9th Annual Biomarkers Congress
Immunogenicity for Biologics 2009
Steigenberger Hotel Berlin
Los-Angeles-Platz 110789 Berlin
Germany,
http://www.informa-ls.com/immuno
Immunogenicity for Biologics 2009
http://www.informa-ls.com/immuno
Steigenberger Hotel Berlin
Los-Angeles-Platz 110789 Berlin
Germany

Schedule of Presentations:

Monday, February 9, 2009
09:30:00 Registration
Tuesday, February 10, 2009
08:00:00 Regulatory Update And Immunogenicity Assay Development
08:00:00 Registration and morning coffee
09:00:00 Chairperson’s opening remarks
09:00:00 SELECTING THE BEST METHODS FOR ASSESSING IMMUNOGENICITY
09:05:00 Methodology for immunogenicity assessment Steve Swanson
09:45:00 DESIGNING AND DEVELOPING IMMUNOGENICITY ASSAYS
09:45:00 A concerted and staggered implementation of different assays and methods for antibody screening and characterisation Julia Schleypen
10:25:00 ECL immunogenicity assays for antibody therapeutics Larry Lo
11:05:00 Morning coffee and poster/exhibition viewing time
11:30:00 Parallel analysis of exposure and immunogenicity by Biacore in pre-clinical studies Annette Zaar
12:10:00 Immunogenicity challenge for enzyme substitution therapies Bin Zhao
12:50:00 Spotlight Session
13:30:00 Lunch and poster/exhibition viewing time
14:20:00 Risk-based immunogenicity testing strategy Daniel Kramer
15:00:00 Monitoring patients treated with IFN- and anti-TNF biologics Klaus Bendtzen
15:40:00 Detection of anti-idiotypic antibodies to rituximab in patients with severe pemphigus Arno Kromminga
16:20:00 Afternoon tea and poster/exhibition viewing time
16:50:00 REGULATORY UPDATE AND GUIDELINES
16:50:00 Immunogenicity of therapeutic proteins: The European regulatory environment Christian Schneider
17:30:00 Discussion Panel: Interpreting latest guidelines and what it will mean for the industry
18:00:00 Closing remarks by the chair
18:05:00 End of Day Two and Networking Drinks
Wednesday, February 11, 2009
08:30:00 ADAs, Assay Validation, Statistical Analysis and Cut Points
08:30:00 Registration and morning coffee
09:00:00 Chairperson’s opening remarks
09:05:00 Anti-drug antibody (ADA) assay validation: Industry survey results and data analysis Boris Gorovits
09:05:00 ANTI-DRUG ANTIBODY ASSAYS: INDUSTRY SURVEY AND METHODS OF VALIDATION
09:45:00 Validation of anti-drug antibody assays for use in preclinical and clinical studies Louise Angell
10:25:00 Morning coffee and poster/exhibition viewing time
11:05:00 ACID DISSOCIATION ELUTION FOR ADA DETECTION
11:05:00 The use of acid dissociation to enhance anti-drug antibody detection Albert Torri
11:45:00 Incurred sample reanalysis – Amgen’s experiences Mark Ma
11:45:00 INCURRED SAMPLE REANALYSIS
12:30:00 Spotlight Session
13:00:00 Lunch and poster/exhibition viewing time
14:00:00 THE DEVELOPMENT AND VALIDATION OF NEUTRALISING ANTIBODY ASSAYS
14:00:00 Neutralising antibody assays: Competitive ligand binding assays vs. bioassays Deborah Finco Kent
14:40:00 Development and validation of a qualitative cell-based neutralisation assay for a human monoclonal antibody Inge Dreher
15:20:00 Neutralising antibody assays, validation and cut points Aparna Kasinath
16:00:00 Afternoon tea and poster/exhibition viewing time
16:30:00 Evaluation of screening and confirmatory cut points for immunogenicity assays
16:30:00 STATISTICAL ANALYSIS AND CUT POINTS
17:10:00 Challenge to establish proper confirmatory assay cut point Dong Geng
17:50:00 Discussion Panel:
18:20:00 Chairperson’s closing remarks
18:25:00 End of Day Three
Thursday, February 12, 2009
08:30:00 Registration and morning coffee
08:30:00 Preclinical and Clinical Development, Formulation and Biosimilars
09:00:00 Chairperson’s opening remarks
09:05:00 White Paper on evaluation of nonclinical immunogenicity Lakshmi Amaravadi
09:05:00 PRE-CLINICAL STUDIES, PREDICTING AND REDUCING IMMUNOGENICITY
09:45:00 Immunogenicity of therapeutic proteins and T-Cell epitopes Matthew Baker
10:25:00 Morning coffee and poster/exhibition viewing time
11:00:00 MONITORING UNWANTED IMMUNOGENICITY DURING CLINICAL TRIALS
11:00:00 Practical experience of immunogenicity in early clinical trials Johannes Nagelschmitz
11:40:00 Clinical immunogenicity of protein therapeutics Surinder Sharma
12:20:00 Spotlight Session
12:50:00 Lunch and poster/exhibition viewing time
14:00:00 Formulation and immunogenicity: What do we know? Wim Jiskoot
14:00:00 IMPACT OF DRUG FORMULATION ON IMMUNOGENICITY
14:40:00 Different types of protein aggregates revealed by new methods of detection and characterisation Tudor Arvinte
15:20:00 Afternoon tea and poster/exhibition viewing time
15:50:00 BIOSIMILARS AND IMMUNOGENICITY
15:50:00 Impact of immunogenicity assessment on the design of clinical trials for biosimilars Alexander Berghout
16:30:00 Biosimilars and immunogenicity Robin Thorpe
17:10:00 Closing remarks from the chairperson
17:15:00 End of Day Four
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