Satoru Nagasaka

Life Science, Healthcare, Digital Health, Pharmaceutical, Medical Device, Biotech, Health Food, Health Device, Regulatory Compliance, Research and Development, Joint Development with Academia, Clinical Trials, Product Development and Commercialization, Marketing Authorization, GxP Compliance, License Agreement, Distribution Agreement, Patent Infringement Litigation, Patent Prosecution and Strategy, Investigation of Fraud, Corruption and Inappropriate Accounting in Life Science Industry, Corporate Dispute Resolution, International Arbitration, Competition Law in Healthcare Sector, Data Privacy and Protection in Healthcare, AI and Digital Health Regulations, Medical Software Development, Telemedicine Regulations, Healthcare M&A, Venture Capital in Healthcare, Medical Device Certification, Pharmaceutical Supply Chain, Clinical Research Compliance, Healthcare Facility Regulations, Medical Professional Liability, Healthcare Industry Restructuring, Cross-border Healthcare Transactions, Healthcare Joint Ventures.

TMI Associates (1994 - 2023)

Hughes Hubbard & Reed LLP, New York (2001 - 2002)

Admitted: Japan, 1994

-Major Japanese and non-Japanese manufacturers of pharmaceutical products, medical devices, diagnostic equipment, and health foods

-Global pharmaceutical companies and medical device manufacturers seeking to enter or expand in the Japanese market

-Japanese and non-Japanese venture businesses and start-ups in biotech, health device and digital health sectors

-Academic institutions and research organizations engaged in life science research and development

-Healthcare technology companies developing AI and digital solutions

-Medical institutions and healthcare providers

-Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs)

-Digital health platform providers and telemedicine service companies

-Medical device software developers

-Healthcare data analytics companies

-Pharmaceutical wholesalers and distributors

-Medical equipment leasing companies

-Healthcare investment funds and venture capital firms

-Medical professional associations and industry groups

-Healthcare consulting firms

University of Washington

LL.M.

2000 - 2001

The University of Tokyo

LL.B.

1985 - 1990