Welcome to the 11th Annual Immunogenicity for Biotherapeutics

Now in its 11th year, Immunogenicity for Biotherapeutics is THE longest running and THE largest event designed by and for the community of scientists driving progress and innovation in immunogenicity studies. The industry’s leading experts and scientists gather annually at the immunogenicity conference to discuss updates on emerging regulatory guidances, industry white papers, and exchange novel case studies and technology dedicated to drive forward the science, as well as, the discovery of solutions to the year’s top immunogenicity challenges.

Are you aware of the new FDA Draft Guidance “Assay Development for Immunogenicity Testing of Therapeutic Proteins”?

In Q4 2009, the FDA released the draft guidance which discusses immunogenicity testing during drug product development and provides recommendations on assay development, clinical aspects of assay validation, assay validation, assay testing implementation, and other aspects of immunogenicity testing. Hear insights regarding this new guidance and have your questions addressed to gain clarity on steps you can take to ensure your compliance with this guidance.

Why the 11th Annual Immunogenicity for Biotherapeutics Event

• Unparalleled analysis of regulatory updates, research study reviews, and white papers directly from the investigators and regulatory agencies
• Technical information delivered in interactive and dynamic formats to improve usability and application when you return to the lab
• Access to the ”founding scientists” of immunogenicity studies and the leading minds of the future

Top 10 Discussions for 2010

• Gain clarity on global regulatory considerations and white paper updates
• Screen, confirm, and characterize neutralizing antibody assays
• Conduct effective bioassays with a special emphasis on consideration of cut-point determination
• Compare accuracy and precision of cut-point methods for non-normal data
• Address assay challenges for a PEGylated biotherapeutic
• Overcome challenges associated with tolerance induction in preclinical and clinical studies
• Access novel methods to overcome drug interference
• Complement factor activation and immune response challenges
• Evaluate the downstream impact of and considerations for data interpretation for assessment of immunogenic potential
• Address technical challenges which have a broad impact on immunogenicity testing