Challenges in drug development and expectations to the Japanese Society of Neurological Therapeutics from a pharmaceutical company's perspective

Abstract

The Japanese Society for Neurological Therapeutics aims to promote clinical research for the further enhancement of treatment of neurological diseases and collaborative research activities for the discovery of new treatments. The first difficulty encountered by pharmaceutical companies in conducting clinical trials in Japan is the collection of information on the patient population of the target disease. Pharmaceutical companies have no choice but to find and interview neurologists who are likely to be treating a large number of patients with the target disease. As a feasible solution, pharmaceutical companies may expect the Society to provide consultation services, including assistance in site selection and patient enrollment, in order to improve the efficiency of locating such neurologists. In this paper, I firstly discuss the current status of global drug development and Japan–specific challenges in drug development, which include high cost and low patient aggregation. I then establish the significance of creating a neurological disease registry as a medium– to long–term means of resolving these issues and set forth our expectations for the Society to promote creating of a neurological disease registry.