From The Stage

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…

BioAgilytix Innovates and Grows in the ‘National Innovation Triangle’

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, CRO Selection

When people hear the word innovation, they most often think of Silicon Valley or the Boston-New York corridor—but as a recent Newsweek Elite Reports article featuring BioAgilytix finds, North Carolina is rising quickly to the forefront of such conversations as the third pillar of the ‘National Innovation Triangle’. In fact, the U.S. Department of Commerce’s Bureau of Economic Analysis found North Carolina to have the nation’s fastest growing economy between Q1 2013 and Q1 2015. Much of this is due to the pharmaceutical and biotech R&D happening in and around…

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…

Toxicology and Agatha Christie: An Arresting Pairing

Peter Brogile
Posted by Peter Brogile / / BioAgilytix Insight

As much as I love my chosen field of toxicology, I don’t often turn to it as a topic for leisure reading. However, A Is for Arsenic: The Poisons of Agatha Christie is a new take on toxicological analysis. Author Kathryn Harkup is both a toxicologist and a fine storyteller. She weaves together the story of Agatha Christie’s life, the horror stories she penned, and the science behind the toxins that killed many in her stories. The book progresses by addressing a different poison used in Agatha Christie novels in…

‘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…

What’s Your System for Cell-Based Assay Method Selection?: Factors in Assessing the Most Advantageous Model for Your Needs

David Rusnak
Posted by David Rusnak / / BioAgilytix Insight, Cell-Based Assays

Cell-based assays are a key component in the creation of new medicine, from early target and drug discovery efforts through clinical trial and manufacturing support. Complex biochemical processes in the body can often be investigated and understood in cell-based model systems, and there is a near limitless variety of cell-based assay platforms that can be developed. Clinical pharmacology studies are a critical part of demonstrating this ‘biosimilarity’, and provide the data for the biosimilarity in drug exposure between the biosimilar and the originator / reference product to confirm no clinically…

Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays

Todd Lester
Posted by Todd Lester / / BioAgilytix Insight, Biosimilars

As per the Food and Drug Administration (FDA) guidance Quality Considerations in Demonstrating Biosimilarity to a Reference Product, a biosimilar is defined as “a biological product that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” Clinical pharmacology studies are a critical part of demonstrating this ‘biosimilarity’, and provide the data for the biosimilarity in drug…

Quality is More Than Good Laboratory Practice (GLP): Perspectives From an Advanced Quality Laboratory

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality

Good Laboratory Practice (GLP). This term is far from new to the world of laboratory science. In fact, the initial development of GLP principles can be traced back to 1978, when the FDA released a set of guidelines intended to create a verifiable testing record in laboratory testing throughout the United States.Since then, GLP has become the industry’s touchstone for reliability and repeatability in the laboratory setting. Many point to GLP adherence as indicative of an advanced commitment to quality. Though related, the two are actually quite different.While an advanced…