From The Stage

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

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / 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…

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…

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

Krystal J. Alligood
Posted by Krystal J. Alligood / / Biosimilars, Industry Update, Pharmacokinetics

According to research from the Biosimilars Council, $81 billion worth of brand name biologics will lose their patents by 2020. As a result, we are seeing a significant increase in the development of lower cost biosimilar alternatives, as well as more applications for FDA approval of biosimilars for expiring biologic drugs. In fact, this market is expected to grow more than 25-fold over the next five years. But because the structure of a biosimilar is unlikely to be identical to that of the reference product, developers must ensure there are…

Assay Design for Immunogenicity Testing: Cell-Based or Ligand Binding?

David Rusnak
Posted by David Rusnak / / Cell-Based Assays, Immunogenicity

Unlike small molecule drugs, large molecule therapeutics face a high chance of detection by the immune system, and are therefore more apt to trigger alarms. The resulting immune responses can range from largely benign to life threatening – which is why immunogenicity testing has become a critical requirement in the biologics development process. But, the development and implementation of such assays can be technically challenging, and this is causing differing industry opinions around the use of cell-based functional assays vs. non-cell-based competitive ligand binding assays for NAb detection. The Turning…

Immuno-oncology: Advancing Innovative Therapeutic Options for Treating Human Cancers

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / BioAgilytix Insight, Immuno-oncology

The clinical landscape for cancer is currently undergoing an exciting shift. Treatment based around generic chemotherapies may be taking a back seat to a host of new, targeted therapies as scientists and doctors are beginning to leverage patients’ own immune systems to eliminate cancer cells – and finding success. While the treatment of cancer by immunological tools can be tracked back to the early 1900s, recent advancements in assay methods and technologies are finally bringing new levels of immune-based curative cancer treatments, and possibly even the eradication of some cancer…

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, including Corinna Krinos-Fiorotti, a Business Development Manager at BioAgilytix, and myself 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…

What a Year! Looking Back at What’s Driving Us Forward in 2017

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight

2016 has been a very eventful year for BioAgilytix. We have marked a number of milestones that will serve as a strong foundation for continuing our commitment to bioanalytical excellence in 2017. As always, none of this would be possible without the support of our customers, and we are excited by the new and expanded capabilities we can bring to these partnerships as we move forward together toward our shared goals in biotherapeutics innovation. In case you missed some of our key announcements, we’ve compiled our favorite events, content, and…