2025 Participant Biographies

Dr. Yoshihito Kano is a board-certified medical oncologist at Institute of Science Tokyo, specializing in gastrointestinal and head and neck cancers. He is deeply engaged in precision oncology and cancer genomics, with a focus on KRAS and MAPK signaling pathways. His translational research has led to novel insights into targeted therapies and resistance mechanisms, resulting in publications in leading journals. Dr. Kano has pioneered the use of liquid biopsy in head and neck cancers, bringing real-time genomic monitoring into clinical practice in Japan. He also mentors young physicians and students and actively promotes cross-sector collaboration. His goal is to bridge research and clinical care, and to contribute to developing robust clinical trial and innovation ecosystems in Japan, inspired by best practices from the U.S.

Dr. Hidetaka Kioka graduated from the University of Osaka Medical School in 2000 and trained as a cardiologist. In 2007, he began basic research and identified G0s2, a protein that enhances mitochondrial oxidative phosphorylation in cardiomyocytes (PNAS2014). After earning his PhD, he served as a chief physician treating advanced heart failure and discovered BAG5 as a novel gene for early-onset and life-threatening dilated cardiomyopathy (Sci Transl Med2022). Dr. Kioka now leads preclinical studies on small molecules targeting G0s2 for heart failure and AAV-based in vivo gene therapy for BAG5-deficient cardiomyopathy. He applied to the Mansfield-PhRMA Research Scholars Program to learn strategies for advancing toward clinical trials.

Dr. Tomoya Kitani is a physician-scientist and Assistant Professor in the Department of Cardiovascular Medicine at Kyoto Prefectural University of Medicine. As a board-certified cardiologist of the Japanese Circulation Society, he is involved in both the clinical care of heart failure patients and research into its molecular mechanisms. He uses human induced pluripotent stem cells to model cardiovascular disease and investigate chemotherapy-induced cardiotoxicity in cardio-oncology. Dr. Kitani has authored more than 20 peer-reviewed publications and has received several honors, including the Young Investigator Award from the Japanese Heart Failure Society and the Best Research Award from the Japanese Onco-Cardiology Society. He is a Fellow of the American Heart Association and serves as a Councilor of the Japanese Heart Failure Society and the Japanese Section of the International Society for Heart Research. His goal is to advance translational research by bridging molecular discoveries in cardiovascular biology with clinical therapies.

Dr. Michihito Kono graduated from Hokkaido University School of Medicine in 2006, completed his clinical training in Rheumatology and earned his Ph.D. from Hokkaido University under the mentorship of Prof. Tatsuya Atsumi. He conducted research on the T cell metabolism in the pathogenesis of systemic lupus erythematosus under the mentorship of Prof. George C. Tsokos at Harvard Medical School. After going back to Japan, he has continued his research focusing on cellular metabolism in autoimmune diseases, and he has been published as corresponding/first author in several major journals, including Nature Communications. He serves as the Secretary General of the Japanese SLE Practice Guidelines Committee. Over the past three years, he has contributed as the principal investigator for 40 industry-sponsored clinical trials. Now, he is Lecturer in Rheumatology and Nephrology, Hokkaido University Hospital.

Dr. Ken Matsuoka is a cardiologist and basic medical researcher working at Osaka University. After graduating from Osaka University School of Medicine in 2003, he worked as a cardiologist but was faced with untreatable heart diseases such as myocarditis and cardiomyopathy and began researching the elucidation of the pathology and development of therapeutic drugs. Currently, as an associate professor in the Department of Medical Biochemistry at Osaka University, he is conducting research on the development of new diagnostic and treatment methods for myocarditis, and the establishment of cardiomyocyte-specific AAV gene therapy for cardiomyopathy. Dr. Matsuoka participated in this training because he is currently aiming to conduct clinical trials and commercialize these seeds.

Dr. Yoshihiro Ono received his M.D. from Keio University School of Medicine in 2004. After completing his internship and general surgery residency in Japan, he underwent specialized training in hepatobiliary, pancreatic, and transplant surgery at Keio University Hospital since 2008. From 2011 to 2014, he completed a clinical fellowship in gastroenterological surgery at the CancerInstitute Hospital, Japanese Foundation for Cancer Research (JFCR). Dr. Ono then spent three years as a research scholar at the University of Pittsburgh, working in both the Departments of Pathology and Surgery. Since 2017, he has been practicing at the Division of Hepatobiliary and Pancreatic Surgery at the Cancer Institute Hospital, JFCR. His clinical and research interests include pancreatic cancer surgery, vascular reconstruction, and multidisciplinary treatment strategies.

Dr. Mashiro Satoh is a board-certified cardiologist engaged in basic research aimed at addressing clinical challenges. Since his time in graduate school and during his research abroad, Dr. Satoh utilized omics approaches-genomics, transcriptomics and epigenomics to elucidate the mechanisms underlying cardiovascular diseases, including heart failure, atrial fibrillation, and congenital heart disease. He actively collaborates on research projects both within Japan and internationally. Notably, a genome-wide association study on spontaneous coronary artery dissection has been initiated in collaboration with Dr. Nabila Bouatia-Naji at INSERM-PARCC in France. In recognition of the significance of this collaborative effort, he was honored with the INSERM-PARCC–RIKEN Young Investigator Award in September of last year. In addition to his research activities, Dr. Satoh also sees patients in cardiology outpatient clinics twice a week, where he strives to bridge basic research with clinical practice to address unmet medical needs.

Dr. Kanako Teramoto is a cardiologist by training and a senior researcher at the National Cerebral and Cardiovascular Center. Following clinical training, I earned a PhD from St. Marianna University School of Medicine (Kawasaki, Japan) in 2017 and a Master of Public Health (MPH) from Harvard T.H. Chan School of Public Health in 2018. Areas of expertise include heart failure, echocardiography, and biomarkers. Mentored by renowned trialists from the US and Asia, she is currently involved in domestic clinical trials and registry-based studies. I serve as a Fellow of the Future Trialists Fellowship, organized by the Cardiovascular Clinical Trialist Forum, with an overarching goal to become a clinical trialist representing the heart failure community in Japan.

Observers from AMED, PMDA, and METI

Dr. Atsushi Mabuchi currently serves as Chief in the Division of Pharmaceutical Research and Development, Department of Innovative Drug Discovery and Development, at the Japan Agency for Medical Research and Development (AMED). In this role, he is engaged in advancing pharmaceutical research and promoting drug development initiatives. After earning a B.A. in Education from Miyagi University of Education, he completed an M.A. in Education and obtained a Ph.D. in science from Osaka City University, where he obtained a Ph.D. He also holds specialized teaching licenses for junior high and high school science education.
Dr. Mabuchi began his research career at Kyushu University. From 2016 to 2019, he worked as a postdoctoral fellow at the Faculty of Science, before moving to the Plant Frontier Research Center, where he held consecutive positions as Postdoctoral Fellow, Specially Appointed Assistant Professor, and Assistant Professor until March 2023. During his time at Kyushu University, he contributed significantly to the field of plant science, both in research and education. In April 2023, he joined AMED in his current capacity, where he leverages his academic and research background to support strategic initiatives in pharmaceutical R&D.

Dr. Yuba Mitsuru is working as a reviewer of Software as a Medical Device (SaMD) in the Pharmaceuticals and Medical Device Agency (PMDA). He is in charge of computer-aided diagnosis (CAD) that utilizes AI technology and products that analyze the results of genetic testing and contribute to the prediction of drug efficacy and the determination of the optimal treatment strategy. Dr. Mitsuru also has experience in reviewing medical devices used in the field of gastroenterology and urology, including robotic surgical devices and colon stents. In addition, he represents Japan as a member of the SaMD Working Group of the International Medical Device Regulatory Forum (IMDRF). Previously, he was a research assistant at Waseda University, where he studied AI-based medical device regulation and earned his Ph.D. Dr. Mitsuru continues to lecture to graduate students as a part-time lecturer at Waseda University and as a visiting associate professor at Hiroshima University.

Mr. Yuta Iwabuchi is the Deputy Director of the Bio-Industry Division, Commerce and Service Industry Policy Group at the Ministry of Economy, Trade and Industry (METI). He joined METI Japan in 2018, and he has been posted several positions, including the Agency for Natural Resources and Energy and the Financial Services Agency. He has been in the current position since June 2024 and in charge of development of the drug discovery ecosystem through support for drug discovery startups etc.

Past Participants

2024 Participants

Dr. Kumiko Kida is an Associate Medical Director of the Department of Breast Surgical Oncology at St. Luke’s International Hospital, Tokyo. She is an attending breast surgeon and a board-certified clinical geneticist. She is one of the leaders of the Hereditary Breast Cancer Guideline Committee and a member of the Risk Prediction Working Group in the Japanese Breast Cancer Society. On the research front, she is involved in the planning and execution of clinical studies on breast cancer, collaborative translational research projects, and serves as the institutional principal investigator for clinical trials as well as the facility representative for clinical trial groups. She is currently engaged in ongoing translational research projects with teams from MD Anderson Cancer Center and the University of Hawaii.
Dr. Kida holds an MD and PhD from Yokohama City University and completed her surgical training and fellowship at St. Luke’s International Hospital. She completed her postdoctoral research fellowship in the Department of Breast Medical Oncology at the University of Texas MD Anderson Cancer Center.

Dr. Masatoshi Minamisawa is an Assistant Professor of Cardiovascular Medicine at Shinshu University School of Medicine and a Research Collaborator at Brigham and Women’s Hospital and Harvard Medical School. He graduated from Shinshu University in 2007 and worked at Shinshu University Hospital and Shinshu Ueda Medical Center, completing an internal medicine residency and a general cardiology fellowship. He obtained his Doctor of Medicine degree, specializing in clinical research on ischemic heart disease, heart failure, and echocardiography, in 2016. He then worked as a postdoctoral fellow in the Cardiovascular Division (Professor Scott D. Solomon’s lab) at Brigham and Women’s Hospital and Harvard Medical School from 2017 to 2021. He returned to Shinshu University and joined the faculty in 2022. He collaborates with both domestic and international clinical trial groups to conduct research aimed at advancing heart failure care, serving as a site investigator or sub-investigator.

Dr. Tojo Nakayama is a Project Associate Professor of Neurology and Neurological Science at the Tokyo Medical and Dental School. He is a physician-scientist with expertise in pediatric neurology and genetics. He completed pediatric neurology training at the National Center for Neurology & Psychiatry (NCNP). After earning his PhD in molecular genetics research on intractable epilepsy at RIKEN, he spent eight years at Boston Children’s Hospital as a postdoc, working on drug discovery programs for pediatric epilepsy disorders. Since relocating to Tokyo Medical and Dental University in 2022, Tojo Nakayama has been engaged in setting up the N-of-1 drug discovery research program in Japan.

Dr. Koichi Ogura is Head of the Department of Musculoskeletal Oncology and International Clinical Development at the National Cancer Center Hospital. He has trained in the fields of musculoskeletal oncology as an orthopaedic surgeon, and completed his graduate PhD work at The University of Tokyo and National Cancer Center (Tokyo, Japan) by focusing on comprehensive characterization of the sarcoma genome using the NGS-based approach. This experience as well as extensive clinical experience as an orthopaedic oncologist has provided him with a deep understanding of sarcoma biology and urged him to choose a postdoctoral career as a research fellow in the Department of Molecular Pathology, Memorial Sloan Kettering Cancer Center. He has developed an innovative approach to apply CRISPR-Cas9 genomic editing to generate model systems to study functional significance and therapeutic implication of clinically relevant molecules which was identified in MSK-IMPACT in Ewing sarcoma.
He is currently appointed as a head surgeon in the Department of Musculoskeletal Oncology and his duties include clinic, operating room, and several basic and translational research projects on sarcoma in collaboration with laboratories at the National Cancer Center Research Institute and some pharmaceutical companies.

Dr. Atsuko Imai-Okazaki, M.D., Ph.D., M.P.H., an Associate Professor of Diagnostics and Therapeutics of Intractable Diseases, Juntendo University, obtained her M.D. degree from Kobe University in 2005 and subsequently received a Ph.D. degree in medicine from Osaka University and M.P.H. degree from University of Manchester in the UK. She is a cardiologist and a specialist in clinical genetics. Dr. Okazaki obtained the skills of bioinformatics, biostatistics, and statistical genetics at McGill University, Baylor College of Medicine, Harvard Medical School and Rockefeller University.
By combining statistical genetics, clinical genetics and computer science, Dr. Okazaki developed a novel statistical method to prioritize sequence variants using Hamming distance. One of the clinical applications of her method is a mitochondrial disease cohort in Japan. She has assessed the relationship between long-term prognosis and genetic background of mitochondrial diseases. Her group also discovered a novel therapeutic agent that improved heart function by increasing mitochondrial energy production.

