Tuesday, November 15, 2011*

SC1: Technical Advice on Assay Development, Validation and Sample Analysis

8:00 – 9:00 am Registration

9:00 – 12:30 pm Short Course

This interactive session will enable attendees to work out an immunogenicity pre-clinical and clinical testing protocol for their particular therapeutic protein. Recent advances will be presented and areas of difficulty will be addressed. Attendees are encouraged to contribute with their own experiences and to bring questions
for discussion.

The following topics will be covered:

• Immunogenicity concerns for different types of product
• Assay methodologies
• Critical issues in assay validation
• Challenges to anticipate
• Application step to discuss sample analysis and any relevant issues

SC2: Development Of Neutralizing Antibody Assays

12:30 – 1:30 pm Registration

1:30 – 5:00 pm Short Course

Neutralizing antibodies not only affect efficacy of the therapeutic but also pose the danger of cross-reacting antibodies and ensuing adverse reactions. This interactive session is designed to enable attendees to work out how to design, develop and validate their assays for neutralizing antibodies, and to interpret the results. Attendees are encouraged to contribute with their own experiences and to bring questions for discussion.

The following topics will be covered:

• Strategy for design, development and validation
• Challenges to anticipate
• Interpretation of results
• Emerging trends
• Clinical implementation
• Regulatory guidance and guidelines

Instructors for both courses:

Deborah Finco, Ph.D., Immunogenicity Lead, Immunotoxicology COE, Drug Safety R&D, Pfizer, Inc.

Jaya Goyal, Ph.D., Principal Investigator, Translational Medicine, Biogen Idec, Inc.

*Separate Registration Required