From The Stage

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / Biosimilars, Industry Update

The US Supreme Court reached a ruling last week that will allow biosimilar companies to launch new biosimilar drugs more quickly. The decision was unanimous that these companies will not need to provide the reference product sponsor with six months’ notice after US Food and Drug Administration (FDA) approval of their intention to launch a generic version of that biological drug. The case was brought to the Supreme Court over the biosimilar drug Zarxio, when the reference product sponsor and competing biosimilar developer disagreed over how language in the Biologics…

Leading the Way in Large Molecule Bioanalysis, Our Way

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

What makes BioAgilytix a different kind of bioanalytical CRO? It’s all in the way we do large molecule bioanalysis, and how we work together with pharmaceutical and biotechnology companies to accelerate development of innovative biotherapeutics that can change and save patients’ lives. As you can see, our approach overcomes the common challenges that customers face when working with traditional CROs. Instead of settling for missed deadlines, little transparency, or hit-or-miss scientific quality, we take a uniquely different stance to help our customers address the most complex aspects of their large…

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both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) have been met and then improved upon or superseded.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…

Key Takeaways from the 11th Workshop on Recent Issues in Bioanalysis

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / BioAgilytix Insight, Industry Update

Scientists from BioAgilytix, myself included, recently attended the 11th WRIB in Los Angeles, CA. I thoroughly enjoyed meeting so many new contacts and taking part in presentations and discussions concerning the most innovative topics in bioanalysis, biomarkers, and immunogenicity. Throughout the workshop it became very clear to me that gatherings like WRIB are vital in staying on the same page about bioanalytical best practices. I was able to learn from my peers and update myself on the latest regulatory guidance, evolving and new methods for large molecule studies, and much…

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 Evolving 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, 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…