Leadership & Team
IDEC proudly offers extensive experience in regulatory consulting and stakeholder alignment in the Japanese pharmaceutical market. Our leadership and team are comprised of industry experts and practitioners committed to helping our clients gain expedient entry into Japan.
Meet Our Leadership
Naoya Kato, MSc
Representative Director and CEO
Mr. Kato has more than 30 years’ experience working at large multi-national pharmaceutical companies, including Roche and Amgen.
regulatory science for the development of global product development strategies. Mr. Kato achieved several successful globally-integrated programs involving Japan by leading global project teams through PMDA consultations and clarifying the regulatory requirements for Japanese submissions—including CTNs and Japanese NDAs—for global product development programs.
Tomomi Goto, RPh, MBA
Vice President, COO, Head of Product Development
Ms. Goto has over 20 years of global drug development and new product planning experience in the pharmaceutical industry. She is responsible for providing strategic project leadership for all IDEC product development services.
Prior to her current role, she led multiple R&D project teams in a variety of therapeutic areas and completed many successful marketing application authorizations (MAA). She has broad experience in multi-disciplinary global leadership positions, including as head of portfolio management and R&D project leader at Sanofi, global project manager at Takeda, and clinical project leader at Eli Lilly Japan.
She also holds an MBA from Waseda University and a B.S. in pharmaceutical science from Nagoya City University.
Yasue Ishida, MBA
Director, Business Operations
Ms. Ishida is responsible for controlling all matters related to Finance, Human Resources and General Affairs at IDEC. Ms. Ishida has strong financial analysis and people management skills developed over 25 years’ experience in a global consumer goods company. Her contributions covered all financial areas, included development of financial strategy, budget and forecast management, accounting, tax, costing, business planning and analysis, total supply chain productivity improvement and agile project management.
Prior to her current role, she also set up a new legal entity for brand divestiture. She led the organization setup, people management, and Finance/Human Resources related process development as controller.
Mikio Ishizawa
Director, Product Planning & Commercial Planning
Mr. Ishizawa had been working over 30 years at multi-national pharma and biotech companies, including BMS, Amgen, MSD and UCB.
In particular, he has held leadership roles in product development projects of biologics for 20 years. He has experience in a broad range of professional areas including not only commercial, but also R&D, and played leading roles at start-up companies.
Always “thinking of a difference” in his mind, he is responsible for Commercial Strategy including Commercial Evaluation, Market Access and Marketing Strategy at IDEC.
He is a registered pharmacist (R.Ph.) and holds a Master’s degree in Healthcare Administration from Graduate School of Pharmacy at The University of Mississippi.
What makes IDEC different?
Non-Clinical
Our team is comprised of specialists in pharmacology, pharmacokinetics, and toxicity, and have been engaged in drug research and development for many years at both domestic and international pharmaceutical companies.
Clinical Team
Experienced in drug research and clinical development at domestic and international pharmaceutical companies, our Clinical team members have expertise in pharmacokinetics, pharmacodynamics, and statistics.
CMC Team
The IDEC team offers CMC expertise across biopharmaceuticals, blood products, human-derived hormone products, and chemically synthesized drugs.
Medical Writing Team
Across disciplines, the IDEC team is experienced and versed in the creation of clinical trial-related documents, application materials, consultation materials, and inquiry correspondence.
Development Compliance Team
With team members serving international pharmaceutical companies and engaged in drug development for more than 30 years, IDEC has experts ready with extensive experience in compliance.
In-House Medical Team
IDEC boasts a unique skill set within its own virtual walls: an in-house medical expert who obtained a license in both Germany and Japan and served as a clinical physician in a Japanese hospital.
Learn how our proven services and process can help you accelerate your product’s path to market.
