Recent DIA initiatives have improved cooperation between government, industry, and academia for the purpose of promoting the commercialization of innovative medical technologies and products in Japan, Europe, and the US. These entities, with the participation of patients, have also worked toward dramatically improving the development of new medical technologies, drugs, and medical devices. These movements share the goal of overcoming common boundaries in order to achieve meaningful medical innovations.
In Japan, two acts were enacted on November 20th, 2013 in order to bring world-class medical technology to the public. One new act, the “Act Concerning Safety Assurance of Regenerative Medicine, etc.,” centered on Regenerative Medicine. In addition, the revision of the Pharmaceutical Affairs Act introduced an Accelerated Drug Approval Program with conditions and time limits based on the characteristics of regenerative and other medicines.
Coupled with this framework of new regulations, breakthrough discoveries and inventions that originated in Japan, such as human induced pluripotent stem (iPS) cells and the medical robot suit, are expected to expand the horizons for health care of the future.
There are a wide variety of boundaries that we must transcend. These include the boundaries between industry, academia, government, and patients. There are also boundaries between specialized fields within science and technology; between pharmaceutical drugs, medical devices, and regenerative medicine; and between separate countries and regions. If the development of pharmaceutical drugs and medical devices only follows traditional methodologies and the assumptions of our current development environment, then it will become increasingly difficult to bring about revolutionary breakthroughs. It is essential that open innovation is encouraged in order to break down these existing barriers.
This year, our conference title calls on us to transcend these boundaries, and even surpass what we have taken as common sense or expected practice up until now with a strong will to make changes that can create a revolution in medical care.
Last year, the theme of the Japan Annual Meeting was “Revolutionary Drug Development.” This year, we would like to help you work across disciplines and areas of expertise to create medical innovation for the realization of a revolution in medical care that truly meets the needs of patients.