Widespread adoption of biomarkers has been impeded by a lack of consistent validation methodology and an unclear regulatory environment. If a biomarker is being used to determine the safety and/or effectiveness of a drug, it should be validated rigorously. Here are five key points to consider.
Although cancer’s status as the leading therapeutic area for drug candidates looks set to remain unrivaled for the foreseeable future, the emphasis on each stage of drug discovery and development tends to fluctuate according to each drug maker’s pipeline. Aidan Synnott from Charles River discusses preclinical cancer drug development in Drug Discovery & Development.
Business isn't always perfect. In Crain's "If I Knew Then…" column, Jim Foster discusses what he's learned from his mistakes, including the importance of working with great people.
Hua Wang was recently nominated for Bioanalysis Zone's New Investigator Award. Hua is a member of our team in Ohio, and joined Charles River as part of WIL Research this year. He is an outstanding scientist who has contributed significantly to a variety of bioanalysis projects to support drug development programs.
Charles River is conducting new studies using animal models to give insight into therapeutic strategies where pharma companies expect to see the most success. These advances in research models are making “moonshots” a reality for cancer patients. Dr. Joseph Murphy from Charles River discusses more on Outsourcing-Pharma.com.
A rapid increase in the number of companies working on development and registration of biosimilars has created a significant market for outsourced services specific to these products. Biosimilar developers turn to contract organizations when they lack either the internal capability or capacity for conducting certain work as well as when they require additional resources to bring products to market rapidly.
After reporting a successful start to FY16, Charles River expects continued success this year driven by customer demand and enhanced strategic partnerships, including expansion of its early stage portfolio.
Variability in conventional LAL reagents highlights the need for a testing method that does not require endotoxin curves. One such method is the Endosafe® Portable Test System™ (PTS), which utilizes a kinetic chromogenic technique and an archived standard curve.
Patient-derived xenografts (PDXs) are fast becoming the new gold standard models for oncological drug development. Learn more from Anne-Lise Peille, Laboratory Head of Biobanking and Molecular Analytics at Oncotest, a Charles River company, in Freiburg, Germany.
Charles River will become the preferred drug discovery and preclinical development partner for BioMotiv through the partnership—designed to help the accelerator translate discoveries from portfolio companies formed to commercialize technologies sourced from academic research and nongovernmental organizations.