CONFERENCE PROGRAMS
Cambridge Healthtech Institute’s 17th Annual
Immunogenicity Assessment & Clinical Relevance
Assay Strategy for Meaningful Evaluation
October 8-9, 2025
This year's Immunogenicity Assessment and Clinical Relevance conference brings the FDA together with leading industry and academic experts to discuss the development, application, and validation of immunogenicity assays to support clinical development. 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. As well as traditional biologics, the meeting will also address novel modalities such as cell and gene therapies, RNA therapies, bispecifics, T cell engagers, multispecifics, fusion proteins, peptides, and antibody-drug conjugates (ADCs).
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Cambridge Healthtech Institute ’s 17th Annual
Immunogenicity Prediction & Control
Regulatory Perspectives, Risk Factors, and Management
October 9-10, 2025
The impact of immunogenicity on safety and efficacy, and consequent cost to the industry, is well understood. Accordingly, investigators are focusing on key factors that contribute to immunogenicity, as well as a number of different approaches to predict immunogenicity in early development. 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 2025 to hear insightful feedback from the FDA and learn from top industry and academics in this field.
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Cambridge Healthtech Institute’s 13th Annual
Optimizing Bioassays for Biologics
Successful Bioassay Development in an Era of Emerging Modalities
October 9-10, 2025
New therapeutic modalities, including cell and gene therapies, immunotherapies, and antibody therapies, continue to push the need for better testing and improved bioassay development. Now in our 13th year, CHI’s Optimizing Bioassays for Biologics conference brings together speakers from industry and academia working in bioassay development, bioprocessing, and bioanalytical. This forum educates new and up-and-coming scientists entering the field by showcasing cutting edge case studies and discussing how regulatory agencies view testing with novel modalities. Join us this October to hear novel bioassay approaches and how our expert speakers overcome the most common challenges in biological assay development, validation, transfer, and maintenance.
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Cambridge Healthtech Institute’s 17th Annual
Immunology for Biotherapeutics
Understanding and Manipulating the Immune System for Therapeutic Advantage
October 7, 2025
Many of the exciting advances 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 of 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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Training Seminar: Biostatistics for Beginners
(In Person Only) *Separate registration is required.
October 8-9, 2025
Statistical analysis is an integral part of designing, developing, validating, and monitoring performance of a bioassay after it is implemented. Statistical tools and techniques are required for experimental design, selecting an appropriate model for the dose response curve, evaluating system and sample suitability, and to measure, control, and communicate the uncertainty of reported potency results. Fundamental concepts are also integral to developing product specifications and making decisions for lot release. This training seminar is intended for people who generate or review bioassay data but have minimal training in statistics. A slower-paced interactive course helps participants understand the meaning of commonly encountered statistical information in context and expand their knowledge of fundamental concepts and tools that are applicable to their daily work. Time is built into the agenda to allow for review of specific topics and open discussion in response to participant questions.
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