From The Stage

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

Posted by / / 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

Posted by / / 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?

Posted by / / 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

Posted by / / 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…