CONFERENCE PROGRAMS
Cambridge Healthtech Institute’s 18th Annual
Immunogenicity Assessment & Clinical Relevance
Optimizing Assays for Clinically Meaningful Insights
October 20-21, 2026
The Immunogenicity Assessment & Clinical Relevance conference convenes FDA, industry, and academic leaders to examine evolving immunogenicity strategies that support informed clinical decision-making. The program will explore fit-for-purpose assay development and validation, management of drug and target interference, interpretation of clinically meaningful ADA data, and approaches to addressing pre-existing immunity. In addition to traditional biologics, the meeting will cover immunogenicity considerations across emerging and complex modalities, including peptides, bispecifics and multispecifics, T cell engagers, oligonucleotides, cell and gene therapies, ADCs, and next-generation therapeutic platforms.
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Cambridge Healthtech Institute’s 18th Annual
Immunogenicity Assessment & Clinical Relevance
Optimizing Assays for Clinically Meaningful Insights
October 20-21, 2026
The Immunogenicity Assessment & Clinical Relevance conference convenes FDA, industry, and academic leaders to examine evolving immunogenicity strategies that support informed clinical decision-making. The program will explore fit-for-purpose assay development and validation, management of drug and target interference, interpretation of clinically meaningful ADA data, and approaches to addressing pre-existing immunity. In addition to traditional biologics, the meeting will cover immunogenicity considerations across emerging and complex modalities, including peptides, bispecifics and multispecifics, T cell engagers, oligonucleotides, cell and gene therapies, ADCs, and next-generation therapeutic platforms.
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Cambridge Healthtech Institute’s 14th Annual
Optimizing Bioassays for Biologics
Precision Potency and Control Strategies for Next-Generation Biotherapeutics
October 21-22, 2026
As biologics expand into genome editing, mRNA, autologous cell therapies, and complex immunotherapies, bioassay expectations continue to evolve. Now in its 14th year, CHI’s Optimizing Bioassays for Biologics brings together industry and academic experts to share practical case studies, statistical strategies, and regulatory insights for developing, validating, and maintaining robust potency assays. Join us this October to explore innovative approaches that align bioassays with mechanism-of-action, clinical relevance, and lifecycle control from early development through commercialization.
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Cambridge Healthtech Institute’s 17th Annual
Immunology for Biotherapeutics
Advancing Immune Understanding and Modulation for Next-Generation Therapeutics
October 19, 2026
Advances in biotherapeutic development increasingly depend on a deeper understanding of immune system biology and its therapeutic manipulation. This symposium explores how adaptive and innate immune mechanisms influence the safety, efficacy, and clinical performance of emerging biologics. Covering immune modulation, immunogenicity, hypersensitivity, and next-generation antibody and cell-based therapies, presentations will highlight strategies to harness immune responses for therapeutic benefit while mitigating risk. Attendees will gain insight into translating immunological understanding into the design and development of safer, more effective biotherapeutics.
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Training Seminar: Biostatistics for Beginners
TBA
Training Seminar: A Guide to Statistical Methods for Bioassay
TBA