From The Stage

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…

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…

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…

What You Won’t Learn in School: Advice to Early Career Scientists

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight

In the 20+ years of my career—spanning R&D, clinical operations, and manufacturing in both technical and commercial roles for multinational pharmaceutical companies, smaller biotechs, and top bioanalytical CROs—I have acquired a great deal of on-the-job knowledge that I hadn’t learned in school. My goal in this entry is to provide some helpful guidance to young science major graduates just starting their careers: the kind of insight that universities can’t teach you about the vast opportunities that await you, and how to choose a scientific career path that best fits your…

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…