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

Osamu Tabuchi

JMDC Inc. Quality Assurance Office manager

I am a dedicated professional with extensive experience in safety management and post-marketing surveillance (PMS) in the pharmaceutical industry. After joining SANWA KAGAKU KENKYUSHO CO., LTD., I focused on risk management for diabetes medications and treatments for dialysis complications. My work included PMS literature development and cardiovascular event evaluations, contributing significantly to drug development.
At CureApp, Inc, a company specializing in software as medical devices, I served as the Safety Management Officer. I successfully established the safety management system and operational processes for Japan's first therapeutic app. My involvement in risk management for various therapeutic applications, including those for hypertension, allowed me to engage deeply with the core aspects of product development.
Currently, I am the Head of Quality Assurance at JMDC, Inc, where I oversee GxP compliance and reliability assurance. I am actively involved in building a new PMS framework that combines e-source data with additional collected data, as well as managing certification acquisition and maintenance.

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)

Tomoko Maeda-Chubachi

TMC Clinical Development Consulting, Inc, President; The Institute of Drug Development Career Promotion, Founding Director; Japan Alliance of Medical School Startups, Director

Dr. Maeda-Chubachi is an advisor and consultant for pharmaceutical and biotech companies and was the Chief Medical Officer at Pelthos Therapeutics (previously Novan), leading First-in-Human to launch preparation. Tomoko is known for her expertise in drug development with over 20 years industry experience. She has led clinical and medical affairs in large pharma as well as a small biotech. She led global drug development teams, resulting in 8 approvals in multiple regions, including Xalatan, Xeljanz, Taltz, Vtama, and Zelsuvmi.　Tomoko has broad knowledge of drug development, of which process is highly regulated and need thorough risk assessment, management, and control. As a Chief Medical Officer, she worked closely with the CEO and board about the strategy and governance.

Hitoshi Takuma

Akiko Yamamoto

Nissan Chemical Corporation
Risk Management ＆Compliance Office
Risk Management Department

Graduated from the Department of Pharmacy at Kyoritsu Collage of Pharmacy (currently Keio University) and received a Ph.D. from Gifu Pharmaceutical University. Engaged in work related to each process of pharmaceutical life cycle (research and development, sales promotion, licensing/alliance, quality assurance and Good Vigilance Practice(GVP)) at Nissan Chemical Corporation. Especially, as the corporate quality assurance department leader, managed the company's pharmaceutical quality system, and maintained and improved appropriate quality assurance systems for API manufacturing sites, manufacturing contractors, and contract testing facilities. Specifically, provided support during FDA inspections and global pharma quality audits, and advised on improvements and response policies for issues raised. Also has experience in implementing regulations and change processes when adding starting material, intermediate and API manufacturing sites, and testing facilities. In addition, has reviewed documents such as license and quality assurance-related contract contents, change applications and master files to be submitted to authorities.