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

May 12, 2011
DoubleTree Hotel, Bethesda, MD

DRAFT 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

8:30

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

8:50Q&A
9:00

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

9:20Q&A
9:30Break
9:45

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

10:05Q&A
10:15

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

10:45Q&A
11:05

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

11:25Q&A
11:30 a.m.Open Public Hearing
12:30 p.m.Lunch

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
2:45 p.m.Adjourn Open Session
3:00 p.m.Closed Session
3:30 p.m.Adjourn Closed Session