Abstract
One of the major challenges facing the healthcare industry is how to personalize, or tailor healthcare products and services to individuals' unique genetic and biomarker make-ups. Biomarkers are characteristics that can be objectively measured and evaluated. They provide information about normal or patho-physiological processes to detect or define disease progression or to predict or quantify therapeutic responses. Once these footprints have been identified and measured, they can then be used to personalize or tailor treatment plans, products and services to each individual's unique makeup and background. Biomarkers enable early diagnosis, guide molecularly targeted therapy and monitor the activity and therapeutic responses across these diseases. Development of new, predictive safety and efficacy biomarkers is expected to reduce the time and cost of drug development. This review summarizes the integration and use of biomarkers in drug development, regulation and clinical practice with special emphasis on autoimmune and inflammatory diseases biomarkers.
Highlights
Autoimmune diseases are a family of more than 80 chronic and often disabling illnesses that develop when underlying defects in the immune system lead the body to attack its own organs, tissues and cells
Since cures are not yet available for most autoimmune diseases, patients face a lifetime of illness and treatment
In contrast to classical inherited genetic diseases like sickle cell anemia, autoimmune diseases are not caused by the defect of a single gene but by the dysfunction of the complex interaction of a group of genes
Summary
Autoimmune diseases are a family of more than 80 chronic and often disabling illnesses that develop when underlying defects in the immune system lead the body to attack its own organs, tissues and cells. Since cures are not yet available for most autoimmune diseases, patients face a lifetime of illness and treatment They often endure debilitating symptoms, loss of organ function, reduced productivity at work, and high medical expenses. 5–8% of the US population suffers from this group of chronic, debilitating diseases[14] Despite their clinical diversity, they have one similarity, namely the dysfunction of the immune system. In contrast to classical inherited genetic diseases like sickle cell anemia, autoimmune diseases are not caused by the defect of a single gene but by the dysfunction of the complex interaction of a group of genes. Main autoimmune and inflammatory diseases include asthma[58], allergic rhinitis[59], alopecia areata, atopic dermatitis, autoimmune hepatitis, autoimmune pancreatitis, autoimmune urticaria, autoimmune uveitis, celiac disease, chronic obstructive pulmonary disease/emphysema, Crohn’s disease, dermatomyositis, diabetes mellitus type 1, graft versus host disease, IJBAR (2012) 03(04)
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