Many great questions were asked by our audience during Dr. Afshin Safavi’s recent webinar on exploratory biomarker testing. We've compiled his answers those he didn’t have time to address during the live session.
In this Q&A session we talk with Eric Nesbit, Bioanalytical Project Manager/Scientist III at BioAgilytix, to learn more about what led him to leave his hometown of Maine for our headquarters in North Carolina, and why he recruited his sister to join our team as well.
As a member of Bioanalysis Zone’s recent panel discussion, Dr. Corinna Fiorotti evaluated the new ICH M10 guideline draft in terms of its practicality, language, and projected influence. Read her expert insights with accompanying video clips.
Did you know that BioAgilytix’s ‘deep bench’ extends beyond those we have working in the lab? Many individuals in our operational departments, from business development to QC, are also formally trained scientists with extensive in-lab experience. One such team member is Jelle Hempenius, who recently joined BioAgilytix as Business Development Director, Europe.
Biomarkers are endogenous molecules with much individual variability, and there is still not yet one clear and concise guidance for biomarker validation – so there are still questions around what it takes to sufficiently validate the performance characteristics of a biomarker assay to ensure it can properly establish the value of the target biomarker as a qualified DDT.
The recent approval of Zynteglo further builds credibility to the specific and emerging class of cell therapies engineered via “ex vivo” gene therapy. We explain how these cell-based gene therapies work, and how they lend themselves to a host of translatable techniques for future therapeutic candidates.
A contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document,” Dr. Afshin Safavi summarizes considerations outlined in the paper designed to establish consensus on the expectations for the validation of assays used in the regulatory qualification of fluid biomarkers.
The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies - but because IgE are 2000-fold less prevalent than IgG antibodies, a very sensitive detection method is required. We discuss why the ImmunoCAP platform provides an ideal system to analyze IgE-mediated drug hypersensitivities.
What are the advantages of using the Biacore™ T200 SPR System for immunogenicity assessments with a tiered approach? Our experts discuss.
The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive 2017/746) and research use only (RUO) kits are used to support the biomarker analysis needed in clinical trials because both types of assays have different strengths and limitations. To select the appropriate kit requires an understanding of these pros and cons in the context of the intended study the assay must support.
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