Cambridge Healthtech Institute’s 11th Annual

Immunogenicity Assessment & Clinical Relevance  

Assay Strategy for Meaningful Evaluation

October 16-17, 2019

 

The industry continues to be challenged by the development, application and interpretation of immunogenicity assays. The FDA has advocated a more stringent approach for cut point 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:

 

  • Clinical Relevance of ADA, NAb and PK Assays: Cost of developing assays and new techniques, collecting good data, detecting ADA and the FDA perspective
  • 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
  • Regulatory Perspectives: Critical feedback from the FDA on new/updated guidance and recent submissions
  • Recent Advances with Novel Modalities: Including but not limited to gene therapy, CAR-T therapy and peptides

 

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

 

The deadline for priority consideration is Friday, April 5.

 

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:
Gemma Smith

Senior Conference Director

Cambridge Healthtech Institute

Phone: (+44) 7754-518-131
Email: gsmith@cambridgeinnovationinstitute.com

 

For partnering and sponsorship information, please contact:

Carolyn Cooke

Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com