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

Masakatsu Noguchi

SMILE CURVE, Inc.

Ph.D. in life sciences. Worked at consulting firm Dream Incubator, consulting in industry-academia collaboration, business support for tech startups (bio, semiconductor, environmental energy), new business development for large corporations, and overseeing government mega-projects. Previously employed at Abbott Japan and Singapore, managing product marketing for diagnostic tests, pharmaceuticals (women's health), and Asia-Pacific marketing for medical IT. As Business Development Director at Sanamedi, facilitated the commercialization of new medical devices, handled regulatory applications and market launches, and supported investments in and assistance to startups. Additionally served as an evaluator for AMED, and as a mentor for NEDO and university accelerator programs. Currently working independently, he serves as a specially appointed associate professor in the Hiroshima University and as an strategic advisor of MEJ.

Hiroyuki Kajiyama

Graduated from Kyoto University Faculty of Pharmaceutical Sciences. Worked at Tanabe Mitsubishi Pharma Corporation in pharmaceutical research and development, primarily handling clinical development tasks. Since 2016, employed at the Pharmaceuticals and Medical Devices Agency (PMDA), Review Management Department, as a Technical Expert in Regulatory Science Strategy Consultation. Engaged primarily in providing consultation services on pharmaceuticals, medical devices, regenerative medicine products, focusing on academia and venture companies.

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.

keiji Asada

Amenichi Consulting, LLC, CEO

Graduated from Auburn University with a degree in Chemical Engineering. Currently, serving as the CEO of Amenichi Consulting, LLC, a consulting firm specializing in regulatory compliance (FDA) and marketing support for companies entering the U.S. market, particularly in the fields of pharmaceuticals, medical devices, and regenerative medicine products. With extensive industry experience and expertise, he assists clients in developing business plans, securing funding, and establishing operational structures. Additionally, he provides comprehensive support, from the formulation to the execution of business strategies, to help clients enhance their competitiveness. Furthermore, he leverages his network to match clients with the most suitable business partners. With a global perspective, he offers customized services tailored to the needs of each client, aiming for sustained growth and success. Amenichi was established in 2018 and has supported over 50 companies since its inception.

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)