Dr. Yasutaka Okita, Assistant Professor of the Department of Medical Center for Translational Research, Osaka University, is deeply passionate about medical innovation. To that end, he plays three roles at Osaka University. First, as a project manager of R&D section, he supports the practical application of basic research discoveries. To date, he has assisted about 20 seeds to develop in vitro diagnostics, small molecule drugs, gene therapies and cell therapies, and he has a particular interest in supporting start-up companies. Second, as a rheumatologist, he examines approximately 70 patients every week and serves as the principal or co-investigator for several clinical studies and trials. Last, as a researcher, he carries out projects such as artificial intelligence development, basic research unraveling the mysteries of autoimmune diseases, and cohort studies as clinical research.
His goal is the improvement of medical care and the development of a curative treatment for autoimmune diseases. His vision drives his commitment to these diverse roles, ensuring that breakthroughs in research translate into real-world medical solutions.

Dr. Kazuki Sudo graduated from Niigata University School of Medicine in 2006 and joined St. Luke’s International Hospital in 2006, where he received initial and specialized surgical training. In 2012, he obtained a Board Certification in Surgery. The same year, he began studying at MD Anderson Cancer Center as a postdoctoral fellow in GI Medical Oncology for research on gastrointestinal cancers.
When he returned to Japan in 2014, he moved to the National Cancer Center Hospital to continue his clinical and research work in medical oncology. In 2017, he obtained a board of medical oncology. In the same year, he became a staff member in the Department of Breast and Oncology at the same hospital. At the same time, he concurrently assumed a position at the Rare Cancer Center. In 2020, he was promoted to head of physicians at the Department of Breast and Oncology (now the Department of Medical Oncology), with the concurrent appointment of Director of the Translational Research Promotion Office, International Development Division. In 2021, he was appointed the Director of the Office of Advanced Medical Care and Cost-Effectiveness Evaluation.

Dr. Mitsumi Terada graduated with his MD from the Jikei University in 2009 and obtained a PhD in 2019. From 2011 to 2016, he worked as a surgeon for gastrointestinal cancer, especially for gastric cancer from 2014. He joined the EORTC in 2017 as a medical research fellow and learned methodology of international clinical trials on European basis. At the EORTC, he proposed and organized some collaborative projects and events between JCOG (Japan Clinical Oncology Group) and EORTC, which let him realize the importance and significance of international collaboration. He is also interested in PRO/QOL research for cancer patients and a chief investigator of an international collaborative study to update the EORTC QLQ STO22, which is a QOL questionnaire for gastric cancer. In 2019, he was mainly involved in the establishment of Asian Partnerships Office (APO) in Bangkok, Thailand under the ATLAS project and appointed General Manager of APO in September 2021. Since December 2021, he has resided in Bangkok, where has has contributed to the development of partnerships with multiple stakeholders including academic institutions, regulatory agencies and pharmaceutical industries, and the establishment of a governance structure for the ATLAS network.

Observers from AMED, PHDA, and METI

Ms. Ai Yoshida joined the Japan Agency for Medical Research and Development (AMED) in August, 2017 and is currently serving as a manager in the Division of Data Utilization at the Department of Health and Clinical Data since April 2022. Her work focuses on establishing frameworks and platforms to facilitate the secondary use of data generated from publicly funded research. AMED platforms aim for not only utilizing data but also nexus of interdisciplinary research. Prior to this, from August 2015 to July 2017, on secondment from University of Occupational and Environmental Health, she worked as a section chief in the Division of Health for the Elderly within the Health and Welfare Bureau for the Elderly. She managed the Long-Term Care Insurance Comprehensive Database, which has the anonymized data from long-term care facilities to insurers. Her role involved preparation of connecting this database with another one. She also worked as an assistant professor in the Department of Preventive Medicine and Community Health from July 2015 to July 2017. She used big data to analyze the clinical conditions of sub-acute inpatients.
She is currently a Visiting Researcher at the Department of Preventive Medicine and Community Health at the University of Occupational and Environmental Health. Previously, She completed coursework in the Department of Social Medicine at Toho University School of Medicine without obtaining a degree in March 2015. She holds a Master of Science in Health Care Management from Keio University, earned in March 2008, and a Bachelor of Economy, also from Keio University, obtained in March 2006.

Ms. Akiko Kubo has been a reviewer of the Office of Pharmacovigilance Ⅱ in the Pharmaceutical and Medical Devices Agency (PMDA) since 2019. She is involved in post-marketing safety monitoring of vaccine products and blood products. Additionally, she has served as a program coordinator at the Asia Training Center for PMDA and been responsible for providing training courses on pharmacovigilance to foreign regulatory authorities. Through the training courses, she contributes to enhancing mutual understanding of regulations, and strengthening the collaboration with Asia and other parts of the world. Recently, her role is expanded as a reviewer of drug applications, including vaccine products and blood products from 2024.
She has a Master’s degree of Pharmacy from Keio University. Prior to her current position, she completed a pharmacy residency at Juntendo hospital, receiving a comprehensive training experience in pediatric pharmacotherapy.

Ms. Reina Kodera joined the Ministry of Economy, Trade and Industry (METI) in 2020 and currently serves as a Deputy Director in the Bio-industry Division, with a focus on the Commerce and Service Industry Policy group. Initially, Ms. Reina worked in the Policy Division of the Energy Conservation and New Energy Department, where she was involved in the overall management of renewable energy-related policies and energy conservation policies. She then spent her second and third years in the Wind Energy Policy Office, New Energy Division, where she worked on human resource development policies, international negotiations (with the EU and embassies of various countries), and the establishment of domestic supply chains. From her fourth year to the present, she has been working as a regenerative medicine, cell and gene therapy manager in the bio-technology division, supporting various related R&D and drug discovery ventures. In particular, she has been working on the development and planning of policies to support the development of automated equipment and manufacturing infrastructure in the manufacturing sector, such as CDMOs.

