NEWS
ABOUT
Supporting the Early Stages of Drug Development
Through Integrated Expertise
The Early Clinical Development Support Office provides startups and other eligible organizations with comprehensive support for the early clinical development of pharmaceuticals and other therapeutic products. Our integrated team of experienced specialists provides expert guidance in a wide range of areas, including manufacturing, nonclinical safety, ADME, pharmacology, clinical development, and regulatory affairs. While ensuring safety and reliability, we support the advancement of scientifically rigorous and efficient drug development.
OUR
MISSION
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To bring safe and effective innovative therapies to patients
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To accelerate innovation in drug and medical technology development in Japan
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To enable safe, scientifically rigorous, and efficient clinical trials
An Alternative Pathway for Early Clinical Development Through Specified Clinical Trials(1)
Specified Clinical Trials are a legal framework established under Japan's Clinical Trials Act and can be utilized for early clinical development, including FIH studies, subject to review by a Certified Review Board (CRB)(2) and appropriate safety oversight. For quality and nonclinical safety assessments requiring a high level of specialized expertise, the scientific validity and safety of the research are ensured by leveraging the expertise of external experts. To advance FIH studies under this framework, the National Cancer Center Japan has established dedicated structures for clinical development support and review.
(1) Specified Clinical Trials are a clinical research framework established under Japan's Clinical Trials Act that may provide an alternative pathway for early clinical development, including FIH studies. The framework is conceptually similar to Australia's Clinical Trial Notification (CTN) Scheme.
(2) Certified Review Board (CRB): An accredited independent review board established under Japan's Clinical Trials Act that reviews the scientific validity, ethical acceptability, and safety of Specified Clinical Trials in accordance with ICH-GCP principles.
Research Support and
Review Structures
for FIH Studies
To support early clinical development, including FIH studies, the National Cancer Center Japan has established a cross-functional network of experts spanning research, nonclinical development, clinical development, and regulatory affairs.
Leveraging extensive experience in early-phase clinical trials and investigator-initiated studies, we provide integrated support from the earliest stages of development, covering nonclinical safety assessments, regulatory strategy, and clinical trial design.
In addition, through an appropriate review framework provided by a Certified Review Board (CRB) and support from professionals with experience in interactions with regulatory authorities, we enable the conduct of FIH studies while ensuring scientific validity, ethical integrity, and patient safety.
TEAM
Expert Support from Specialists in Each Field
A multidisciplinary team of accomplished specialists is assembled to address the unique challenges of each project and provide expert guidance throughout development.
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Toshihiko Doi, MD, PhD
Director, National Cancer Center Hospital EastAdvancing innovation in oncology from discovery to patient care demands more than scientific excellence. It requires a comprehensive support ecosystem that bridges research, development, and clinical implementation. Guided by leading experts and built upon extensive experience in early clinical development, we are dedicated to accelerating the successful translation of innovative medicines and medical technologies through strategic support grounded in global quality standards.
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Program Lead
Akihiro Sato, MD, PhD, MBA
Deputy Director, Head of Clinical Research Support Office,
National Cancer Center Hospital EastAt the National Cancer Center Japan, we have established a comprehensive support framework that brings together a diverse network of experts with extensive experience in early-phase clinical trials, investigator-initiated clinical trials, and regulatory strategy. Through this initiative, we go beyond conventional development frameworks by proposing integrated development strategies that take a cross-functional view of research, nonclinical development, clinical development, and regulatory affairs. By doing so, we aim to accelerate the translation of promising innovations originating in Japan into practical applications, while reducing development timelines and optimizing development costs.
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Office
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Hideaki Takahashi, MD
Head,
Regulatory Affairs Section,
NCCHE -
Ayae Minobe
Clinical Research Support Office,
NCCHE -
Eiji Matsumura, PhD
Head, Startup Support Section,
NCCHE Former clinical development professional at a major pharmaceutical company -
Eri Sugiyama, MD, PhD
Researcher, Department of Immunogenomic Medicine, NCCRI
Staff, Department of Thoracic Oncology,
NCCHE
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Early Clinical Development Experts
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Yasutoshi Kuboki, MD, PhD
Chief, Department of Experimental Therapeutics,
NCCHE -
Shigehiro Koganemaru, MD, PhD
Department of Experimental Therapeutics,
NCCHE -
Junichiro Yuda, MD, PhD
Chief, Department of Hematology and Experimental Therapeutics,
NCCHE
Regulatory Affairs Expert
Hideaki Takahashi, MD
Head, Regulatory Affairs Section,
NCCHE Professional Experience:2018–2025
New Drug Review Division V, PMDA -
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Pharmacology and MoA Evaluation Expert
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Akihiro Ohashi, PhD
Division Head,
Division of Collaborative Research and Developments,
EPOC -
Keisuke Watanabe, MD, PhD
Senior Staff Scientist,
Division of Cancer Immunology,
NCCRI -
Masataka Amisaki, MD, PhD
Researcher,
Department for the Promotion of Drug and Diagnostic Development,
NCCHE
Manufacturing and Nonclinical Development Experts
Additional support will be provided by experts with research and development experience in pharmaceutical companies, both within and outside the National Cancer Center Japan. -
NCCHE = National Cancer Center Hospital East
NCCRI = National Cancer Center Research Institute
EPOC = Exploratory Oncology Research & Clinical Trial Center
SERVICE
Practical Development Support
Bridging Research and Clinical Development
The National Cancer Center Japan has extensive experience in early-phase clinical trials and investigator-initiated registration-directed trials. We provide expert and strategic advice on clinical trial design from leading Key Opinion Leaders (KOLs). The Exploratory Oncology Research & Clinical Trial Center includes researchers with experience in pharmaceutical companies and startups, as well as specialists with expertise in cutting-edge technologies. By integrating perspectives from both academia and industry, we provide practical support for drug development. We also have experience conducting and reviewing FIH studies of radiopharmaceuticals under the framework of Specified Clinical Trials, enabling us to support pharmaceutical development based on this expertise. By bringing together these capabilities, experiences, and resources, we provide strategic guidance to advance rational and efficient clinical development while ensuring safety and reliability.
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Advice on Pharmacology
and Mechanism of Action (MoA) -
Advice on Manufacturing
and Nonclinical Development -
Development Strategy
Incorporating Regulatory Requirements -
Clinical Trial Planning
and Support
- TARGET
AUDIENCE -
Startup companies and other innovators with oncology-focused therapeutic seeds, including
pharmaceuticals and regenerative medicine products, with the goal of advancing them toward
clinical application.
※Prospective startups are also eligible.
Projects that have advanced in the evaluation of product design, manufacturing processes, target indications, and routes of administration are particularly well positioned to benefit from the strategic support offered through this program.
CONTACT
Please Feel Free to Contact Us
FLOW
Steps to Consultation
Please complete the Early Clinical Development Support Application Form and submit it to the email address below.
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Submission Email Address : soukirinshokaihatsu●east.ncc.go.jp(Please replace "●" with "@")
