From The

Expert perspectives focused on the latest bioanalytical topic & trends

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

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

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Immuno-oncology: Advancing Therapeutic Options for Treating Human Cancers

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 traced back to the early 1900s, recent advancements in assay methods

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Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis

The whitepaper based on discussions at the 10th Workshop on Recent Issues in Bioanalysis (WRIB) has been published! Everyone who participated, 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

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Looking Back at What’s Driving BioAgilytix Forward in 2017

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

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

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CRO Communication: Responsiveness for Better Bioanalytical Results

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

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In Bioanalysis, Timing is Everything: Can Your CRO Keep Up with Your Innovation Demands?

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

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Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other

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

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

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

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Crystal City VI Workshop Report: A Positive Step in Furthering the Dialogue on Biomarker Assay Challenges

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

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Biomarker Development: Clearing the Way for Faster Biomarker Innovation

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

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