HulmeLot ReleaseJoseph Quander III
Yandong QiangPharmacovigilanceWei Hua
Hector IzurietaEpidemiology (Effectiveness)Richard Forshee
Anthony HawkinsBIMOPatricia Holobaugh
Randa MelhemFacilities/DMPQChiang Syin
Jei HeFacilities/DMPQChiang Syin
James KenneyProduct QualityRajesh Gupta
Manju JoshiProduct QualityWilliam McCormick
Lokesh BhattacharyyaProduct QualityWilliam McCormick
Karen CampbellProduct QualityWilliam McCormick
David SchwabElectronic Integrity ReviewLaraine Henchal

OTHER ATTENDEES:

Wellington Sun

Richard Forshee

Elizabeth Sutkowski

Lewis Schrager

Erik Henchal

 

1.0

PURPOSE

The objectives of this meeting were:
 

  1. To update Management on the review progress
  2. To update the review team on the new review timelines
  3. To discuss remaining topics that need to be addressed before the Action Due Date

2.0

BACKGROUND

The proposed indication of BLA STN 125419 is for active immunization for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.

3.0

DISCUSSION TOPICS

3.1

Milestones and Meetings

MilestoneProjected Date
Application ReceivedFebruary 22, 2012
Committee AssignmentMarch 7, 2012 (FDA Tracked Milestone)
1st Committee MeetingMarch 12, 2012
Filing MeetingApril 9, 2012
Filing Letter IssuedApril 22, 2012
1st draft reviewsJune 21, 2012
Mid-Cycle Review MeetingJuly 20, 2012 (FDA Tracked Milestone)
2nd draft reviewsAugust 30, 2012
Final Reviews (Signed/Uploaded)October 14, 2012 (Delayed by Major Amend.)
Present to PeRCSeptember 26, 2012
Labeling Comments to SponsorNovember 9, 2012 (FDA Tracked Milestone)
First Action DueDecember 22, 2012
Final Reviews (Signed/Uploaded)February 4, 2013 (Updated due date)
Notify GSK of PMC/PMRFebruary 15, 2013
Labeling CompleteMarch 5, 2013
Major Amendment Action Due DateMarch 23, 2013
MeetingsDate
First Committee MeetingMarch 6, 2012
Filing MeetingApril 9, 2012
Monthly Team Meetings

May 8, 2012
June 11, 2012
July 9, 2012
August 3, 2012 (revised date)
August 31, 2012 (revised date – Sept. Meeting)
October 5, 2012 (revised date)
November 6, 2012 (revised date)
December 10, 2012
January 7, 2013
February 11, 2013
March 11, 2013

Mid-Cycle Review MeetingJuly 20, 2012
PeRCSeptember 26, 2012
VRBPACNovember 14
SWGNot Scheduled
Labeling Meetings

October 22, 2012,
October 25, 2012,
November 2, 2012,
December 14, 2012,
December 20, 2012,
January 7, 2013

3.2

Team Reports:

3.1

Chair

Management and reviewers were updated on the new due dates (above) and the status of carton/container and package insert (PI) labeling. A second set of comments regarding the carton/container labels were sent to GSK on 12/21/2012. A second set of comments regarding the PI label were are? circulating internally and would be ready to send to GSK by 1/11/2013. Reviewers were asked to report any PMCs they anticipated including in the Approval Letter.

3.2

Clinical

Clinical indicated that the final review would be completed by 1/21/2013. Both the Clinical Branch Chief and the DVRPA Division Director indicated that they would have memos in support of the Clinical review uploaded to the EDR by February 4, 2013. Clinical did not have any PMCs to report.

3.3

Statistical

The Statistics reviewers indicated that their reviews are progressing and would be completed by 1/21/2013. The Statistics reviewers did not have any PMCs to report.

3.4

CMC/Product

One CMC review is complete and uploaded to the EDR. The remaining CMC review was waiting for GSK to respond to the 12/20/2012 IR. The CMC reviewers did not have any PMCs to report.

3.5

Facilities/DMPQ

The Facilities reviewer indicated that the final review was waiting for GSK to respond to the 12/20/2013 IR. Facilities may request a PMC regarding GSK’s use of -------(b)(4)---------------- as alternative (b)(4) for storage of the H5N1 Antigen depending on their response to the 12/20/2012 IR.

3.6

Pharmacovigilance

The Pharmacovigilance review was with the supervisor. Pharmacovigilance did not have any PMCs to report.

3.7

DBSQC and Lot Release

Three of the 4 DBSQC reviews were completed. The lot testing plan was completed. DBSQC was waiting on GSK’s response to the 1/2/2013 IR regarding the LRP to finalize the last review.

