Cambridge Healthtech Institute’s 10th Annual

Immunogenicity Prediction & Control  

Regulatory Perspectives, Risk Factors, and Management

October 24-25, 2018


The impact of immunogenicity on safety and efficacy, and consequent cost to the industry is well understood. Accordingly, investigators are focusing on factors that contribute to immunogenicity as well as a number of different approaches to predict immunogenicity at the drug discovery stage. There are several major problematic areas such as gene therapy products with viral vectors, and Factor VIII for hemophilia, and efforts are being made to suppress immune responses to these products and to introduce tolerizing and deimmunization approaches.


FDA Regulatory Perspectives on Immunogenicity Risk Assessment from Phase I IND to BLA and Beyond
Steven Bowen, PhD, Team Lead, Office of Biotechnology Products, CDER/FDA

Case Studies: Updating Immunogenicity Risk Assessment during Study Conduct
Joleen T. White, PhD, Director, Head of Project Support NBE Drug Disposition, EMD Serono


Case Study on the Impact of Aggregation and Impurities on Immunogenicity
Daniela Verthelyi, PhD, Chief, Immunology Lab, Therapeutic Proteins, CDER/FDA


Detection of Memory B Activity against a Therapeutic Protein in Treatment-Naïve Subjects
Karen Liao, PhD, Investigator and Associate Fellow, GSK

Modelling to Understand Efficacy and Safety of Immune-Modulatory Biotherapeutics
Renu Dhanikula, PhD, Senior Research Investigator, Metabolism and Pharmacokinetics, Bristol-Myers Squibb

T Cell Assay to Predict Immunogenicity of Biotherapeutics
Sivan Cohen, PhD, Genentech, Inc.


Application of Mechanistic Modelling to Prediction of Immunogenicity
Timothy Hickling, PhD, Immunogenicity Sciences Lead, Biomedicine Design, Pfizer, Inc.

Practical Application of Tools for Immunogenicity Prediction
Valerie Quarmby, PhD, Staff Scientist, BioAnalytical Sciences, Genentech, Inc.

Application of Predictive Tools, Interpretation, and Translation into the Clinic
Jad Mammory, PhD, Senior Scientist, Merck and Co., Inc.

Clinical Relevance of Immunogenicity Risk Assessment Tools and Application for Product Engineering and Selection
Li Xue, PhD, Senior Principal Scientist, BioMedicine Design, Pfizer, Inc.


Importance of Recent Development in Immuno-Oncology and Autoimmune Disease on Immunogenicity and Tolerance Induction
Amy Rosenberg, FDA

Update on Inducing Immunological Tolerance to Biotherapeutics Ira Pastan, MD, Co-Chief, Molecular Biology, National Cancer Institute, National Institutes of Health

Mitigation of Immunogenicity to AAV Gene Therapy Vectors with Tolerogenic Nanoparticles Enables Re-Treatment for Systemic Gene Therapy Applications
Kei Kishimoto, PhD, CSO, Selecta Biosciences

Removing T Cell Epitopes with Computational Protein Design
Indigo King, PhD, Scientist, Immunology, Cyrus Biotechnology

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:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: (+1)  781-972-5412