Cambridge Healthtech Institute’s 15th Annual
Immunogenicity Assessment & Clinical Relevance
Assay Strategy for Meaningful Evaluation
October 3-4, 2023 - IN-PERSON & ONLINE
This year's Immunogenicity Summit brings the FDA together with leading industry and academic experts to discuss the development, application and validation of immunogenicity assays. Learn how to manage drug and target interference and tolerance,
understand the impact of pre-existing antibodies and interpret the clinical significance of assay data. Novel modalities including cell and gene therapies are posing new challenges to the industry, all of which will be discussed in-depth at this meeting.
Cambridge Healthtech Institute ’s 15th Annual
Immunogenicity Prediction & Control
Regulatory Perspectives, Risk Factors, and Management
October 4-5, 2023 - IN-PERSON & ONLINE
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 with novel modalities. Efforts are being made to suppress immune responses to these products and to introduce tolerizing and deimmunization approaches. Attend in
2021 to hear insightful feedback from the FDA and learn from top industry and academics in this field.
Cambridge Healthtech Institute’s 11th Annual
Optimizing Bioassays for Biologics
Case Studies Demonstrating Successful Bioassay Development
October 4-5, 2023 - IN-PERSON & ONLINE
New therapeutic modalities, including cell & gene therapies, immunotherapies, and antibody therapies, continue to push the limit on bioassay development and implementation. New formats present challenges including determining what reference materials
to use and how to validate the assay. Health authorities and USP have provided guidance for the design and validation of a bioassay; however, they are just starting to consider solutions to common problems springing from this revolution in technology.
Cambridge Healthtech Insitute's 9th Annual Optimizing Bioassays for Biologics will bring together leaders working in bioanalytical and bioassay development to present case studies and best practices for handling the most common issues in biological
assay development, validation, transfer, and maintenance. be presented along with recommendations for implementation to ensure a steady drug development pipeline.
Cambridge Healthtech Institute’s 13th Annual
Symposium: Immunology for Biotherapeutics
Understanding and Manipulating the Immune System for Therapeutic Advantage
October 2, 2023 - IN-PERSON & ONLINE
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 virtual 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 2, 2023- IN-PERSON ONLY
Biostatistics is the science of learning from biological data. Inferential statistics use data from a sample to make generalizations or predictions about a population. The process of sampling naturally incurs error and statistics are needed to measure, control, and communicate the uncertainty of reported results. This workshop is intended for people who generate or review bioassay data, but have minimal training in statistics. This slower-paced course will help participants understand the meaning of commonly encountered statistical information and expand their knowledge of fundamental concepts and tools that are applicable to their daily work.View Program