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U.S. Department of Health and Human Services

Advisory Committees

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May 12, 2011: Allergenic Products Advisory Committee Meeting Final Agenda

AGENDA

Open Session

8:00 a.m.

Welcome and Introduction of Committee
Robert Hamilton, Ph.D., D. ABLMI, Chair

8:10

Meeting Statement
Gail Dapolito, Designated Federal Official

8:15

Recognition of Committee Service
Karen Midthun, M.D., Director
Center for Biologics Evaluation and Research (CBER), FDA

Topic I:   Committee Updates/Discussion Points

8:30

Laboratory of Immunobiochemistry: Structure and Activities
Ronald Rabin, M.D., Chief
Laboratory of Immunobiochemistry, CBER, FDA

8:50Q&A
8:55

ISO 17025 Accreditation
Sandra Menzies, M.S., Consumer Safety Officer
Laboratory of Immunobiochemistry, CBER, FDA

9:10Q&A
9:15

ELISA Replacement of RID Assays for Potency Determinations of Cat and Ragweed Pollen Allergen Extracts 
Ronald Rabin, M.D.

9:35Q&A
9:45Break
10:00

Statistical Considerations for the Design and Interpretation of Phase III Clinical Trials of Allergenic Products
Tammy Massie, Ph.D., Lead Mathematical Statistician
Office of Biostatistics and Epidemiology, CBER, FDA

10:20Q&A
10:30

Environmental Exposure Chambers for Phase III Studies of Allergenic Products
Ronald Rabin, M.D.

10:50 a.m.Q&A
11:00 a.m.Open Public Hearing
12:00 p.m.Committee Discussion
12:30Lunch
Topic II:   Research Overview
1:30

Overview of Research Program - Center for Biologics Evaluation and Research, FDA
Carolyn Wilson, Ph.D., Associate Director for Research, CBER

1:45Q&A
1:50

Overview of Research Program – Office of Vaccines Research and Review, CBER
Konstantin Chumakov, Ph.D., Associate Director for Research,
Office of Vaccines Research and Review, CBER

2:00Q&A
2:05

Overview of Research Program – Division of Bacterial, Parasitic and Allergenic Products (DBPAP)
Jay Slater, M.D., Director,  
Division of Bacterial, Parasitic and Allergenic Products, CBER, FDA

2:15Q&A
2:20

Overview of Research Program – Laboratory of Immunobiochemistry, DBPAP
Ronald Rabin, M.D., Chief, Laboratory of Immunobiochemistry

2:40Q&A
2:45Break
3:00Closed Session
3:30 p.m.Adjourn