Translational medicine: Achievements and challenges

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Translational medicine: Achievements and challenges

Despite tremendous efforts and investments, despite the cloning of the entire human genome, innovations at the patient level are becoming rare events. Failures to predict human efficacy/safety of new drugs from early discovery and development work are being blamed to cause early or late attrition of too many drug projects. The pressure of increasing R&D costs and low output in terms of critically novel drugs forced the Federal Drug Administration (FDA) to reconsider its own actions and those of major players in biomedical research in terms of time lines, costs, design and, ultimately, success. The ‘critical path initiative’ of 2004 represents a milestone in this context. It reflects a concerted action initiated by a regulatory authority criticized for its ‘retarding’ activities claimed to result in the low output syndrome described above. Though certainly not the first public initiative to address translational medicine issues as major concern, it was one of the most influential and respected ones. American universities addressed the challenge as well and established centers for translational medicine, e.g. at Duke or Pennsylvania University. In Europe, The European Organization for the Treatment of Cancer (EORTC) which is committed to making translational research a part of all cancer clinical trials, and the National Translational Cancer Research Network announced by the British government to facilitate and enhance translational research in the United Kingdom are working on this route. Almost all major drug companies have addressed the issue of translational medicine in one way or the other. The institutional structures range from independent departments of translational or discovery medicine to entirely ‘embedded” dependent structures which are part of the drug discovery/development teams without central facilities. In general, US biomedical players have invested the most (NIH has announced to spend a total of up to 10 billion USD) and are at the forefront of translational institutionalization, with Europe lagging behind at very different distances as far as the individual countries are concerned. Commercialization of academic inventions has traditionally been much more efficient in the US than the EU, and translational medicine has a lot to do with expertise accrued during commercialization processes. One dimension and particular challenge of this novel science is certainly the assessment of the translational potential of an innovative project, thereby rating the risk of investment and creating a base for portfolio considerations. In a structured approach following prespecified algorithms, the translatability potential of a given drug, device or diagnostic test project may be assessed by analysis of multiple variables. Biomarkers, disease models, test tube results, genetic and ‘omics’ data and other dimensions will be integrated into a translatability scoring system to achieve two goals:

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