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
A Harmonized Approach to Interpretation and Reporting of Clinical Immunogenicity Data
Valerie Quarmby, Ph.D., Staff Scientist, BioAnalytical Sciences, Genentech, Inc.
Regulatory Authority Advice on How the Product and Its Quality affect Immunogenicity, and Consequent Immunogenicity Assessment
William Hallett, Ph.D., Immunogenicity and CMC Assessor, Therapeutic Proteins, CDER/FDA
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
Lessons Learned from the European Experience Regarding Biosimilars and Immunogenicity
Paul Chamberlain, NDA Consulting
Strategies for Immunogenicity Risk Assessment
Bonnie Rup, Ph.D., Biopharmaceutical Development Expert
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
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.
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
A Neutralizing Antibody Assay Based on a Reporter of Antibody Dependent Cell-Mediated Cytotoxicity
Yuling Wu, Ph.D., Principal Scientist, Translational Sciences, MedImmune
Evaluation of Pre-Existing Antibodies: How Meaningful is the Investigation?
Lakshmi Amaravadi, Ph.D., Senior Director, Translational Medicine, Biogen Idec, Inc.