At AIT Bioscience, we want to help you be on the cutting edge of therapeutic invention: from drug discovery and pre-clinical trials all the way through post-market approval. Over the past decade, while the amount of time and money needed to develop a new chemical entity (NCE) has increased, the number of approved drugs has decreased. This disparity has led to an increased desire to identify promising drug candidates at an early stage. The publication of the Critical Path Initiative by the FDA in 2004 and the subsequent formation of the Biomarker Consortium in 2006 have highlighted biomarkers as a critical tool for decision making in the pharmaceutical industry. A biomarker, as defined by the Biomarker Consortium are “objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to therapeutic intervention”.
Biomarkers can be used in various facets: as diagnostic indicators of disease, indicate biological pathways for new therapeutics, efficacy and safety determinations, and as a phamacodynamic (PD) measures of therapeutics pharmacokinetic (PK) profile. The use of biomarkers can usher in a new era of predictive, preventative, and personalized medicine, where therapeutics can be tailored to a patient’s unique biology.
Because of the diversity of biomarker applications for drug development and diagnostics, regulatory requirements are not well defined. For the purpose of biomarker applications, the pharmaceutical industry has adapted a “Fit-for-Purpose” philosophy where the rigor of validation is defined by the intended use of the data.
For more information about AITB biomarker processes, contact us by email or phone at 317-715-8800.