2022 Participant Biographies

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 asolid biological hypothesis was necessary for successful clinical trials, she then began training as a scientist. After one year inthe division of Epigenomics at NCCH at 2018, Kawai- Kawachi moved to Gustave Roussy as an ESMO translational researchfellow, 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 ofthe 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 Departmentof 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.

Past Participants

2019 Biographies

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

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

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

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

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

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

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