Irina Antonijevic - Articles and news items

Biomarkers in CNS drug discovery and development – focus on molecular blood markers

Issue 3 2009, Past issues / 29 May 2009 /

In established economies, mental disorders account for a larger burden of disease than all cancers combined. Yet reliable, measurable, markers of such diseases (biomarkers) are not uniformly known and without them, prediction that a new drug candidate makes contact with its target is poor. This is unfortunate because the attrition rate of new chemical entities (NCEs) in clinical development for CNS disorders is high and primarily driven by failure to show efficacy and often without knowing that the drug reached its intended target for action. Today, several companies have reported efforts towards the discovery of molecular biomarkers for CNS disorders. Confirmation, and ultimately validation of molecular (and other) biomarkers will hopefully foster new drug developments for multiple, currently poorly understood and inadequately treated CNS disorders.

Designing a program for early CNS development

Issue 6 2006, Past issues / 28 November 2006 / Irina Antonijevic, Douglas Craig and Christophe Gerald, Lundbeck Research USA, Inc.

Only a few innovations have been made in recent decades with regard to psychiatric, and particularly antidepressant, drugs (Insel et al., 2006) (Figure 1). This conundrum reflects, at least partly, the lack of understanding of the disease biology. This poses a challenge not only to inventive drug development, but also to clinical practice, which faces remission rates of 30 per cent and less in patients given state-of-the-art pharmacological treatment for major depressive disorders (Trivedi et al., 2006). The situation is further aggravated by the exclusive current use of clinically based diagnostic criteria for major depression, which some critics view as ‘a pseudo-category, effectively homogenizing multiple expressions of depression’ (Parker, 2004).


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