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Schedule:

Event Date: Friday, May 17, 2013
Event Time: 8:45-17:00
Event Type: Workshop
Event Name: Immunogenicity and Toxicity of Biologics: Detection, Prediction, and Clinical Impact
Registration fee: Regular: $150; For unemployed: $0; Webcast: $215; Plus course material fees
Location: SF Bay Area: Foster City Crowne Plaza
Registration: http://www.PBSS.org
Further Information:

Registration deadline:

4/30/2013 (it will close sooner if the seating cap is reached)

Speakers:

: Michael Tovey (INSERM), Dan Mytych (Amgen), Becky Schweighardt (BioMarin), Gary Taniguchi (BioMarin), Ago Ahene (XOMA), Kate Peng (Genentech), Jörgen Dahlström (Phadia Diagnostics), Kathleen Meyer-Tamaki (Meyer Nonclinical Consulting)

Workshop Outline:

Biotechnology-derived (biologics) therapeutics including monoclonal antibodies, proteins, peptides, and enzymes have provided patients with targeted and effective medicines for numerous diseases. All therapeutic proteins have the potential to generate immune responses or immunogenicity through the anti-drug antibody (ADA) formation or cell based immune responses. The challenge for industry is to understand the factors contributing to and predicting immunogenicity, to design assays to measure and monitor the immune response, and find improved methods of administering the biologic therapeutics to minimize any negative impact. This workshop will discuss state-of-the-art methods for measuring ADA in nonclinical and clinical studies, the potential impact of ADA, and strategy for minimizing immunogenicity in the clinic. The European initiative ABIRISK (anti-biopharmaceutical immunization: prediction and analysis of clinical relevance to minimize RISK) will also be discussed.

This workshop will cover the following topics:

• Designing bioanalytical assays for detection of anti-drug antibodies and neutralizing antibodies
• Ligand-binding assay design and the impact of anti-drug antibody on the pharmacokinetic profile
• The state-of-the-art of immunogenicity assays
• Impact of pre-existing antibodies on immunogenicity assay development and interpretation
• Strategic approaches towards assessing immunogenicity of protein therapeutics in drug development
• The predictive value of current in silico, in vitro, and in vivo approaches for biopharmaceuticals
• Detection and monitoring of immunogenicity in the clinic
• Clinical impact of immunogenicity
• The impact of ABIRISK on development of biopharmaceuticals