Immunogenicity of biotherapeutics is costing the industry huge amounts as a result of loss of efficacy and potential cross-reactivity. Moreover, patients are being denied life-saving treatments when given immunogenic products. Leaders in the field are determining what product characteristics and handling can cause immunogenicity, how to predict immunogenicity and how to work out a risk assessment plan. Other experts are focusing on de-immunizing approaches and the induction of tolerance. Over 100 participants, including four presenters from the FDA attended in 2014.
Quote from 2014: “Phenomenal presentations of great advances in multiple fronts. The most exciting meeting pertaining to immunogenicity of biotherapeutics.”
Potential Consequences of Immunogenicity to Immunotherapies, Gene Therapy, Cell-Surface Targeting Biotherapeutics, Excipients etc.
Amy Rosenberg, Ph.D., Director, Therapeutic Proteins, FDA/CDER
Relevance of Animal Models for Immunogenicity Prediction
Jack Ragheb, Ph.D., Principal Investigator, Therapeutic Proteins, FDA/CDER
Impact of Different Types of Aggregate on Immunogenicity
Narendra Chirmule, Ph.D., Consultant, 7Immune Consulting
Studies on Types of SVP that Do and Do Not Break Tolerance
Atanas Koulov, Ph.D., Group Head, Pharma Technical Development Europe, Roche A.G.
Methods for Examining Impurities that May Impact on the Immune Response, and Relevance for Comparability and Biosimilars
Daniela Verthelyi, Ph.D., Chief, Immunology Lab, Therapeutic Proteins, FDA/CDER
Evaluating Relative Risk of Immunogenicity of Biotherapeutics with Chemical Modifications and Impurities
Marisa Joubert, Ph.D., Senior Scientist, Process Development, Amgen, Inc.
Development of Mechanistic Models for the Prediction of Immunogenicity Outcomes in the Clinic
Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.
Decreasing Immunogenicity of Recombinant Immunotoxins by Identifying and Modifying B and T Cell Epitopes
Ira Pastan, M.D., Co-Chief, Laboratory of Molecular Biology, National Cancer Institute, National Institutes of Health
Developments with Inducing Tolerogenic Mechanisms
Matthew Macauley, Scientist, Chemical Physiology, Scripps Research Institute
Tolerance Induction in a Therapeutic Non-Naïve Setting
Takeshi Kishimoto, CSO, Selecta Biosciences
Induction of Tolerance Using Engineered Regulatory T and Cytotoxic T Cells with Chimeric Antigen Receptors
David W. Scott, Ph.D., Professor and Vice Chair for Research, Department of Medicine (MED), Uniformed Services University of Health Sciences
Inducing Immune Tolerance to Highly Foreign Therapeutics by Engineering for Erythrocyte Binding
Stephan Kontos, Ph.D., Co-Founder, Director of Research, Anokion
Anti-Drug Antibody – A Challenge in the Field of Therapeutic Proteins, Lessons Learned from Pompe Disease; Immune Tolerance Induction in ERT
Zoheb Kazi, Medical Genetics, Pediatrics, Duke University Medical Center