elivering impactful and affordable pharmaceuticals, medical devices, and regenerative medicine to patients is an industry-wide challenge all around the world, including Japan. To meet this challenge, various technologies have been invented and developed in the context of collaborations among pharmaceutical companies, academic organizations, and medical institutions. The word “innovation” has a wide scope, ranging from science to decision-making to social systems. Innovations such as robotics, artificial intelligence, IT, and digital health are expected to lead to productivity improvement and resource optimization, and discussions surrounding innovation are playing an important role that promotes the merging of new ideas across industries.

DIA Japan organized a symposium Cutting Edge Series–The Present and Future of Utilization of AI and Digital Technology in Drug Development to further focus on the latest technologies that promote innovation.

When considering industrial growth and technological innovation, the driving forces of continuous innovation, regardless of industry, are:

(1) promote technology as the core of innovation,
(2) apply technology in numerous areas, including commercialization, and assess the level of usefulness and improvement;
(3) consider and expand the potential for further process efficiency and organizational productivity; and
(4) foster talent with high potential, find experts, and connect them to promote further innovation.

Can We Say It Is Efficient?

When we consider the medical product research and development chain (“R&D chain”), which includes basic research through post-marketing safety measures, can we say that it is efficient? The global approach to medicine development has become popular, and it has the advantages of sharing similar systems, production flows, and resources. But the process has become extremely complex; the number of working processes and documents and amount of information we need to manage are increasing dramatically. We have a very labor-intensive model. Thus, we need to consider the R&D chain from end to end and identify the challenges and critical problems that we can solve or at least support with novel technology to achieve further efficiency.

First, empowering new technology with novel collaborations (academia, industry, and governmental organizations) is a key driver of global innovation. The development and application of new technology in the R&D chain, including AI-based new approaches and Robotic Process Automation (RPA), have spread rapidly. In fact, various ideas to improve efficiency and productivity in the R&D chain, in compound screening and optimization, in genomics and proteomics, in regulatory dossier creation, in translations, in clinical operations, and in pharmacovigilance workflows, were reviewed and discussed at the symposium. These are core ideas on how to establish an “end-to-end AI and digital technology-based platform” for a rationalized R&D model for the future.

Second, there is a better understanding of how Japan is playing an important role and contributing to global technology advances. Currently, there is a great focus on “AI-based systems of digital imaging technology” for diagnostic purposes. Many Japanese technology companies have been driving advances in imaging technology and have greatly contributed to the development of worldwide digital technology. Currently, there are vast troves of high-quality imaging data to support machine learning. High-quality data are generated by advanced imaging tools. Ultra-high definition imaging technology can provide valuable imaging data for machine learning, a key algorithm to support medical diagnosis.

Third, the symposium featured the slogan of “let’s meet the challenge together.” This concept was put forward and fully supported by regulators from MHLW and PMDA, including MHLW keynote speaker Kiyohito Nakai, (one of the leaders in regulatory science, the SAKIGAKE designation scheme, and the early approval scheme in Japan) and PMDA’s Yoshiaki Uyama, who has been leading the important “national initiative for establishing medical data utilization platform” called MID-NET (Medical Information Database Network). These regulatory leaders stated that “Japan regulators are very welcoming of frank discussions on innovations.” Japanese regulatory authorities have accumulated knowledge through deep collaborations with external experts to prepare for developing innovative medical devices containing AI. For example, “a consortium working on speeding up development of artificial intelligence in the health care field” was established by MHLW in January 2017 in anticipation of rapid technological progress.