A comprehensive portal site for Medical Innovation Support Office (MEDISO).Medical Innovation Support Office

Hiroya Kuwahara

Department of Neurology and Neurological Science / Institute of Innovation Advancement
Tokyo Medical and Dental University

M.D. (graduated from Tokyo Medical and Dental University), and Ph.D. (completed doctral course at Graduate School, Tokyo Medical and Dental University). Specialist and Attending Neurologist of the Japanese Society of Neurology, and Fellow and Board Certified Member of the Japanese Society of Internal Medicine. He is engaged in 1) clinical practice, research, and education in neurology, 2) research and development of fudamental technologies for drug discovery (especialy nucleic acid drugs and drug delivery system), 3) promotion of clinical research and industry-academia collaboration, at Tokyo Medical and Dental University. He has a career of a Deputy Director at Research and Development Division, Health Policy Bureau, at the Ministry of Health, Labour, and Welfare from 2018 to 2019, and was involved in establishing a nationwide system for promoting clinical research and accelerating venture companies in the healthcare field. He provides consultations on the needs of clinical practice, on collaborative research and field provision in relation to project implementation, and on clinical research and development.

Ruka Takeuchi

Discovery Biotech Consulting　　Representative
PARKS　Commercialization Producer

I have been engaged in marketing and business development for more than 30 years in the life science market, mainly in the medical and pharmaceutical fields, both in Japan and overseas. Currently, I have established my own consulting firm and provide business consulting services to foreign and domestic companies from start-ups to small and medium-sized enterprises. I would be happy to be of service to you by drawing on my past business experience as well as my daily experience in providing hands-on support to various companies and projects.

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.

Masaho Ishino

After engaging in medical research for 25 years, I became a patent attorney (JAPAN). Over the next 20 years, I have supported medical researchers in creating intellectual property and planning research strategies, as well as engaged in contract practice and technology transfer of university IP. Intellectual property strategies for regenerative medicine and other new modalities require not only a high level of expertise in both cutting-edge medical research and intellectual property rights, but also comprehensive knowledge covering clinical development and regulations. Utilizing my experience of contributing to the development research and practical application of university-originated seeds as a representative of an institution responsible for the AMED's Project of Translational and Clinical Research Core Centers and an organizer of nationwide academia intellectual property networks, I aim to contribute to raising the potential of intellectual property of academia/venture.

Yuka Ichijo

Global Program and Regulatory Portfolio Management Consultant

Global Program and Regulatory Portfolio Management: Expertise in driving the execution of clinical/regulatory goals across a company’s product portfolio in close collaboration with global cross-functional teams. Proven track record of facilitating development of regulatory strategies and overseeing timely execution to achieve global program milestones. Skilled leading strategic resource/timeline plannings for achieving goals with efficiency. Experience managing programs of multiple therapeutic areas including infectious disease, neuroscience, and immunotherapy including rare disease, in Japan, US and EU. Adept managing international & alliance programs and site monitoring of clinical trials. Key Areas of Expertise: Skills: Program Management, strategic leadership, operational efficiency, prioritization, critical thinking & problem-solving, team development & collaboration, decision making, empowerment, active listening Indications: infectious diseases (bacterial & viral), pain (post-operative, cancer, chronic), diabetic peripheral neuropathy, Alzheimer’s disease, AL Amyloidosis, hATTR Amyloidosis Phases: 1, 2, 3, post-marketing Regulatory interactions/submissions: CTN/NDA/ODA, PMDA/MHLW meetings (Japan), IND, NDA, sNDA, BLA & MAA preparations, Type A, B, C meetings with FDA including Pre-IND, Fast Track, Special Protocol Assessment, EOP, EOP2, pre-NDA (US), Scientific Advice (EMA)