Takayuki Hasegawa
CEO
Hanover Park,IL
Summary
Strategic and results-oriented executive CEO with a distinguished career in the pharmaceutical and biotechnology industries, specializing in corporate restructuring, high-stakes regulatory navigation, and global market expansion. Pioneered the world’s first FDA IND clearance for a Xeno-Celltransplantation clinical trial, establishing a historic regulatory precedent for cell-based therapies in the United States. A transformative leader with proven expertise in greenfield entity establishment; orchestrated the strategic transition from a representative office to a fully operational U.S. subsidiary and architected the foundational framework for expatriate management, ensuring seamless talent deployment and operational readiness. Successfully converted a 50:50 joint venture into a 100% owned subsidiary and executed complex debt equity swaps (DES) to optimize corporate capitalization. Expertise spans the full product lifecycle, from R&D and clinical execution to managing mega-brands that achieved ¥40 billion in annual sales and ranked among the top 5 most prescribed products in Japan. Recognized for bridging scientific innovation with disciplined financial management and visionary leadership to drive organizational growth and long-term shareholder value in global markets.
Overview
20
20
years of professional experience
7
7
Certifications
Work History
Director, Program Management Office
Otsuka Pharmaceutical Factory America, Inc.
08.2025 - Current
- Played a pivotal role in the strategic transition from a representative office to a fully operational U.S. subsidiary, supporting the greenfield establishment of the legal entity.
- Architected the foundational framework for expatriate management during the pre-incorporation phase, establishing critical protocols for visa, taxation, and relocation to ensure seamless talent deployment from Japan.
- Spearheaded the first-ever FDA IND submission and clearance for a Xeno Cell Transplantation program in a developed nation, navigating complex regulatory landscapes to secure the global clinical supply chain.
- Managed strategic partnerships with external CROs, optimizing performance, ensuring quality compliance, and driving cost efficiency across all outsourced activities.
- Directed end-to-end clinical development execution, including IND strategy, site engagement, and trial operations while maintaining strict compliance with FDA regulations.
- Operationalized the corporate infrastructure required for the entity launch, ensuring HR, legal, and administrative systems were robust and aligned with global standards.
- Led and oversee multiple global development programs, ensuring rigorous alignment with corporate strategy, project timelines, and financial objectives.
- Established and operationalized a clinical development platform in the United States, integrating regulatory, clinical, and manufacturing functions to accelerate program advancement.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
- Managed budgets effectively to ensure optimal use of resources while maintaining financial stability.
Board Director and CEO
DIATRANZ OTSUKA Ltd.
08.2016 - Current
- Orchestrated the strategic acquisition of a 50:50 joint venture to establish a 100% owned subsidiary, streamlining the corporate structure for enhanced operational agility.
- Restructured corporate capitalization through Debt Equity Swaps (DES) and other financial instruments, fortifying the balance sheet and optimizing the entity’s financial health.
- Led the organizational transformation to simplify corporate governance, reducing structural complexity and improving decision-making efficiency at the executive level.
- Drove global business expansion by identifying high-growth market opportunities and building long-term strategic alliances with international partners and Key Opinion Leaders (KOLs).
- Spearheaded commercial strategy development, successfully positioning the organization as a leader in xenotransplantation and diagnostic innovation.
- Cultivated and maintained executive-level relationships with global stakeholders, ensuring alignment between regional operations and parent company objectives.
Head of U.S. Office
Otsuka Pharmaceutical Factory, Inc/ Otsuka America Pharmaceutical Inc.
12.2016 - 07.2025
- Established and led the U.S. representative office, serving as the primary strategic liaison to identify market expansion opportunities across U.S. and European territories.
- Cultivated high-level strategic partnerships and KOL relationships to strengthen corporate presence and facilitate cross-functional business development initiatives.
- Directed regional market intelligence and strategic planning, delivering actionable insights to inform global commercialization and portfolio growth strategies.
- Resolved problems, improved operations, and provided exceptional service.
Xenotransplantation Project Lead, Research and Development Center
Otsuka Pharmaceutical Factory, Inc.
01.2016 - 07.2025
- Led the world’s first FDA IND clearance for the Diabeebull program, establishing a pioneering regulatory pathway for xenotransplantation in the United States.
- Architected the development ecosystem, integrating non-clinical, manufacturing, and clinical platforms to meet rigorous FDA requirements for first-in-human trials.
- Orchestrated strategic advocacy with global KOLs, successfully shaping professional opinion to support the introduction of a novel therapeutic modality.
Deputy Director, U.S. Business Development
Otsuka Pharmaceutical Factory, Inc.
