Cambridge Healthtech Institute ’s 11th Annual

Immunogenicity Prediction & Control

Regulatory Perspectives, Risk Factors, and Management

October 17-18, 2019

 

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:

 

  • Translation into the Clinic: How can the data generated be used in the clinic? What is the true value of the pre-clinical assays and how can this be proved?
  • Risk Assessment: Overcoming issues with impurities and aggregation, what does the FDA want to see?
  • Predictive Assays, Studies and Tools: How can these be improved? Examples include but not limited to T cells, MAPPS and Abirisk
  • Immune Tolerance: Immunosuppression, tolerance induction, check point inhibitors and cytokine therapies
  • Regulatory Perspectives: Critical feedback from the FDA on new/updated guidance and recent submissions
  • Informatics and Statistics: Sucessful implementation of algorithms and mathematical models  
  • 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