Record of Telephone Conversation - December 17, 2009 - Prevnar 13

System Info - 114310  SMITH, MICHAEL J  17-Dec-2009 16:08:22  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.

Telecon Date/Time:  17-DEC-2009 11:41 AM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Other

Author:  MICHAEL SMITH

Telecon Summary:
Recommendation for future validation methods for PnELISA's.

FDA Participants:   Mike Smith, Julie Vaillancourt and Colleen Sweeney

Non-FDA Participants:    Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

 ______________________________________________

From:                     Smith, Michael (CBER) 
Sent:                      Thursday, December 17, 2009 11:41 AM
To:                          'Love Jack'; 'Devlin Carmel'
Cc:                          Vaillancourt, Julienne; Sweeney, Colleen
Subject:                RE: Comment from Dr. Lev Sirota regarding the bioassay statistical review

Jack and Carmel,

    Dr. Lev Sirota completed his statistical review of the bioassays and there is one comment (see below) regarding any potential future validation assays.

• In the Pneumococcal Enzyme-linked Immunosorbent Assays (PnELISAs) sub-section of section 5.3.1.4 “Analytical and Bioanalytical Methods” you used a criterion for linearity of R>(b)(4). This criterion appears to be too liberal. All presented linear regression data in this part of study demonstrate a coefficient of correlation of 0.99 and above. CBER recommends that you make criterion more stringent for future validations of the method. Please comment.

If you have any questions, please contact Julie or myself.

Thank you,

Mike

Mike Smith, Ph.D.
Lieutenant Commander (LCDR), U.S. Public Health Service
Regulatory Project Manager
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

Phone:    301-827-9047
BB:         240-839-0823
Fax:        301-827-3532
E-mail:   michael.smith2@fda.hhs.gov

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