2023 Participants

Dr. Asumi Iesato is a clinical research fellow at the NEXT-Ganken program in the Japanese Foundation for Cancer Research (JFCR). After graduating from Shinshu University School of Medicine, she worked as a breast and endocrine surgeon for 10 years. From the time she was a graduate student through her postdoctoral fellowship at Beth Israel Deaconess Medical Center, Harvard Medical School, her main research interest was aggressive thyroid cancer. After returning to Japan, she worked at the Breast Center, Cancer Institute Hospital for the JFCR and then started reverse TR research. Her major research topics are thyroid cancer and breast cancer. Her goals are to improve the anaplastic thyroid cancer prognosis by more than one year and to develop targeted therapies for breast cancer with lymphatic invasion. Her long-term goal is to create a system that acts as a bridge between the hospital and the lab to provide basic research results to the bedside rapidly.

Dr. Mitsuho Imai is a Medical Oncologist at the National Cancer Center Hospital East. She concurrently works in the Department of Drug Development Promotion, TR Support Office, International Research Promotion Office, and Department of Genetic Medicine. As a core member of the SCRUM-Japan project based on genome screening, she is engaged in clinical research, in silico analysis such as AI/machine learning (ML) and Wet analysis as TR research, and practice of hereditary tumors. After specialized training in gastrointestinal oncology at Tokyo Metropolitan Komagome Hospital, she received her Ph.D. from the Graduate School of Medicine at the University of Tokyo. From 2015 to 2018, as a Ph.D. at the University of California, San Francisco (UCSF), she worked as a Ph.D. researcher to analyze cancer mechanisms, such as the metastatic mechanism of TNBC and the relationship between ncRNA and epigenetics in urogenital cancer, while also being involved in the establishment of a system for cancer genomic medicine.

Dr. Tomoya Kurokawa is an ENT physician and has been an Assistant professor at the Clinical Research Center of Chiba University Hospital. His main responsibilities include seeing ENT patients and supporting other researchers to make study protocols and regulatory strategies. As for his research, he is currently conducting a phase 1 clinical trial for Head and Neck cancer patients using iPS-NKT cells. Additionally, he has been researching Real world database analysis and decentralized clinical trials.

After he received M.D. from Chiba University in 2011, he worked at Chiba Medical Center and Chiba University Hospital as Junior Resident Doctor (2011-2013) and at Metropolitan Komagome Hospital as ENT Senior Resident Doctor (2013-2016). He also served as Clinical Reviewer at Anti-cancer Review Division and other offices at PMDA (2016-2018) before he received Ph.D. from the Graduate School of Medicine, Chiba University, in 2020.

Dr. Mamoru Ogawa is an Ophthalmologist at the Department of Ophthalmology, Keio University School of Medicine, where he also served as a Project Assistant Professor in 2021. Prior to the current position, he served as Research Fellow PD (2022) at JSPS, Research Fellow (2020), Junior Research Associate (2016), Student Trainee (2015) at the Laboratory for Metabolomics of RIKEN Center for Integrative Medical Sciences (IMS).

He is currently interested in microbiome and lipid metabolism in the eye. It aims to find new bioactive lipid metabolites in the eye, understand molecular mechanisms of eye diseases, and the development of therapeutic drug discovery using a mass spectrometer (MS). He received M.D. from Nippon Medical School in 2011 and a Ph.D. from the Department of Ophthalmology of Keio University School of Medicine in 2021.

Dr. Yukinori Ozaki is currently engaged in medical treatment, education, and research specializing in the field of breast cancer. He graduated from Keio University in 2008, worked at Kameda Medical Center from 2010 to 2014, at Toranomon Hospital from 2014 to 2020, and from 2020 at the Cancer Institute Hospital of Japanese Foundation for Cancer Research in Tokyo, which treats the largest number of breast cancer patients in Japan. He is affiliated with the Department of Breast Medical Oncology and the Department of Advanced Medical Development as a head physician.

He is interested in clinical trials for breast cancer, especially leading translational research for investigator-initiated clinical trials and immunotherapy. He collaborates with domestic and international clinical trial groups to conduct clinical trials to advance breast cancer care.

Dr. Tatsunori Shimoi is currently a medical oncologist specialist, 17 years after graduation, and is involved in the treatment of a wide range of cancer types, including breast cancer, gynecologic cancer, urologic cancer, and rare cancers. He generally recommends appropriate treatments for patients and administers anticancer drugs. Additionally, he is interested in developing and implementing valuable healthcare policies and addressing social issues such as drug lag and drug loss in Japan. His previous experience in healthcare administration as a medical officer at the Ministry of Health, Labour and Welfare and his daily involvement in drug price standard formulation as a member of the Drug Pricing Organization has motivated him to propose healthcare insurance administration improvements in the future.

Dr. Hiroya Tamai is currently working at the clinical and translational research center at Keio university hospital, participating in a new program to learn about clinical research from the viewpoint of ARO from April 2023.

From 2016, he worked as a rheumatologist at Keio University and engaged in clinical practice of connective tissue disease and clinical research about rheumatoid arthritis and adult Still’s disease to obtain better prognosis. Aiming for better treatment in rheumatoid arthritis, he has been working on a phase IV randomized controlled trial on rheumatoid arthritis since 2017, which showed the possibility of reducing the dose of a key drug in 2023. His experience in this prospective intervention clinical trial has led him to his current position since April 2023 to learn more about clinical research.

Dr. Nami Yamashita is currently working as a breast surgeon and as a research scientist at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. Prior to present position, she worked at the Department of Surgery and Science, Kyushu University, and started her research carrier to elucidate the molecular background of Triple-negative breast cancer (TNBC), the most challenging subtype of breast cancer that lacks specific treatment targets and is classified into recalcitrant cancer. From 2019-2022 she also engaged in research at Dana-Farber Cancer Institute (Kufe Lab), focusing on molecular mechanisms of Mucin1 and the stemness of TNBC.

During her research experience, she realized the importance of sustainable networking with people from different industries or laboratories for translational research and drug discovery. On the other hand, she and other board-certified breast oncologists are working together as “BC Tube,” a general incorporated association, to provide the public with correct information about breast cancer and to promote breast awareness.

Observers from AMED, PMDA, and METI

Dr. Juyoung Park is a Deputy Manager at the Department of International Strategy in Japan Agency for Medical Research and Development (AMED). Prior to the current position, she worked as Chief Researcher at Astellas Research Technologies Co. Ltd. in Japan from 2009 to 2018, and as Chief Researcher at the Department of Biotechnology, National Institute of Technology and Evaluation (NITE) from 2002 to 2008. She also worked as Research She received a Bachelor’s and Master’s in Natural Sciences from Pusan National University, Korea, in 1995 and in 1998 respectively, and a Ph.D. in Agricultural Sciences, Department of Global Agricultural Sciences, The University of Tokyo in 2002, where she was also Research student from 1998 to 1999. She is currently interested in solving neglected infectious diseases. She is working at AMED in cooperation with related ministries and agencies to solve global problems that are difficult for one country or region to solve alone and require joint efforts by the international community.　Her main responsibility is to support International Collaborative research on emerging and re-emerging infectious diseases occurring in developing countries.

Dr. Masaki Kasai is Deputy Review Director of the Office of Pharmacovigilance Ⅱ in the Pharmaceutical and Medical Devices Agency (PMDA). He joined the PMDA in 2011 and has been mainly engaged in product reviews of regenerative medical products (cellular and tissue-based products and gene therapy products) for over 10 years. Currently, he is involved in post-marketing safety monitoring of regenerative medical products and vaccine products from 2022. I have several years of international experience at the International Pharmaceutical Regulators Programme (IPRP), which facilitates the implementation of ICH and other internationally harmonized technical guidelines for pharmaceuticals. He also engaged in global discussions at the International Coalition of Medicines Regulatory Authorities (ICMRA) COVID-19 vaccines etc. He graduated from Gifu Pharmaceutical University with a Doctor of Pharmacy in 2011. The research topic of his studies was the development of treatments for spinal cord injury and the elucidation of the healing mechanisms.

Mr. Takeya Sho has been the Deputy Director of the Bio-Industry Division at the Ministry of Economy, Trade and Industry (METI) since July 2021, engaging in the implementation of Japan’s industrial policies to promote the Japanese bio-industry, especially pharmaceutical startups and strengthening the vaccine manufacturing base against COVID-19. Before he took up this position, he was the Deputy Director of the Americas Division from April 2019. He was involved in the negotiation and implementation of the Trade Agreement between Japan and the United States of America and in the launch of Japan-US cooperation in the Biden administration. Prior to this position, he was a junior staff member of the Nuclear Facilities Development and Nuclear Fuel Cycle Industry Division at the Agency for Natural Resources and Energy (ANRE) from 2017 to 2019. Mr. Takeya Sho holds a Master of Engineering (Biotechnology) from the Tokyo Institute of Technology.

2022 Participants

Naohiko Aketa is currently working at the Clinical and Translational Research Center at Keio University Hospital, mainly supporting clinical research on regenerative medicine. From 2014 to 2019,he worked as an ophthalmologist at Keio University and its affiliated hospitals, eventually becoming acornea fellow and engaged in clinical research on ocular surface diseases, performing numerouscataract surgeries and corneal transplants. Aiming to reduce blindness, he and his colleagues invented a smartphone-attachable slit lamp that can easily diagnose eye diseases and won the top prize at the KEIO Healthcare Venture Contest 2018. Making the most of his experience as a physician and an entrepreneur, he spent three years at the Pharmaceuticals and Medical Devices Agency (PMDA) from 2019 to 2022 reviewing more than fifteen drugs, medical devices, and regenerative medical products before taking his current position.

Kazuki Heishima is a G-YLC (the Young Leaders Cultivating program)- designated Assistant Professor at the Gifu University Institute for Advanced Study (GUiAS). His area of expertise includes experimental pathology and mitochondrial molecular biology. His research focuses on developing novel anti-cancer strategies targeting mitochondrial metabolism. He joins the MMMF- PhRMA program with a strong desire and ambition to develop more efficient and safer anti-cancer agents targeting mitochondria-associated cancer metabolism. Dr. Heishima received a PhD in cancer biology from Gifu University United Graduate School of Veterinary Medicine and attended Yale Cancer Center, Yale University as a postdoctoral associate. He also received a DVM degree fromIwate University and is certified as a Diplomate JCVP (Japanese College of Veterinary Pathologists).

Emi Inagaki is a project lecturer at the Department of Ophthalmology, Keio University School ofMedicine. She is a board-certified ophthalmologist and a regenerative medicine physician. Inagaki is currently serving as a principal investigator for clinical trials using stem cells for ocular surface intractable diseases. In addition, she is also a research fellow of the Japan Society for the Promotion ofScience (JSPS) at the Department of Physiology, Keio University School of Medicine. Her research areas include disease modeling in cell culture dishes using stem cells and attempts at age-modifying factor interventions, targeting senescence. Inagaki has published extensively in her field, with her most recent research on in vivo tumorigenicity tests accepted by Stem Cell Translational Medicine this year. Dr. Inagaki holds an MD from Hamamatsu University School of Medicine and a PhD in Ophthalmology from Keio University School of Medicine.

Asuka Kawai-Kawachi is a clinical scientist at the National Cancer Center Tokyo Hospital since March 2022. She works in three departments, the Cancer RNA Research Unit, the Department of Medical Oncology, and the International Translational Research Section. She is primarily responsible for leading basic research projects, as well as implementing and supporting translational research. Kawai-Kawachi completed her training as an oncologist at the National Cancer Center Hospital Tokyo in 2017. During her training, she supported two investigator-initiated clinical trials for uterine sarcoma and clear cell sarcoma. Coming to the conclusion that a solid biological hypothesis was necessary for successful clinical trials, she then began training as a scientist. After one year in the division of Epigenomics at NCCH at 2018, Kawai- Kawachi moved to Gustave Roussy as an ESMO translational research fellow, where she is now leading a project investigating new treatment strategies for desmoplastic small round cell tumors under the supervision of Dr. Postel-Vinay.

Anna Kiyomi is a researcher focusing on clinical pharmacology, drug safety, pharmacoepidemiology,and economic evaluation of health care and medication outcomes. She received a bachelor’s degree and PhD in Clinical Pharmacology from the Tokyo University of Pharmacy and Life Sciences. Kiyomi’s current project aims to identify the incidence rate and risk factors of the side effect of anticancerdrugs using a Japanese nationwide administrative database. She was a visiting scholar at the University of California, San Francisco (UCSF) from 2021-2022 and is affiliated with the Medication Outcomes Center at UCSF. As a joint researcher with UCSF, she conducts pharmacoepidemiologic research regarding COVID-19 treatment outcomes, health disparities, and health policy. Kiyomi also has experience as a community pharmacist, as post- marketing surveillance staff for the Department of Hematology inTokyo Medical University, and as a clinical trials pharmacist. Now, she is concurrently a visiting researcher at the Institute ofMedical Science Hospital at the University of Tokyo and the National Hospital Organization.

Miho Nakajima is a pediatric oncologist at the Department of Pediatric Oncology, National Cancer Center Hospital. She graduated from Miyazaki University in 2002 and received training in general pediatrics and pediatric oncology in Japan and the United States. After returning to Japan, she realized that standard treatments for pediatric cancer, such as anti-GD2 antibody for neuroblastoma, have not yet been established in Japan and that Japan is clearly behind Europe and the United States in the development of new molecular-targeted drugs and other drugs that are known to be effective in the treatment of childhood cancer. The problem of ‘drug lag’ in rare cancer treatments, including pediatric cancer, is very serious, and Nakajima seeks to help solve this problem byutilizing her experience and the knowledge of physicians in Japan and the United States. Nakajima’s long-term goals are to establish translational research and drug development programs to avoid drug lag, provide better treatment for cancer patients, and establish and improve educational curriculums for future researchers in this field.

Yoko Takahashi is a breast surgeon working in collaboration with basic researchers as a member of the NEXT-Ganken program at the Cancer Institute Hospital for the Japanese Foundation for Cancer Research. As a clinician, she performs patient treatments at inpatient and outpatient clinics, while also teaching. Previously, she worked at a Keio University Hospital and focused on drug delivery systems via nanoparticles. She is interested in translational research. Currently, her research focuses on ctDNA and epigenomics to formulate novel strategies for breast cancer treatment. She is a member of the Inflammatory Breast Cancer (IBC) Connect Team with MD Anderson Cancer Center. Takahashi’s research for IBC with MDA researchers is ongoing, and she is currently scheduling the implementation of clinical trials. She received her MD from Yamagata University in 2000.

Yuma Yokoi is the section chief of clinical research and educational promotion at the National Center of Neurology and Psychiatry (NCNP). He graduated from Tokyo Medical and Dental University in 2004, with a Bachelor of Medicine and also gained clinical experience in psychiatry. He then conducted clinical research, specifically for Alzheimer’s disease patients, at Johns Hopkins University from 2011 to 2013. After returning to Japan, he obtained board certification in psychiatry and geriatric psychiatry. While involved in clinical studies, he became increasingly interested in clinical trials and began a career as a medical reviewer at PMDA in 2018. Since spring 2022, he has been working at NCNP to support clinical research on treatments and tests that benefit psychiatric and dementia patients, along with educating clinical researchers.

Observers from AMED and PMDA

Mayu Fujita is a reviewer for Pharmaceuticals and Medical Devices Agency (PMDA). She graduated from the Nagoya City University Graduate School of Pharmaceutical Sciences with a master’s degree in Pharmacy in March of 2010. After graduation, she joined PMDA where she worked on post-marketing safety measures for six and a half years, with a specific expertise in digestive drugs, and then for 3 years in the regulatory review of anti-infective drugs. Since January 2020, Fujita is doing her second stint in the post-marketing safety measures department, in charge of oncology drugs. Her work involves analyzing adverse drug reports and reviewing medical literature from pharmaceutical companies and healthcare professionals to determine if any further safety information is needed on drug packaging.

Naoko Kojima is Deputy Manager of the Office of International Collaboration in the Department of International Strategy at AMED. Since she joined AMED in 2017, she has been responsible for funding programs in Asia and the Pacific region, such as the e-ASIA Joint Research Program and the Strategic International Collaborative Research Program (SICORP) with Singapore, Australia, and other countries. Before joining AMED, she worked as an Assistant Professor at the Department ofResearch and Development of Next Generation Medicine at Kyushu University and later engaged in nine years of data management and statistical analysis in the clinical developmental phase in the pharmaceutical and medical device industry, including at CRO and Johnson & Johnson K.K. Kojima holds a Master of Professional Studies in Bioenvironmental Engineering from Cornell University(USA) and a PhD in Medicine from Fukuoka University in Japan.

2019 Participants

Hiroki Akiba is project researcher in the Laboratory of Pharmacokinetic Optimization at the Center for Drug Design Research, National Institutes for Biomedical Innovation, Health and Nutrition. Prior to his current role, he worked as a postdoc at The University of Tokyo in the field of protein engineering and biomolecular recognition. Currently, he conducts research on the optimization of antibody molecules. His research covers optimization strategy for the improvement of affinity or stability, developing novel bispecific antibody scaffolds and antibody fusions, and selecting antibody variable fragments for optimal development of biparatopic antibodies. Dr. Akiba received his PhD from the Department of Advanced Interdisciplinary Sciences, School of Engineering at the University of Tokyo in 2013, by a study of a chemical sensor to detect tyrosine phosphorylation. He also holds a MS from the Department of Chemistry and Biotechnology, School of Engineering at the University of Tokyo (2010), and a BS from the Faculty of Engineering at the University of Tokyo (2008).

Seiji Kishi is associate professor at the General Medicine section at Kawasaki Medical School. Previously, he worked as an assistant professor at Tokushima University Hospital, where he conducted clinical practice, student and resident education on kidney disease. Prior to that, he was employed in the Renal Division of the Department of Medicine at Harvard Medical School/Brigham and Women’s Hospital as a research fellow. He has also worked at the Hyogo Prefectural Amagasaki Hospital as an attending physician and fellow. In his current capacity, he works as a general internist at the University Hospital, and also educates medical students, residents, and fellows at clinical practice sites. His research focuses on elucidating the molecular mechanisms of why acute kidney injury transitions to chronic kidney disease, using genetically modified animals and organoids. Dr. Kishi received his PhD in Nephrology from Tokushima University Graduate School in 2011, as well as an MD from the Department of Medicine at Tokushima University in 2000.

