會議議程


Cambridge Healthtech Institute’s 11th Annual

Immunogenicity Assessment & Clinical Relevance
( 免疫原性評價與臨床上相關性 )

做出有意義評價的測定策略

2019年10月16-17日

The industry continues to be challenged by the development, application and interpretation of immunogenicity assays. The FDA has advocated a more stringent approach for cut point setting and assay validation creating further difficulties. Moreover, the industry remains uncertain about when the more challenging neutralizing antibody assays should be applied and which type of assay is reliable and acceptable. Additional ongoing challenges concern managing drug and target interference, understanding and handling the impact of pre-existing antibodies, and interpreting the clinical significance of assay data.

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Cambridge Healthtech Institute ’s 11th Annual

Immunogenicity Prediction & Control
( 免疫原性預測與控制 )

法規機構的看法、風險要素、管理

2019年10月17-18日

The impact of immunogenicity on safety and efficacy and consequent cost to the industry is well understood. Accordingly, investigators are focusing on factors that contribute to immunogenicity as well as a number of different approaches to predict immunogenicity at the drug discovery stage. There are several major problematic areas such as gene therapy products with viral vectors, and Factor VIII for hemophilia, and efforts are being made to suppress immune responses to these products and to introduce tolerizing and deimmunization approaches.

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Cambridge Healthtech Institute’s 7th Annual

Optimizing Bioassays for Biologics
( 用於生物製劑的生物測定最佳化 )

生物測定開發的成功案例研究

2019年10月17-18日

As the bioassay field continues to move forward, new technologies and software are changing the way scientists view experimental design and data analysis. The health authorities and USP have provided guidance for the design and validation of a bioassay; however, they do not discuss solutions to common problems springing from this revolution in technology. At Cambridge Healthtech Institute's Seventh Annual Optimizing Bioassays for Biologics, leaders working in bioanalytical and bioassay development will come together to provide case studies and best practices for handling the most common issues in biological assay development, validation, transfer, and maintenance. There will also be a focus on new modalities including cell therapies (encompassing immunotherapies), gene therapies and antibodies. In addition, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.

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Cambridge Healthtech Institute’s 2nd Annual

Symposium: Immunology for Biotherapeutics
( 學術研討會:應用在生物製劑的免疫學 )

帶來治療上優點的免疫類的理解與操作

2019年10月15日

Many of the exciting developments in drug discovery and development today concern the immune response and its manipulation and control. Our understanding of immune involvement in therapeutic disorders and their treatment is developing rapidly. T and B lymphocyte subsets, innate lymphoid cells (ILCs), macrophages, dendritic cells and cytokines are all involved in a complex manner. There is the potential for manipulation for therapeutic advantage, yet the danger disastrous consequences if not well understood. At this symposium, attendees will find out how to utilize the immune system and overcome inhibitory factors without overlooking potential safety issues.

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Workshop: Biostatistics for Beginners
( 工作坊:初學者也能懂的生物統計學 )

 

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