Archived Content


3rd Annual  

Immunogenicity of Protein Therapeutics May 3 - 4

Immunogenicity continues to be a major concern for the biologics industry regarding its impact on safety and efficacy. This event examines factors that contribute to immunogenicity,   development of predictive tools, and approaches to overcome this problem. It also presents expert advice on pre-clinical and clinical assessment strategies, risk assessment and regulatory considerations and guidance.

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12:00 pm Registration


Predictive Methods For Immunogenicity 

1:30 Chairperson’s Opening Remarks

Paul Chamberlain, NDA Advisory Board

1:40 Beyond in silico: Advancing Pre-Clinical Immunogenicity Testing

Jack-RaghebJack Ragheb, M.D., Ph.D., Principal Investigator, Immunology, Therapeutic proteins, CDER/FDABiography 

“Humanized” mice that fully recapitulate the human hematopoietic system may permit direct in vivo assessment of human immunogenicity to a therapeutic protein. This session will describe the nature, limitations, utility, and predictive value of in vitro and in vivo model systems. Case studies will illustrate how pre-clinical data and a risk-based assessment may help inform the probability of immunogenicity in humans.


2:10 Amgen’s Perspective on Immunogenicity Prediction Tools and Efforts

Theresa-GoletzTheresa J. Goletz, Ph.D., Senior Personalized Healthcare Leader, Clinical Immunology, Amgen, Inc. - Biography



2:40 Conversion of Manual Acid Dissociation Assays into an Automated Format for Immunogenicity

Robert A. Durham, Ph.D., Manager, Field Applications Scientist, Gyros US. Inc. 

Detection of anti-drug antibodies (ADA) is challenging in the presence of the biotherapeutic drug in circulation. Particularly at high concentrations, ADA:drug complexes can interfere with the measurement of ADA in the sample matrix.  Sample pretreatment using acid dissociation has been shown to improve drug tolerance and is typically a manual protocol that requires overnight incubation.  Gyros has developed a new ADA CD solution to automate the acid dissociation pretreatment and the assay workflow for the measurement of anti-drug antibodies in serum.  The development and evaluation of an automated, drug tolerant ADA immunoassay method on the Gyrolab nanoliter-scale immunoassay platform will be presented.

2:55 Sponsored Presentation (Opportunity Available)
3:10 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00-5:00 Problem Solving Breakout Discussions

Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.

Practical Application of Immunogenicity Pre-Clinical Risk Assessment

Moderators: Amy S. Rosenberg, M.D., Director, Division of Therapeutic Proteins, Office of Biotechnology Products, FDA; Paul Chamberlain, NDA Advisory Board

• Pertinent risk factors
• Features of a good risk analysis and risk mitigation plan
• Sharing of experiences of applying risk assessment in pre-clinical and clinical studies
• How should we interpret bioanalytical signals relative to clinical significance?
• Sharing experiences in presenting an immunogenicity risk assessment to the regulatory authorities.
• Risk mitigation: when is immune tolerance induction indicated?

Relevance of Animal Models for Predicting the Immunogenicity of Therapeutic Proteins

Moderator:  Jack Ragheb, M.D. Ph.D., Principal Investigator, Immunology, Therapeutic proteins, CDER/FDA

• Are relative immune responses (aggregated vs. non-aggregated human protein in a mouse) a valid measure?
• How might known differences in the human and mouse adaptive and innate immune systems impact the results?
• What, if any, is the role of adjuvants in such studies?

Product-Related Factors that Contribute to Immunogenicity

Moderator:  Wim Jiskoot, Professor, Drug Delivery Technology, University of Leiden (wants a co-host)

• Which structural variants increase immunogenicity?
• How SVPs may impact immunogenicity, safety and efficacy
• Comments on impact of formulation on SVPs and immunogenicity
• Relation between formulation, dosing , packaging and immunogenicity
• Measures to ensure long-term stability and avoid aggregation in protein drug products

Immune Tolerance Approaches

Moderator:  Alexandra Joseph, Ph.D., Associate Scientific Director. Investigative Clinical Immunology, Genzyme, a Sanofi Company

• Factors that promote tolerance / promote immunogenicity
• Impact of the dosing regimen on drug immunogenicity
• Impact of formulation and formulation change on immunogenicity
• Design of therapeutics for reduced immunogenicity

Predictive Tools for Immunogenicity

Moderator:  Theresa J. Goletz, Ph.D., Director, Medical Sciences Clinical Immunology, Amgen, Inc.

• How predictive are the methods to analyze T cell epitopes?
• Pros and cons of in silico, in vitro and in vivo methods.
• Engineering to avoid immunogenicity

Dealing with Pre-existing Positive ADA Activity in Study Patients

Moderator:  Boris Gorovits, Ph.D., Director, Pharmacokinetics Pharmacodynamics & Metabolism, Pfizer, Inc.

• Prediction of reactivity in naive samples vs. reactivity in pre-dose samples collected from study patients 
• If pre-dose samples with high levels of reactivity are identified, should we care?  If so, what are the appropriate follow up activities?
• Open exchange - what have you seen when characterizing pre-existing ADA and their impact?
• What are the regulatory expectations for characterizing pre-existing ADA?

Challenges in Developing Neutralizing Antibody Assays

Moderator:  Jaya Goyal, Ph.D., Principal Investigator, Translational Medicine, Biogen Idec, Inc.

• Factors for selection of cell-based NAb vs. non-cell-based NAb assays
• Bioanalytical challenges
• Challenges for NAb validation
• Interpretation of the results and implications for risk assessment

5:30-8:30 pm Recommended Dinner Short Course* 

*Separate registration required.


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