Cambridge Healthtech Institute’s 15th Annual

Immunogenicity Assessment & Clinical Relevance

Assay Strategy for Meaningful Evaluation

October 3-4, 2023


This year's Immunogenicity & Bioassay Summit brings the FDA together with leading industry and academic experts to discuss the development, application, and validation of immunogenicity assays. Learn how to manage drug and target interference and tolerance, understand the impact of preexisting antibodies, and interpret the clinical significance of assay data. Novel modalities including cell and gene therapies are posing new challenges to the industry, all of which will be discussed in-depth at this meeting.


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), peptides, bispecifics, trispecifics, 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
    • 2022 FDA Guidance on Immunogenicity in Drug Product Labeling
      • Assay Development and Validation: Selecting the optimal format for your assay, overcoming technical challenges, data reporting, and cut point calculations
      • 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
      • Immunogenicity assessment and clinical considerations for COVID therapeutics and COVID vaccines


      The deadline for priority consideration is April 3, 2023.


      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:



      For more details on the conference, contact:

      Gemma Smith

      Senior Conference Director

      Cambridge Healthtech Institute

      Phone: (+44) 7866-506-196



      For sponsorship and exhibit information, contact:

      Aimee Croke

      Business Development Manager

      Cambridge Healthtech Institute

      Phone: (+1) 617-292-0777



      For media and association partnerships, contact:
      James Prudhomme
      Senior Marketing Manager
      Cambridge Healthtech Institute
      Phone: (+1) 781-972-5486

      Register Early for Maximum Savings