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Drug toxicology studies - Articles and news items

Man on a phone analysing data and charts on computer screen

Integrating preclinical data into early clinical development

Contract Research, Issue 4 2012 / 3 September 2012 / Vikash Sinha, Clinical Pharmacology Leader, Janssen Research and Development

One of the important goals in preclinical and early clinical drug development is to reduce attrition rates and to improve our ability to pick winners and drop potential loser drug candidates. By being able to efficiently translate preclinical data and observations into possible clinical outcomes, one can make the drug development process more cost-effective. Identifying preclinical models – in silico, in vitro, in vivo – or assays that can best predict clinical observations is not trivial. It requires understanding of preclinical-to-clinical correlations and the success of translational science may vary depending on the therapeutic area where one is working. For example, anti-infectives or cancer therapeutic areas have validated biomarkers which can be useful in selecting the right drug candidate in early drug development…

drug discovery & drug development

The need for proteomic-based biomarkers in the drug development pipeline

Issue 3 2012, Proteomics / 10 July 2012 / Paul C. Guest, Department of Chemical Engineering and Biotechnology, University of Cambridge and Sabine Bahn Department of Chemical Engineering and Biotechnology, University of Cambridge & Department of Neuroscience, Erasmus Medical Centre

Pharmaceutical companies are under increasing pressure to improve their efficiency and returns on drug discovery projects. This is a daunting task considering that the average drug costs approximately one billion US dollars to develop and takes around 12 years from initial discovery to reach the market1. In addition, approximately 70 per cent of drugs fail to recover their research and development costs and around 90 per cent fail to provide a satisfactory return on investment. Therefore, minimising risk is one of the most important aims in pharmaceutical discovery programs today.

There are now efforts to establish standard operating procedures to navigate through these problems and, at the same time, meet the regulatory demands. To facilitate this process, the regulatory health authorities have encour aged the incorporation of biomarkers into the drug discovery pipeline and the Food and Drug Administration (FDA) has called for efforts to modernise and standardise approaches for the delivery of more effective and safer drugs2.

Proteomics is the most applicable tech – nology for implementing biomarker app – roaches in drug discovery given that virtually all existing drug targets are proteins3. Proteomics is a systems approach for the global study of protein expression changes4.


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