Scientists from BioAgilytix, myself included, recently attended the 12th WRIB in Philadelphia, PA. Meeting new contacts in the industry and taking part in discussions concerning the most innovative topics in bioanalysis, biomarkers, and immunogenicity was a genuinely valuable and enjoyable experience. Events like WRIB are necessary when working in a constantly evolving industry like bioanalysis, and allow scientists to stay on the same page about bioanalytical best practices and novel drug development innovations. The following are a few of the topics that our team found to be most interesting at WRIB this year:
Cut Points for Anti-drug Antibodies (ADAs)
Cut points are the threshold values for the distinction between positive and negative results in immunogenicity assays. Establishing appropriate cut points is crucial to ensuring acceptable assay sensitivity. At WRIB, there was a lot of discussion on whether cut point guidelines are set so low that the ADA positives are not clinically relevant. This is important to consider when setting cut points in immunogenicity assays, and a push back on sensitivities of these assays from the standpoint of clinical relevance could be seen by some participants.
Neutralizing Antibodies (NAb) for Low-Risk Molecules
When it comes to the development and validation of NAb assays, the type of drug and its mechanism of action (MoA) will help determine the assay format and technical platform for NAb assessment. There were many discussions at WRIB on the use of NAb for low-risk molecules, with presentations of proposed approaches for demonstrating that clinical data drives the NAb requirements.
Hybrid Assay Acceptance Criteria
Bioanalytical methods can be considered valid if specific acceptance criteria set in advance are met for accuracy and precision of the QC samples over the range of the standard curve during the validation study. But what are the acceptance criteria for a hybrid assay? At WRIB, the general consensus is that current ligand binding assay (LBA) guidelines are the right place to start, which tend to be more lenient that LCMS.
Fit-for-Purpose Biomarker Validation
Unsurprisingly, fit-for-purpose biomarker validation was a big topic of discussion at WRIB this year. We discussed which parameters to include in the validation, how to set up the acceptance criteria for each parameter, and the importance of conducting parallelism for biomarker studies. I also saw that an increasing number of scientists have accepted that biomarker assay validation is different than PK assay validation, and it was also evident that more scientists are using the assay’s context of use (COU) to drive the validation plan.
Critical Reagent Characterization
Characterization of critical reagents was another hot topic at WRIB, and scientists continued to ask for additional characterization of critical reagents by vendors. However, it was clear from the discussions I took part in that not everyone has the appropriate resources and budget to perform an extensive characterization of every individual critical reagent in their assays.
After the 12th WRIB, our team is excited to continue innovating in bioanalysis, using what we have learned from our peers during the event. Taking part in such a reputable event with other thought leaders in the industry has motivated us all to continue to produce premium science for our clients and the patients they serve.
If you have any questions about how BioAgilytix handles issues in bioanalysis please feel free to reach out to me personally.