Cambridge Healthtech Institute’s 10th Annual

Immunogenicity Assessment & Clinical Relevance  

Assay Strategy for Meaningful Evaluation

October 23-24, 2018

The industry continues to be challenged by the development, application and interpretation of immunogenicity assays. Recently the FDA have advocated a more stringent approach for cutpoint setting and assay validation creating further difficulties. Moreover, the industry remains uncertain about when the more challenging neutralizing antibody assays should be applied, and which type of assay is reliable and acceptable. Additional ongoing challenges concern managing drug and target interference, understanding and handling the impact of pre-existing antibodies, and interpreting the clinical significance of assay data. 

Coverage will include, but is not limited to:

  • Challenges encountered and overcome with immunogenicity assessment of specific products and specific therapeutic areas; e.g., immuno-oncology products; gene therapies, enzyme replacements, ADCs, non-MAbs ranging from large proteins to small peptides, interferons, pegylated proteins, etc
  • Case studies on assay development: managing assay issues such as the positive control; unusual observations
  • Critical issues with cutpoints and ADA assay validation; experiences with application of FDA guidelines, managing complications and challenges, and interpretation of data
  • NAbs: Strategies to determine assay format; cell-based NAb assays and comparisons with ligand-binding assays; implementation of automation and DoE
  • Clinical immunogenicity: immunogenicity challenges; interpretation of the data and determination of the relevance; relation to clinical PK, safety and efficacy, and working with physicians
  • Managing and understanding pre-existing positive ADA activity
  • Experiences with managing drug and target interference: challenges facing the industry with drug tolerance and examples of how this is overcome
  • Experiences with meeting regulatory expectations: challenges encountered in translating the current guidances on immunogenicity testing
  • Late stage clinical and post-marketing strategies
  • CRO perspectives: dealing with the many approaches to ADA and NAB testing; ensuring validations meet client/agency expectations

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for priority consideration is April 13, 2018.

All proposals are subject to review by session chairmen and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute 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.

For more details on the conference, please contact:
Nicole Lyscom, PhD
Senior Conference Director
Cambridge Healthtech Institute
Phone: +44 7791 866489

For partnering and sponsorship information, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412