We have previously reported on the European Medicine Agency’s (EMA) increased focus on the area of personalised medicines. The original blog post can be found here.

The EMA and the Committee for Medicinal Products for Human Use (CHMP) has now released for consultation a concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle. The use of predictive biomarkers is an aspect of personalised medicine used to decide treatment or dose selection.Continue Reading Update on personalised medicines: Predictive biomarkers

Traditional medicine applies the same treatment approach to all patients affected by a disease (‘one size fits all’). However, we are all unique. Our health is determined by our inherited genetic differences combined with our lifestyles and other environmental factors. Personalised medicines are medicines that are targeted to individual patients based on their genetic make-up.

Variants in our genetic code can also be used to predict the potential for adverse drug reactions. For example, the hyper-sensitivity experienced by certain patients to the HIV drug Abacavir has been found to be linked to a particular genetic variant, allele HLA-B5701. The requirement that patients take a test to ensure this allele is absent before being given Abacavir has greatly reduced the incidence of hyper-sensitivity.

Since 2011, personalised medicine has been on the agenda of the European Commission, which has committed two billion Euros of health research funding to the cause. Personalised medicine has been defined by the European Council as a “Medical model using characterisation of individuals’ phenotypes and genotypes or tailoring the right therapeutic strategy for the right person at the right time, and to determine the predisposition to disease and/or deliver timely and targeted prevention, and it relates to the broader concept of patient-centred care, which takes into account that, in general, healthcare systems need to better respond to patient needs.”Continue Reading Update on personalised medicines