Wednesday, July 18, 2012

Bioassays & Bioanalytical Method Development Session Spotlight: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective

Your job – and your customers’ lives – depends on your ability to design safe and non-immunogenic biomolecules. The best way for you to meet regulatory expectations and company deadlines is through expert insight straight from the source. We are pleased to invite you to get your questions answered by one of the FDA’s top bioassay experts.  Today we spotlight the presentation "Bioassays: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective," from Zuben Sauna, PhD, Principal Investigator, Department of Hematology, CBER, FDA.

For more information on Bioassays and Bioanalytical Method Development, download the agenda.  If you'd like to join us in Berkeley, CA this October 1-3, 2012, as a reader of this blog when you register to join us and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective
Presented by: Zuben Sauna, PhD, Principal Investigator, Department of Hematology, CBER, FDA 
About the session: Your drug development pipeline and submission testing procedures depend upon your sound understanding of the underlying risks and causes of immune response, and your ability to engineer biomolecules that are less immunogenic. You must also understand the preferred reporting thresholds and procedures of domestic and international regulatory agencies.
  • • Status of newest regulatory guidelines
  • • Expectations for cell-based NAb test validation
  • • Preferred methods for following up after positive immunogenic results>
  • • Desired drug tolerance levels across multiple phenotypes

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