＜Report＞The 3rd GSDM International Symposium
“Global Governance and Innovation in the Fields of Medicine and Health”
23rd Feb, 2016 　13:30~17:30
(Ito Hall, Ito International Research Center, Hongo Campus of the University of Tokyo)

Crosscutting speeches: Global public health and medical innovation

Report
In cross-cutting session, three professors delivered their passionate and inspirational speeches on “global public health and medical innovation”.
First speaker was Professor Hideaki Shiroyama, GSDM Program Coordinator and Dean of the Graduate School of Public Policy. He kicked off the session with a brief introduction of the GSDM Program and then moved on to current issues in global health governance and its possible countermeasures, which require cross-sectoral approach. Namely, (1) strengthening of international surveillance system, which is centered on the International Health Regulations (IHR), (2) development of independent risk assessment framework in emergency setting, especially that of the Public Health Emergency of International Concern (PHEIC), and (3) establishment of sustainable financing mechanism for emergency response and improvement of health system in non-emergency setting. He discussed the need for institutional improvement in international organizations, multilevel and interagency cooperation between private organizations, NGOs, and the international organizations, and reform of the present system to enable the transition, and concluded his speech by showing practical measures and steps to tackle the situation.
Second speaker was Professor Kenji Shibuya from the Department of Global Health Policy, Graduate School of Medicine. Professor Shibuya first introduced the path Japan has taken to contribute to global health. From the establishment of the Global Fund at the Kyushu-Okinawa summit in 2000 to the promotion of universal health coverage (UHC) around the world, Japan has been playing a pivotal role for achieving a peaceful and healthier world. Unfortunately, despite the substantial increase in the funding for health in developing countries, the Ebola virus outbreaks exposed fundamental weakness in the global health governance. In the end of the presentation, Professor Shibuya highlighted the importance of collective action to promote research and development, especially in neglected tropical diseases (NTDs) and diseases threatened by antimicrobial resistance (AMR), for global health security and to not again repeat the tragedy of Ebola.
Last speaker was Professor Vish Krishnan from Rady School of Management, UC San Diego. Huge investment and uncertain recapture of profit, bio-medical industry always lacks the incentive to innovation. Professor Krishnan pointed out the reason is that there is a translational gap from lab to market. But can we improve it? He mentioned 4 principles: (1) being with the end goal, (2) agile development approach, (3) leverage predictive, safety & efficacy biomarkers, and (4) training the workforce and management of the future is a major task! Not only from academic field and market field, government also plays an important role to facilitate the development of bio-medical industry. Through regulations, policies or special system, government can short the gap from lab to market. That is the reason why the National Institutes of Health (NIH) translational sciences always cooperate with several different fields, and try to integrate all stakeholders to trigger the innovation engine for the entrepreneurial economy. (466 words)
　　　

Session 1 “Global Health Governance”

　　　
Session 1 focused on the theme of building a crisis management framework for the threat of possible global pandemics in the future, as well as on the concept of ideal governance of global health. Five experts specializing in global health were invited from international organizations, the Government of Japan, various foundations, and private partners to participate in an extensive discussion from different perspectives with students for further understanding of the themes.
　　　
Panel Reports
In light of the Ebola hemorrhagic fever epidemic last year, Dr. Shams Syed of the World Health Organization emphasized that the essential elements of global health are the designing by each state of a health system oriented toward the local level, quality improvement of healthcare services and access to clean water and surgical care, and concrete actions taken so that the policies do not remain merely theoretical. The spread of Ebola exposed the lack of communication between organizations involved in its response. Mr. Atsuyuki Oike, Ambassador at the Ministry of Foreign Affairs, reported the plan to set up a committee that oversees individual WHO-related bodies, as well as to establish a professional organization that specializes in coordinating the roles played by the respective bodies, both of which are currently in discussion. Dr. Tadataka Yamada subsequently introduced the key recommendations recently put forward by the National Academy of Sciences, which included the following: making an additional annual investment of a billion dollars in research and development, considering that countermeasures against infectious diseases are a matter of national security; establishing a committee that reviews the portfolios in order to eliminate redundancy in the functions of individual bodies and biased investments; and conducting evidence-based assessment especially in times of such emergencies. Dr. B. T. Slingsby then briefly touched on the funding mechanism and private partners and foundations of the GHIT Fund, a public-private partnership that funds drug discovery catalyzed by Japanese innovations. Lastly, Mr. Tetsuo Yoshioka, Councillor of the Cabinet Secretariat, introduced the government’s policy to contribute to the funding mechanism in times of emergency, to develop a platform for public-private partnership in times of peace, and to implement programs for the training of personnel actively involved in works at international organizations and in countries experiencing epidemics.
　　　
Discussion with Students
The students shared similar views with the panel in terms of the recently experienced epidemic, that the strengthening of the health system in times of peace is critical in preparing for emergencies. For the improvement of the health system in the long term, they also indicated the need for investments based on the proper assessment of governance, using clear benchmarks. Questions were raised regarding the fact that less emphasis is placed on the development of diagnostic technologies; quick and accurate diagnosis of patients with unidentified fever is critical in preventing the spread of an infection, and yet the investment plan by the GHIT Fund allocates only a small percentage on the development of diagnostic technologies.
The panel then answered the questions raised by the students. For the question about the ways to build a sustainable and effective health system, the suggestions included proposing a system modeled after a successful example, as well as developing states investing in their own national health systems instead of resorting to development aids. For the question about whether to prioritize global health or economic growth, most of the panel members agreed that the two ideas do not necessarily contradict each other; some argued that investment in global health rather promotes economic growth, as seen in how the development of vaccines contributed to economic progress. Lastly, the following future challenges and issues were also raised, contributing to a fruitful discussion: all states should be responsible for recognizing the importance of countermeasures against infectious diseases and investing in their research and development; and the lack of emphasis placed on the development of diagnostic technologies in Japan is due to the small number of proposals submitted, as well as the incompletion of a platform for development.
　　　

Session 2 “Biomedical Innovation”

Report
In session 2, five specialists, namely, Professor Vish Krishnan (Rady School of Management, University of California, San Diego), Professor Mamoru Mitsuishi (Dean of the School of Engineering, the University of Tokyo), Mr. Keita Mori (Co-CEO, Chairman, Co-Founder, SanBio, Inc.), Mr. Masahiko Saito (General Manager, Commercial Risk Solutions Department of Sompo Japan Nipponkoa Insurance Inc.), and Ms. Hiroko Otsubo (Cabinet Secretariat, the Office of Healthcare Policy) were invited to discuss with Global Leader Program for Social Design and Management (GSDM) students measures to fill the gap between R&D activities and their applications to clinical practices.
　　　
First, Professor Vish overviewed the overall process from research and development to applications in medical scenarios. This overview was followed by reference to the peculiarity of R&D in biomedical sciences, including long and continuous efforts required and uncertainties involved in it. Then he talked about global issues such as outbreaks of new infectious diseases and emphasized the necessity of utilizing information science and configuring networks for a faster and more effective process to manage such situations. Next, Professor Mitsuishi and Mr. Mori introduced the current situations and issues to be solved from the perspectives of a researcher engaged in R&D activities and a practitioner, respectively. Professor Mitsuishi presented the stages of medical equipment development in the academia through examples of cases with surgical robots. Then he suggested that as future research themes, the security/effectiveness evaluation systems for quicker pharmaceutical approval reviews could be reexamined and human resources could be developed in R&D activities from a perspective that fully incorporates the approval reviews. Mr. Mori discussed a case of transplanting stem cells into brain as an example of business model in regenerative medicine to emphasize the importance of both business approaches and research and development, including fund raising, production management, and partnership in order to commercialize new medical technology. Next, Mr. Saito cited cases of insurance products targeting regenerative medicine, to emphasize the role of private insurance companies in supporting R&D in innovative medical technology and the latter’s commercialization with respect to funding, as well as the necessity of industry–government collaborations. Last, Mr. Otsubo introduced a governmental strategy to develop new medical and pharmaceutical products using an “All-Japan” approach by creating a drug development support network provided by Japan Agency for Medical Research and Development (AMED), which connects drug development and out-licensing for practical use.
　　　
Building on the presentations by the five panelists, a team of GSDM students (represented by Mr. Mehtonen) introduced four themes obtained through process mapping from R&D to clinical applications: selection of optimum research target, improvement of efficiency in the approving process, bridging of R&D in academia with the industry, and development of cross-sectional and fluid human resources in the industry, government, and academia. Drawing on the exchange of opinions among the panelists on these themes, Professor Hiroshi Suzuki, the moderator, pointed out the importance of incorporating an economic perspective and governmental strategy in addition to social and patient needs when choosing a research target. He suggested that this will help create an ecosystem for innovations in medical services to reduce the gap between R&D and practical applications. He also suggested future research themes, including utilization of data science for improved efficiency of the overall process; fluidity of human resources and deployment of R&D into global channels; and construction of platform, including networking, to support them.