Immunogenicity Summit
Immunogenicity and Bioassay Summit

Cambridge Healthtech Institute’s Eighth Annual
Immunogenicity Assessment & Clinical Relevance
Regulatory Perspectives, Assay Development, Neutralizing Antibody Assays, and Case Studies

   October 26-27, 2016 | Hyatt Regency Baltimore | Baltimore, Maryland 
Part of CHI's Immunogenicity and Bioassay Summit 2016

Immunogenicity risk assessment is of the utmost importance to the biopharmaceutical industry to ensure safety and efficacy of the product and to prevent product failure during clinical development. Although regulatory guidance and white papers exist, there remains uncertainty regarding the details. Investigators are unsure about which assays to carry out, how to determine cutpoints and validate the assays, and how to overcome the considerable challenges such as target interference and drug interference which need to be understood and correctly handled. Moreover pre-existing antibody clouds the interpretation. This conference will present case studies from leaders in the field on their strategies and experiences.

CHI's Immunogenicity Assessment & Clinical Relevance conference is important for all those investigating biotherapeutics and novel products (innovators and biosimilars) especially those working on enzymes, Interferons, bispecifics, ADCs, pegylated proteins and/or immunotherapies.

Who should attend: This conference on Immunogenicity Assessment & Clinical Relevance 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 proposals on the following topics:

  • Current regulatory perspectives on immunogenicity assessment: pre-clinical risk assessment and risk mitigation plans; interpretation of current guidance; recommended types of assay.
  • Regulatory perspectives on setting up a clinical immunogenicity study for a biosimilar: data required and challenges to anticipate.
  • Case studies on assay development: experiences with managing the positive control; critical issues in ADA assay validation.
  • Experiences with neutralizing antibody assays: cell-based neutralizing antibody assays and comparisons with ligand-binding assays.
  • Managing drug tolerance: challenges facing the industry with drug tolerance and examples of how this is overcome.
  • Immunogenicity assessment of specific products: e.g. bispecifics, ADCs, enzymes, interferons, pegylated proteins, immunotherapies, etc.
  • Case studies on clinical immunogenicity and relation to clinical PK, safety and efficacy
  • Correlations between predictive immunogenicity and the clinical outcom
  • Dealing with pre-existing positive ADA activity in study patients
  • Experiences with anti-drug antibody immune complexes

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 April 6, 2016 

 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.
Senior Conference Director
Cambridge Healthtech Institute
Tel: +44 7791 866489

For exhibit and sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 1 781-972-5412

For media and association partnerships, please contact:
James Prudhomme
Senior Marketing Manager
Cambridge Healthtech Institute
Tel: 781-972-5472

Register Today!

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