Affiliation:
1. Tufts Center for the Study of Drug Development (Tufts CSDD), Tufts University, 75 Kneeland St., Suite 1100, Boston, MA 02111, USA.
Abstract
After 50 years of wandering among new discovery technologies and a worrying antiquated development process, the research and development (R&D) enterprise may finally have found a way out of its wilderness through the auspices of translational medicine. For that to happen, a number of problems have to be confronted. Most prominent is the traditional problem credited with giving rise to translational medicine – the lack of a feedback loop from bench to bedside. However, there are equally significant roadblocks to be confronted at every turn along the R&D pathway, from basic research through discovery and preclinical testing and, finally, into the clinic. Translational medicine is now beginning to encompass other powerful and promising innovations such as personalized medicine, bioinformatics, advanced imaging and biomarkers to help move beyond these roadblocks. Although translational medicine has attracted significant financial support in recent years, the economics of the movement are still challenging, as public and private sector funding are both difficult to come by due to the economic downturn. Some of the dearth of monies has been redressed by foundations and public–private partnerships, which combine resources and, hence, divide the risk to the benefit of all. More recently, the inherent tension among the traditional roles of ‘big pharma’, biotechs and the public sector, which had waned somewhat in the wake of the Bayh–Dole legislation in the USA, has re-emerged owing to the furor over conflicts of interest. Translational medicine may help alleviate these tensions by its example of successful precompetitive collaboration, such as the Predictive Safety Testing Consortium and its effective use of project management techniques in multidisciplinary, multiphasic, multisectoral projects to bring the discipline necessary for the efficient functioning of consortia. Changing a research paradigm that has remained substantially unchanged for half a century will require considerable time, money and effort. However, there is reason to be optimistic that translational medicine is the right solution for the right problem at the right time.
Subject
Pharmacology,Molecular Medicine,General Medicine
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