Cambridge Healthtech Institute’s 10th Annual
Immunogenicity Assessment & Clinical Relevance
Assay Strategy for Meaningful Evaluation
October 23-24, 2018
The industry continues to be challenged by the development, application and interpretation of immunogenicity assays. Recently the FDA have advocated a more stringent approach for cutpoint setting and assay validation creating further difficulties. Moreover,
the industry remains uncertain about when the more challenging neutralizing antibody assays should be applied, and which type of assay is reliable and acceptable. Additional ongoing challenges concern managing drug and target interference, understanding
and handling the impact of pre-existing antibodies, and interpreting the clinical significance of assay data.
Case Study on Delineation of Immunogenicity Confirmatory Assay: Full Validation Strategy and Implementation of Assay Cutpoint Factor Assessment GuidelinesMauricio Maia, PhD, Senior Scientist, BioAnalytical Sciences, Genentech, Inc.In Vitro Immunogenicity Assay Analytical Validation and HarmonizationJochem Gokemeijer, PhD, Associate Director, Molecular Discovery Technology, Bristol-Myers Squibb
Impact of Cut Point Determination on Immunogenicity Assessment
Michael Partridge, PhD, Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals
Assay Design Strategies and Clinical Impact of Pre-Existing ADA
Kevin Larimore, PhD, Senior Scientist, Bioanalytical Sciences, BioMarin
Case Study on Determination of a Level of Sensitivity in the NAB Assay That Is Clinically Meaningful in a Post-Marketing Study
Devangi Mehta, PhD, Associate Director, Biogen, Inc.
Challenges and Strategies for Improving Drug Tolerance of Nab Bioassays
Zhihua Jiang, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
ADA Interference of PK Immunoassays in Preclinical Studies
Christian Ruzanski, PhD, Senior Scientist, Bioanalysis, Novo Nordisk
Alternatives to the Current Acid-Dissociation Based Anti-Drug Antibody Extraction to Increase ADA Recovery in Immunogenicity Testing
Weifeng Xu, PhD, Senior Research Investigator, Bioanalytical Science, Bristol-Myers Squibb
Developing Robust ADA Assays Focused on Clinically Relevant Responses.
Chris Stebbins, PhD, Principal Scientist, Translational Medicine, Biogen, Inc.
Best Practices for Successful Immunogenicity Assay Review by the Agencies
William Hallett, PhD, Biologist, CDER/OPQ/OBP
Immunogenicity Bioanalytics for the New Drug Modalities: CART and Gene Therapies
Lilia Macovei, PhD, Senior Scientist, Pfizer, Inc.
Case Study on Challenges of Immunogenicity Assessment for a Short Peptide Therapeutic
Mitra Azadeh, PhD, Principal Scientist, Bioanalytical & Biomarker Development, Shire
Immunogenicity Challenges Surrounding Immunogenicity Assessment of Gene Therapy Vectors
Terry P. Combs, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
For more details on the conference, please contact:
Nicole Lyscom, PhD
Senior Conference Director
Cambridge Healthtech Institute
Phone: +44 7791 866489
For partnering and sponsorship information, please contact:
Business Development Manager
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412