08Dr. OCHI MitsuoBorn in 1952 in Ehime Prefecture, Dr. Ochi graduat-ed from the School of Medicine, Hiroshima Universi-ty, in 1977. In 1995, he was named Professor at Shi-mane College of Medicine (the present-day School of Medicine of Shimane University). In 2002, he as-sumed the post of Professor at Hiroshima University Graduate School of Biomedical and Health Sciences (Section of Orthopedic Surgery). After serving as the Director of Hiroshima University Hospital for several years, he has been President of Hiroshima University since 2015. Dr. Ochiʼs medical specialization is ortho-pedic surgery with a focus on knee joints and sports medicine. The regenerative treatment of cartilage that he developed is the first medical care of its kind that has become entitled to public health insurance coverage in Japan. In 2015, Dr. Ochi was awarded the Order of Culture, Medal with Purple Ribbon. His major committee appointments include the Special Committee on Comprehensive Policy of the Council for Science and Technology of the Ministry of Education, Culture, Sports, Science and Technology (MEXT) (member, 2019-2021 and 2021-2023), the Science Council of Japan (member, 2017-2022; col-laborating member, 2011-2017 and 2022-), and the Central Council for Education of MEXT (member).also has a division in charge of conducting results), and the subsequent procedures of commercialization. They even teach the regulatory aspect, what the FDA (Food and Drug Administration) does. In Japan, on the other hand, clinical trial methodology and other matters relating to regulatory issues are not covered at all.Ochi: Are you taking any action in your capacity as PMDA Chief Executive?Fujiwara: Yes, of course. We have been ap-pealing to MEXT for the inclusion of the drug commercialization process in the medical school curriculum. Weʼve also been speaking out about the importance of doing this, but itʼs been a real challenge. To change the current situation, action would be necessary in all aspects, including financial review and overall institutional restructuring.Ochi: I hope you will continue working on it. Now, let us look back on our college days a little. What did you enjoy the most in college? What are the courses and programs that turned out to be particularly useful for your professional life later?Fujiwara: I enjoyed the whole range of experiments using rabbits and mice the most, rather than lectures. I was able to totally immerse myself in what I enjoyed doing. I believe many such experiences led me to go into Pathology later.Ochi: At Hiroshima University, we are working on reform measures that would lead to secondary school environments where stu-dents can freely pursue their interests, rather than simply focusing on preparation for col-lege entrance exams. Such measures would include an admission system that evaluates candidates based on individual activities, and not just by one-off exam results.Fujiwara: Because people usually excel in what they love doing.Ochi: Before closing our talk, would you like to share with us what you expect from Hiroshima University in the future?Fujiwara: I would love to see HU offer an undergraduate or postgraduate course that teaches the commercialization process of pharmaceuticals and medical devices. Today, most universities are halfway there. They excel in basic research, but don't teach enough about how to apply that knowledge to transform medical care for people. I want Hiroshima University to be one capable of such equipping.Ochi: To do so on our own, we must secure exceptional faculty members.Fujiwara: One way to do that is forming part-nerships with overseas universities. At pres-ent, the university thatʼs leading the world in this regard is probably Oxford. Harvard international joint clinical trials. I think you could make the changes you desire if Hiroshi-ma University formed partnerships with such universities.Ochi: Weʼd love that, building new frame-works, with your cooperation, perhaps. Dr. Fuji-wara, thank you very much for your time today.Fujiwara: Perhaps itʼs the idea that "Friends who have shared the same pot of rice will look after each other for life." If somebody I've been through thick and thin with is struggling, I make sure to lend a helping hand and try to find a way out together. I think this idea is influenced by jin (Revere heaven and love people).”Ochi: Offering sincere support is important. You became the PMDA Chief Executive in 2019. How do you find Japanʼs medicine and medical community today viewed from your position?Fujiwara: Japan has an excellent universal health insurance system that allows access to high-quality medical care anywhere. But recently, we are facing an extremely serious problem of so-called “drug loss,” that is, new drugs are not as readily developed and imported into Japan as before.Ochi: Is that because drug prices are lower in Japan?my maternal grandfatherʼs motto, “Kei ten, ai Fujiwara: Thatʼs one reason, but mostly itʼs because an increasing number of newly founded foreign companies donʼt find devel-opment in Japan attractive. Thatʼs for such reasons as having to communicate in Japa-nese and many Japanese medical institutions becoming less and less research-oriented.Ochi: I have also noticed that tendency. Japanese medical institutions love to spend a lot of money on large-scale equipment and innovative research projects, but I feel that they donʼt allocate their funds generously to younger researchers. How do you think the Japanese medical community should establish a research system that is attractive to overseas companies?Fujiwara: We need doctors who are well-versed in the process of drug development, from clini-cal trials to the marketing of actual products. In 1996, when I was in the US, the American Society of Clinical Oncology and the American Association for Cancer Research commenced a joint organization of workshops on clinical trial methodology for young physicians. For each workshop, about 100 participants chosen from all over the country gather together to intensively learn about the commercialization of drugs. The workshops are still held today. I donʼt know of any such initiatives in Japan. It would be very difficult to do something similar in Japan because there are very few people who can serve as trainees. Speaking of commercial-ization, Dr. Ochi, you have set an example with the new treatment method you developed.Ochi: I developed a regenerative medicine treatment that involves taking out a small healthy part of a patientʼs knee cartilage, culturing it three-dimensionally, and transplanting it onto the damaged part of the patientʼs knee cartilage. In the process of de-veloping this treatment, the cartilage culture technology was transferred to an Aichi-based venture company, Japan Tissue Engineering Co., Ltd. The treatment has since helped numerous athletes as a definitive repair for knee cartilage damage often caused by sports injuries. Moreover, in April 2013, the surgery using this technique became reimbursable by public health insurance. Our research serves patients and has also given birth to a new business using regenerative medicine.Fujiwara: Your case is extremely rare, and this kind of possibility is not made known to medical students today.Ochi: To turn around the situation in Japan, how about having organizations like PMDA launch workshops like those in the U.S., for-malizing them into a certification program?Fujiwara: I think education is the key. In the US, medical schools provide thorough instruction in basic research, translational research (research aimed at translating basic research results into practically applicable In the PMDA Chief Executive's Office, surround-ed by piles of documentsReform in Japanʼs medicine starting from medical school
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