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.
Coverage will include, but is not limited to:
- Advances with Complex and Emerging Modalities: Immunogenicity assessment for bispecifics, multispecifics, T cell engagers, fusion proteins, ADCs, PDCs, peptides, oligonucleotides (mRNA, siRNA, ASOs), cell therapies (CAR T, engineered Tregs), gene therapies (AAV, re-dosing), CRISPR therapies, biosimilars, and immunotherapies
- Immunogenicity of Peptides: Stage-appropriate strategies, impurity-driven risk, lifecycle management, Integrated Summary of Immunogenicity (ISI), and alignment with evolving FDA guidance
- Implementation of AI and ML: Case studies demonstrating advanced analytics to address pre-existing immunity and data interpretation
- Regulatory Perspectives: FDA and global regulatory insights on new and evolving guidance, recent submissions, and opportunities for harmonization
- Clinical Relevance of ADA (Anti-Drug Antibodies): Interpreting ADA data in context, balancing assay sensitivity and relevance, assessing impact on PK, safety, and efficacy, and defining clinically meaningful thresholds
- Key Industry Initiatives: Reference materials and best practices for qPCR and dPCR assay development and validation supporting cell and gene therapy programs
- Root Cause and Characterization of Immunogenicity: Case studies exploring product, process, and patient-related drivers, including impurities and pre-existing antibodies
- Assay Development and Validation: Selecting fit-for-purpose formats, overcoming technical challenges, cut-point determination, data reporting, and industry harmonization
- Managing Drug Tolerance and Assay Interference: Strategies to improve drug tolerance and manage assay and target interference, including advanced dissociation techniques
The deadline for priority consideration is April 10, 2026.
All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
Opportunities for Participation: