title: Drug discovery in renal disease--towards a more efficient framework.
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.
authors.affiliation: United Centers for Advanced Research and Translational Medicine, Tohoku University Graduate School of Medicine, 2-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Miyata
authors.affiliation: Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Ando
authors.affiliation: Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan.
authors.forename: Hisami
authors.initials: H
authors.lastname: Hiragi
authors.affiliation: Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan.
authors.forename: Kanako
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan.
authors.forename: Fumi
authors.initials: F
authors.lastname: Yamamoto
authors.affiliation: Feinberg Cardiovascular Research Institute, Northwestern University Feinberg School of Medicine, Galter Pavilion, Suite 3-150, 251 East Huron Street, Chicago, IL 60611-2908, USA.
authors.forename: Douglas E
authors.initials: DE
authors.lastname: Vaughan
authors.affiliation: Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, 1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan.
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Kurokawa
authors.affiliation: Graduate School of Pharmaceutical Sciences, Tohoku University, 6-3 Aoba, Aramaki, Aoba-ku, Sendai, Miyagi 980-8578, Japan.
authors.forename: Yoshiteru
authors.initials: Y
authors.lastname: Oshima
authors.affiliation: Service de Nephrologie, Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium.
authors.forename: Charles
authors.initials: C
authors.lastname: van Ypersele de Strihou
authors.affiliation: Research Center for Clinical Pharmacology, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo 108-8641, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takeuchi
mesh_terms: D015415:Biomarkers; D002986:Clinical Trials as Topic; D003906:Developing Countries; D015195:Drug Design; D055808:Drug Discovery; D004345:Drug Industry; D015507:Drugs, Investigational; D006801:Humans; D007564:Japan; D007674:Kidney Diseases / Q000188:drug therapy*; D007676:Kidney Failure, Chronic / Q000628:therapy; D055818:Public-Private Sector Partnerships; D035583:Rare Diseases / Q000188:drug therapy; D006435:Renal Dialysis / Q000191:economics / Q000639:trends
chemical_list: D015415:Biomarkers; D015507:Drugs, Investigational