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
June 26th | Noon to 1 PM ET
Implementing a Risk-Based Immunogenicity Strategy to Accelerate ASO Drug Development
Our understanding of immunogenicity risk of anti-sense oligonucleotide (ASO) therapeutics has evolved with over a decade of clinical experience, and we have adopted a risk-based approach to guide our ADA testing strategy. Despite this many in the industry are still deploying immunogenicity assessments typically devised for protein biologics using the 2019 FDA immunogenicity guidance as the basis for their approach. However, ASO therapeutics have been demonstrated to be far less immunogenic compared to protein-based modalities and are often delivered directly to relatively immune privileged sites, like the CNS. Often there is no clear scientific rational to support intensive monitoring of immunogenicity that has no expected clinical impact on safety or efficacy.
Dr. Chris Stebbins, Scientific Director of Translational Sciences, will present case studies of comprehensive immunogenicity risk assessments conducted for ASO therapeutics and determine the value of ADA monitoring in each case. In addition, we will present collective evidence of approved ASO therapeutics that demonstrate the lack of clinically relevant immunogenicity reported in this emerging and growing therapeutic modality.
We will discuss how applying a science-first approach to immunogenicity evaluation can yield the critical information necessary to support product approval and avoid unnecessary and often confounding immunogenicity analyses that can derail development teams.
Our upcoming webinar, "Implementing a Risk-Based Immunogenicity Strategy to Accelerate ASO Drug Development" (June 26th, 12-1 pm EST), will explore strategies for assessing immunogenicity risk in anti-sense oligonucleotide (ASO) therapeutics.
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?