Accelerating Regulatory Science Initiatives for the Development of Drugs for Alzheimer's Disease in Japan

Clinical Therapeutics
Takashi Moritoyo

Abstract

The Ministry of Health, Labour and Welfare (MHLW) of Japan launched a regulatory science research project in which the aim is to promote the establishment of guidelines for the development of innovative drugs thorough interactions between academia and Japan's regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA). In this project, a research system with the aim of developing a guideline for the clinical evaluation of drugs intended for the treatment of Alzheimer's disease (AD) was established. Two research groups were set up: (1) the Biomarker and Clinical Evaluation Group to establish biomarker-based criteria for the clinical evaluation of drugs for AD, and (2) the Modeling and Simulation (M&S) Group to create a disease model of AD using M&S techniques based on data from the Alzheimer's Disease Neuroimaging Initiative (ADNI). Furthermore, a human resource exchange between the University of Tokyo Hospital and the PMDA is conducted to establish a guideline that is suitable for regulatory use. As an interim report of this project, issues that require consideration for the clinical evaluation and development were summarized, including topics such as the use of biomarkers in the inclusion criteria, the efficacy en...Continue Reading

References

Mar 9, 2010·Reviews on Recent Clinical Trials·Michael S Rafii
Mar 15, 2013·The New England Journal of Medicine·Nicholas Kozauer, Russell Katz
Aug 13, 2013·Alzheimer's & Dementia : the Journal of the Alzheimer's Association·Michael W WeinerUNKNOWN Alzheimer's Disease Neuroimaging Initiative

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Citations

Mar 28, 2018·Stroke; a Journal of Cerebral Circulation·Kiyohiro HoukinUNKNOWN Working Group for Guidelines on Development of Cell-Based Products for the Treatment of Cerebral Infarction

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