The first episode in Phacilitate:Exchange's Top Tips series is brought to you by Lee Buckler, President and CEO of RepliCel Life Sciences. In this episode, Lee provides his expert perspective on the question…has Japan’s regenerative medicine experiment paid off?
The story of Japan’s regulatory reform is broken down into four sections:
1. The rationale behind the reform
Dr Yamanaka’s Nobel Prize win in (and huge national pride), plus an ageing demographic and politico-economic factors all led to a top-down recreation of the regulatory framework for regenerative medicine and, in particular, cell therapies.
A grand experiment in policy-driven economic reform begins…
2. New regulatory pathways
The regulatory paradigm was recreated in Japan. The much talked about PMD Act provided expedited market access based on a small pool of data. Simultaneously, a brand-new act, the ‘Act for the Safety of Regenerative Medicine’ (ASRM), was created. A lot of clinical trials, R&D and manufacturing were being done in an academic or hospital setting and the ASRM meant that these facilities could be certified while still providing a fast track to commercialisation.
3. Early indications of success
The whole world is watching to see if these major reforms create a new industry, a new economic base and bring new therapeutic products to Japan. The past three years have shown some positive indications; the creation of a whole manufacturing infrastructure that didn’t exist beforehand. There is also some infrastructure popping up for other ancillary services.
Another strong indication of growth and success is the new wave of partnerships and even foreign companies setting up without a national partner, which indicates the maturity of the infrastructure.
4. Establishing operations in Japan
RepliCel first set up in Japan in 2013 in partnership with Shiseido and there have been a lot of changes since then. There is a new appetite of Japanese investment both directly into foreign companies or in the joint ventures and partnerships being set up. The evolution of the investment model is having a significant impact on commercial decisions.