Cambridge Healthtech Institute’s 17th Annual

Immunogenicity Assessment & Clinical Relevance

Assay Strategy for Meaningful Evaluation

October 16-17, 2024

This year's Immunogenicity Assessment & 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).
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).
Regulatory Perspectives: Critical feedback from the FDA on new/updated guidance and recent submissions
Route Cause and Characterization of Immunogenicity: Case studies
Assay Development and Validation: Selecting the optimal format for your assay, overcoming technical challenges, data reporting, and cut point calculations. Industry harmonization.
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
Managing Assay/Drug/Target Interference and Drug Tolerance: Strategies to improve drug tolerance and manage interference including double acid association
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: