Topics The "General Meeting of the Drug Evaluation Committee for FY2022" was held Paving the way for the future of healthcare through Digital Transformation! ～From Disease to Pre-Disease and Well being
The 141st General Meeting of the Committee on Drug Evaluation was held on November 25, 2022 at Muromachi Mitsui Hall & Conference (Chuo-ku, Tokyo). Considering the transmission of the new coronavirus, approximately 40 pharmaceutical association executives and members of the Drug Evaluation Committee attended the meeting at the venue, while approximately 630 others participated online.
The venue
The General Assembly started with an explanation of the purpose of the meeting by Mr. Kazuhiko Mori, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ). After the external lecture, the activities of digital transformation (DX) being undertaken by the Task Forces (TFs) of each subcommittee and committee of the Pharmaceuticals Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) were introduced. In the panel discussion, the challenges and future of DX in the Drug Evaluation Committee were also discussed, providing an opportunity for future initiatives. Finally, the four-hour general meeting ended with closing remarks by Manabu Yanagisawa, Chair of the Drug Evaluation Committee.
Part 1
■External Speeches
Realizing a Sustainable Future through Digital Innovation
Mr. Hiroshi Nishikawa, Senior Director, Communication Strategy Management Division, Fujitsu
Since 2013, Fujitsu has annually published the Fujitsu Technology and Service Vision (FT&SV), which presents a vision of the future that the company wants to realize and proposes how technology can contribute to its realization. The vision also serves as a compass for all Fujitsu employees.
In response to the fact that the next decade will be marked by declining diversity, climate change, persistence of the new coronavirus, and further expansion of poverty and education issues on a global scale, Fujitsu is working to achieve its sustainability transformation through digital innovation technologies.
An analysis of the results of a survey of 1,800 business leaders in nine countries to examine trends around the world showed that although sustainability is recognized as an important management issue, its realization varied. Among them, successful companies have defined a corporate purpose (leadership that the CEO personally and passionately encourages employees to follow), and based on that purpose, they are building a human-centric (empowering employees), data-driven (using data and digital technology), and connected (an ecosystem in which people, goods, and services (building an ecosystem in which people, goods, and services are connected safely and securely).
Based on these, in 2020, Fujitsu has set its Purpose as "bringing trust to society through innovation and making the world more sustainable," and has set three goals: (1) a "borderless world" where the real and digital worlds converge, (2) a "dynamic resilience" where the uncertain future is predicted with a digital twin, and (3) a "dynamic future" where the future is predicted with a digital twin. (3) "Discovery Revolution" using quantum computers and AI, and (4) "Trust for All" using decentralized trust technology to protect the borderless world. The company will invest in "Computing" such as the development of quantum computers, "Network" such as 5G and 6G wireless technologies, "AI" such as the ability to infer causal relationships from ultra-large scale data, "Data&Security" such as distributed ID technologies, and "Converging Technologies" such as the construction of real-time digital twin infrastructures. We are investing in "AI" (e.g., inferring cause-and-effect relationships from data), "Data&Security" (e.g., distributed ID technology), and "Converging" (e.g., real-time digital twin infrastructure) to realize Purpose. Furthermore, we have launched "Fujitsu Uvance" to promote sustainability transformation by connecting people, products, and ideas.
Part 2
The following eight DX activities, etc., which are being undertaken by the various subcommittees and committee TFs of the Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), were explained.
