From The Stage

The Evolving Treatment of Lung Cancer: From Combination Chemotherapy to Immune Checkpoint Inhibitors

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

Lung cancer quickly became the most common cancer worldwide in the last decade of the 20th century due to an increase in smoking rates. 1.8 million patients were diagnosed with the disease in 2012, and in the same year 1.6 million patients died from this cancer (1). However, in the last three decades milestones in treating both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) have been met and then improved upon or superseded. The first significant milestone in treating this disease came from combination chemotherapy for…

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…

Considerations to Set ADA Cut Points

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / BioAgilytix Insight, Immunogenicity

Cut points are the threshold values for the distinction of positive and negative results in immunogenicity assays. Establishing appropriate cut points is crucial to ensuring acceptable assay sensitivity, and, although there are assay-specific characteristics to be considered when setting the cut point, some fundamental aspects should be considered when setting cut points in immunogenicity assays. 1. Statistical Methods Cut points should be calculated applying newest statistical tools using samples from treatment-naïve subjects to obtain robust numbers and take the variability of the assays into account. The cut point should be…

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 Future of Bioanalytical Outsourcing: What It Means for Our Industry

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

Today’s pharmaceutical and biotechnology organizations must constantly innovate and evolve to meet novel requirements of developing increasingly effective (but increasingly complex) biotherapeutic innovations. This has spurred the need for new, more efficient approaches to biologics development, and while outsourcing has always played a key role in the bioanalytical field, the way pharma and biotech are using outsourced partners is continuing to change. A recent survey conducted by Bioanalysis Zone of leading pharma, biotech, and CRO organizations reveals some interesting outsourcing trends and gives us a glimpse into the role that…

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…

Novel Gene Therapy Technique Creates a Breakthrough in Sickle Cell Anemia Treatment

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / BioAgilytix Insight, Gene Therapy

Innovations in gene therapy solutions are being made every day, improving treatments and creating cures for many previously untreatable genetic diseases. In fact, According to a recent report on global trends in gene therapy, the number of gene therapy products in development doubled between 2012 and 2015. The exciting news is that, based on a recent study within the scientific community, sickle cell disease may soon be treatable with gene therapy. It is estimated that 50 million people worldwide carry the genetic mutation for sickle cell disease. This debilitating disease…

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…

BioAgilytix: From Solution Provider to Problem Solver

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

As a bioanalytical lab, of course we’re expected to provide our customers with bioanalytical services. However, we work to provide our customer with more than just what they hire us for. We are not just a service provider; we are expert partners and problem solvers, fully committed to each and every one of our customers’ studies. Going the extra mile is how we have been able to build our business to a point where we as a trusted partner to 23 of the top 25 global pharma and biotech companies…