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. 

CRITICAL ISSUES WITH CUTPOINTS, CONFIRMATORY ASSAYS AND VALIDATION

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 Harmonization
Jochem 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

STRATEGIES FOR HANDLING PRE-EXISTING ANTIBODIES

Assay Design Strategies and Clinical Impact of Pre-Existing ADA
Kevin Larimore, PhD, Senior Scientist, Bioanalytical Sciences, BioMarin  

NEUTRALIZING ANTIBODY ASSAYS

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.

MANAGEMENT OF DRUG INTERFERENCE / IMPROVEMENT OF DRUG TOLERANCE

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

ADA ASSAYS AND CLINICAL RELEVANCE

Developing Robust ADA Assays Focused on Clinically Relevant Responses. 
Chris Stebbins, PhD, Principal Scientist, Translational Medicine, Biogen, Inc.

REGULATORY PERSPECTIVES

Best Practices for Successful Immunogenicity Assay Review by the Agencies
William Hallett, PhD, Biologist, CDER/OPQ/OBP

IMMUNOGENICITY ASSESSMENT OF SPECIFIC PRODUCTS

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
Email: nlyscom@healthtech.com

For partnering and sponsorship information, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: cbenton@healthtech.com