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

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)

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.

Hirokazu Yamaguchi

Masato Kishida

My global achivements are categorized in two main types as follows: 1. Succesfully cordinating and facilitating several business globalization projects of some orphan products for CNS disorders and inherited metabolic disorders as a project leader, and 2. Outstanding success in the legal entities' establishment of three key area, e.g., a global clinical development head office in EU, two clinical and RA offices in the US & Brazil and an ASEAN region business head office in Singapore. Global business expansion is composed of two main phase. First one is to elaborate specific business plan from global business policy to clinical development strategy to draw the master of global business big picture. Next one is to implement the fixed road map and steamlined action plans on the timeline basis under the frequent risk assessment and business environment analysis.

Rou Irisawa

IRISAWA Consulting LLC

Worked at Chugai Pharmaceutical Co., Ltd. for 27 years, primarily in antibody drug research and development, CMC regulatory affairs, and quality assurance, from preclinical trials stage to BLA stage. Involved in the BLA of Japan, US and EU approval for the CTD-Q of Actemra, Japan's original first antibody drug. And also involved in Japan BLA for several biologics Genentech original. Since 2017, involved in the development of many new modalities, including three SAKIGAKE designated cell products, and participated in 21 times PMDA consultations responsible for CMC regulatory and QA for cell products and gene therapy products. In 2023, became independent as a CMC regulatory consultant. Author of ""CMC Pharmaceutical Design - CMC Pharmaceutical Strategy in the Era of New Modality Pharmaceuticals"" (Yakuji Nipposha, 2022), and is the overall supervisor of the Japanese translation of A-CELL (CMC Development Guidance for CAR-T). Fellow at Tama University's Medical Care Solutions Research Institute, and a top performer in the regular course of Pharmaceutical Evaluation Science at the University of Tokyo Graduate School of Pharmaceutical Sciences in 2024. Certified in generative AI skills (November 2025).　Currently involved in various projects, including serving as CMC lecturer at seminars on how to proceed with the development of CMC for antibody drugs, cell products, gene therapy products, etc　for small company to semi-major company.