Meeting Highlights: DIA Japan 2021
Japan and the Pandemic: New Challenges, New Solutions
Pfizer R&D Japan
Stewart Geary
Eisai Co., Ltd.
he theme of DIA Japan 2021, “New Challenges, New Solutions: To Overcome With People All Over the World,” reflected the current background of marshaling resources from regulatory authorities, industry, and academia to develop innovative new therapies in the midst of an unexpected public health emergency while simultaneously transforming daily work practices during lockdowns and limited public access to hospitals.
New Society and Healthcare Ahead of the Digital Revolution
Current and Future State of Drug Development Under COVID-19
PMDA in Japan, as well as the EMA and FDA, issued regulatory guidance for sponsors in changing trial protocols to adapt to the pandemic and yet ensure essential GCP compliance. Other impacts highlighted the need for further collaboration on GMP inspections in response to sudden shifts in supply chains. Globally, the role of the International Coalition of Medicines Regulatory Agencies (ICMRA) has become more important during the pandemic, as it has held several workshops on the development of vaccines and therapeutics and issued official statements on clinical trials, regulatory flexibility, remote inspections, emergency authorizations, and a host of issues related to public health and confidence in vaccines.
Collaboration and transparency between regulators, industry, healthcare professionals, and patients will remain essential to enabling rapid adoption of new processes and tools. The drug and vaccine regulatory evaluation system must continue to earn and sustain the public’s trust. Transparency in policy making is as important as transparency in science, or “open science,” which we’ve seen demonstrated by several sponsors publishing their COVID-19 vaccine study protocols for broader use. The multiplication of media sources providing sometimes incomplete or inaccurate information presents the public with a wide range of both useful and misleading information, making it difficult for people to know which source they can trust. What are the public’s most pressing questions about the pandemic, and what would they like to learn more about? Answering these questions is essential to transparent public communication.
Session Chairs: Junko Sato, PMDA; Hironobu Saito, Daiichi Sankyo.
Panelists: Emer Cooke, EMA; Yasuhiro Fujiwara, PMDA; Satoshi Iwata, National Cancer Center Hospital; Theresa M. Mullin, FDA; George Nakayama, Daiichi Sankyo.
PMDA Town Hall
Session Chairs: Toshihiko Doi, National Cancer Center Hospital East; Takuko Sawada, Shionogi & Co. Ltd.
Panelists: Mie Ikeda, Office of Safety I; Kiyomi Ueno, Office of Safety I; Yasuhiro Araki, Deputy Director; Kenichi Tamiya, Associate Executive Director; Kensuke Ishii, Office of Medical Devices I; Yoshiaki Uyama, Office of Medical Informatics and Epidemiology.