Immunogenicity Summit
Immunogenicity and Bioassay Summit
Archived Content


Immunogenicity Assessment and Clinical Relevance
October 10-11

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THURSDAY, October 11

7:30-8:15 am Sponsored Breakfast Presentation Available

(Opportunity available, please contact Tim McLucas,

8:30 Chairperson’s Remarks

Stephen Keller, Ph.D., Associate Director II, Pre-Clinical & Clinical Development Sciences, GPRD Abbott Biotherapeutics Corp. 


8:35 Clinical Trial Strategy and Immunogenicity Assessment for a Novel Protein Therapeutic

Josi Holz, M.D., CMO, Ablynx NV - Biography 

This talk will provide an introduction to the Nanobody technology platform and outline the non-clinical development and immunogenicity risk assessment program together with the clinical strategy and the immunogenicity risk management. Experiences with the Regulatory Authorities will be presented.

9:05 Pre-Existing Reactivity and Risk Mitigation

Jim McNally, Ph.D., Senior Principal Scientist, Pfizer, Inc.

The increased frequency of pre-existing reactivity to biotherapeutics during clinical assay development have led us to implement a risk mitigation plan that relies upon early identification of protein modalities more likely to be targeted by pre-existing reactivity and disease indications more likely to manifest these reactivities.



9:35 Fundamental Considerations for Defining “Comparable” Immunogenicity of Biosimilar Therapeutic Monoclonal Antibodies

Paul ChamberlainPaul Chamberlain, NDA Advisory Board - Biography 

This presentation will reflect on methodological limitations for interpretation of relative Immunogenicity of biosimilar and reference therapeutic monoclonal antibodies, in emphasizing the relevance of correlation of bioanalytical signals with appropriate clinical endpoints and the possible need for post-marketing observational studies to indicate the impact of detected differences in anti-drug antibody (ADA) incidence and magnitude on sustainability of treatment benefit. Arguably, there can be no pre-defined margin of difference based on incidence and magnitude of detected ADA’s.

10:05 PerkinElmer NEW 2009Immunogenicity Assessment Using Novel ELISA Alternative Detection TechnologiesMartin Boissonneault, Senior Scientist, PerkinElmer Life Science and TechnologiesBiotherapeutics often elicit immune responses and clinical consequences of anti-drug antibodies (ADA) can result in adverse events. The presence of ADA is a safety concern and must be evaluated and correlated with pharmacological or toxicological observations. The development of rapid, sensitive assays for ADA detection is essential. AlphaLISAÒ and DELFIAÒ assays used to detect ADA in serum samples can detect ADA in the low ng/mL range, maintain excellent performance in serum and exhibit high drug tolerance.

10:35 Coffee Break in the Exhibit Hall with Poster Viewing


11:10 Immunogenicity Considerations in the Approval of Generic Enoxaparin in the US

Daniela VerthelyiDaniela Verthelyi, M.D., Ph.D., Chief, Immunology, Therapeutic Proteins, CDER/FDA - Biography 

Enoxaparin belongs to a of drugs known as low molecular weight heparins (LMWH). These products can form complexes in vivo with chemokine PF4 and elicit immune responses that have been linked to a serious adverse effect: heparin induced thrombocytopenia. Approval of generic enoxaparin required establishing bioequivalence of the API as well as assessing the risk that the generic enoxaparin product would pose a greater risk of immunogenicity.

11:40 Immunogenicity Assessment of Biosimilars: Fit For Purpose Strategy with Totality of Evidence

Daniela Verthelyi Patrick Liu, M.D., Ph.D., Global Head, Bioanalytical Sciences and Technologies, Teva Pharmaceutical Industries, Ltd. - Biography 

Immunogenicity testing has become one of the most critical considerations for the development of therapeutic biologics. This presentation will provide an overview of technology and methodology issues and challenges for biosimilars and advice on a fit-for-purpose immunogenicity assessment program, discuss totality of evidence and immunogenicity data interpretation, and examine immunogenicity comparability of biosimilars. 

12:10 pm Luncheon Presentation

(Opportunity available, please contact Tim McLucas, or Lunch on Your Own


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