Cambridge Healthtech Institute’s 17th Annual
Immunogenicity Assessment & Clinical Relevance
Assay Strategy for Meaningful Evaluation
October 8-9, 2025
This year's Immunogenicity Assessment and Clinical Relevance conference brings the FDA together with leading industry and academic experts to discuss the development, application, and validation of immunogenicity assays to support clinical development. Learn how to manage drug and target interference and tolerance, understand the impact of pre-existing antibodies, and interpret the clinical significance of assay data. As well as traditional biologics, the meeting will also address novel modalities such as cell and gene therapies, RNA therapies, bispecifics, T cell engagers, multispecifics, fusion proteins, peptides, and antibody-drug conjugates (ADCs).
Coverage will include, but is not limited to:
- Clinical Relevance of ADA: Cost of developing assays and new techniques, collecting good data, detecting ADA, the FDA perspective and the physician’s perspective (impact of ADA on patients and how to mitigate)
- Regulatory Perspectives: Critical feedback from the FDA on new/updated guidance and recent submissions
- Update on Key Industry Initiatives: Reference materials, recommendations for method development and validation of qPCR and dPCR assays in support of cell and gene therapy drug development
- Route Cause and Characterization of Immunogenicity: Case studies
- Advantages and Implementation of AI and ML: Case studies
- Recent Advances with Novel Modalities: Including but not limited to cell therapy (e.g., CAR T and edited stem cell), gene therapy (e.g., AAV vectors, re-dosing, companion diagnostics), gene-edited therapies, peptides, bispecifics, multispecifics, biosimilars, immunotherapies, ADCs and oligonucleotides (e.g, mRNA, microRNA, siRNA, ASOs)
- Assay Development and Validation: Selecting the optimal format for your assay, overcoming technical challenges, data reporting, cut point calculations and industry harmonization
- Managing Assay/Drug/Target Interference and Drug Tolerance: Strategies to improve drug tolerance and manage interference including double acid association
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: