Chris Brünger, MD
President and CEO, Chief Medical Officer
Dr. Brünger has >25 years of global drug development experience and held senior R&D positions for Schering AG and Pharmacia Corporation in Japan and Germany from 1989 to 2003, before founding IDEC. He is also a licensed physician in Germany and Japan.
Dr. Brünger’s unique experience in Japanese clinical practice and medical research, and expertise in international drug development enable him to work with clients to develop effective solutions to integrating Japanese regulatory and marketing requirements into global development programs. He has prepared and managed >50 PMDA consultations, and pioneered Japanese-Korean clinical co-development and studies in ethnic Japanese outside Japan.
Naoya Kato, MSc
Senior Director, Product Development & Regulatory Science
Mr. Kato has more than 30 years experience working at large multi-national pharmaceutical companies including Roche and Amgen.
Mr. Kato has broad experience in global drug development with particular expertise in the clinical and regulatory management of Japanese development projects integrating Japan into global product development programs. Especially, with his broad experience in regulatory science for the development of global product development strategies, He 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.
Eiji Aoyama, PhD
Director, Non-Clinical Development & Clinical Pharmacology
Dr. Aoyama, who holds a PhD in Pharmaceutical Science, has >25 years of global drug development experience, and is an expert in Non-clinical Development and Clinical Pharmacology (transition from pre-clinical to clinical phase). He gained his working experience at Takeda, and most recently at Eli Lilly in Japan, where he was a Team Leader of Eli Lilly’s Japan PKPD Group.
Dr. Aoyama’s experience covers a wide range of therapeutic areas including Diabetes, Cardiovascular, CNS, Oncology, and Immunology, with an in-depth understanding of the Japanese regulatory environment to support the design and implementation of required studies for regulatory approval in Japan.
Mr. Miyamoto has >25 years of experience in CMC-RA area of pharmaceutical development with a wide range of products including controlled release drugs and genetically recombinants, and has an excellent expertise in reviewing and drafting CTD documents in both English and Japanese in order to fulfill Japanese regulatory requirements.
Prior to joining IDEC, he worked for some Japanese subsidiaries of global pharmaceutical companies including BMS, Novo, Janssen, US-Merck and Ferring as a CMC-RA expert or the head of CMC-RA section.
Director, Business Development
Mr. Fujisawa brought biotechnology company from startup to IPO as the founder, prior to joining IDEC. His experience covers product portfolio analysis, strategy development and planning in GSK, also contributing in alliance management and capital fund raising startup Bio Venture as an advisor.
Mr. Fujisawa is an honorary member of the Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc., assigned by Prince Tomohito Mikasa. Mr. Fujisawa was appointed to an evaluation committee member at New Energy and Industrial Technology Development Organization Japan (NEDO) in METI.
Akira Sakai, PhD
Senior Consultant, Program Management
Dr. Sakai holds a PhD in medicine from Tohoku University and was a postdoctoral fellow at Stanford University Medical Center. Dr. Sakai’s research subjects were immunology, oncology, virology, cell biology and pharmacology. He has >15 years of basic pharmacological research and >15 years of drug development experience at Japanese and foreign pharmaceutical companies.
Dr. Sakai’s particular expertise is to create overall Japanese development strategies and plans.