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Koji Hagimoto
Associate Director, Project Management Department at EPS International Holdings Co., Ltd.
Professional Background
Koji Hagimoto is a highly respected veteran in the Pharmaceutical and Medical Device Industry, with an impressive career spanning since 1983. Throughout his extensive experience, he has demonstrated exceptional success in numerous areas of drug and medical device development, ranging from initial product concepts to pivotal regulatory submissions such as NDAs (New Drug Applications), PMAs (Premarket Approvals), and 510(k) filings. His adept leadership role as Head of Regulatory Affairs in both the US and Japan highlights his dual expertise and comprehensive understanding of international regulatory landscapes.
Koji has accrued over seven years of professional experience in the United States, including a substantial tenure at a prominent US pharmaceutical company. His in-depth knowledge of US-based clinical research planning and project management in clinical development has positioned him as a key player in ensuring the efficacy and safety of healthcare solutions.
In Japan, Koji has successfully designed, established, and implemented innovative programs aimed at the development and registration of pharmaceutical products tailored for the Japanese market. His proficiency extends beyond regulatory processes as he has conducted several Phase 1 and Phase 2 studies in the US, reflecting his capability in executing comprehensive clinical trials and research initiatives.
Education and Achievements
Koji's journey in the sciences began with a Bachelor of Science (BS) degree in Animal Science and Animal Breeding from Kyoto University. His foundational education laid the groundwork for his exceptional understanding of biological sciences, which is crucial in the domains of pharmaceuticals and medical devices. Prior to his university studies, Koji completed his high school education at Rakusei High School and his junior high education at Rakusei Junior High School.
Professionally, Koji has held multiple prestigious positions within a variety of esteemed organizations. His career encompasses roles such as Associate Director within the Project Management Department at EPS International Holdings Co., Ltd, and several leadership positions at IQVIA Services Japan. In his capacity as Director and Unit Head, he guided teams through critical phases of clinical operations, significantly enhancing the efficacy of medical device and diagnostics projects.
His earlier roles included Clinical Program Director at Integrated Development Associates Co. Ltd. and Director of Clinical Research and Regulatory Affairs at Anaeropharma Science, Inc. Notably, his history at Toray Industries, Inc. exemplifies his career trajectory, where he undertook various impactful positions including Head of Regulatory Affairs and Alliance Management. This breadth of experience across clinical research, regulatory affairs, and project management showcases Koji's strong leadership and strategic planning skills in the industry.
Notable Achievements
Koji has achieved myriad successes throughout his career, including the attainment of three market authorizations for pharmaceuticals in Japan and two for medical devices in the United States. His ability to access and liaise with key opinion leaders (KOLs) in both the US and Japan has been instrumental in fostering collaborative relationships that bolster development efforts.
A highlight of his career includes co-chairing workshops on global development efforts in New York, focusing on cross-border collaboration and best practices in the regulatory landscape. Furthermore, he actively contributed to discussions on regulatory changes impacting the medical device sector, specifically after the revision of the Act on Securing Quality, Efficacy, and Safety of Products, which speaks volumes about his commitment to staying abreast of industry trends and regulatory shifts.
In addition to his professional accomplishments, Koji has displayed strong management prowess by successfully leading the merger of two weekend schools as President of Parents Associations. This showcases not only his leadership abilities but also his dedication to community involvement and educational advancements.
Koji Hagimoto is driven by a profound passion for advancing healthcare; he is fervently committed to making innovative drugs and medical devices accessible to patients with unmet medical needs as expediently as possible. His enthusiasm for driving change and improving patient outcomes is evident in his dedication to clinical excellence, regulatory integrity, and collaborative partnerships.
Questions
How did Koji Hagimoto develop his extensive expertise in regulatory affairs and clinical research? What innovative programs has Koji Hagimoto implemented in pharmaceutical product development in Japan? Can Koji Hagimoto share insights from his co-chairing experience at global development workshops? How does Koji Hagimoto approach the challenges of obtaining market authorizations in the pharmaceutical and medical device sectors?
Tags
Pharmaceutical industry Medical device development Regulatory affairs Clinical trials NDA preparation PMA submission 510(k) registration Project management Clinical research KOL engagement Global development Healthcare innovation Animal science education Leadership in healthcare Japan market authorizations US pharmaceutical experience
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