Institute for International Research

FDA CONFIRMED!

Hear The FDA Perspective on Pre-Screening Protein Therapeutics at the Pre-Conference Full Day Symposium!

The 2007 Panel Answers are Here! Click here to view.

Dear Colleague,

Regulatory Answers

Are you feeling the pressure from increasing regulatory agencies’ interest in immunogenicity strategies? Hear discussions and follow up from recent regulatory meetings regarding FDA comments on the new EMEA guidelines. Join us for all new data case studies highlighting Statistical Analysis, Assay Development and Validation, White Paper Updates, and Regulatory Considerations.

Overcome Your Assay Development Challenges

Are you struggling with the complex assay development and validation strategies in your immunogenicity studies? Hear from thought leaders in the industry, get your questions answered, and find solutions to your toughest issues.

Now that you know what methods help you identify an immunogenic response – let’s focus on validation of these assays. Hear our expert panel discuss strategies for validation design and controls, cut-points, sensitivity, and more.

The 9th Annual event delivers the largest speaking faculty of senior level scientists and white paper authors ready to release new data on:

• How to allow higher sensitivity, more efficient throughput and better drug tolerance
  
• Solutions to clinical and preclinical drug tolerance issues
  
• Understanding immunogenicity formats: Direct, bridging, acid dissociation
  
• Assay sensitivities and drug tolerance strategies
  
• Current connection of industry with FDA’s expectations
  
• Risk of first-infusion-related Cytokine Release Syndrome (CRS) of biologics
  
• Risk management strategies for immunogenicity
  
• Learn to bridge from ELISA to more sensitive ECL assay format

You must join us for THE Immunogenicity event of the year featuring over 30 new case studies!

We look forward to welcoming you to the conference on May 19th in Tysons Corner!

Courtney Leonard
Conference Producer
Institute for International Research
CLeonard@iirusa.com

Anne Reel
Program Director
Institute for International Research
AReel@iirusa.com