Combined Session: Parts One and Two - Immunogenicity Summit




12:30 pm Registration for Part Two

1:30 Chairperson’s Remarks

Steven J. Swanson, Ph.D., Executive Director, Clinical Immunology, Amgen, Inc.


1:35 Developing a Risk-Based Approach to Immunogenicity Assessment

Steve SwansonSteven J. Swanson, Ph.D., Executive Director, Clinical Immunology, Amgen, Inc.

When developing a strategy to determine the immunogenicity of a therapeutic protein it is important to consider the likelihood of mounting an immune response and the clinical consequences of an immune response. Understanding the answers to these important questions can allow a determination of how comprehensive the immunogenicity testing to support the therapeutic protein should be. This presentation will focus on ways to understand risk and how to fit an assessment strategy to best match that risk.

2:05 Visible and Subvisible Aggregates: New Pre-Clinical Models for Assessing their Potential Impact on Immunogenicity

Jack RaghebJack A. Ragheb, M.D., Ph.D., Principal Investigator, Laboratory of Immunology, Division of Therapeutic Proteins, Office of Biological Products, CDER, FDA

Our understanding of how protein aggregate attributes such as size, and external factors such as dose, route, and patient characteristics contribute to immunogenicity is very limited. This talk will focus on visible and subvisible protein aggregates, how they may interact with the immune system, the potential impact these particles could have on a product’s safety and efficacy profile, the factors affecting this risk, and recent efforts to evaluate and control the associated risk.

Joao Pedras-Vasconcelos2:35 Immunogenicity of Protein Therapeutics: An Updated Regulatory Perspective

João A. Pedras-Vasconcelos PhD Visiting Associate DTP-OBP-CDER-FDA

Immunogenicity is a significant safety and efficacy concern for protein therapeutics. This talk will provide an update on the new FDA immunogenicity guidance document for biological therapeutics including: FDA expectations regarding the submission of assay development and validation data; clinical assessment of immunogenicity; managing immunogenicity and immunogenicity studies as part of comparability exercises. Common pitfalls in submissions will be discussed.

3:05 Challenges and Successes of Measuring Antigen-Specific T cell Responses  
Sponsored by
Cellular Technology logo
Magdalena Tary-Lehmann, M.D., Ph.D., Chief Scientific Officer, Cellular Technology Ltd
Assessing immunogenicity is a challenge as an increasing number of new drugs and vaccines aim to elicit a response from the cellular components (e.g. T cells) of the immune system.  Therefore, monitoring antigen-specific T cells and their effector functions is crucial for the understanding of the efficacy of specific immune therapies.  ELISPOT assays have recently emerged as a primary tool for monitoring antigen-specific, low frequency measurements of cellular immunity, recording two cardinal features of cell-mediated immunity: the clonal sizes and the cytokine effector class which will be discussed during the presentation.

3:20 Networking Refreshment Break, Poster and Exhibit Viewing

Ralf Hess4:00 Update on EU Regulatory Guidance

Ralf Hess, Ph.D., Principal Consultant, Early Stage Drug Development, Parexel International GmbH

The European Medicines Agency (EMA) published a guideline on immunogenicity assessment of biotech-derived proteins (EMEA/CHMP/BMWP/14327/2006) which came into effect April 2008. This guideline provides for the first time an algorithm on how to assess unwanted immunogenicity and what assay technologies to use. Interestingly the guideline on development, production characterization, and specifications for monoclonal antibodies and related products (EMEA/CHMP/BWP/157653/2007), which came into effect July 1, 2009 only cross references to the immunogenicity assessment guideline and is focused on CMC issues.There are two concept papers and guidances currently released for consultation such as the concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies (EMEA/CHMP/BMWP/632613/2009), and the concept paper on immunogenicity assessment of monoclonal antibodies for in vivo clinical use (EMEA/CHMP/BMWP/114720/2009). These regulations will be discussed with respect to assess unwanted immunogenicity of therapeutic proteins.


Mikael Sorud4:30 Health Authority Expectations for Immunogenicity Data Required for Second Generation Manufacturing Changes for Insulin Products

Mikael Sørud, M.Sc., Director, Regulatory Affairs, Novo Nordisk A/S

Novo Nordisk has specialised in insulin manufacture for almost 90 years. Over the last decade a couple of second generation manufacturing processes for insulin human and insulin analogues have been developed and submitted to health authorities world wide. Pre-submission consultations on the requirements for immunogenicity studies have been conducted with several authorities, including EMA, FDA, TGA, SFDA, PMDA and BGTD with very different outcomes. Differences in regulations and specific requirements will be discussed as well as recommendation on how to approach different authorities with a global strategy.

5:00 Discussion

5:30 End of Part One

5:45 Break-Out Sessions for Part Two attendees

6:30– 7:30 Networking Reception for Part Two Attendees



Part Two

By Series:
By Region: