Institute for International Research

Online Documentation Now Available

Dear Colleague,

With Increasing FDA Scrutiny on Immunogenicity, This is a Must-Attend Event!

Welcome to the largest conference dedicated to overcoming immunogenicity study challenges with 30+ new case studies highlighting assay development, validation and data analysis. This is the only US conference to deliver the latest clarification on emerging regulatory guidances and industry white papers.

We Listen and We Understand

We work with scientists like you year-round who are faced with overcoming the day-to-day immunogenicity challenges including: identifying, characterizing and reducing antibody and cell-based responses during development, pre-clinical and clinical studies.

Next Steps

You have identified an immunogenic response, so now what? How do you deal with it? What does it mean? Hear our expert panel discuss strategies for the next steps in assessing the impact of the antibody response.

This 8th Annual event delivers the largest speaking faculty of senior level scientists and white paper authors ready to release new data on how to:

• Take a risk-based approach to evaluate immunogenicity
  
• Use cell based assays for detection of neutralizing antibodies
  
• Identify the technical challenges that have broad impact on immunogenicity testing
  
• Evaluate different technology platforms to determine the best one for your application
  
• Examine the role of pre-existing anti-therapeutic antibodies
  
• Characterize a developing immune response
  
• Predict and monitoring effects of unwanted immunogenicity
  
• Design validated platform that is repeatable, precise and accurate
  
• Troubleshoot calibrator curve of immunogenicity assays
  
• Transfer immunogenicity assays to CROs
  
• Determine assay sensitivity, drug interference, cut point determination challenges on various drug programs
  
• Develop a systematic approach to comply with European and US regulators in early phase assays development

Plus...More Case Study Findings!

• Explore a novel approach for designing and validating an immunodepletion assay to an antibody drug conjugate (ADC)
  
• Compare an illustration of approaches taken to ensure consistent sensitivity and quantitation of a calibrator curve assay using a polyclonal calibrator source, with comparisons made to maintenance of cutpoint/titer assays
  
• Improve management of the inherent variability of polyclonal calibrator sources; maintaining both relative sensitivity and quantitation
  
• Hear the qualification process for confirmatory assays and feedback from the FDA
  
• Discover a novel statistical approach for establishing positivity in immunogenicity confirmatory assays
  
• Validation of a bioassay for neutralizing antibodies that was developed while the interference problems were investigated
  
• Evaluate neutralizing antibodies assays in the context of FDA postmarketing commitments
  
• Troubleshoot immunogenicity assays by measuring parallelism, linearity, and relative potency for bioassays and immunoassay data

You cannot afford to miss this event! For registration information, early registration prices and group discounts, please see page 11.We look forward to welcoming you to the conference on May 8th in San Diego!

Sincerely,

Anne Reel, Program Director,
Immunogenicity and Cell Based
Assays Programs, IIR
areel@iirusa.com

Valerie Bowling
Managing Director,
Pharmaceutical & Biotech Division
IIR

"New information regarding immunogenicity testing"
-Lynne LeSauteur, Scientific Director, CHARLES RIVER LABORATORIES

"To learn what others are doing, and to learn new approaches to dealing with drug in samples"
-Deborah Finco-Kent, Senior Scientist, PFIZER

What did you like best about Immunogenicity for Biotherapeutics 2006?

"Learning what other companies are doing in this field and the sharing of information"
- Cindy Pauley, Senior Research Associate, MERCK and CO.

"Sessions that provide case studies and useful applications--of which most presentations did. This was the best conference yet (with respect to presenting data and case studies)"
-Deborah Finco-Kent, Senior Scientist, PFIZER

"It's a very focused group. Everybody has the same concerns and similar experience, which can be shared among others."
- Xing Li, Senior Scientist, VIRON