The Current Situation of Oncology Drug Lag in Japan and Strategic Approaches for Pharmaceutical Companies

Abstract

Drug lag, especially for oncology drugs, has recently been a big issue in Japan. Drug lag is considered to be the result of three separate types of delay or a combination of these: delay in the start of development, delay in the progress of development, and delay in review by regulatory authorities. Although various actions have been implemented, they are mainly for improving the latter two types of delay. As for delay in the start of development, there may be two major reasons: reactive or untimely decision making, and limited R&D resources at Japanese affiliates of multinational pharmaceutical companies. Concerning reactive or untimely decision making, authorities and study sites are also responsible to some extent. As it may not be practically feasible for Japanese affiliates to initiate development of all compounds at the same time as global headquarters, strategic approaches are needed to compensate fordelay in thestart of development. Globaldevelopment and data sharing with other nations, especially in East Asia, could be workable options. By adopting these options, Japanese affiliates will be able to realize more productive drug development with less human and budgetary resources. By saving resources, Japanese affiliates may Join global studies at earlier stages and lead development of drugs for tumor types prevalent in Asia.