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Dr. Corinna Fiorotti
Posted by Dr. Corinna Fiorotti BioAgilytix Insight, Industry Update

Key Takeaways from 2018’s AAPS PharmSci 360

Key Takeaways from 2018’s AAPS PharmSci 360

We look forward to AAPS’ annual meeting each fall, as it provides a perfect forum to meet with industry experts and influencers and discuss how we can collectively address the latest challenges in biotherapeutic drug development. This year was no different, and our team had the opportunity to both attend and present at a number of content-rich sessions during the 2018 PharmSci 360 event. These discussions touched on a variety of bioanalytical hot topics, from emerging regulations impacting bioanalysis to the practical implications of new guidance in the laboratory. These conversations will have a direct impact on our own work moving forward, and we wanted to summarize a few of the key takeaways we found most interesting and valuable.

Biomarker Method Validation
As we all know, the regulatory landscape is constantly evolving, especially when it comes to biomarkers. A presentation from John Kadavil of the FDA reminded those of us at PharmSci 360 that the 2018 Bioanalytical Method Validation Guidance for Industry equips us with the means to align biomarker validation practices with agency recommendations. It states that we should be able to address questions such as: “does the method measure the intended analyte?”; “what is the variability and limit(s) associated with these measurements?”; and “are we adhering to the extended requirements around sample management and handling?”

Biomarker validation should establish, through documented evidence, that the biomarker is relevant for its intended use. While there is yet to be clear-cut guidance specific to assay validation in support of clinical biomarker qualification, applying the above agency recommendations to the biomarker validation process can help ensure successful biomarker audits in regulated studies and ultimately streamline regulatory decision-making for approval.

NAb Assay Validation is Needed
The human body’s immune response is multi-faceted and occurs in a cascade. Assays for the detection of neutralizing antibodies (NAbs) are to be included in this cascade when it comes to immunogenicity assessment as they are critical to understanding immune responses to biologics. There are different approaches when it comes to the designing assays for NAb detection, with the use of either cell-based or competitive ligand binding assays considered acceptable. There are pros and cons to each, and format selection should be dependent on factors including the therapeutic mechanism of action (MoA), the evidence of desirable assay performance characteristics, and the risk of immunogenicity.

However, the bigger issue that was raised during PharmSci 360 is that some organizations are still not validating NAb assays at all. No matter what assay approach is used, the same validation parameters (e.g., assay cut-point, sensitivity, selectivity, drug tolerance, assay precision, bench top and freeze/thaw stability, etc.) should be assessed. This reminds us that while the process of validation can be challenging, it is absolutely necessary to ensure reliable data on the biologic’s safety and efficacy.

ELNs and the Capture of Accurate Information
In an effort to help scientists move to digitized record-keeping in the lab, many vendors now offer electronic laboratory notebooks (ELNs). The challenge is that there are a number of different ELN systems currently on the market, and during one session at AAPS, FDA inspectors discussed how they are seeing discrepancies among ELN platforms during inspections, particularly related to accurate capture of information.

This reiterated the fact that successful ELN implementations, particularly those used for regulated bioanalysis, will require careful strategic assessment of platform options and full workflow validation, to ensure your lab can maintain record-keeping accuracy while reaping the full benefits of electronically stored and shared research data.


Events like PharmSci 360 are necessary when working in a constantly evolving industry like bioanalysis. My colleagues and I find great value in participating in discussions that allow us as an industry to stay on the same page about bioanalytical best practices and novel drug development innovations.

If you would like to hear more about BioAgilytix’s perspective on these and other important topics in bioanalysis today, feel free to reach out to me to continue the conversation.

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