Cambridge Healthtech Institute’s 18th Annual
Immunogenicity Prediction & Control
Risk Assessment, Translation, and Mitigation
October 21-22, 2026
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.
Coverage will include, but is not limited to:
- Non-Clinical Immunogenicity Risk Assessment: IDC phase 2, Quality by design, B cell risk assessment and ML to predict CD4 T cell responses
- Translation into the Clinic: How can the data generated be used in the clinic? What is the true value of the preclinical assays and how can this be proved?
- FDA Perspectives: Critical feedback from the FDA on new/updated guidance and recent submissions
- The Role of AI and ML to help de-risk candidates and engineer better candidates
- The Role of Innate Immune Responses to Biologic Therapeutics—FDA/EMA/Industry/Academia
- T Cell Antigenicity: T cell activation assays, peptide-based activation, ELISPOT etc.
- Dendritic/Innate Cells: Innate cell activation and DC uptake
- Immunogenicity Mitigation: Sequence engineering and tolerance induction techniques
- Risk Assessment: How to communicate results, informing program teams, preparing for IND, overcoming issues with impurities and aggregation, interactions with CMC
- Predictive Assays, Studies and Tools: How can these be improved? Examples include but are not limited to T cells, MAPPs and Abirisk
- In silico Evaluations of Therapeutics: MAPPs assays—do they over-predict?
- B Cell Antigenicity, e.g., pre-existing ADA
- Advances with Complex and Emerging Modalities: Preclinical immunogenicity risk assessment strategies for new modalities including, but not limited to, cell therapy (e.g., CAR T and edited stem cell for oncology and autoimmune disease), gene therapy (e.g., AAV vectors, re-dosing), CRISPR therapies, peptides, T cell engagers, bispecifics, multispecifics, biosimilars, immunotherapies, antibody-drug-conjugates, conjugates, and oligonucleotides (e.g., mRNA, microRNA, siRNA, ASOs)
- Immune Tolerance: Immunosuppression, tolerance induction, checkpoint inhibitors and cytokine therapies
- Informatics and Statistics: Statistical analysis, cut-points, successful implementation of algorithms and mathematical models
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: