Topics The 10th Annual Meeting of the Regulatory Science Society of Japan held
The "10th Annual Meeting of the Regulatory Science Society of Japan" was held at the Academic Center for Science and Technology (Chiyoda-ku, Tokyo) on September 11-12, 2020, under the theme of "Life Cycle and Regulatory Science of Pharmaceuticals and Medical Devices".
Scene of the symposium
Introduction
The Society for Regulatory Science was established in August 2010 with the founding philosophy of bringing together people in the medical field, universities, research institutions, industry, and regulatory authorities on an equal footing to openly discuss research results and ideas related to regulatory science of pharmaceuticals and medical devices, and to promote the academic progress and dissemination of such science. The Society was established in August 2010 with the founding principle of openly discussing research results and ideas related to regulatory science. The Society will celebrate its 10th anniversary in 2020, during which time the concept of regulatory science is becoming widely accepted.
In 2020, the 10th Annual Conference of the Society for Regulatory Science was held on September 11-12, 2020, under the theme of "Life Cycle of Pharmaceuticals and Medical Devices and Regulatory Science," with about 250 participants engaging in lively discussions in each section.
The conference consisted of the 10th Anniversary Conference Symposium (4 titles), Symposium (12 titles), and general presentations (14 oral presentations and 29 posters).
10th Anniversary Conference Symposium
At this conference, Satoshi Toyoshima—who previously served as a Director and Head of the Review Center at the Pharmaceuticals and Medical Devices Agency (PMDA) and is currently the Representative Director of the Japan Pharmacists Training Center, a public interest incorporated foundation—served as Conference Chair and delivered a lecture on developing the infrastructure to promote the creation of innovative pharmaceuticals originating in Japan.
Following this, a special lecture for the 10th Anniversary Symposium was presented by four speakers, with Mr. Yasuo Ohno, President of the Society for Regulatory Science, and Mr. Toshio Toyoshima serving as moderators.
Next, Dr. Yutaka Kirino, President Emeritus and Professor Emeritus of Tokushima Bunri University, gave a lecture titled "The 10th Anniversary of the Regulatory Science Society of Japan: Past and Future" on the activities of the Regulatory Science Division of the Pharmaceutical Society of Japan, issues in the core curriculum of pharmacy, and the role of pharmacists in He also spoke about the benefits of introducing formularies as a practice of regulatory science by pharmacists.
In addition, Mr. Tatsuya Kondo, Chairman of the Board of Medical Excellence Japan (MEJ), delivered a lecture titled “Moving Forward Toward Further Implementation of Regulatory Science,” in which he discussed MEJ’s initiatives as an international contribution to healthcare, drawing on his experience as PMDA Chief Executive.
In addition, Dr. Ryozo Nagai, President of Jichi Medical University, gave a lecture titled "Challenges of the Clinical Research Act" on the challenges posed by the exemptions to the Clinical Research Act that came into effect in 2018, which made some observational research subject to the Act.
Dr. Hiroshi Kasanuki, Professor of Waseda University, gave a lecture titled "Consensus Building System and Decision Making Process in Regulatory Science" on the importance of paradigm shift from scientific evidence to value judgment, going back to "evaluation science" by Dr. Mitsuru Uchiyama, the proponent of the regulatory science concept. The lecture was given by Dr. Mitsuru Uchiyama.
Main symposia on pharmaceutical-related topics
Symposium 1
Keiko Katsui of the Japan Agency for Medical Research and Development (AMED) and Osamu Mogami of Pfizer chaired the session on "Patient and Public Involvement (PPI) in Japan" Kazuo Hasegawa of the NPO Lung Cancer Patients' Association One Step, Ms. Naoko Song of Cancer Institute Hospital Clinical Research and Development Center, Ms. Ayaka Hiramatsu of PMDA New Drug Evaluation Division 2, and Mr. Takayuki Imaeda of Pfizer R&D gave presentations on their respective efforts from the standpoints of patients, medical institutions, government, and companies, followed by a presentation on "TOYAMA, the Silicon Valley of Drugs" by Mr. Kazuo Mori, the head of the Toyama Pharmaceuticals Silicon Valley Creation Consortium. Afterwards, Mr. Kazuhiko Mori, the project manager of the Consortium for the Creation of "TOYAMA, the Silicon Valley of Drugs," welcomed the audience for a lively discussion. In Japan, various activities are underway, including reports by the JPMA, the activities of the AMED Task Evaluation Committee, and the PMDA's Working Group on Patient Involvement, while in Europe and the U.S., there are activities such as guidance and drug development consortiums that are actively engaged in collaboration with patients, and there is a need for further discussion on how to exchange opinions with patients in the future. The issues to be discussed were clarified, such as how to exchange opinions with patients, creating a platform for patient participation, and raising the awareness of R&D personnel.
Symposium 6
With Ms. Kyoko Imamura of the University of Tokyo Graduate School and Mr. Hirobe Matsuzawa, Chairperson of the Clinical Evaluation Subcommittee of the JPMA Drug Evaluation Committee, serving as moderators, a session was held on the theme “Toward the Implementation of Decentralized Clinical Trials (DCT)—A Clinical Trial Method Not Dependent on Visits to Medical Institutions—in Japan.”At the outset, Ms. Imamura delivered a presentation on the current situation and challenges, noting that interest in new drugs has increased during the COVID-19 pandemic, online medical consultations and remote care have been promoted, and the effective use of ICT is now desired in clinical trials as well.Next, Soichiro Matsushima, a member of the Clinical Evaluation Subcommittee of the Drug Evaluation Committee of the JPMA, presented on “Toward the Realization of Clinical Trial Methods Not Dependent on Visits to Medical Institutions—Current Status and Challenges from the Perspective of Pharmaceutical Companies”—; Mr. Haruo Kuroki of the Sotogawa Children’s Clinic, part of the Medical Corporation Shigyo-no-Kai, spoke on “Expectations and Key Considerations for the Use of Online Consultations in Clinical Trials”; Mr. Taishiro Kishimoto of Keio University discussed “Industry-Academia Collaboration Initiatives Toward Centralized Evaluation and Location-Flexible Trials in the Field of Psychiatry”;Ms. Yumiko Nomura of the Research and Development Promotion Division, Medical Policy Bureau, Ministry of Health, Labor and Welfare, presented on “The Potential of New Clinical Trial Methods for Improving Patient Access.” This was followed by a panel discussion featuring lively debate.Challenges associated with DCTs included the consent acquisition process, the conduct of tests, ensuring subject safety, approaches to data reliability, and regulations regarding the use of medical devices.
