Message
CEO’s Message
Introduction of Consultants
Representative Director, CUES Consulting Inc.
Specialization
- Streamlining pharmacovigilance organizations
- Planning safety assurance measures
- Transferring safety data at the time of succession
- Creating risk management plans
- Planning global safety measures
Career History
- Daiichi Pharmaceuticals: Sales Planning, Clinical Development Project Leader
- Wyeth: Clinical Development Project Leader
- Sanofi: Clinical Development Project Leader, PV Database Management
- Shire: Head of Pharmacovigilance, Safety Manager
- Ferring: Head of Pharmacovigilance, Safety Manager, Post-Marketing Surveillance Manager
- Medtronic: Head of Clinical Trial Safety Management, Safety Manager
Chairman of CUES Consulting Inc.
Takashi Yoshida
Specialization
- Regulatory affairs strategy (development, post-marketing regulatory affairs)
- Corporate risk management
- Mergers and acquisitions, product succession
Career History
- Fujisawa Pharmaceutical Co., Ltd.: Clinical development, Head of Development Regulatory
- Affairs, US Project Management Astellas Pharma Inc.: Head of Development Regulatory Affairs
- Sanofi: Executive Officer, Head of Regulatory Affairs, Head of Pharmacovigilance, Head of Reliability Assurance, Head of Regulatory Affairs for Japan-Pacific Region, Overall Manufacturing and Marketing Manager
- GlaxoSmithKline: Director of Regulatory Affairs, Head of Public Affairs, Overall Manufacturing and Marketing Manager
Specialized Consultants / Career Backgrounds
CMC Regulatory Affairs
Head of CMC Regulatory Affairs at a major foreign pharmaceutical company (New drug development to post-marketing change management).
CMC Manager and research laboratory experience at major Japanese and global pharmaceutical companies
CMC Manager and research laboratory experience at major Japanese and global pharmaceutical companies
Epidemiology & Clinical Statistics
Clinical statistics at a major domestic pharmaceutical company (Statistical analysis in new drug development), Epidemiological research and post-marketing clinical trial planning at a major foreign pharmaceutical company.
Non-Clinical
Research institute of a major domestic pharmaceutical company (New drug discovery), Global project leader (International joint development), Institute director, Business development for domestic venture businesses (Introduction and export of seeds).
Safety Research Institute at a major global pharmaceutical company (toxicology and pharmacokinetics); Pharmacovigilance Department (Safety Management Supervisor, safety assessment, safety database management, etc.)
Safety Research Institute at a major global pharmaceutical company (toxicology and pharmacokinetics); Pharmacovigilance Department (Safety Management Supervisor, safety assessment, safety database management, etc.)
Medical Writing
Clinical development at a major foreign pharmaceutical company (Monitoring, clinical plan formulation), Medical writing, Application document preparation (CTD editing), Medical affairs (Post-marketing clinical trial planning).
Global Business Consultant
General Manager at a major foreign pharmaceutical company (New market entry, resource management, corporate integration & business divestiture, new product launch, partner business promotion, organizational design & sizing & talent acquisition).
Distribution
Head of distribution department at a major foreign pharmaceutical company (Distribution schemes, distribution function construction for new market entry business, 3PL setting, proposing the best distribution form according to product characteristics, transitioning the profit system to wholesalers from a margin business to a Pay for Performance fee business).
Drug Pricing
Public Affairs at a major foreign pharmaceutical company (New drug pricing strategy development (acquisition of usefulness addition), drug price negotiations, insurance reimbursement).
Collaboration with External Companies
Domestic medical writing company (CTD document preparation), drug pricing consulting firm (Drug pricing strategy planning for pharmaceuticals, medical devices, regenerative medicine products, drug pricing application preparation, drug pricing negotiation representation), electronic application document preparation company (CDISC, Gateway compliance), etc.