3.8

Toxicology

3.8.1

Review Uploaded to EDR

3.9

Epidemiology (Effectiveness Study)

3.9.4

Review Uploaded to EDR

3.10

BIMO

3.10.1

Review Uploaded to EDR

3.11

APLB

3.11

Review Uploaded to EDR

3.12

Other Disciplines

4.0

Information Requests / Amendments

Request DateCBER Rep(s)RequestCBER Requester for InfoBLA Amendment ResponseReview Pending?Reviewed by and
Date Reviewed

4/30/2012a

Carmen Collazo-Custodio

IR for Pediatric Plan, stability data, clinical assay validation, HA content by SRID validation, other assay validation, facilities information, pharmacovigilance

Andrea James, Hana Golding, Surender Khurana, Tsai-Lien Lin, Tielin Qin, Manju Joshi Lokesh Bhattacharyya, Yandong Qiang, Randa Melhem

125419.3
125419.4
125419.5
125419.11

Yes

Surender Khurana – 125419.4
Hana Golding – 125419.4

4/30/2012b

Carmen Collazo-Custodio

Revised 356h form, SRID testing reagents and results

Carmen Collazo, Karen Campbell

125419.1
125419.2

Yes

 

6/15/2012

Carmen Collazo-Custodio

Questions about location of information in the submission.

-

-

No

 

6/21/2012

Carmen Collazo-Custodio

Adjuvant lots and SRID calculation spreadsheet

Karen Campbell

-

No

 

7/30/2012

Carmen Collazo-Custodio

Product Manufacturing Questions

James Kenney, Hyesuk Kong, Karen Campbell, Surender Khurana, Randa Melhem

125419.6
125419.9
125419.10

Yes

Surender Khurana – 125419.9
125419.10

8/10/2012

Kirk Prutzman

AS03 Manufacturing Quality

Randa Melhem

125419.8

Yes

 

8/15/2012

Kirk Prutzman

Follow questions to GSK’s responses to questions 16, 17d, 18, 21, 22 from the 4/30/2012 IR

Lokesh Bhattacharyya

125419.11

Yes

 

8/16/2012

Carmen Collazo-Custodio

IR Regarding GSK’s SRID Results

Manju Joshi, Rajesh Gupta, Karen Campbell

125419.7
125419.10

Yes

 

9/10/2012

Jeremy Wally

Response on Timing of Amendment Submission

-

-

No

 

9/25/2012

Jeremy Wally

IR regarding SRID assay and additional comments on VRBPAC and Proper Name

Manju Joshi
Carmen Collazo-Custodio

125419.10

Yes

 

9/26/2012

Jeremy Wally

September 25, 2012, IR/Comments Follow-Up

-

-

No

 

9/28/2012

Carmen Collazo-Custodio

Comments regarding the Pharmacovigilance Plan for Influenza A (H5N1) Virus Monovalent Vacine (Version 2: July 2012*) provided in the submission of July 18, 2012.

Yandong Qiang

125419.17

Yes

 

10/2/2012

Kirk Prutzman

IR for qualification test reports for the AS03 Adjuvant

James Kenney

125419.12

Yes

 

10/10/2012

Carmen Collazo-Custodio

IR regarding the PVP

Yandong Qiang

125419.17

Yes

 

10/15/2012

Kirk Prutzman

IR Regarding Clinical Items

Andrea James

125419.15

Yes

 

10/16/2012

Carmen Collazo-Custodio

IR Regarding Lot Release Protocol

Karen Campbell

125419.13

Yes

 

10/17/2012

Carmen Collazo-Custodio

IR comments: clinical (subgroup analyses) and clarification on filling of AS03 (---------(b)(4)----------------------------- )

Andrea James
Tsai-Lien Lin
Randa Melhem

125419.16
125419.18

Yes

 

10/18/2012

Kirk Prutzman

IR Regarding Anti-Microbial Effectiveness Testing

James Kenney

125419.14

Yes

 

10/22/2012

Carmen Collazo-Custodio

IR comment on GSK’s PVP

Yangdong Qiang

125419.17

Yes

 

10/31/2012

Carmen Collazo-Custodio

Request for CRFs for subjects in study Q-Pan-002

Andrea James

125419.15

Yes

 

11/5/2012

Kirk Prutzman

IR regarding ---(b)(4)------- levels in the Adjuvant

Hana Golding

125419.19

Yes

 

11/8/2012

Carmen Collazo-Custodio

IR regarding further clarification on filling of AS03 (------(b)(4)--------------------------- )

Randa Melham

125419.18

?

