Abstract
The time and cost involved in bringing new drugs to the market hamper their approval. This problem is especially apparent in the case of renal diseases. Efficient drug research requires an a priori understanding of disease pathophysiology, target validation, rational and efficient drug discovery strategies and early testing of the physiological and pharmacological effects of the new agent in humans. Drug development initiated by academia benefits from international research networks and relies on internationally acceptable high-quality nonclinical data packages and bulk investigational drugs. Academics should, therefore, better understand pharmaceutical practice regulations and novel, efficient drug-development strategies. Many researchers remain unfamiliar with these areas and should collaborate with regulatory authorities to discover and validate surrogate markers for use in drug development, and to efficiently and effectively maximize the benefits and minimize the adverse effects of new drugs. The Japanese government and regulatory authorities have implemented a framework to encourage such collaborations; extension of this framework beyond its current reach is envisaged.
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Acknowledgements
T. Dan, N. Hirasawa, K. Akahori and K. Miyata contributed to helpful discussions. The authors' work is supported in part by grants from the Ministry of Health, Labour and Welfare of Japan (Initiative to facilitate development of innovative drug, medical devices, and cellular and tissue-based products), from the Japan Science and Technology Agency (Adaptable & Seamless Technology Transfer Program through Target-driven Research and Development) and from the National Institute of Biomedical Innovation (Advanced Research for Medical Products Mininng Programme).
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All authors wrote the article. T.M., T.A., H.H., K.W., F.Y. and M.T. researched the data and made substantial contributions to discussions of the content. D.E.V., T.K., Y.O. and C.v.Y.d.S. reviewed and/or edited the manuscript before submission.
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Miyata, T., Ando, T., Hiragi, H. et al. Drug discovery in renal disease—towards a more efficient framework. Nat Rev Nephrol 10, 290–296 (2014). https://doi.org/10.1038/nrneph.2014.36
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DOI: https://doi.org/10.1038/nrneph.2014.36