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December 11, 2013: Allergenic Products Advisory Committee Meeting Draft Agenda

FOOD AND DRUG ADMINISTRATION
Center for Biologics Evaluation and Research
26th Meeting of the Allergenic Products Advisory Committee
FDA White Oak Campus, Bldg. 31 Great Room A
Silver Spring, Maryland
December 11-12, 2013

DRAFT AGENDA

Wednesday, December 11, 2013

9:00 a.m.  Call to Order and Opening RemarksMichael Nelson, MD, PhD
Chair, APAC
 Conflict of Interest StatementDonald Jehn, MS
DFO, APAC
9:15 a.m.Recognition of departing committee membersPhil Krause, PhD
Deputy Director, OVRR
Topic 1: Safety and efficacy of Oralair, a Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Bluegrass Mixed Pollens Allergen Extract, tablet for sublingual use, manufactured by Stallergenes
9:20 a.m.Introduction, Background and Presentation of QuestionsJay Slater, MD
Director, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccine Research and Review, FDA
 Stallergenes Presentation 
9:45 a.m.IntroductionThomas Lang, PhD
President, Stallergenes
9:50 a.m.Scientific Background           Professor Ulrich Wahn, MD
Department of Pediatric Pulmonology and Immunology
University Hospital Charite
Berlin, Germany
10:00 a.m.Clinical Development, Program EfficacyRobert K. Zeldin, MD, FAAAI
Senior Vice President, Global Clinical
Development, Stallergenes, SA
10:25 a.m.Clinical Safety and PharmacovigilanceBrigitte Bons, MD
Vice President, Corporate Pharmacovigilance
10:40 a.m.Summary and ConclusionsDavid B.K. Golden, MD, FAAAAI, FACAAI, FACP
Chief, Allergy Division, Department of Medicine, Franklin Square Hospital
Chief, Allergy Division, Department of Medicine, Sinai Hospital of Baltimore
Associate Professor of Medicine, Johns Hopkins University
10:45 a.m.Questions 
11:00 a.m.Break 
11:10 a.m.FDA PresentationRonald Rabin, MD
Chief, Laboratory of Immunobiochemistry
11:55 a.m.Questions 
12:10 p.m.Open Public Hearing 
12:40 p.m.Lunch 
1:40 p.m.Committee Discussion and Vote 
3:40 p.m.Adjourn for the day