Pre-Conference Short Courses - Immunogenicity Summit

 

Pre-Conference Short Courses*

MONDAY, OCTOBER 18


Instructors for both courses:

Lakshmi Amaravardi, Ph.D., Director, Pre-Clinical & Clinical Development, Biogen Idec, Inc.

Arno Kromminga, Ph.D., CEO, Immunology, IPM BIOTECH

Shobha Purushothama, Ph.D., Scientist, Bioanalytical R&D, Pfizer, Inc.

 

SC 1: 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:

  • Immunology behind immunogenicity
  • 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

 

SC 2: DEVELOPMENT OF CELL-BASED NEUTRALIZING ANTIBODY ASSAYS

12:30 – 1:30 pm Registration

1:30 – 5:00 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 of neutralizing antibody assays
  • Challenges to anticipate
  • Interpretation of results
  • Emerging trends in the development of neutralizing antibody assays
  • Clinical implementation of established neutralizing antibody assays
  • Regulatory guidance and guidelines

*Separate Registration Required



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