Mansfield-PhRMA Research Program 2024
Participant Biographies
Dr. KIDA KumikoDr. Kumiko Kida is an Associate Medical Director of the Department of Breast
Surgical Oncology at St. Luke’s International Hospital, Tokyo. She is anattending breast surgeon and a board-certified clinical geneticist. She is one ofthe leaders of the Hereditary Breast Cancer Guideline Committee and a memberof the Risk Prediction Working Group in the Japanese Breast Cancer Society.
On the research front, she is involved in the planning and execution of clinicalstudies on breast cancer, collaborative translational research projects, and serves
as the institutional principal investigator for clinical trials as well as the facility representative forclinical 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 AndersonCancer Center.

Dr. MINAMISAWA Masatoshi
Dr. Masatoshi Minamisawa is an Assistant Professor of Cardiovascular Medicineat Shinshu University School of Medicine and a Research Collaborator atBrigham and Women’s Hospital and Harvard Medical School. He graduatedfrom Shinshu University in 2007 and worked at Shinshu University Hospital andShinshu Ueda Medical Center, completing an internal medicine residency and ageneral cardiology fellowship. He obtained his Doctor of Medicine degree,specializing in clinical research on ischemic heart disease, heart failure, andechocardiography, 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 Schoolfrom 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. NAKAYAMA Tojo
Dr. Tojo Nakayama is a Project Associate Professor of Neurology andNeurological Science at the Tokyo Medical and Dental School. He is a physicianscientist with expertise in pediatric neurology and genetics. He completedpediatric neurology training at the National Center for Neurology & Psychiatry(NCNP). After earning his PhD in molecular genetics research on intractableepilepsy 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. OGURA Koichi
Dr. Koichi Ogura is Head of the Department of Musculoskeletal Oncology andInternational Clinical Development at the National Cancer Center Hospital. Hehas trained in the fields of musculoskeletal oncology as an orthopaedic surgeon,and completed his graduate PhD work at The University of Tokyo and NationalCancer Center (Tokyo, Japan) by focusing on comprehensive characterizationof 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 modelsystems 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 somepharmaceutical companies.

Dr. OKAZAKI Atsuko
Dr. Atsuko Imai-Okazaki, M.D., Ph.D., M.P.H., an Associate Professor ofDiagnostics 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. degreefrom 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 ofMedicine, Harvard Medical School and Rockefeller University.
By combining statistical genetics, clinical genetics and computer science, Dr. Okazaki developed anovel statistical method to prioritize sequence variants using Hamming distance. One of the clinicalapplications of her method is a mitochondrial disease cohort in Japan. She has assessed therelationship between long-term prognosis and genetic background of mitochondrial diseases. Hergroup also discovered a novel therapeutic agent that improved heart function by increasing
mitochondrial energy production.

Dr. OKITA Yasutaka
Dr. Okita, Assistant Professor of the Department of Medical Center forTranslational Research, Osaka University, is deeply passionate about medical
innovation. To that end, he plays three roles at Osaka University. First, as aproject 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 arheumatologist, he examines approximately 70 patients every week and serves as the principal or coinvestigator 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 thatbreakthroughs in research translate into real-world medical solutions.

Dr. SUDO Kazuki
Dr. Sudo graduated from Niigata University School of Medicine in 2006 andjoined St. Luke’s International Hospital in 2006, where he received initial andspecialized surgical training. In 2012, he obtained a Board Certification inSurgery. The same year, he began studying at MD Anderson Cancer Center asa postdoctoral fellow in GI Medical Oncology for research on gastrointestinalcancers.
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 samehospital. At the same time, he concurrently assumed a position at the Rare Cancer Center. In 2020, hewas promoted to head of physicians at the Department of Breast and Oncology (now the Departmentof 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.

TERADA Mitsumi
Dr. Terada graduated with his MD from the Jikei University in 2009 andobtained a PhD in 2019. From 2011 to 2016, he worked as a surgeon for
gastrointestinal cancer, especially for gastric cancer from 2014. He joined theEORTC in 2017 as a medical research fellow and learned methodology ofinternational clinical trials on European basis. At the EORTC, he proposed andorganized some collaborative projects and events between JCOG (Japan ClinicalOncology Group) and EORTC, which let him realize the importance andsignificance 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 QLQSTO22, 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 ofpartnerships with multiple stakeholders including academic institutions, regulatory agencies andpharmaceutical industries, and the establishment of a governance structure for the ATLAS network.

Observers from AMED, PMDA, and METI
Ms. YOSHIDA Ai
Joining the Japan Agency for Medical Research and Development (AMED) inAugust, 2017, Ms. Yoshida is currently serving as a manager in the Division ofData 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 fromUniversity of Occupational and Environmental Health, she worked as a section chief in the Divisionof Health for the Elderly within the Health and Welfare Bureau for the Elderly. She managed theLong-Term Care Insurance Comprehensive Database, which has the anonymized data from longterm care facilities to insurers. Her role involved preparation of connecting this database withanother one. She also worked as an assistant professor in the Department of Preventive Medicineand Community Health from July 2015 to July 2017. She used big data to analyze the clinicalconditions 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 withoutobtaining a degree in March 2015. She holds a Master of Science in Health Care Management fromKeio University, earned in March 2008, and a Bachelor of Economy, also from Keio University,obtained in March 2006.

Ms. KUBO Akiho
Ms. Akiko Kubo has been a reviewer of the Office of Pharmacovigilance Ⅱ in
the Pharmaceutical and Medical Devices Agency (PMDA) since 2019. She isinvolved 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, andstrengthening 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, shecompleted a pharmacy residency at Juntendo hospital, receiving a comprehensive training experiencein pediatric pharmacotherapy.

Ms. KODERA Reina
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 ofrenewable energy-related policies and energy conservation policies. She thenspent her second and third years in the Wind Energy Policy Office, New Energy
Division, where she worked on human resource development policies, international negotiations (withthe EU and embassies of various countries), and the establishment of domestic supply chains. Fromher 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 thedevelopment of automated equipment and manufacturing infrastructure in the manufacturing sector,
such as CDMOs.