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.
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).
Symposium of the 10th Anniversary Meeting
The conference was chaired by Dr. Satoshi Toyoshima, who served as Director and Director of the Review Center at the Pharmaceuticals and Medical Devices Agency (PMDA) and currently serves as Representative Director of the Japan Pharmacists Training Center.
This was followed by special lectures on the 10th Anniversary Congress Symposium by four speakers, chaired by Dr. Yasuo Ohno, President of the Regulatory Science Society of Japan, and Dr. Toyoshima.
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, Dr. Tatsuya Kondo, President of Medical Excellence Japan (MEJ), gave a lecture titled "Progress toward Further Implementation of Regulatory Science" about his efforts at MEJ as an international contribution to healthcare based on his experience as President of PMDA.
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 themes
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, such as reports by the Pharmaceutical Manufacturers Association of Japan (PMAJ), activities of the AMED Task Evaluation Committee, and the PMDA's Working Group on Patient Involvement (WG), while in Europe and the United States, there are activities such as guidance and drug development consortia that are actively engaged in collaboration with patients. 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
The theme of the meeting was "Decentralized Clinical Trial (DCT) - a clinical trial method that does not depend on visits to medical institutions - in Japan," chaired by Kyoko Imamura of the University of Tokyo Graduate School of Medicine and Hiroshi Matsuzawa, Chairman of the Clinical Evaluation Committee, Pharmaceutical Evaluation Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ). The theme was "Decentralized Clinical Trial (DCT) - a clinical trial method that does not depend on visits to medical institutions - in Japan. At the beginning of the session, Dr. Imamura gave a lecture on the current situation and issues in the Corona Disaster, where interest in new drugs is growing, online medical care and remote access are being promoted, and the use of ICT in clinical trials is desired. Next, Mr. Soichiro Matsushima, a member of the Clinical Evaluation Subcommittee of the Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan, gave a presentation entitled "Toward the Realization of Clinical Trial Methods that Do Not Require Visits to Medical Institutions: Current Status and Issues from the Standpoint of Pharmaceutical Companies," followed by Mr. Haruro Kuroki of Sotobo Kodomo Clinic of Medical Corporation Tsugyokai. Haruo Kuroki of Sotobo Children's Clinic, Medical Association of Japan, "Expected value and points to keep in mind for the use of online medical care in clinical trials," Yasushiro Kishimoto of Keio University, "Industry-academia collaboration for central evaluation and Location Flexible Trial in psychiatry," and Yumiko Nomura of the Research and Development Promotion Division, Medical Policy Bureau, Ministry of Health, Labour and Welfare, "New clinical trials to improve patients' access. The issues to be addressed in DCT include the process of obtaining consent, implementation of tests, ensuring the safety of subjects, the concept of data reliability, and regulations on the use of devices. The issues included the process of obtaining consent and conducting tests, ensuring the safety of subjects, the concept of data reliability, and regulations on device utilization.
Symposium 11
Junko Sato, Director of PMDA's International Division, and Yuji Kashiwatani, Chairman of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan, 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 Pharmaceutical Manufacturers Association of Japan (PMAJ), and Makiko Hama, a member of the PMAJ, 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 Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) presented the following two topics.
The results of the questionnaire survey, which has been continued every year under the theme of "Questionnaire on the Review Status of New Drugs 2020," were presented by committee members Keikei Yamamoto and Natsuko Hamada, who also presented the results of the survey on the review fields, review formats, and electronic data submission status of items approved in 2019 by the 72 member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ). The survey also presented opinions and requests received from the companies that responded to the survey, such as the timing of important inquiries regarding the package inserts and risk management plans (RMPs).
Masahito Kurishita, Osamu Sugiyama, and other committee members presented the current status of development projects at the member companies of the Pharmaceutical Affairs Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) under the theme of "Consideration from the Global Development Implementation Status of Development Projects at the Member Companies of the JPMA Pharmaceutical Affairs Committee" regarding more efficient global development strategies 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. Although ICH-E17 has been implemented in many countries and the training material was published on the website of the 2019 International Conference on Harmonization of Pharmaceutical Regulations (ICH), its active use has not been recognized in Japan, and we will continue to monitor 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.
Scene of the Poster Session
Closing 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.
(Dr. Saiko Murata and Dr. Miyoko Onoda, Pharmaceutical Affairs Committee)