Immunogenicity and Bioassay Summit

Immunogenicity Prediction & Mitigation
Identification of Risk Factors and Tolerogenic Approaches
Part of the Seventh Annual Immunogenicity and Bioassay Summit
November 18-19, 2015 | Hilton | Baltimore, Maryland

Immunogenicity of biotherapeutics is costing the industry huge amounts as a result of loss of efficacy and potential cross-reactivity. Moreover patients are being denied life-saving treatments when given immunogenic products. Leaders in the field are determining what product characteristics and handling can cause immunogenicity, how to predict immunogenicity and how to work out a risk assessment plan. Other experts are focusing on de-immunization approaches and the induction of tolerance. Over 100 participants, including four presenters from the FDA attended in 2014.

Quote from 2014: “Phenomenal presentations of great advances in multiple fronts. The most exciting meeting pertaining to immunogenicity of biotherapeutics.” 

Who should attend: This conference will bring together individuals from regulatory affairs, bioanalytical development, clinical and non-clinical immunology, PKPD, Pharmacology, toxicology safety and R&D.

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

  • Risk factors that contribute to immunogenicity
  • Tools and approaches for immunogenicity risk prediction
  • Development of mouse models for predictive studies
  • Impact of different routes of administration on immunogenicity
  • Roles of sub-visible particles and aggregates in immunogenicity
  • Impact of impurities on the immune response
  • Deimmunization approaches
  • Progress towards inducing immunological tolerance to biotherapeutics
  • Focus on challenging therapeutic areas such as enzyme replacement therapy, anti-TNF and Factors VII and VIII

Proposed short courses:
Basics of Immunogenicity
Overcoming the Challenges of Immunogenicity Assessment
Immunogenicity Risk Assessment and Regulatory Strategy
Strategic Bioassay Design and Analysis

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

Deadline for submission is May 7, 2015. 

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, please contact:
Nicole Lyscom, Ph.D.
Conference Director
Cambridge Healthtech Institute
Tel: +44 7791 866489

For exhibit & sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5412

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Submit Your Speaker Proposal 

 2014 Brochure Cover 


IMN Podcast iconReducing and Monitoring Bioassay Variability 

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