Rethinking Bioanalysis Discussion Forum

The Rethinking Bioanalysis Discussion Forum is dedicated to providing educational resources and promoting robust scientific dialogue amongst our scientific community. With a quarterly live discussion, 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

January 16th | Noon to 1 PM ET

Rational ≠ Radical: A scientific perspective on immunogenicity risk and assessment

This session will examine how context-of-use principles can transform traditional assessment approaches by reframing immunogenicity as a biomarker. It will offer insights to guide more effective risk evaluation, optimize testing strategies, and simplify the interpretation of results. Drawing from over 20 years of industry experience, the presentation provides practical perspectives on enhancing the established 3-tiered paradigm to focus on clinically meaningful outcomes while potentially reducing regulatory complexity.

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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

Missed one of the live sessions?

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