CONFERENCE PROGRAMS

Cambridge Healthtech Institute’s 17th Annual

Immunology for Biotherapeutics

Advancing Immune Understanding and Modulation for Next-Generation Therapeutics

October 19, 2026 ALL TIMES EDT

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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Cambridge Healthtech Institute’s 18th Annual

Immunogenicity Assessment & Clinical Relevance

Optimizing Assays for Clinically Meaningful Insights

October 20 - 21, 2026 ALL TIMES EDT

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 Prediction & Control

Risk Assessment, Translation, and Mitigation

October 21 - 22, 2026 ALL TIMES EDT

Immunogenicity remains a critical determinant of safety, efficacy, and regulatory success, with increasing complexity introduced by emerging biologics and advanced modalities. The focus has shifted from identification to prediction, translation, and control—integrating non-clinical risk assessment, AI/ML-driven candidate optimization, and deeper understanding of T cell, B cell, and innate immune activation. As regulatory expectations evolve, investigators are refining predictive assays, in silico tools, and statistical approaches to better inform IND strategy and clinical decision-making. Particular attention will be given to complex modalities including multispecifics, conjugates, and cell and gene therapies. Join leading voices from the FDA, industry, and academia to explore practical strategies for de-risking programs, communicating immunogenicity risk, and implementing mitigation and tolerance approaches with real translational impact.

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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 ALL TIMES EDT

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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