 

11/9/2012

Kirk Prutzman

PI, Carton, Container comments to GSK

 

125419.20
125419.21

  

11/9/2012

Kirk Prutzman

IR regarding HA minimum release acceptance criterion

Tsai-Lien Lin
Hana Golding
Surender Khurana
Manju Joshi

125419.20

Yes

 

11/16/2012

Carmen Collazo-Custodio

Additional comments on the Package Insert and the Carton Labels

 

125419.21

  

11/19/2012

Kirk Prutzman

IR Regarding Lot Release Protocol in Amendment 13

Catherine Poole

125419.19

Yes

 

11/20/2012

Kirk Prutzman

Additional IR item regarding Lot Release Protocol

Catherine Poole

125419.19

Yes

 

11/20/2012

Kirk Prutzman

IR regarding Amendment 16 submitted on November 15, 2012

Andrea James

125419.19

Yes

 

11/26/2012

Carmen Collazo-Custodio

IR Regarding the Ste. Foy and the Rixensart/Wavre facilities

Randa Melhem

125419.22

Yes

 

11/29/2012

Carmen Collazo-Custodio

Characterization of new working seed banks

Surendur Khurana

125419.19

Yes

 

11/30/2012

Carmen Collazo-Custodio

IR regarding cleaning validation

Randa Melhem

125419.22

Yes

 

12/1/2012

Carmen Collazo-Custodio

Conference Call Summary and CBER’s Response to GSK’s Potency Specifications Proposal

---

---

No

 

12/3/2012

Carmen Collazo-Custodio

Request to clarify if ---------------------------(b)(4)----------------------------.

Randa Melhem

125419.22

Yes

 

12/5/2012

Carmen Collazo-Custodio

CBER’s comments to GSK’s response submitted on November 30, 2012, regarding the proposed Lot Release Protocol.

Karen Campbell

   

12/20/2012

Carmen Collazo-Custodio

IR on alternative ---(b)(4)------ used to storage the H5N1----------------(b)(4)----

Randa Melhem

 

Yes

 

12/21/2012

Carmen Collazo-Custodio

Second Round or Carton/Container comments

---

   

1/2/2013

Kirk Prutzman

IR Regarding LRP

Karen Campbell

 

Yes

 

Amendments

Date/STNSummary

May 3, 2012
(125419.1)

Partial response to 4/30/2012b IR. Revised 356h form.

May 25, 2012
(125419.2)

Partial response to 4/30/2012b IR. Answers to Item 2.

June 20, 2012
(125419.3)

Partial response to 4/30/2012a IR. Answers to Items 24-34 (facilities).

July 18, 2012
(125419.4)

Partial response to 4/30/2012a IR. Answers to Items 2-23 and 35-36.

July 19, 2012
(125419.5)

Partial response to 4/30/2012a IR. Answer to Item 1. All responses to IR now submitted.

August 13, 2012
(125419.6)

Partial response to 7/30/2012 IR. Answer to Item 1. Addition of Robert D. Brobst as secondary POC

August 29, 2012
(125419.7)

Response to 8/16/2012 tcon; updated 356h form; updated list of POC’s.

September 10, 2012
(125419.8)

Response to 8/10/2012 tcon

September 14, 2012
(125419.9)

Response to Questions 2, 3, and 5-18 from CBER’s 7/30/2012 IR.

September 28, 2012
(125419.10)

Response to Information Requests dated July 30, 2012, August 16, 2012, and September 25, 2012.

October 10, 2012
(125419.11)

Response to Information Requests dated April 30, 2012, and August 15, 2012.

October 18, 2012
(125419.12)

Response to IR from CBER dated October 2, 2012

October 26, 2012
(125419.13)

Response to IR from CBER dated October 16, 2012 regarding the LRP

November 5, 2012
(125419.14)

Response to IR from CBER dated October 18, 2012 regarding the Anti-Microbial Effectiveness Testing

November 6, 2012
(125419.15)

Response to 2 IRs from CBER dated October 15, 2012, and October 31, 2012, regarding clinical issues

November 15, 2012
(125419.16)

Response to IR from CBER dated October 17, 2012, regarding subgroup analyses of all primary immunogenicity and safety endpoints by age, race and gender in studies Qpan-001, Q-Pan-002 and the ISS analyses.

November 19, 2012
(125419.17)

Responses to 3 Information Requests from CBER dated 9/28/2012, 10/10/2012, and 10/22/2012 regarding the PVP.

November 30, 2012
(125419.18)

Responses to 2 Information Requests from CBER dated 10/17/2012, and 11/8/2012.

November 30, 2012
(125419.19)

Responses to 5 Information Requests from CBER dated 11/5/2012, and 11/19/2012, 2 Irs on 11/20/2012, and 11/29/2012.

December 4, 2012
(125419.20)

Response to PI labeling comments from CBER on November 9, 2012. Response to MRAC IR from CBER dated November 9, 2012.

December 8, 2012
(125419.21)

Response to Carton and Container comments from CBER on November 9, 2012 and November 16, 2012. Response to comments regarding the toxicity study described in Section 8.1, Pregnancy, of the proposed Package Insert from CBER date November 30, 2012.

December 13, 2012
(125419.22)

Response to information requests from CBER dated 11/26/2012, 11/30/2012, and 12/3/2012. Response to questions from telephone-tcons dated 11/29/2012, 11/30/2012, and 12/5/2012.

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