From The Stage

The Scientific Topics that Shaped Our 2017

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, Industry Update

Throughout 2017, BioAgilytix scientists continued to establish themselves as thought leaders in the industry through the publication of blogs and industry articles, covering topics from biomarkers and immunogenicity to investing in bioanalytical technology. We thank you for engaging with our posts this year, and we look forward to sharing more about our rapidly changing industry with you in 2018. Take a look back at some of 2017’s hot topics in bioanalysis through some of our favorite content pieces: 1. Immuno-oncology: Advancing Innovative Therapeutic Options for Treating Human Cancers Learn more…

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…

Managing Diverse Bioanalytical Talent in an Evolving Industry

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Industry Update

Great people are the foundation of any successful company, and particularly when it comes to bioanalysis. Laboratories critically need the right blend of talent—including not just scientists, but also quality personnel, project leaders, etc.— to produce high quality bioanalytical results for their clients. But our ever-evolving field, combined with the realities of today’s job market and increasingly discerning preferences of job seekers and employees, can make talent management a challenge. So what practices are leading CROs using to attract, retain, and enrich talent today? Recruiting the best new people, while…

A Dose of Pharma and Biotech News: August 9, 2017

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

In order to keep up with the speed of innovation in our industry, scientists at BioAgilytix are committed to keeping on the pulse of bioanalytical innovation in the pharmaceutical and biotechnology industries. We do this to keep our services innovative and to best serve our customers’ evolving large molecule needs. Here are some of the headlines we’ve been most interested in recently: Altering Genes to Beat Leukemia The New York Times, July 12, 2017 A Food and Drug Administration panel recommended that the FDA approve a treatment that genetically modifies…

Preparing for the Implications of “Brexit” in the Pharmaceutical Industry

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Industry Update

In 2016, citizens of the United Kingdom (UK) voted in a referendum to leave the European Union (EU) by a slim margin. This departure, dubbed “Brexit” by the media, will have widespread implications for organizations that do business in the UK, especially those in highly regulated and technical industries. While all EU primary and secondary law will continue to apply to the UK until March 2019, when the withdrawal is planned for completion, pharmaceutical and biotechnology organizations must begin to prepare now for the changes that will occur. To help…

A Dose of Pharma and Biotech News: June 28, 2017

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Industry Update

BioAgilytix’s team is committed to keeping on the pulse of bioanalytical innovation in the pharmaceutical and biotechnology industries, and sharing these insights with you, our valued colleagues and customers. Here are some of the headlines we’ve been most interested in recently: Blood Biomarker Signals Huntington’s Disease Bioanalysis Zone, June 7, 2017 Researchers from University College London (UK) recently published a study report on their search for a Huntington’s disease biomarker (HD), which found that amplified levels of neurofilament light chain circulating in the blood were present in both HD patients…

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

Todd Lester
Posted by Todd Lester / / 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…

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…

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…

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…