Biotech China 2014
Immunogenicity Assessment and Clinical Relevance
Loews Philadelphia Hotel
1200 Market Street
Philadelphia, Pennsylvania 19107
http://www.healthtech.com/imn/imna
Immunogenicity Assessment and Clinical Relevance
Cambridge Healthtech Institute 

Schedule of Presentations:

Monday, October 26, 2009
13:00:00 Registration for Conference A
14:00:00 WHITE PAPERS AND GUIDANCE ON ASSAYS
14:00:00 Chairperson’s Opening Remarks
14:05:00 Update on Guidance and White Papers: What has been Achieved. Filling the Gaps, and Future Direction Opening Presentation Susan Richards
14:35:00 Crossroads in Immunogenicity Assays: Where Tolerance and Interference Meet Michele Fiscella
15:05:00 Confirmatory Assays, Cut Points, Statistical Analysis and Clinical Interpretation Dong Geng
15:35:00 Networking Refreshment Break, Poster and Exhibit Viewing
16:10:00 Comparison of Cell-Based and Competitive Ligand-Binding Assay Formats to Characterize Neutralizing Antibody Responses Bonnie Wu
16:40:00 Sponsored Presentation
17:00:00 Development and Validation of Anti-drug Antibody Assays for an Antibody Fragment Conjugated to Pseudomonas Exotoxin A Meina Liang
17:30:00 Break Out Sessions
17:35:00 Table 2: The Cut Point Analysis for the Neutralizing Antibody Assay Dong Geng
17:35:00 Table 1: Dealing with Unexpected Pre-Existing Positive ADA Activity in Study Patients Boris Gorovits
18:00:00 Networking Cocktail Reception in the Exhibit Hall
19:00:00 End of Day One of Immunogenicity Assessment and Clinical Relevance
Tuesday, October 27, 2009
08:25:00 PRE-CLINICAL IMMUNOGENICITY TESTING AND ASSESSMENT OF RISK
08:30:00 Chairperson’s Remarks
08:35:00 Current Regulatory Expectations for the Incorporation of Immunogenicity Assessments in Pre-clinical Studies Joy A. Cavagnaro
09:05:00 Commonly Encountered Issues and Challenges in Pre-clinical Immunogenicity Assessments: Overview of the Biosafe White Paper, Consequences, and Specific Examples for Application Featured Presentation Bonnie Rup
09:35:00 Sponsored Presentation
09:55:00 Practical Application of Immunogenicity Pre-clinical Risk Assessment Nadja S. Prang-Richard
10:25:00 Networking Coffee Break, Poster and Exhibit Viewing
10:40:00 CLINICAL IMPLICATIONS
11:00:00 Clinical Impact of Anti-Drug Antibodies KEYNOTE Meena Subramanyam
11:30:00 Clinical Immunogenicity Assessment of an Adnectin Evaluated from a PK and PD Perspective Jochem Gokemeijer
12:00:00 Sponsored Presentation
12:20:00 Luncheon Presentation
13:30:00 CASE STUDIES
13:30:00 Chairperson’s Remarks
13:35:00 Development of Cell-based Assays for Neutralizing Antibodies for Routine Clinical Immunogenicity Studies Featured Presentation Michael G. Tovey
14:05:00 Generation of Anti-idiotype Antibodies as Reagents for the Development of Immunogenicity Assays Claire Dobson
14:35:00 Challenges with Development of Anti-Therapeutic Antibody Assays to Detect Antibodies of IgE Subtype Sally Fischer
15:05:00 Sponsored Presentation
15:25:00 Networking Refreshment Break, Poster and Exhibit Viewing
16:00:00 Development and Validation of Drug Specific IgE Antibody Assays for use in Clinical Trials Erik D. Foehr
16:30:00 Evolution of Immunogenicity Assays over the Life-cycle of a Clinical Program Albert Torri
17:00:00 Break Out Sessions
17:10:00 Table 1: What Can and Cannot be Learned from Pre-clinical Studies and Animal Models and How to Carry Out a Meaningful Risk Assessment Joy A. Cavagnaro
17:15:00 Table 2: Immunogenicity Testing During Clinical Trials Meena Subramanyam
17:15:00 Table 3: Monoclonal Antibodies: Level of Immunogenicity-Related Risk Relative to Other Product Types Paul Chamberlain
17:30:00 End of Day Two of Immunogenicity Assessment and Clinical Relevance
Wednesday, October 28, 2009
07:30:00 Registration for Conference B
08:30:00 Chairperson’s Remarks
08:35:00 A Regulatory Perspective on Protein Therapeutics Featured Presentation Susan Kirshner
09:05:00 FDA Expectations for Immunogenicity Assessment: Is the Target Moving? Steve Keller
09:35:00 Sponsored Presentation
09:55:00 Networking Coffee Break, Poster and Exhibit Viewing
10:30:00 Priorities for EU Guidance on Immunogenicity Risk Assessment for Therapeutic Monoclonal Antibodies KEYNOTE Paul Chamberlain
11:00:00 Panel Discussion with the Speakers
11:05:00 FORMULATION AND AGGREGATES
11:30:00 Impact of Formulation and Drug Product Features on Immunogenicity of Proteins Joël Richard
12:00:00 Focus on Sub-visible Aggregates and their Impact on Immunogenicity Jack A. Ragheb
12:30:00 End of Immunogenicity Assessment and Clinical Relevance Lunch on Your Own for Conference B Attendees
4th Annual Pharma R&D Asia Congress
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