- life sciences/pharma sector
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2nd Annual Immunogenicity
Assessing the Risk and Clinical Relevance of Immunogenicity in Biotherapeutics Development
Event Date: 14-15 Jan 2010
Location: Avenida Palace Hotel, Barcelona, Spain
- key conference topics
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- Understand and apply developments regarding EMEA and FDA guidelines for biotherapeutics
- Interpret immunoassay results in the context of the study with a view to understanding the effect on the whole body
- Translate clinical immunogenicity findings into risk assessments to ensure regulatory approval and profitability
- Characterise clinical immune responses in the face of complicating factors such as concomitant therapies
- Select the most promising leads for development with early-stage immunogenicity assessments
- key conference features
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- Developing assays that maintain their performance throughout long, late-stage clinical trials with Human Genome Sciences
- Discussing the predictive value of in silico methods, in vitro and in vivo pre-clinical risk assessment from a regulatory perspective with LFB Biotech
- Exploring how formulation issues such as protein aggregation influence immunogenicity with Ipsen
- Designing assays that lend themselves to continued efficacy after transfer with Crucell
- conference focus
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marcus evans 2nd Annual Immunogenicity As an increasing number of biotherapeutics reach later phases of development, industry is focusing on the clinical relevance of immunogenicity for patients and regulators. At the same time, more data becomes available to test and refine our predictive strategies and ensure the success of future therapeutics.
This marcus evans conference offers an intimate environment for benchmarking and networking with thought-leading researchers in immunogenicity, as they present in-depth industry case studies and new academic findings.