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…
When it comes to analyzing large numbers of samples, it is a common misconception that the quality of instrumentation and facility are enough to ensure accurate, consistent results. This may be true for analysis of small molecule drugs, which have simple, stable, well-defined structures and little ability to initiate immune responses. However, the characteristics of large molecule drugs are very different, with numerous intricacies that can impact bioanalytical results. Consider the disparity in levels of complexity alone: aspirin, a typical small molecule drug, has 21 atoms; whereas a large molecule…
Because of the inherent complexities of large molecule bioanalysis, open communication throughout every study is vital to success. Ideally, there should be a constant stream of information flowing between the customer and the lab conducting their research, in order to proactively identify pitfalls, address potential challenges, and overcome issues before they cause project delays or compromised results. However, sponsors today still lack confidence in traditional CROs’ ability to communicate actively and cooperatively, as evidenced by the 2015 Contract Pharma survey where 46% of respondents cited poor communication as the biggest…
A 2015 survey from ISR Reports found that among the top metrics evaluated by sponsors when selecting a bioanalytical lab partner were turnaround time and on-time data and report delivery. This is logical in today’s fast-paced world of pharma and biotech innovation, where missed deadlines and timeline creep can not only compromise a competitive advantage, but delay the release of life-saving biologics to the market. And while a 2016 NiceInsight survey found that 50% of sponsor respondents said they would actually switch CROs based on lack of on-time delivery, the…
When pharma and biotech organizations look to work with a CRO or bioanalytical lab, quality is always among the top priorities. In fact, a recent Nice Insight survey on outsourcing trends in 2016 found that 70% of respondents agreed that quality is the most important driver when selecting a CRO to partner with. But quality is not a single checkbox on the list of factors for CRO selection; rather, it is the collection of all attributes and capabilities that the CRO brings to the table, which enable quality to permeate…
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…
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…
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…
When people hear the word innovation, they most often think of Silicon Valley or the Boston-New York corridor—but as a recent Newsweek Elite Reports article featuring BioAgilytix finds, North Carolina is rising quickly to the forefront of such conversations as the third pillar of the ‘National Innovation Triangle’. In fact, the U.S. Department of Commerce’s Bureau of Economic Analysis found North Carolina to have the nation’s fastest growing economy between Q1 2013 and Q1 2015. Much of this is due to the pharmaceutical and biotech R&D happening in and around…
Parallelism is a vitally important factor in clinical trial biomarker studies, but is still regularly overlooked in the industry. There are two definitions that I feel summarize parallelism best: Miller et. al describes it as “a condition in which dilution of test samples does not result in biased measurements of the analyte concentration”; whereas Lauren Stevenson and Shobha Purushothama define it as “a demonstration that the sample dilution response curve is parallel to the standard concentration response curve”. Essentially it means that when a test sample is serially diluted to…