Takahiro Kogawa is staff physician at the Department of Experimental Therapeutics and Department of Breast Medical Oncology at the National Cancer Center East Hospital. He has previously worked at the Department of Medical Oncology at the KKR Sapporo Medical Center Tonan Hospital. In his current position, he performs patient treatments at inpatient and outpatient clinics, and implements clinical trials for phase I studies for cancer agent developments. He also engages in educating residents and fellows at his institution for clinical treatment methods and research activity guidance. Dr. Kogawa completed his postdoctoral fellowship at the University of Texas, MD Anderson Cancer Center in 2014, and received his PhD in Gastroenterology from the Graduate School of Sapporo Medical University in 2007. He received his MD from Sapporo Medical University in 2000.

Narihito Nagoshi is assistant professor at the Department of Orthopaedic Surgery at Keio University’s School of Medicine. Previously, he worked as a spine surgeon at the Department of Orthopaedic Surgery, at the Spinal Cord Injury Center in Hokkaido Chuo Rosai Hospital, as well as at the Department of Orthopaedic Surgery at Murayama Clinical Center. In his current capacity, his research focuses on regenerative medicine for spinal cord injury, and is also responsible for clinical research on patients with spinal cord injuries using iPS cells. He also engages in teaching appropriate diagnostic techniques and treatment methods for spine and spinal cord diseases for trainees, as well as perform over 100 surgical operations a year as chief of a spinal cord disease treatment group. Dr. Nagoshi received his PhD in Orthopaedics in 2009 from Keio University’s Graduate School of Medicine, and a MD in 2002 from Keio University’s School of Medicine.

Hitomi Okuma is medical oncologist at the Clinical Trial Management Section in the Research Management Division of the Clinical Research Support Office, and the Department of Breast and Medical Oncology at the National Cancer Center Hospital. Her current responsibilities include conducting a project related to platform (basket/umbrella) trials with a registry study for rare cancers (MASTER KEY Project). In addition to coordinating between the multiple committees involved in the project, she plans and designs clinical trials and accompanying research, and acting as liaison between academic researchers and companies, with the goal of accelerating drug approval for rare cancers. Dr. Okuma received her PhD from the Graduate School of Medical and Pharmaceutical Sciences at Chiba University in 2017, and holds a MD from Nagasaki University School of Medicine (2011).

Kazutaka Otsuji is an assistant professor at the Department of Breast and Endocrine Surgery at the University of Tokyo Hospital. Previously, he worked as a general surgeon at JR Tokyo General Hospital. In his current role, he engages in medical practice and treatment of diseases related to the breast and thyroid gland. He also researches the application of droplet-digital PCR as a diagnostic tool for breast cancer and breast fibro epithelial tumors. He is also involved in educating the medical students, trainees, and graduate students at the University Hospital. Dr. Otsuji received his PhD in Surgical Science from the Graduate School of Medicine at the University of Tokyo in 2018, and an MD from the University of Tokyo, Medical School in 2009.

Masamichi Takahashi works at the Department of Neurosurgery and Neuro-Oncology at the National Cancer Center Hospital as a neurosurgeon, neuro-oncologist, and a basic researcher for patients with malignant brain tumors. His current research involves overseeing the distribution of multicenter, phase II, investigator-initiated clinical trials of eribulin mesylate in patients with recurrent glioblastoma. Prior to his current position, he was a postdoctoral fellow in the Department of Medicine at the University of California at Los Angeles (UCLA) for three years, and conducted basic scientific research, focusing on translational research and developing novel gene therapy from bench to bedside. Dr. Takahashi holds a PhD in Neuroscience from the University of Tokyo, Graduate School of Medicine (2011), and a MD from the School of Medicine at Niigata University (2001).

Hiroyoshi Tanaka is assistant professor at the Department of Pharmaceutical Biomedicine at the Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, at Okayama University. His research pertains to elucidating the pathogenesis and formulating novel therapeutic strategies for pancreatic cancer. In addition to analyzing human histopathology as well as conventional animal models, he works in collaboration with clinicians and basic researchers of other disciplines to generate novel in vitro platforms using original 3D culture techniques. These 3D models enable for screening of compounds that control the malignant tumor microenvironment. Mr. Tanaka received his MD from the University of Tokyo, Faculty of Medicine in 2013, and was subsequently enrolled in the Graduate School of Medicine, Department of Pathology, Immunology and Microbiology, at the University of Tokyo until 2016.

Takao Watamoto is division chief at the Division of Project Promotion, Department of Cyclic Innovation at the Japan Agency of Medical Research and Development (AMED). Previously, he worked at Tokai-Hokuriku Regional Bureau of Health and Welfare as section chief, as well as at the Graduate School of Biomedical Science in Nagasaki University as an assistant professor. In his current role, Dr. Watamoto manages the Cyclic Innovation for Clinical Empowerment project at AMED. Dr. Watamoto holds a PhD in Prosthodontics from the Graduate School of Dentistry, Osaka University (2005), and has graduated the School of Dentistry, Osaka University in 2001.

Nariaki Iwasawa is reviewer at the Office of Pharmacovigilance II and Office of New Drug V, at the Pharmaceuticals and Medical Devices Agency (PMDA). Previously, he worked at the Office of New Drug II at PMDA, where he was involved in drug approval review, specifically in evaluating efficacy and safety data of clinical studies and pharmacological data of non-clinical studies. In his current role, he formulates post marketing risk management plans regarding anticancer drugs, in which he looks at the risk involved after marketing, based on safety data of clinical and non-clinical studies, adverse reaction reports, as well as results of post-marketing surveillance. Dr. Iwasawa holds a PhD and a Master’s degree from the Graduate School of Biostudies, Kyoto University (2014 and 2011, respectively), and a Bachelor’s from the Faculty of Pharmaceutical Sciences at Kyoto University (2009).

