Mansfield-PhRMA Research Scholars Program 2022
Participant Biographies
Naohiko Aketa is currently working at the Clinical and Translational ResearchCenter 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 a cornea fellow
and engaged in clinical research on ocular surface diseases, performing
numerous cataract 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 thePharmaceuticals 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 andmitochondrial molecular biology. His research focuses on developing novel anticancer strategies targeting mitochondrial metabolism. He joins the MMMFPhRMA program with a strong desire and ambition to develop more efficientand 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 from Iwate 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 of Medicine. She is a board-certified ophthalmologist and aregenerative medicine physician. Inagaki is currently serving as a principal
investigator for clinical trials using stem cells for ocular surface intractablediseases. In addition, she is also a research fellow of the Japan Society for thePromotion of Science (JSPS) at the Department of Physiology, Keio University
School of Medicine. Her research areas include disease modelling in cell culture1

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 ofMedicine.
Asuka Kawai-Kawachi is a clinical scientist at the National Cancer CenterTokyo Hospital since March 2022. She works in three departments, the Cancer
RNA Research Unit, the Department of Medical Oncology, and theInternational Translational Research Section. She is primarily responsible forleading basic research projects, as well as implementing and supportingtranslational 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 thenbegan training as a scientist. After one year in the division of Epigenomics at NCCH at 2018, KawaiKawachi moved to Gustave Roussy as an ESMO translational research fellow, where she is now leadinga project investigating new treatment strategies for desmoplastic small round cell tumors under thesupervision 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 ofanticancer drugs using a Japanese nationwide administrative database. She was avisiting scholar at the University of California, San Francisco (UCSF) from 20212022 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, healthdisparities, and health policy. Kiyomi also has experience as a community pharmacist, as postmarketing surveillance staff for the Department of Hematology in Tokyo Medical University, and asa clinical trials pharmacist. Now, she is concurrently a visiting researcher at the Institute of Medical
Science Hospital at the University of Tokyo and the National Hospital Organization.

2Miho Nakajima is a pediatric oncologist at the Department of PediatricOncology, National Cancer Center Hospital. She graduated from Miyazaki
University in 2002 and received training in general pediatrics and pediatriconcology in Japan and the United States. After returning to Japan, she realizedthat standard treatments for pediatric cancer, such as anti-GD2 antibody forneuroblastoma, have not yet been established in Japan and that Japan is clearlybehind Europe and the United States in the development of new moleculartargeted 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, andNakajima seeks to help solve this problem by utilizing her experience and the knowledge of physiciansin Japan and the United States. Nakajima’s long-term goals are to establish translational research anddrug development programs to avoid drug lag, provide better treatment for cancer patients, andestablish 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 InstituteHospital for the Japanese Foundation for Cancer Research. As a clinician, she
performs patient treatments at inpatient and outpatient clinics, while alsoteaching. 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 graduatedfrom Tokyo Medical and Dental University in 2004, with a Bachelor ofMedicine and also gained clinical experience in psychiatry. He then conductedclinical 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 clinicalstudies, he became increasingly interested in clinical trials and began a career as a medical reviewer at3

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 clinicalresearchers.

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 safetymeasures for six and a half years, with a specific expertise in digestive drugs, andthen 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 andreviewing medical literature from pharmaceutical companies and healthcare professionals todetermine if any further safety information is needed on drug packaging.
Naoko Kojima is Deputy Manager of the Office of InternationalCollaboration in the Department of International Strategy at AMED. Since shejoined AMED in 2017, she has been responsible for funding programs in Asiaand the Pacific region, such as the e-ASIA Joint Research Program and theStrategic International Collaborative Research Program (SICORP) withSingapore, Australia, and other countries. Before joining AMED, she worked as
an Assistant Professor at the Department of Research and Development ofNext 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 fromFukuoka University in Japan.

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