PROGRAMS


Cambridge Healthtech Institute’s 11th Annual

Immunogenicity Assessment & Clinical Relevance

Assay Strategy for Meaningful Evaluation

October 16-17, 2019

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

Regulatory Perspectives, Risk Factors, and Management

October 17-18, 2019

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

Case Studies Demonstrating Successful Bioassay Development

October 17-18, 2019

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

Understanding and Manipulating the Immune System for Therapeutic Advantage

October 15, 2019

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

Coming soon.