From The Stage

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 Tide Cell-based assays…

Immuno-oncology: Advancing 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 traced 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, 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 immunogenicity. WRIB is a unique gathering because it is specifically designed…

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…

Large Molecule Sample Analysis for a Large Number of Samples: Why Veteran Expertise is Critical to Success

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / CRO Selection, Sample Analysis

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…

CRO Communication: Responsiveness for Better Bioanalytical Results

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality, CRO Selection

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…

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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality, CRO Selection

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…

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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality, CRO Selection

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…