06.2013 - 12.2015
- Established a joint research institute with a leading U.S. university to accelerate innovative product development and strengthen the R&D pipeline through academic-industrial collaboration.
- Orchestrated the evaluation and successful in-licensing of pharmaceutical products from European partners, expanding the regional product portfolio and driving market entry strategies.
- Supported the successful establishment of subsidiaries in India and New Zealand, facilitating global organizational expansion and operational readiness in new markets.
Head of Promotion & Marketing Communications
MSD K.K (formerly Banyu Pharmaceutical)
07.2010 - 06.2013
- Orchestrated the successful U.S. market launch of two innovative pharmaceutical products, exceeding initial sales targets and market penetration forecasts by a significant margin.
- Led a high-performing team of 9 Brand Promotion Managers and 2 secretaries, spearheading integrated promotional strategies across diabetes, pediatrics, and infectious diseases.
- Developed and executed data-driven marketing campaigns that rapidly increased brand awareness and secured a dominant market share within the first year of product introduction.
- Optimized advertising agency partnerships and contract compliance, ensuring high-impact delivery of promotional assets while maintaining budget efficiency.
Brand Manager (Mucosta), Product Management Group
Otsuka Pharmaceutical Co., Ltd.
08.2006 - 07.2010
- Propelled Mucosta to become Otsuka’s first pharmaceutical brand to achieve ¥40 billion in annual sales, setting a historical milestone for the company’s domestic revenue.
- Achieved the #1 market share position in gastroprotective agents in Japan, ranking among the top 5 most prescribed pharmaceutical products nationwide.
- Expanded the physician prescriber base by over 20,000 within three years through strategic lifecycle management and targeted clinical advocacy.
- Orchestrated high-level KOL engagement via advisory boards and symposia, significantly enhancing product clinical acceptance and brand authority.
- Supervised and mentored a team of Associate Brand Managers to execute integrated marketing strategies, ensuring consistent growth and dominant market presence.
- Earlier Career Progression | Otsuka Pharmaceutical Co., Ltd.April 1993 – July 2010Senior Manager, Sales Planning & Marketing (Feb 2006 – Dec 2006): Led strategic marketing initiatives and optimized sales operations to drive brand growth in competitive therapeutic areas.Chief Medical Representative, Tokyo Branch (Oct 1999 – July 2002): Established foundational expertise in physician engagement and market analysis, consistently exceeding sales quotas in high-stakes territories.Therapeutic Application Development, R&D Dept. (Oct 1997 – Sept 1999): Bridged scientific data with commercial needs, contributing to R&D-driven market strategies and product positioning.Sales Representative, Kitatano Branch (April 1993 – Sept 1997): Executed high-impact sales activities for a diverse product portfolio, securing consistent growth and local market share
Education
Bachelor - Biochemistry and Pharmacy
Meiji Pharmaceutical University
03-1993
Skills
Strategic Planning & Business Development
Regulatory Compliance & IND Approvals
Leadership & Team Management
Key Opinion Leader (KOL) Engagement
Cross-functional Collaboration
Problem-solving
Decision-making
Affiliations
- Member American Transplantation Society (ATS)
- Member International Society for Xenotransplantation (ISX)
Certification
Licensed Pharmacist Japan ・ 1993
AWARDS & HONORS
President’s Award Otsuka Pharmaceutical-2004, Award of Excellence(New Launch) MSD K.K.(formerly Banyu Pharmaceutical Co.,Ltd)-2009, Certificate of Appreciation(Propecia’s Sales Rank First Worldwide) MSD K.K.- 2010
Timeline
Director, Program Management Office
Otsuka Pharmaceutical Factory America, Inc.
08.2025 - Current
Head of U.S. Office
Otsuka Pharmaceutical Factory, Inc/ Otsuka America Pharmaceutical Inc.
12.2016 - 07.2025
Board Director and CEO
DIATRANZ OTSUKA Ltd.
08.2016 - Current
Xenotransplantation Project Lead, Research and Development Center
Otsuka Pharmaceutical Factory, Inc.
01.2016 - 07.2025
Deputy Director, U.S. Business Development
Otsuka Pharmaceutical Factory, Inc.
06.2013 - 12.2015
Head of Promotion & Marketing Communications
MSD K.K (formerly Banyu Pharmaceutical)
07.2010 - 06.2013
Brand Manager (Mucosta), Product Management Group
Otsuka Pharmaceutical Co., Ltd.
08.2006 - 07.2010
Bachelor - Biochemistry and Pharmacy
Meiji Pharmaceutical University