Immunogenicity and Bioassay Summit

Immunogenicity Prediction and Mitigation

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.” 


REGULATORY CONCERNS

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


FACTORS CONTRIBUTING TO IMMUNOGENICITY

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


RISK ASSESSMENT

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.


DEIMMUNIZATION AND TOLERANCE MECHANISMS

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

 

clinical case study on tolerance induction

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 

 

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 2014 Brochure Cover 

Podcast 

IMN Podcast iconReducing and Monitoring Bioassay Variability 

2013 Speaker: Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefenseDivision, Emergent BioSolutions