2018 Participants

Kensuke Ikenaka, Assistant Professor, Department of Neurology, Osaka University Graduate School of Medicine
Masahito Kawabori, Associate Professor, Department of Neurosurgery, Hokkaido University Hospital
Takuya Kawahara, Project Assistant Professor, Biostatistics Division of the Central Coordinating Unit, The University of Tokyo Hospital’s Clinical Research Support Center
Eisuke Kobayashi, Head of Musculoskeletal Oncology, National Cancer Center Hospital
Hiroko Masuda, Assistant Professor, Department of Breast Surgical Oncology, Showa University
Yuta Mishima, Research Fellow, Japan Society for the Promotion of Science (JSPS), Center for iPS Cell Research and Application (CiRA), Kyoto University
Yuya Sasaki,Japanese Fellow, United States Naval Hospital Yokusuka
Kentaro Tomii, Leader, Intelligent Bioinformatics Research Team, Artificial Intelligence Research Center, National Institute of Advanced Industrial Science and Technology (AIST)
Yoshihiro Katsura, Technical Officer, Division of Pharmacopoeia and Standards for Drugs, Office of Standards and Guidelines Development, Pharmaceuticals and Medical Devices Agency (PMDA)
Yumiko Tomoyasu, Deputy Manager, Office of Project Coordination, Japan Agency for Medical Research and Development (AMED)

2017 Participants

Hiroshi Arakawa, Assistant Professor, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Natsuko Kishishita, Researcher, Laboratory of Mockup Vaccine, National Institutes of Biomedical Innovation, Health and Nutrition
Mayumi Kusunose, Project Researcher, Department of Public Policy, Institute of Medical Science, University of Tokyo
Kiyoshi Nobori, Associate Professor, Clinical Research Center, Department of Cardiovascular Medicine, Tokyo Medical and Dental University
Munenori Takata, Assistant Professor, Clinical Research Support Center, Department of Cardiovascular Medicine, University of Tokyo Hospital
Makiko Uchiyama, Research Lecturer, Center for Clinical and Translational Research, Kyushu University Hospital
Norihisa Yamamoto, Clinical Fellow, Division of Infection Control and Prevention, Osaka University Hospital
Osamu Yoshida, Assistant Professor, Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Shintaro Nakano, Reviewer, Office of New Drug V, Pharmaceutical and Medical Devices Agency (PMDA).
Yoshihiko Furusawa, Deputy Manager, Division of Rare/Intractable Disease Research, Japan Agency for Medical Research and Development (AMED)

2016 Participants

Koji Fujita, Assistant Professor, Department of Orthopaedic and Spinal Surgery, Graduate School of Medical and Dental Science at Tokyo Medical and Dental University
Atushi Hashizume, Clinical Fellow, Department of Neurology, Graduate School of Medicine at Nagoya University
Ryuji Kato, Associate Professor, Department of Basic Medical Science, Laboratory of Cell and Molecular Bioengineering, Nagoya University Graduate School of Pharmaceutical Sciences
Sumimasa Nagai, Senior Assistant Professor, Division of Genetic Therapeutics, Advanced Clinical Research Center, the Institute of Medical Science, University of Tokyo (IMSUT) & Department of Hematology/Oncology and Center for Translational Research, IMSUT Hospital.
Haruka Nakada, Project Research Fellow, Department of Public Policy, Human Genome Center, the Institute of Medical Science, University of Tokyo
Yukika Nishimura, Deputy Manager, Department of Clinical Research and Trials, Japan Agency for Medical Research and Development (AMED)
Takeshi Ohama, Associate Professor, Department of Veterinary Pharmacology, Joint Faculty of Veterinary Medicine, Yamaguchi University
Wataru Shibata, Associate Professor, Advanced Medical Research Center, Yokohama City University
Yukata Shimazu, Project Researcher, Department of Immunology, Institute for Frontier Medical Services, Kyoto University
Tomohiro Yamaguchi, Medical Reviewer, Office of New Drug V at the Pharmaceuticals and Medical Devices Agency (PMDA)

2015 Participants

Hisayoshi Hashimoto, Research Resident, Division of Molecular and Cellular Medicine, National Cancer Center Research Institute
Yoichi Ito, Associate Professor, Department of Biostatistics, Hokkaido University Graduate School of Medicine
Tomoko Iwata, Biostatistics Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA)
Hiroya Kuwahara, Research Assistant Professor, Department of Neurology and Neurological Science, Tokyo Medical and Dental University
Kazue Mizuno, Research Fellow of Japan Society for the Promotion of Science, Department of Materials and Science, The University of Tokyo, School of Engineering
Fumihiko Nakatani, Head, Musculoskeletal Oncology, National Cancer Center Hospital
Shinichi Okudaira, Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA)
Takayoshi Shimohata, Associate Professor, Department of Neurology, Niigata University, Brain Institute
Keiko Ueda, Chief Researcher, Department of Regenerative Medicine, National Cardiovascular Center
Kiyoshi Yamaguchi, Assistant Professor, Division of Clinical Genome Research, The Institute of Medical Science, The University of Tokyo

2014 Participants

Kazuki Hattori – Project Assistant Professor, The University of Tokyo
Akihiro Hirakawa – Lecturer, Nagoya University Hospital
Mako Kamiya – Assistant Professor, The University of Tokyo
Ken Kato – Chief/Head, National Cancer Center Hospital
Masahisa Katsuno – Associate Professor, Nagoya University Graduate School of Medicine
Makiko Kusama – Lecturer, The University of Tokyo
Akiko Nitta – Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA)
Kiyoshi Okada – Project Associate Professor, Okada University Hospital
Koichiro Yuji – Project Lecturer, The University of Tokyo

2013 Participants

Yasushi Goto – Assistant Professor, The University of Tokyo Hospital
Taizo Hirata – Associate Professor, Okayama University Hospital
Yukako Imanaka – Officer, National Institute of Biomedical Innovation (NIBIO)
Toru Komatsu – Assistant Professor, The University of Tokyo
Kuniyasu Niizuma – Clinical Associate Professor, Tohoku University Graduate School of Medicine
Toru Oga – Associate Professor, Graduate School of Medicine, Kyoto University
Daisuke Sugiyama – Unit Leader and Associate Professor, Center for Clinical and Translational Research of Kyushu University Hospital
Kanako Takatsuki – Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA)
Issei Takayama – Technical Officer, Pharmaceuticals and Medical Devices Agency (PMDA)
Kan Yonemori – Medical Staff, National Cancer Center Hospital, Tokyo

Mansfield-PhRMA Research Scholars