Cambridge Healthtech Institute’s 10th Annual

Immunogenicity Prediction & Control  

Strategies for Safe and Efficacious Products in the Clinic

October 24-25, 2018

The impact of immunogenicity on safety and efficacy, and consequent cost to the industry is well understood. Accordingly, investigators are focusing on factors that contribute to immunogenicity as well as a number of different approaches to predict immunogenicity at the drug discovery stage. There are several major problematic areas such as gene therapy products with viral vectors, and Factor VIII for hemophilia, and efforts are being made to suppress immune responses to these products and to introduce tolerizing and deimmunization approaches.

Coverage will include, but is not limited to:

  • Immunogenicity risk assessment from Regulatory Authority and industry perspectives: interpretation of current guidance, risk mitigation plans, challenges to anticipate, practical application
  • Risk factors that contribute to immunogenicity such as aggregates, product-related attributes and process-related impurities: detection and control, synergies and counterbalances, and evidence that they act as adjuvants
  • Current tools and approaches for immunogenicity risk prediction: sequence-based risk and target-based risk, and how risk is assessed and translates to the clinic
  • Experiences with different models for predictive studies: knock-in, knock-out, humanized, partially humanized, etc; how studies with these models do/do not translate to people
  • Measures to control immunogenicity of specific products: gene therapy and vectors, immune-oncology products, enzymes, interferons, pegylated proteins, Factor VIII, etc.
  • Tolerizing regimens and deimmunization approaches: progress towards inducing immunological tolerance to biotherapeutics

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