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
April 17th | Noon to 1 PM ET
Rethinking Bioanalysis: Biomarker Assay Validation Strategies
"The approach described in the guidance for industry M10 Bioanalytical Method Validation and Study Sample Analysis for drug assays should be the starting point for validation of biomarker assays..." —FDA, January 2025
The new FDA guidance references M10 as a starting framework, while acknowledging that biomarker assays require unique considerations. Many bioanalytical scientists are seeking clarity on how to implement appropriate validation strategies that align with both scientific principles and regulatory expectations.
Our upcoming webinar, "Rethinking Bioanalysis: Biomarker Assay Validation Strategies" (April 17, 12-1pm EST), will explore the key principles that remain consistent from the 2018 guidance and provide a scientific roadmap for developing appropriate biomarker validation strategies.
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?