Immunologix Scientific Discussion Forum

The ILX Scientific Discussion Forum is dedicated to providing educational resources and promoting robust scientific dialogue amongst our scientific community. Together, we drive science forward by sharing ideas and challenging ourselves to regularly rethink current practices and approaches and update them in response to emergent data to improve the course of drug development.

Rethinking Bioanalysis: A Scientific Discussion Forum Series

The Rethinking Bioanalysis Series provides an interactive forum for industry professionals to discuss hot topics in bioanalytical and biomarker analysis with our expert Translational Sciences team. Through this series of webinars, our scientists will provide historical perspective on the origins of current practices and paradigms, highlight key challenges and lessons learned, and provide a first principles reframing of the topic, with the goal of building scientific frameworks that can accommodate the needs of the ever changing landscape of 21st century modalities. Each session will begin with a short presentation that frames the content for discussion, followed by a guided discussion that allows for active audience participation and Q&A.

Upcoming Events/Topics

May 30, 2024 | Time TBD

The first installment of our Rethinking Bioanalysis series, entitled “Immunogenicity assays are biomarker assays: Does the current paradigm serve your context of use?” will provide context on the origins of the current 3-tiered paradigm, demonstrate how immunogenicity is a biomarker and highlight how adopting a biomarker assay approach for anti-drug antibody assays can mitigate many of the technical and data interpretation challenges encountered with the current paradigm.

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Future Discussion Topics

  • Immunogenicity assays are biomarker assays - creating clarity from confusion
  • The importance of bioanalytical strategies and how to effectively communicate them to regulators
  • Neutralizing antibody assays are biomarker assays - why cell-based and competitive ligand binding assays are not your only options
  • Defining immunogenicity risk - start with impact, not incidence
  • Immunogenicity risk assessment for ASOs
  • Surrogate matrix - when it’s not only acceptable, but the better option
  • The real-world costs of unnecessary neutralizing antibody assessments
  • Case study: Success story of an approved biologic without need for a Nab assay
  • The Type D meeting: When and how to leverage it for your drug program