[Press Release] The Life Science Sector of Japan: Event Overview
Mar 23, 2016
CAMBRIDGE, MA - On Friday, March 18th, JETRO and MOITI hosted a one-day seminar to discuss new deregulation developments in the Life Science Sector of Japan. Over sixty professionals attended the event, which featured speeches by several prominent members of the public and private sectors of the life science industry.
The sold out event featured several presentations, followed by a panel discussion that opened questions to the audience. Speakers addressed the recent changes to Japan’s Life Science sector, with emphasis on the regenerative medicine and pharmaceuticals markets, which have continued to grow in the last several years.
According to Pharmaceutical-Technology, a digital life science news outlet, “Japan’s pharmaceutical market is the second-largest in the world behind the U.S., representing 9.7% of the world pharma market in 2013.” Although it has traditionally been viewed as a “closed” market for foreign companies, recent deregulation changes have challenged this assumption. Japan’s life science markets continue to offer new opportunities to foreign companies interested in expanding into the Japan market.
Takumi Kuroiwa, Bio-industry division, Ministry of Economy, Trade and Industry, discussed the new legal framework of regenerative medicine in Japan. He spoke of the new era Japan was entering, emphasizing subsidies and governmental support for foreign companies.
Takuya Yokokawa, FUJIFILM, Head of the Steering Committee, Forum for Innovative Regenerative Medicine (FIRM), continued the discussion of the regenerative medicine market from the perspective of FIRM. He emphasized the attractiveness of the market and stressed how Japanese industries welcome foreign companies for collaboration in order to maximize opportunity.
Shogo Nakamori, Corporate Vice President, Clinical Research Services, Asia Pacific General Manager-Japan Country Operation, PAREXEL International, focused his presentation on the current state of the market from the perspective of a large corporation. He discussed the demographic changes and their impact on national medical care expenditure forecasts. He also stressed the positive change of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to support the business of the sector. His advice to the audience was that now is the time to go to Japan.
Masako Nakamura, Head of Asia & Vice President/General Manager, Japan, Aegerion Pharmaceuticals, expounded upon the experiences of a company that had just established business in Japan. She focused on the technical opportunities and challenges that face startups that enter the Japanese Market. She also explained how helpful JETRO had been to her experience.
Keisuke "Kaye" Suzuki, Principle Keisuke Med Tech Consulting, LLC., discussed the knacks and pitfalls to entering Japan from the perspective of the medical device industry. He focused on the importance of determining how and when to enter Japan and the need to focus on reimbursements in relation to regulatory options.
The panel discussion featured a number of questions for the speakers, including:
- Why is the Japanese government focusing on the promotion of Regenerative Medicine and what does the government expect from US companies?
- Through FIRM’s experience of finding partners for US companies, what kind of companies do Japanese companies look for in partners and can you share tips on finding partners?
- What should the applicant pay attention to and/or consider in order to make J-NDA approval easier?
- How is the recruitment of patients in Japan managed?
- Could you please share your past experience on getting device approval in Japan and tell us the differences between Japan and the U.S.?
- Takumi Kuroiwa: New Era of Regenerative Medicine with New Legal Framework (1611KB)
- Takuya Yokokawa: Welcome to Japan's Regenerative Medicine Market (1608KB)
- Shogo Nakamori: The Japanese Regulatory and Market Access Environment (1330KB)
- Masako Nakamura: Establishing a Business in Japan (506KB)
- Keisuke "Kaye" Suzuki: Entering Japan, Knacks and Pitfalls (1386KB)
- Tim Applebury: Activities of JETRO New York (876KB)
The Life Science Sector of Japan: Deregulation, Expedited Approval, Open for Business
Cambridge, MA | MassBio: Massachusetts Biotechnology Council
Friday, March 18, 2016 from 10:00 AM to 1:00 PM (EDT)
- Opening Remarks
- Takumi Kuroiwa, Bio-industry division, Ministry of Economy, Trade and Industry
- Takuya Yokokawa, FUJIFILM, Head of the Steering Committee, Forum for Innovative Regenerative Medicine (FIRM)
- Coffee Break
- Shogo Nakamori, Corporate Vice President, Clinical Research Services, Asia Pacific General Manager-Japan Country Operation, PAREXEL International
- Masako Nakamura, Head of Asia & Vice President/General Manager, Japan, Aegerion Pharmaceuticals
- Keisuke "Kaye" Suzuki, Principle Keisuke Med Tech Consulting, LLC.
- Panel Discussion
- JETRO New York
- Closing Remarks
- Lunch and Networking Event