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.
Coverage will include, but is not limited to:
- 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?
- Regulatory 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
- Risk Assessment: Overcoming issues with impurities and aggregation—what do the FDA want to see?
- Reference Panel: HESI/AAPS reference panel for preclinical immunogenicity risk assessment
- Predictive Assays, Studies and Tools: How can these be improved? Examples include but are not limited to T cells, MAPPS and Abirisk
- Recent Advances with Novel 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, bispecifics, T cell engagers, multispecifics, biosimilars, immunotherapies, antibody-drug-conjugates, conjugates, and oligonucleotides (e.g., mRNA, microRNA, siRNA, ASOs)
- Immune Tolerance: Immunosuppression, tolerance induction, check point inhibitors and cytokine therapies
- Informatics and Statistics: Cut-points, successful implementation of algorithms and mathematical models
The deadline for priority consideration is March 28, 2025.
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: