Creative Animodel, an experienced contract research organization in the area of biomarker studies, has conducted various related assays. With professional experts and technology platforms, we guarantee our clients high-quality and reliable results in a time-saving and cost-efficient manner.
An Overview of Biomarkers
Generally, a biomarker is a measurable indicator of a disease state, some physiological state, pathogenic process or pharmacologic responses to a therapeutic intervention. As shown in figure 1, biomarkers have a variety of uses in drug discovery and development. For instance, biomarkers can provide a rational basis for selecting lead compounds, help determine or refine mechanism of action or pathophysiology, as well as work as a surrogate endpoint. Depending on their application, biomarkers can be divided into seven categories, including susceptibility/risk biomarkers, diagnostic biomarkers, monitoring biomarkers, prognostic biomarkers, predictive biomarkers, pharmacodynamics/response biomarkers, and safety biomarkers. Biomarkers are an essential element in making good decisions faster in an early stage of drug development. More and more pharmaceutical companies rely on biomarkers to assess the safety, efficacy and mechanism of drugs to decide whether to continue their drug development.
Figure 1. How biomarkers are used in drug development
Biomarkers Services at Creative Animodel
Biomarkers play an important role in the pharmaceuticals development, where they can work as indicators of safety and efficacy. Creative Animodel offers professional services, including:
• Novel biomarker identification. The identification and use of biomarker has become a part of drug discovery and development process. By using various technologies and multi-omics strategies, our scientists are able to discover and select the appropriate biomarkers.
• Biomarker assays development. It is important to develop specific assays for analyzing identified biomarkers. The types of biomarkers (small molecules, proteins, cDNA, etc), matrices (plasma, serum, cells, etc), and the techniques (ELISA, LC-MS/MS, qPCR, etc) all need to be selected to fit intended needs and comply with regulatory requirements.
• Validation. Validation of methods is important in generating data to be used in support of regulatory submissions. Based on the purpose of the biomarkers, we offer validation ranging from exploratory biomarkers to definitive quantitative assays.
• Suitable for a wide range of therapeutic areas, including oncology, cardiovascular, and metabolic diseases
• Equipped with the advanced technology, including mass spectrometry, affinity chromatography, and radiolabel techniques
• Complying with the regulatory guidelines, such as GLP, GCP, and GMP
By working closely with clients, Creative Animodel has successfully provided biomarker services for years. We will leverage our comprehensive experience and professional knowledge to help our clients with biomarker studies. If you have any questions or specific requirements, please feel free to contact us.
1. Wagner J. A. Overview of biomarkers and surrogate endpoints in drug development. Disease markers, 2002, 18(2): 41-46.
2. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. 2016.