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CHI's Immunogenicity Assessment & Clinical Relevance Conference - Immunogenicity and Bioassay Summit 2015



Immunogenicity Assessment & Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results
Part of the Seventh Annual Immunogenicity and Bioassay Summit
November 17-18, 2015 | Hilton | Baltimore, Maryland

The industry is becoming much more knowledgeable about immunogenicity but work is still to be done. Many White Papers have been put together and people are applying them. Assays are becoming far more sensitive but there is uncertainty about what the data means and its relevance to PK. The focus is still on choice and development of assays and overcoming the interfering factors, while more and more attention is focusing on risk assessment, life-cycle management, and presentation of immunogenicity data to the regulatory authorities. Meanwhile the regulatory authorities are helping the industry to develop more consistent approaches. In the rapidly developing biosimilar field the EMEA and FDA have well defined guidance, which has been put into practice with the recently approved biosimilars.

Presentations at Immunogenicity Assessment and Clinical Relevance will feature case studies and expert advice from Industry Leaders including AAPS White Paper authors and regulatory experts to help attendees to manage their immunogenicity challenges and produce safe and efficacious products in the clinic


KEYNOTE:

A Harmonized Approach to Interpretation and Reporting of Clinical Immunogenicity Data

Valerie Quarmby, Ph.D., Staff Scientist, BioAnalytical Sciences, Genentech, Inc.


REGULATORY EXPECTATIONS REGARDING IMMUNOGENICITY ASSESSMENT FOR INNOVATORS AND BIOSIMILARS

Regulatory Perspectives on Setting up the Clinical Immunogenicity Study for a Biosimilar

Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, CDER/FDA


RISK ASSESSMENT

Strategies for Immunogenicity Risk Assessment

Bonnie Rup, Ph.D., Biopharmaceutical Development Expert


CLINICAL CASE STUDIES ON SPECIFIC BIOTHERAPEUTICS

Immunogenicity Testing in Patients Treated with Anti-TNF: What is the Best Measure of Clinical Response?

Theo Rispens, Ph.D., Senior Scientist, Immunopathology, Sanquin

Immunogenicity and Clinical Relevance Assessment Enabling the Approval of a Subcutaneous Formulation of Herceptin

Rebecca Elliott, M.Sc., Manager, BioAnalytical Sciences, Genentech, Inc.

Development of New and Better ADA Methods to Replace the Complex Legacy ADA Testing Scheme in the Area of Lysosomal Storage Disease

Yongchang Qiu, Ph.D., Senior Director, Head, Bioanalytical and Biomarker Development, Shire

Rapid ADA Response against a C5a Receptor Antagonist Impacting PK and PD

Per Holse Mygind, Ph.D., Senior Scientist, Immunogenicity Assessment, Novo Nordisk


OVERCOMING TARGET INTERFERENCE IN NON-CLINICAL STUDIES

Case Studies in Non-Clinical Immunogenicity Testing with Fit for Purpose Assays: Isotype Control Assays for Overcoming Target Interference

Michael Partridge Ph.D., Staff Scientist, Bioanalytical Sciences, Regeneron, Inc.


DIFFERENT ASSAY FORMATS AND TECHNOLOGIES FOR IMMUNOGENICITY ASSESSMENT

Choosing an Appropriate ADA Assay for Preclinical Studies: Comparison of Different ADA Assays in NHP Case Studies

Jianyong (Jerry) Wang, Ph.D., Scientist, Biochemical and Cellular Pharmacology, Genentech, Inc.

Advances in Ligand-Binding Assay Technologies and their Impact on Immunogenicity Assessments

Renuka Pillutla, Ph.D., Director, Bioanalytical Sciences – Biologics, BMS


CHALLENGES IN DEVELOPING NEUTRALIZING ANTIBODY (NAB) ASSAYS

A Neutralizing Antibody Assay Based on a Reporter of Antibody Dependent Cell-Mediated Cytotoxicity

Yuling Wu, Ph.D., Principal Scientist, Translational Sciences, MedImmune



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