From The Stage

The Challenges of Standardizing Commercial Kits for Biomarker Quantification: Work Planning and Vendor Selection

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

As we mentioned in Part 1 of our series, there are some pitfalls that need to be avoided when using a commercially available immunoassay kit for biomarker quantification. Many of these can be overcome in the earliest phases of kit selection and validation, if you have the right biomarker work plan in place from the start. We all know the saying “it all starts with a plan”, and novel biomarker assay development is no different. The objective of a biomarker work plan is to define the intended use of the…

The Challenges of Standardizing Commercial Kits for Biomarker Quantification in Drug Development: Part 1

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Commercial immunoassay kits are an increasingly popular solution for pharmaceutical and biotechnology companies to expedite the drug development process during the discovery, preclinical and clinical study phases, and to rein in growing drug development costs in their organization. However, issues can arise when working with commercial immunoassay kits, because the way in which kit manufacturing companies characterize, describe, and market their kits is not standardized, and this can sometimes negatively impact the quality of the data produced. I believe that as an industry, we need to move towards a more…

I Saw the Future and the Future is Biomarkers

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers, Industry Update

The field of bioanalytical biomarkers is constantly evolving and innovating; it’s an undertaking to keep up with its constant growth. As bioanalytical scientists we encounter challenges inherent in working with a scientific field that is still incomplete. The questions we ask ourselves on a daily basis are vital to developing a more robust understanding of how to continue to rapidly expand our knowledge of biomarkers as we move into the future. Challenges in Working with Biomarkers We all know biomarkers can prove vitally important in many areas of science and…

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

In 2016, 5.4 million Americans were living with Alzheimer’s disease (AD), and a large majority of those people are over the age of 65. AD can often be difficult to distinguish from other types of dementia, which makes it hard for physicians to diagnose confidently even though it is is the most common type of dementia, accounting for 50-70 percent of total patients. The predicated rise in AD occurrence, in correlation with the rapidly aging population in the United States, is forcing the scientific and medical communities to take a…

Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Industry Update

The whitepaper based on discussions at the 10th Workshop on Recent Issues in Bioanalysis (WRIB) has been published! Everyone who participated, are very excited to share the knowledge of industry leaders and regulators that was aggregated during the weeklong event. This year’s WRIB was quite a successful event. Close to 700 industry leaders from biopharmaceutical and biotechnology companies, CROs, and regulatory agencies gathered in Orlando, Florida to share, review, and discuss topics in bioanalysis related to PK, biomarkers, and immunogenicity. WRIB is a unique gathering because it is specifically designed…

Crystal City VI Workshop Report: A Positive Step in Furthering the Dialogue on Biomarker Assay Challenges

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Yes, it is true! The workshop report from AAPS Crystal City VI is finally here. I know those of us that participated in the 2015 workshop—in which we focused for two days on how to deal with ligand binding assay (LBA) and LCMS biomarker validation and sample analysis—have been wondering what the outcome was of that 2-day discussion. We certainly heard very different views and practices between the presenters on day one versus those on day two about who is right and who is wrong: the clinical chemistry folks, the…

Biomarker Development: Clearing the Way for Faster Biomarker Innovation

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers, Uncategorized

This spring, BioAgilytix attended The Biomarker Conference in San Diego along with other biomarker experts to discuss best practices for an industry that is still maturing in areas such as discovery, development, clinical application, and regulatory approval. A range of topics were covered, from identifying accurate biomarkers to developing standard protocols. The event ended with an exciting takeaway: while there are still many complexities involved in bringing new biomarkers to the clinic, substantial progress is already being made to create clearer paths for overcoming biomarker development challenges. Presenters at the…

The Importance of Parallelism in Biomarker Assay Development

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Parallelism is a vitally important factor in clinical trial biomarker studies, but is still regularly overlooked in the industry. There are two definitions that I feel summarize parallelism best: Miller et. al describes it as “a condition in which dilution of test samples does not result in biased measurements of the analyte concentration”; whereas Lauren Stevenson and Shobha Purushothama define it as “a demonstration that the sample dilution response curve is parallel to the standard concentration response curve”. Essentially it means that when a test sample is serially diluted to…

‘It’s All Relative’: The Concept of Accuracy in Biomarker Analysis

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Ligand-binding assays (LBAs) measure an analyte concentration via immunoreactivity of antibody, or binding partner, to the analyte of interest. When dealing with PK assays, reference materials are well-characterized because they are typically available in pure form and simple buffers. But in the world of biomarker LBAs, the calibrators are typically recombinant materials and therefore most often not identical to the endogenous form in the biological matrix being measured. In addition, most often it is hard to find a “clean matrix” to perform spike-recovery studies, and to confirm that the assay…

Overcoming the Challenges of Critical Reagent and Kit Lot-to-Lot Variability in Support of Clinical Trial Biomarker Studies

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Critical reagents are essential components of ligand binding assays (LBA), and include many reagent categories including antibodies, engineered proteins, conjugated proteins, chemically synthesized molecules, complex biologics, and solid-supported reagents. Their unique characteristics are crucial to assay performance, and as such, they require thorough characterization and documentation. Additionally, generation and/or the purchase of critical reagents is a large investment, so setting up proper ways to manage them is extremely important to maintaining the integrity of your assays for years to come. The most important benefit of a critical reagent management system…