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1.Task Force for Promotion of Utilization of Medical Information DB Mr. Jisei Aoki, Leader
To promote the utilization of medical information databases, activities are focused on infrastructure development, including improvement of personal information protection legislation, such as data structure discrepancies and consent, which is currently an issue. -
2.Basic Research Subcommittee Mutsuzuki Suzuki, Chair
Structuring and databasing data generated in non-clinical areas to examine the possibility of using SEND data, background data from past toxicity studies as a control group, and AI pathology judgment. -
3.Tomoyuki Tabata, Vice Chair, Clinical Evaluation Subcommittee
Introduction of study results on issues such as utilization of real world data (RWD)/registry, examination of clinical trial methods that do not depend on visits to medical institutions, and utilization of digital health. -
4.Makoto Miyazaki, Chair, Pharmacovigilance Subcommittee
Development and review of DX activities, including publication of remote investigation (reexamination) guidance, creation of detailed survey forms for adverse drug reactions using electronic forms (PDF) instead of paper, improvement of access to information and drug risk management plan (RMP) materials for patients through DX, and corporate Bold future vision of pharmacovigilance in the pharmaceutical industry. -
5.Satoru TSUCHIYA, Vice Chairman, Data Science Subcommittee
Through the activities of "Model-informed drug development," a drug evaluation that uses models to help speculate on the future, and ICH M11, which examines the international standardization of protocols, we will introduce a future where content can be easily reused in other documents, such as analysis plans and summary reports. The future that can easily reuse the contents for other documents such as analysis plans and summary reports will be introduced. -
6.Miki Someya, Leader, Electronic Information Subcommittee
Introduced the introduction status of eConsent, the convenience of eTMF metrics, the introduction status of ePRO, the use of IoT in clinical trials, and future issues. -
7.Medical Affairs Subcommittee Yutaro Wakamura, Vice Chair
Through the draft guidance on "Provision of Medical and Scientific Information" by medical departments, the status of digital utilization (Digitation, Digitalization) according to the types and methods of information to be considered in medical and scientific information and the issues at present The future prospects for DX are also introduced. -
8.DX Study Task Force: Ken Kaiabe, Executive Director
Sharing of the need to accelerate DX being undertaken by member companies and stakeholders by comparing DX being undertaken by the Drug Evaluation Committee with the goals of individual companies and making environmental improvements and policy recommendations. Presented the need to promote DX activities to realize the future need for prevention and health maintenance efforts, not only after a disease has occurred.
Part 3
A panel discussion was held with Mr. Kazuhiko Mori, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and Mr. Toshiharu Sano, Vice Chair of the Drug Evaluation Committee, as chairpersons, with Mr. Nishikawa, Steering Secretary Kaiabe, Leader Aoki, and Chairperson Miyazaki as panelists, in addition to Mr. Hiroshi Matsuzawa, Chair of the Clinical Evaluation Subcommittee.
The discussion focused on the theme of this year's Annual Meeting, "What DX can do for Well-being," keeping in mind what DX can be used for and for whom and what it can provide. The discussion began with an explanation of the purpose of the event, which was to provide an opportunity to think about DX in drug development. Citing the change in the rules of Major League Baseball due to the emergence of Shohei Ohtani, a major leaguer who transcended existing frameworks, the possibility of rules and regulations changing with the emergence of new digital technologies was discussed.
Panelists suggested that clinical trials that do not depend on visits to medical institutions may become a reality with the advent of online medical care, wearable devices, etc., and that in the future it may be possible to participate in necessary clinical trials anywhere in the world. Some suggested that connecting clinical trials to a site that can manage disease treatment guidelines will promote access to clinical trials, and that if post-marketing safety surveillance becomes smarter with the advancement of DX, clinical development may be approved at an earlier stage and the remaining challenges may be handled by smarter post-marketing safety surveillance.
On the other hand, there was also the opinion that whether or not to tolerate an overly monitored society may differ from person to person. As a solution to this problem, it was suggested that it is necessary to develop technologies that can identify the will of individuals and obtain their consent.
In the drug evaluation process, the Japanese regulatory authorities, unlike their global counterparts, require documents to be written in Japanese, and there is a language barrier. In addition, the discussion focused on the issue of personal data and whether or not users are aware of the advantages of using personal data in different ways, such as the fact that search engines do not require strict regulations even though the data is used for other purposes, while the rate of acquisition of personal number cards has not increased. There was a shared recognition that whether or not the benefits are perceived to be beneficial may be different. This point is considered to be an important element in future discussions on the construction of medical information databases.
Finally, the panel discussion concluded with the common recognition that the definition of "well being" that pharmaceutical companies aim for is not a simple one, and that it is necessary to give detailed consideration to it, and that DX has the potential to provide new value to this definition.
Panel Discussion
( Takayuki Imaeda, Vice Chairman, Drug Evaluation Committee)