Background

The increased prevalence of chronic disease tempered by the demand for cost-effective therapies is partly responsible for the rise in prominence of evidence-based medicine.

Evidence-based access to therapies may be seen as an early stage in the provision of the "tailored" treatments that will constitute personalised medicine. Although the promise of personalised medicines may ultimately be driven by the widespread acceptance of pharmacogenetics, the routine utilisation of objective non-genetic testing in treatment decisions can provide confidence and overcome emotive barriers associated with genetic testing using, in some cases, markers that are already validated and useable. Integrated Medicines Ltd (IML) seeks to manage the integration of objective testing, in the form of surrogates or diagnostics, with the development and promotion of medicines.

The use of objective diagnostic testing to define the nature & severity of disease and to guide treatment options is already evident in the oncology and infectious disease therapeutic areas, examples being Herceptin and her2 diagnostic tests or viral genotyping tests and selection of HIV therapies. Integration of objective testing with medicines may not yet be accepted as routine in all therapeutic areas, but the merger of the UK Medicines Control Agency with the Medical Devices Agency into a single regulatory agency is a clear sign of this developing. As regulators become increasingly conscious of the opportunities offered by an integrated medicines approach, so those involved in the development of such medicines may require additional guidance and support. For example, the marketing approval of diagnostics in the EU is now highly regulated, involving evidence of performance ("efficacy") in clinical trials akin to the approval of medicines by the EU Mutual Recognition Procedure (MRP), and so it will require substantial knowledge of both diagnostic and drug development to co-ordinate the launch of these integrated tests and medicines. This is the practical expertise offered by IMC.