Institute for International Research

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9:00 AM
Opening Remarks: ECL and ELISA Platform Selection which Platform is right for your application
Frederick Holtsberg, Manager, Contract Research, BIOVERIS CORPORATION

9:15 AM
Optimization and Validation of Immunogenicity Screening and Confirmatory Assays for Monoclonal Antibody Thearpeutic
Valerie Theobald, Senior Scientist, Clinical Laboratory Science, GENZYME CORPORATION

10:00AM
Development and Validation of Improved Drug Tolerant Immunoassays
Jim Bourdage, Laboratory for Experimental Medicine, ELI LILLY & COMPANY

11:00AM
Comparison of ELISA, Biacore and ECL for Immunogenicity Testing
Marie-Christine Fanget, Associate Scientist and Clinical Development Sciences, PDL BIOPHARMA

11:00AM
Comparison of ELISA, Biacore and ECL for Immunogenicity Testing
Lauri Neyer, PhD, Pre-Clinical and Clinical Development Sciences, PDL BIOPHARMA

1:30 PM
Effect of Assay Design on Evaluating Antibodies in Clinical Samples: Indirect ELISA vs. Bridging ECLA
Joleen White, PhD, Scientist II BioAnalytical Sciences, BIOMARIN PHARMACEUTICALS

2:15 PM
Multi-Array ™ Electrochemiluminescence: Overcoming Challenges through Greater Information Content
Pankaj Oberoi, PhD,  Director, Scientific Services, MESO SCALE DISCOVERY

8:00 AM
Opening Remarks: the History of Immunogenicity Studies
Eugen Koren, Fellow Research Scientist, ABBOTT VASCULAR

8:15 AM
Case Study #12: Understand Immunogenicity Assessment of Protein Therapeutics
Michael Moxness, Principal Scientist Clinical Immunology, AMGEN

9:15 AM
Case Study #14: New Data Generated from the Qualification and Validation of Two New Assays
Thi-Sau Migone, Senior Director of Bioanalytical Sciences, HUMAN GENOME SCIENCES

10:15 AM
Case Study #15: Development and Validation of Drug Tolerant Immunogenicity ECLIA for Therapeutic Antibody
Gennady Samokhin,GERRY KLOAITIS & SURENDA BANSAL HOFFMAN-LA ROCHE, INC. NUTLEY

10:45 AM
FDA Panel
Susan Kirshner, Laboratory of Immunology, Office Therapeutics Proteins,  FDA
Holly W. Smith, Research Scientist, Biomolecular Interactions, ELI LILLY & COMPANY
Eugen Koren, Fellow Research Scientist, ABBOTT VASCULAR
Shalini Gupta, Director, Clinical Immunology, AMGEN
Ago B. Ahene, Associate Director, Drug Metabolism and Phamcokinetics, ROCHE

1:00 PM
Case Study #17: Compare and Contrast White Paper Screening Cut Point Calculations
Martin Kane, Senior Manager, Process Statistics, HUMAN GENOME SCIENCES

1:30 PM
Case Study #18: Long-Term Maintenance of a Calibrator Curve Immunogenicity Assay Used to Support Clinical Trials
Michael L. Fox,  Senior Supervisor, Bioanalytical Assays, GENETECH

2:00 PM
Case Study #19: Designing and Validating an Immunodepletion Assay to Characterize an Immunogenic Response to an Antibody Drug Conjugate
Angela Gieber, Senior Research Associate, GENENTECH

2:30 PM
Case Study #20: Use of a Novel Statistical Approach for Confirmatory Assays
Lauri Neyer, Staff Scientist, Pre-Clinical and Clinical Development Sciences, PDL BIOPHARMA

3:30 PM
Considerations for the Design and Validation of Neutralizing Antibody Assays Focus on the 2007 White Paper
Shalini Gupta,  Director, Clinical Immunology, AMGEN

4:30 PM
Case Study #22: Comparison of Neutralizing Antibody Assays for Receptor Binding and Activity of the Enzyme Replacement Therapeutic Naglazyme
Erik Foehr, Associate Director, Pharmacology and Toxicology, BIOMARIN PHARMACEUTICALS

5:00 PM
Case Study #23: Case Study: IFN-b Reporter Gene Neutralizing Antibody Assay
Michaela Lerner, MS, Senior Manager, Clinical Science & Technology, BIOGEN IDEC

8:30 AM
Case study  #24: Early Phase Development of Assays for Evaluation of Biologics and Biotherapeutics – a Systematic Approach to Satisfy European and US Regulators
Cledwyn L Davies, Qualified Person, Manager, Product Quality & Regulatory Affairs, Health Protection Agency, CENTRE FOR EMERGENCY PREPAREDNESS & RESPONSE

9:00 AM
Clinical Validation of the "in-silico" Prediction of Immunogenicity of a Human Recombinant Therapeutic Protein
Vibha Jawa, Senior Scientist, Clinical Immunology, AMGEN

9:30 AM
Overcoming Obstacles in Outsourcing Immunogenicity Studies
Shalini Gupta, Director, Clinical Immunology, AMGEN
Michaela Lerner, MS, Senior Manager, Clinical Science & Technology, BIOGEN IDEC

10:45 AM
Case study #26: Real-life Challenges in the Development of Immunogenicity Assays and Discuss Approaches to Address these Successfully to Derive Meaningful Results from the Clinical/Pre-clinical Studies
Lakshmi Amaravadi, PhD, Principal Scientist, Clinical Science & Technology, BIOGEN IDEC

11:15 AM
Case study #27: Novel Routes to Assess and Minimize the Immunogenicity of Biologicals
Harald Kropshofer, PhD, Head & Global Coordinator, Immunosafety of Biotherapeutics, F. HOFFMANN LA ROCHE BASEL

11:45 AM
White paper meeting discussion: Methods for Pre-Screening and Reengineering Protein Therapeutics for Potential Immunogenicity: Review of Available Tools and Techniques, and Development of a Standard for Comparison
Annie DeGroot CEO, EPIVAX, Associate Professor, B ROWN MEDICAL SCHOOL 

1:45 PM
Case study #28: Characterization of Pre-Existing Antibodies
Ingrid Caras, Senior Director, Pre-clinical and Clinical Development Sciences, PDL BIOPHARMA

2:15 PM
Case study #29 & 30: New Phase 3 Data - Evaluating Immunogenicity Data in the Context of Clinical Safety and Efficacy: NaglazymeÒ Detection of IgE Antibodies Specific to the Enzyme Replacement Therapeutic -A Reversed ELISA Format
Bin Zhao, Scientist II, BioAnalytical Research & Development, BIOMARIN PHARMACEUTICALS