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Among the major issues in recent new medicine development, problems such as species differences when extrapolating non-clinical study results to humans and the differences between clinical trial subjects and actual patients when we apply clinical trial results to patients in clinical practice, stand out as challenges which must be overcome in regulatory science research which aims for the proper utilization of medicines considering each patient’s individual risks.

Recent technological progresses in the medicine and pharmacology are expected to provide powerful tools to overcome these barriers, and a longawaited platform that enables patient-engaged new medicine development is gradually being developed. For example, the human genetic code can be analyzed rapidly and at low cost due to the progress of genetic engineering, and searches of disease specific genes in patients’ clinical samples have accelerated. The discovery of iPS cells made it possible to study diseases by direct use of patient cells as well as to enhance new medicine development through screening for efficacy and safety in ways that were previously impossible. Simulation techniques for physiologic and disease conditions have enabled better prediction, which was not possible in prior non-clinical and clinical trials. Moreover, there is the potential for gaining further information which can be applied to individual patients by pharmacoepidemiological research using the enormous quantity of data generated by clinical practice.

This year, Dr. Tatsuo Kurokawa will become the first Japanese President of  DIA. In this memorable year, we would like to provide a forum where academia, government and industry gather to discuss new scientific technologies which will provide breakthroughs for future regulatory science research at the DIA Japan Annual Meeting. It goes without saying that quality, efficacy and safety of medical products are supported by all stakeholders’ ethics and compliance. While the number of stakeholders is increasing due to the large scale of global medicine development, and the wide variety of people who are involved with these new technologies, we would like this meeting to be an opportunity to deeply consider our highest priority objective; ‘for patients’.