Cambridge Healthtech Institute’s 16th Annual

Immunogenicity Prediction & Control

Regulatory Perspectives, Risk Management, and Predictive Tools

October 17-18, 2024

The impact of immunogenicity on patient safety and efficacy, not to mention cost, is well understood. Accordingly, investigators are always 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 2024 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 pre-clinical assays and how can this be proved?
Regulatory Perspectives: Critical feedback from the FDA on new/updated guidance and recent submissions
Recent Advances and Experience with Novel 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). Preclinical immunogenicity risk assessment strategies for new modalities.
Predictive tools and strategies to de-risk candidates
Role of AI/ML to help de-risk candidates and engineer better candidates
Reference Panel: HESI/AAPS Reference Panel for Preclinical Immunogenicity Risk Assessment
Predictive Assays, Studies, and Tools: How can these be improved? Examples include, but not limited to, T cells, MAPPS, and Abirisk
Immune Tolerance: Immunosuppression, tolerance induction, checkpoint inhibitors, and cytokine therapies
Informatics and Statistics: Cut-points, successful implementation of algorithms and mathematical models
Immunogenicity considerations for therapeutic proteins used in patients with COVID

The deadline for priority consideration is April 5, 2024.

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: