Cambridge Healthtech Institute’s 13th Annual

Immunogenicity Assessment and Regulatory Approval of Biologics

Establishing Effective Prediction and Validation of Assays

May 6 - 7, 2020

Immunogenicity has always been a critical safety concern, especially when many biotherapeutics are becoming increasingly complex. Understanding and controlling immunogenicity-related risks are essential in the development of biotherapeutics to ensure meeting the regulatory requirements. The 13th Annual Immunogenicity Assessment and Regulatory Approval of Biologics conference brings industry, regulatory and scientific experts together to share the best practices in assessing immunogenicity of novel biologics along with biosimilar products. The sessions will also discuss the challenges and solutions for addressing new regulatory guidelines in assay development and validation for cell and gene therapies and other platforms.

Preliminary Agenda


Fully Automated Cell-Based Binding Neutralizing Antibody Assay on MSD Platform

Weifeng Xu, PhD, Principal Scientist, PPDM, Regulated Immunogenicity and Molecule, Merck

What Is the Best Approach to Overcoming Drug Interference in Immunogenicity Assays, BEAD, SPEAD, or Maybe LCMS?

Hao Jiang, PhD, Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb

Anti-Drug Antibodies – Keep Calm and Carry On

Immunogenicity Risk Factors Associated with Multi Domain Biotherapeutics

Boris Gorovits, PhD, Senior Director, Pharmacokinetics, Dynamics & Metabolism, Pfizer Inc.

Evaluation of Statistical Approaches for the Monitoring of Anti-Drug Antibody (ADA) Assay Performance during Clinical Development

Ching-Ha (Vicky) Lai, PhD, Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.

Predictive Immunogenicity Assays

Predicting Immunogenicity of Biopharmaceuticals through Integrating in silico, in vitro, and Immune Systems Data

Timothy Hickling, PhD, Immunogenicity Sciences Lead, Pfizer Inc.

Experimental Design Recommendations for Evaluating Assay Sensitivity According to the 2019 FDA Guidance

Kelli R. Phillips, PhD, MBA, Laboratory Manager, PPD® Laboratories

A Case Study on Prediction of Immunogenicity Potential of Therapeutic Proteins

Sivan Cohen, PhD, Scientist, BioAnalytical Sciences, Genentech

Benchmarking Predictions and Experimental Data for HLA Class II Binding, Eluted Ligands and Immunogenicity

Alessandro Sette, Dr. Biol. Sci., Professor, Head and Member, La Jolla Institute for Immunology


Effective Presentation of Immunogenicity Risk Assessments and Related Data in Regulatory Dossiers

Paul Chamberlain, PhD, NDA Advisory Board

FDA Regulatory Perspective on the Harmonized ADA Validation Testing and Reporting

Zhenzhen Liu, PhD, FDA/CDER/OPQ/Office of Biotechnology Products, FDA

FDA Guidance on Bi and Tri Platforms

Mark Ma, PhD, Executive Director, Bioanalytical Development, Alexion Pharmaceuticals, Inc.

Tales from the Vault: Case Studies of Immunogenicity Assay Validation from the FDA’s Office of Biotechnology Products

Leopold Kong, PhD, Chemist, Product Quality Reviewer, Biotechnology Review & Research IV, Office of Biotechnology Products, OPQ, CDER, FDA

* The program is subject to change without notice, due to unforeseen reason.

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