Topics The 139th Annual Meeting of the Committee on Drug Evaluation held Reflecting on the New Coronavirus - Sharing Best Practices and Resolving Domestic Issues
The 139th General Meeting of the Committee on Drug Evaluation was held on November 2, 2021 at Muromachi Mitsui Hall & Conference (Chuo-ku, Tokyo) and via webcast. Although the fifth wave of novel coronavirus infection is subsiding, the situation was still not reassuring. Therefore, only about 40 executives of the Pharmaceuticals Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and speakers participated from the venue again this time, while about 700 other committee members participated online.
General view
The program of the meeting consisted of three parts, with the first part focusing on the efforts of companies and academia, and the second part on the future of the pharmaceutical industry in light of the pandemic and the state of regulatory science under emergency conditions. In Part 3, panelists included speakers from Parts 1 and 2, with Kazuhiko Mori, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and Chikara Kikuchi, Vice Chairman of the Drug Evaluation Committee, serving as chairpersons, who discussed the difficulties of drug development during a pandemic of a new coronavirus infection, the experiences of changing from normal conditions, and what the future should be based on these experiences. The panel discussion was chaired by Mr. Mori, Senior Vice President and Chairman of the Board of Directors.
Part 1: Learning from actual cases of novel coronavirus vaccine and drug development
1) "Development of comunities
Dr. Noriko Morikubo, Group Leader, Development and Regulatory Affairs Group 2, Pfizer R&D
Mr. Masui explained how Pfizer R&D's Cominati obtained Emergency Use Authorization (EUA) for vaccine development in about 10 months, which normally takes more than 10 years to complete. He explained that the short EUA was achieved not only because of the scientific foundation of the mRNA vaccine, which had already been established, but also because of the flexibility of the regulatory authorities, the innovation of clinical trial operations, the use of real world evidence (RWE), and the investment of funds and the determination of regulatory and internal priorities in the face of the risks involved. The presentation also included an introduction to the company.
2) "Development to Approval of Baricitinib as a Treatment for SARS-CoV-2 Pneumonia
Dr. Atsushi Tsukada, Manager, Development Regulatory Affairs Specialty Section, Regulatory Affairs Department, R&D and Medical Affairs Division, Eli Lilly Japan
He explained about Eli Lilly Japan's baricitinib, from therapeutic drug discovery to innovations in clinical trial design and evaluation, as well as its strategy for submitting for approval. In May of the same year, an investigator-initiated global Phase III clinical trial (ACTT-2) was initiated, and in November of the same year, an EUA was obtained in the United States. He also introduced the importance of early agreement with Global and close communication with the authorities in order to achieve early submission and approval in Japan.
3) "Novel Coronaviruses and Ivermectin
Dr. Hideaki Hanaki, Professor and Director, Center for Infection Control Research, Kitasato University
He also explained the efficacy and safety of ivermectin against novel coronaviruses, focusing on the PK/PD theory. He also introduced the results of clinical trials in Lebanon, Bangladesh, India, and other countries, as well as the current situation in Africa, Argentina, Peru, India, and the Dominican Republic, showing that ivermectin administration may have reduced the number of deaths due to novel coronavirus infection. Finally, he described clinical reports and peer-reviewed papers on ivermectin, pointing out problems and questions with the withdrawn papers.
Part 2: Novel coronaviruses, domestic regulations, and regulatory science
1) "The Future of the Pharmaceutical Industry as Read from the Pandemic
Mr. Keita Masui, Executive Officer, Deloitte Tohmatsu Consulting
He suggested that the pandemic may have revealed the need to improve productivity in drug research and development, and presented data showing that productivity in drug development may have actually stopped declining in 2020 and then begun to rise. He explained that homogenization, standardization, and digitalization are influencing this productivity improvement, and that it is important to pay attention to information technology. In addition, the use of various healthcare data and evolving digital technologies is enabling the pharmaceutical industry to become more efficient and value-added, and the increasing confidence in pharmaceutical and biotech companies due to the pandemic has made further disclosure of information necessary. The need for further disclosure of information was also indicated. The participants shared the view that it is necessary to pay attention to the advantages of "collaborative creation" in the future, and that standardization, standardization, assurance of trust, and advocacy to the public are necessary for this purpose.
2) "Regulatory Science in the COVID-19 Emergency"
Dr. Hiroshi Kasanuki, Advisor, Institute of Medical Regulatory Science, Waseda University
The number of positive cases in Japan and the main activities and meetings held during that period were explained. He talked about how regulatory science should be applied in special situations such as a pandemic, not in normal times, and the importance of risk-benefit balance assessment, prompt prediction, evaluation, and judgment based on little data information, and decision making and implementation from the viewpoint of scientific rationality, social rationality, and political rationality. He talked about the importance of making decisions and implementing them from the viewpoint of scientific rationality, social rationality, and political rationality. Finally, he touched on the challenges and ideal state of clinical development and emergency approval of domestically produced vaccines and therapeutics under pandemic conditions from the perspective of regulatory science, suggesting that now is the last chance for Japan to be reborn as a vaccine superpower.
Part 3: General Discussion (Panel Discussion)
The panel discussion began with the chairperson, Mr. Mori, Executive Director, asking the four panelists (Mr. Kasanuki, Mr. Masui, Mr. Morikubo, and Mr. Tsukada), "What has changed due to the coronavirus disaster?
Mr. Tsukada shared that the trigger for the development was the results of AI analysis, and that although this was the first time for Eli Lilly Japan to submit an application only for investigator-initiated clinical trials, it was an experience that will be useful in the future. Mr. Masui shared that the world has changed greatly and that the virtual Dr. Masui shared that the world has changed drastically and virtual digital technology and in-silico drug discovery are rapidly being implemented, and that an information infrastructure that is not closed, including IT, is necessary for rapid decision-making. Mr. Kasanuki shared his opinion that the relationship between science and politics will change drastically, and that science-based innovation and regulatory science for emergencies are also necessary.
Dr. Tsukada shared the importance of leadership as a Japanese corporation and cooperation with regulatory authorities.
The panelists also emphasized the importance of open and sufficient communication with the public, which is also linked to Patient Centricity, the importance of public relations, investor relations, and advocacy, and the importance of regulatory science for the benefit of people and society. He also emphasized the importance of transparency and accountability, although there is no right answer.
The four-hour General Meeting of the Drug Evaluation Committee was concluded with a closing speech by Mr. Mori, Executive Director.
(Drug Evaluation Committee, Toshiharu Sano )