Cambridge Healthtech Institute’s 12th Annual
Immunogenicity Assessment & Clinical Relevance
Assay Strategy for Meaningful Evaluation
October 7-8, 2020
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.
Cambridge Healthtech Institute ’s 12th Annual
Immunogenicity Prediction & Control
Regulatory Perspectives, Risk Factors, and Management
October 8-9, 2020
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.
Cambridge Healthtech Institute’s 8th Annual
Optimizing Bioassays for Biologics
Case Studies Demonstrating Successful Bioassay Development
October 8-9, 2020
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.
Cambridge Healthtech Institute’s 3rd Annual
Symposium: Immunology for Biotherapeutics
Understanding and Manipulating the Immune System for Therapeutic Advantage
October 6, 2020
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.
Workshop: Biostatistics for Beginners
October 6, 2020
Nancy C. Sajjadi, Independent Quality Consultant
Training Seminar: Bioassay Design, Development, Analysis, Validation, and Monitoring
October 7, 2020
David Lansky, PhD, President, Precision Bioassay, Inc.