Following year-on-year success, CHI presents the Sixth Annual Immunogenicity and Bioassay Summit 2014: 3 conferences, 8 FDA presenters plus 40+ additional presentations, 15+ interactive breakout round table and panel discussions, 4 short courses, exhibit/poster hall, and networking opportunities. Immunogenicity Prediction & Mitigation is designed to help investigators design and select non-immunogenic products for early-stage decision making, while Immunogenicity Assessment & Clinical Relevance and Optimizing Bioassays for Biologics will enable investigators to overcome the complexities of bioassays and immunoassays and develop programs that ensure their products are safe and efficacious, and satisfy regulatory requirements. Browse through this website to view the final agenda. Register today to attend the Number 1 Immunogenicity and Bioassay Event bringing together industry, academia and regulatory authorities.
What’s NEW for 2014?
- More on immunogenicity challenges in clinical development;
pre-existing reactivity, target interference, Fc-Fc interactions,
drug interference, impact of higher order complexes, characterization of ADAs, assay validation and cut points
- Focus on specific products: interferon beta, enzyme replacement therapy, Knob-and-Hole therapeutics, ADCs, Factor VIII, immunotoxins, hemophilia products, Adnectins
- Choice of 14+ new interactive breakouts for in-depth discussion
- More focus on the impact of sub-visible particles, aggregates and impurities
- New angle on impact of route of administration
- Increased coverage and case studies and feedback from health authorities
- Presentations on working with molecules with multiple mechanisms such as ADCs, bispecifics, and fragments
- and much more!
- SC1: Basics of Immunogenicity Testing
- SC2: Challenges of Immunogenicity Assessment
- SC3: Immunogenicity Risk Assessment & Regulatory Strategy
- SC4: Strategic Assay Design and Analysis