From The Stage

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

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

There is a lot of confusion in the world of biomarker testing when it comes to the terms “assay qualification” and “assay validation”. These two terms are not strictly defined and are even used interchangeably at times. This confusion stems from the diverse scientific backgrounds and disciplines of those of us working in the biomarker field. Scientists from a manufacturing setting, clinical setting, or research setting have a somewhat different understanding of these two terms. Conversely, there is a clear distinction between “qualification” and “validation” for those working in analytical…

Modern Challenges of Single and Multiplex Biomarker Validation

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

Biomarker validation can be confusing. We constantly hear about qualification versus validation, fit-for-purpose validation, and context of use. Due to the ‘grey area’ nature of biomarker work, many companies interpret these concepts and approaches differently. As scientists working on biomarker projects, we have to deal with a lot of variability between reagent and kit lots, high or low biomarker endogenous levels, and how to precisely assess antibody specificity in commercial kits, among other things. In a perfect world, we would have decisive guidance on how to manage all of these…

Novel Circulating Biomarkers and Pathways May Help Predict Type 2 Diabetes More Efficiently

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

In 2015, 29 million people in the United States had type 2 diabetes, according to the American Diabetes Association. Type 2 diabetes is generally a result of a decline in beta cell function, however this indicator is rarely measured because of flaws in the current method of assessment that can lead to inaccurate results. As such, definitively diagnosing this disease is difficult. Early intervention in those at risk for type 2 diabetes is crucial to the patient’s overall outlook for recovery or for successful disease management. Diagnosis of this disease…

Outsourcing Clinical Biomarkers: Challenges and Opportunities

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Biomarkers

Outsourcing complex bioanalysis has not always been a common course of action for pharmaceutical research and development divisions. In the past, companies generally only outsourced more routine projects, often for cost cutting reasons. But today organizations have begun to view outsourcing of more complicated assays in a different light, as a way to not only cut costs, but to take advantage of specialized expertise that drives efficiency in drug development processes, and frees up internal R&D functions to focus on the company’s core competencies. Clinical biomarkers have come into focus…

The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 3: Ensuring the Right-Fit Kit

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

If you’ve been following the other posts in this series, you know that the use of commercial biomarker assay kits is on the rise as a lower cost, less resource-intensive option to support drug development programs. But commercially available immunoassay kits are created for a larger market, so even when procured from the optimal vendor, it is unlikely that a kit in its purchased state will be a perfect fit for the needs of your study. That being said, it is still important to be critical and thorough during kit…

The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 2: 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…

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…