Symposium 11
Junko Sato, Director of PMDA's International Affairs Department, and Yuji Kashitani, Chairperson of the JPMA's Regulatory Affairs Committee, chaired the session on the theme of "New Systems Surrounding Pediatric Drugs and Expectations for the Promotion of Future Development. Mr. Hidefumi Nakamura of the National Center for Child Health and Development's Clinical Research Center gave a presentation entitled "What Pediatricians and Pediatricians Can Contribute to Pediatric Drug Development Now"; Mr. Yasuhiro Araki, Director of the Vaccine and Other Drugs Review Department of PMDA, gave a presentation entitled "Revision of the Pharmaceuticals and Medical Device Law and Pediatric Drug Development"; Ms. Michiyo Sakiyama of the Vaccine and Other Drugs Review Department of PMDA After the presentation, four speakers were joined by Makiko Natori, a member of the Drug Evaluation Committee of the JPMA, and Makiko Hama, a member of the Drug Evaluation Committee of the JPMA, to introduce their respective positions and approaches to pediatric drug development. A panel discussion followed with four speakers and two members of the Pharmaceutical Manufacturers Association of Japan (PMAJ), Makiko Natori and Natsuko Hamada. While recognizing the need to consider formulations suitable for pediatric patients, the panel also discussed the difficulties of development, including the aspect of preferences that vary from country to country and region, the need to encourage patient participation in pediatric drug development by healthcare professionals, and the need for greater collaboration with regulatory authorities in Europe and the U.S. From a regulatory perspective, many issues that should be addressed on an ongoing basis were actively discussed. I thought we were able to share a common awareness that regulators, healthcare professionals, academia, and pharmaceutical companies should work together as one team.
Chairperson of Symposium 11
General presentations (oral and poster)
The general oral presentations and poster presentations were divided into two separate rooms for active discussions among industry, academia, and government. Unlike previous years, poster presentations were divided into two separate rooms and the discussion time was extended in order to ensure social distance.
In the poster presentations, the JPMA Regulatory Affairs Committee presented the following two topics.
The results of the questionnaire survey, which has been conducted every year under the theme of "Questionnaire on the Status of Review of New Drugs 2020," were presented by committee members Keikei Yamamoto and Natsuko Hamada, who also presented opinions and requests from the companies that responded to the questionnaire regarding the field of review, review format, electronic data submission status, etc. of the items approved in 2019, which were obtained by 72 JPMA member companies. The survey also presented opinions and requests received from the companies that responded to the survey, such as the timing of important inquiries related to the package inserts and risk management plans (RMPs).
Masahito Kurishita, Osamu Sugiyama, and other committee members presented the current status of development projects at member companies of the JPMA Regulatory Affairs Committee on the theme of "The Current Status of Development Projects at Member Companies of the Japan Pharmaceutical Manufacturers Association (JPMA): Considerations from the Status of Global Development Implementation. The presentation focused on the current status of development projects at the member companies of the Pharmaceutical Affairs Council of Japan (PAC) and how development should be conducted in Japan based on the "General Principles for the Planning and Design of Global Clinical Trials" guidelines (ICH-E17), which were implemented in June 2018. The number of projects under development/application was analyzed for 962 development projects, including regenerative medicine products, etc. As in the trend until 2019, the percentage of projects for anti-cancer drugs was high, 46% overall, 52% for foreign capital, 60% for the top six domestic capital, and 60% for the top six domestic capital. The International Council for Harmonisation of Technical Requirements for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the training material on its website in 2019, but the active use of ICH-E17 has not been recognized in Japan, and we will keep a close eye on the future trends.
The oral and poster presentations by academia, pharmaceutical companies, regulatory authorities, and others from various fields, which were analyzed and reviewed with the goal of being presented at the conference, were all very interesting and provided a forum for the exchange of useful information across the boundaries between industry, academia, and government.
Poster Session
Concluding Remarks
Unlike previous years, this year's conference was held in such a way as to avoid the so-called "three-person limit" by limiting the number of registrations to half of the maximum number of participants in order to prevent the spread of new coronaviruses.
This year marked the 10th anniversary of the Society for Regulatory Science, and with approximately 1,000 members in 2020, the original goal of industry-academia-government collaboration seems to have become quite widespread. In addition, the number of members from academia has increased compared to the initial number, which suggests that research and education in regulatory science have also progressed at universities, where education is conducted. This is why many academicians participated as chairpersons and presenters. Symposiums were also held on a wide range of topics with several keywords, such as medical devices, decentralized clinical trials, MID-NET, pediatric drugs, etc., and there seemed to be a lively exchange of opinions between industry, academia, and government. I believe that the many discussions from various perspectives will lead to mutual awareness, which will further promote regulatory science and cooperation between industry, academia, and government, and I expect that the activities of this society will become more and more active along with the development of regulatory science.
(Ms . Saiko Murata and Ms. Miyoko Onoda, Regulatory Affairs Committee)