Immunogenicity Summit

Cambridge Healthtech Institute’s 6th Annual
Immunogenicity Prediction & Mitigation
Risk factors, predictive tools, deimmunization and tolerance induction
Part of the Sixth Annual Immunogenicity and Bioassay Summit
November 18-19, 2014 | Hyatt Regency Bethesda | Bethesda, Maryland

The Holy Grail for the biotherapeutics industry is for the production of products with absent or reduced immunogenicity.  In this track we examine factors that may impact on immunogenicity, particularly aggregates and sub-visible particles, report on innovative tools used by the experts to predict immunogenicity, and examine novel approaches for deimmunization and tolerance induction. Immunogenicity Prediction & Mitigation is particularly important at the early stages of development for informed decision-making on candidate selection, dosing and formulation.

I am looking for case studies and practical experience of the following: 

Risk Factors that Contribute to Immunogenicity  

  • Relationship between product characteristics and immunogenicity
  • Impact of production, purification, formulation, dosing and storage on immunogenicity
  • The role of T cell epitopes
  • Impact of the route and frequency of administration
  • Roles of component peptides in immunogenicity
  • Genotyping as a method for immunogenicity risk assessment

Sub-Visible Particles, Aggregates and Immunogenicity  

  • Analytical tools to assess and characterize sub-visible particles
  • Impact of sub-visible particles and aggregates on immunogenicity, safety and efficacy
  • Factors contributing to aggregation
  • Risk assessments and risk mitigation plans based on propensity to aggregate 

Current Tools and Approaches for Immunogenicity Risk Prediction 

  • Experiences with implementation of new tools for use in early development 
  • In silico, in vitro and in vivo tools for immunogenicity associated risk
  • Design and utilization of epitope-based databases
  • Novel approaches
  • Prediction using animal models / transgenic immune tolerant mice

Focus on Controlling Immunogenicity for Specific Products such as Interferon Beta 

  • Measures to design drugs with reduced immunogenicity

Tolerance Mechanisms 

  • Antibody engineering to reduce the impact of immunogenicity
  • Methods for immune tolerance induction
  • Methods for identification and removal of T cell epitopes and evidence for its impact on reducing immunogenicity
  • Deimmunization approaches
  • Novel approaches

Additional Tracks 

  • Immunogenicity Assessment & Clinical Relevance
  • Bioassays

Proposed Short Courses: 

  • Basics of Immunogenicity
  • Overcoming the Challenges of Immunogenicity Assessment
  • Immunogenicity Risk Assessment and Regulatory Strategy

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

Deadline for submission is May 2, 2014 

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program.  Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships. 

For more details on the conference, contact:
Nicole Lyscom, Ph.D.
Conference Director
Cambridge Healthtech Institute (CHI)
Tel: +44 7791 866489
Email: nlyscom@healthtech.com 

For details on sponsorship and exhibit opportunities, contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute (CHI)
Tel: 781-972-5412
Email: cbenton@healthtech.com 

For details on media and association partnerships, contact:
James Prudhomme
Senior Marketing Manager
Cambridge Healthtech Institute (CHI)
Tel: 781-972-5486
Email: jprudhomme@healthtech.com 

2013 Brochure Cover

Download Brochure 


Podcast 

IMN Podcast iconReducing and Monitoring Bioassay Variability 

2013 Speaker: Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefenseDivision, Emergent BioSolutions