Tissue-Based Biomarkers: A Critical Tool in the Development of New Drugs and Therapies
August 30, 2012 - In a post-genomic era that has yielded a wealth of new genes with unknown functions and a growing appreciation that gene expression profiling alone is not sufficient, an understanding of protein expression and activity is needed to determine gene function and to define mechanisms underlying cell function and disease. For these reasons, biomarkers are increasingly valuable in the development of novel drugs that target a variety of molecular sites. Our specialty pathology program offers tissue-based biomarkers to facilitate target validation, proof of target, proof of mechanism and proof of efficacy. We use immunohistochemical detection to demonstrate marker proteins within target tissues. With a plethora of antibodies available to target molecular sites that control cellular processes, we use antibodies of the highest possible quality to visualize protein expression at the cellular level through light and fluorescent microscopy within intact tissue.
Charles River currently has qualified staining methods in place for a variety of markers for processes including angiogenesis, apoptosis and cell proliferation, as well as markers for neural cells, hematopoietic and/or inflammatory cells, cytokines, growth factors and cytokine/growth factor receptors. Because each project has its own unique requirements, our pathologists and scientists will work closely with you to identify which markers to assess. If the project demands a marker that we have not utilized in the past, or one that is new to our lab in that particular species, we will do our best to develop a suitable staining method. Once markers have been selected, we will design a scientifically rigorous approach to sample testing and provide a bridge between preclinical and clinical biomarker development.
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We have established an in vivo screening platform to provide fast and cost-effective screening of compound effects on motor behavior and brain functionality for the study for central nervous system diseases.
We offer a package of well-established, state of the art in vitro mode of action assays that are suitable for early phase biocomparability studies, lot release and stability. These tests can accelerate the time it takes to get a new product ready for market submission.
May 21–May 24
RDD Europe 2013 is a forum for pulmonary and nasal drug delivery experts from all around the world to exchange scientific knowledge and expertise.
May 23–May 23
This full-day seminar encompasses selected topics from our Charles River Short Course on Laboratory Animal Science. We would like to acknowledge Michigan State University for hosting this event and extend our heartfelt thanks to guest speaker Dr. Danielle Ferguson.
This position is responsible for serving as a as a study director (SD), project scientist (PS) and/or principal investigator (PI) in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research; coordinating all phases of the study planning process with appropriate departments; generating high-quality project plans, protocols, amendments and reports appropriate for assigned studies; reviewing, interpreting, integrating and presenting data on assigned studies; and functioning as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
This position is responsible for managing international aspects of US Federal income tax compliance; assisting with international tax planning, including identification of planning opportunities, designing and implementing plans, and transfer pricing process; overseeing quarterly ETR forecast process; and participating in the tax provision process, including assessment of tax risks, documentation of key positions, and review of non-US tax provision submissions.
Charles River Laboratories, Inc.