4:00 Problem Solving Breakout Sessions
Concurrent Problem Solving Breakouts are interactive sessions hosted by a moderator to discuss a topic in depth. They are open to all attendees, sponsors, exhibitors, and speakers and provide a forum for discussing key issues and meeting potential partners. Please pick a topic of your choice and join in.
TABLE 7: Understanding the Role of Aggregates in Immunogenicity
Moderator: Wim Jiskoot, Ph.D., Professor, Drug Delivery Technology, Leiden University
Moderator: Melody Sauerborn, Ph.D., Utrecht Institute for Pharmaceutical Sciences, Department of Pharmaceutics, Utrecht University
• Why aggregates are immunogenic from a theoretical point of view
• How can we verify the theory
• Risk factors for immunogenicity - beyond aggregates
TABLE 8: Immunogenicity Risks and Prediction Approaches
Moderator: Li Xue, Ph.D., Senior Research Scientist II, Immunogenicity Sciences, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.
• What are the high risk factors that impose immunogenicity response in humans?
• How to deal with high prevalence of pre-existing antibodies seen in clinical studies?
• Approaches to immunogenicity prediction: strategy, assays and interpretation
TABLE 9: Strategies to Address Drug Interference
Moderator: Maria Barbosa, Ph.D., Senior Principal Scientist, Bristol-Myers Squibb
Moderator: Darshana Jani, Ph.D., Scientific Manager, Clinical Science & Technology, Biogen IDEC
• Pre-clinical and clinical immunogenicity assessment of biotherapeutics: drug interference
• Selecting the time for sample collection
• Anti-drug antibody (ADA) assays suitable for the intended purpose
- Choice of assay platform
• ADA assay validation: drug tolerance
• Improving drug tolerance of ADA assays
- Sample pre-treatment
TABLE 10: Pre-Existing Drug-Reactive Antibodies in Human Serum Specific to Afucosylated Therapeutic Antibodies
Moderator: Shan Chung, Ph.D., Scientist, Bioanalytical Technologies and Strategies, Genentech
• Characterization of pre-existing drug-reactive antibodies in humans.
• Overcoming pre-existing drug-reactive antibodies in immunogenicity assays.
• Potential impact of pre-existing drug-reactive antibodies on immunogenicity risk.
TABLE 11: Immunoassays and Risk-based Approaches to Immunogenicity
Moderator: Jack Ragheb, Ph.D., Senior Regulatory Research Officer and Principal Investigator, Division of Therapeutic Proteins, FDA
• What constitutes an appropriate positive control in your immunoassay?
• IgE assays: issues of sensitivity and interference
• Risk based approaches to immunogenicity