米国での医薬品開発に関するショートコースを開催しました。
下記に開催報告を掲載します。

トピック：Drug Development and the Regulatory Response
日時：2021年10月22日(金)　9：30～11：00
実施方法: オンライン(ZOOM)

Report
Kyoto University School of Public Health Short Course on October 22, 2021.
Regulators’ Paradox to Bring in Novel Medicine

Speaker:
Dr. Lu Chia-feng, Senior Partner, Greenberg Traurig LLP (Washington D.C. and Tokyo)

Brief Description of the Short Course:
The organizational reputation of the regulator in medicine has been the primary source of its power, yet also one of its ultimate constraints. Extremely diversified and inconsistent expectations from different stakeholders to the regulator further complicate the regulator’s mandate in the regulation of the novel medicine development, supply, and distribution. This short course would like to take advantage of the past expedited development of COVID-19 vaccine story and current Biogen/Eisai’s Aduhelm approval to examine the regulator’s response to the medical needs of the society. Chia-Feng Lu has obtained his first-hand experience through the U.S.’s Operation Warp Speed for the development and partnership negotiation for the medicinal product launch. His current base in Washington D.C. also offers us a close look at ongoing PDUFA VII and 21st Century Cures Act version 2.0 negotiation on the Capitol Hill. This short course aims to inspire us to contemplate what the actual policy making know-how we should acquire, the infrastructure of the society we should invest, and how we can eventually bear the fruits of our enthusiasm to global health in the actual reality.

Summary:
Dr. Lu taught the participating students and faculty members about the underlying ideas among the US general public as well as the policy makers concerning various decisions to be made in the American society, including how to deliver therapeutic medicine such as COVID-19 vaccine. As freedom and right to choose are highly valued in the United States, no government agencies are mandated with the authority to impose a specific and same method to everyone, when trying to create a policy to prevent the spread of COVID-19. Dr. Lu also highlighted the importance of appointing the right leader to oversee a new project such as combating with COVID-19. It is important for a leader to understand and make decisions with the knowledge about not only the unprecedented scientific viewpoints but also procedural obstacles such as supply chain issues of the vaccine. The selection of the leader and associated criteria shall be well established before the need emerges. Moreover, the leader must be able to make decision to involve key stakeholders such as pharmaceutical companies so that they can provide the new vaccine in a timely manner and still can be profitable to sustain their business. Such stakeholder engagements and alignments shall be set forth by the due process and mechanism agreed by the society upfront. Ideally, the decision to provide COVID-19 vaccine is based on science and bring merits to everyone, but in reality, it is important to be strategic and take into considerations of timeliness and fair distribution of the vaccine. A sensible policy making during the public health crisis is determined by a competitive decision-making process and mechanism, and the society shall invest most its time and resources to construct such process and mechanism.

Special Thanks to:
Prof. Koji Kwakami, Department of Pharmacoepidemiology, School of Public Health, Graduate School of Medicine, Kyoto University.

Organized by:
Dr. Ayako Kohno, Program-specific Assistant Professor, Internationalization Promotion Office (IPO), Kyoto University School of Public Health