For more information on this conference please download the brochure here http://www.smi-
“In our clinical trials of treating mesothelioma patients with immunotoxin we found that 100% of the patients developed neutralizing antibodies after one or two cycles of treatment. The patients benefited from the drug significantly;
•Why do you think Immunogenicity is an important subject area and how will your presentation benefit the audience?Interview insights from Key Opinion Leaders:
We have seen leukemia patients that did not develop immunogenicity responses (due to the nature of the disease) these patient had complete remission from their cancer.
We believe that a diminish, (even though not complete elimination)
•How do you see the future of Immunogenicity developing over the next 12 months?
“There will be a publication from the AAPS Biosimilar committee which will give the industry clear direction on how to validate assays and use these assays in support of Biosimilar drug development.
Another developing area from an immunogenicity perspective is with Antibody-Drug conjugates.”
•In your experience what do you feel are the main challenges in the field of Immunogenicity?
“In my opinion the harmonization of the ADA assays are a main challenge and the lack therefore currently prevents comparing results between labs. In addition, the fact that immunogenicity is semi-quantitative also impairs comparison. This is a result of the currently used positive controls, which in most cases is raised in animals who respond against the foreignness of the therapeutic and follow a wanted immunogenicity mechanism (classical immune response). In my view, the positive control is very artificial and makes data interpretation difficult. This conference offers a very broad selection of topics in addition to very well-known names in the field of immunogenicity.”
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About SMi Group
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-
We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. We hold events in over 30 major cities throughout the world including London, Paris and Singapore and to date have welcomed over 200,000 participants from 80 countries.
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