Japan is making bold moves to redefine how cell therapies make it to market, and the world is taking notice. In late January, the Japan External Trade Organization (JETRO) collaborated with the Centre for Commercialization of Regenerative Medicine (CCRM) to host a seminar in Toronto. This meeting brought together Canadian and Japanese experts from government, academia and industry to discuss Japan’s innovative approach to developing regenerative medicine (RM) products. The roster of speakers included the President and CEO of CCRM, Michael May; Research Fellow at Astellas Pharma Inc., Fusako Nishigaki; OIRM Executive Director, Janet Rossant; and the President and CEO of RepliCell, Lee Buckler.
It is estimated that by 2050, the global market for RM products will have grown to U.S. $380 billion, from $1 billion in 2012. The Japanese government is taking advantage of this remarkable opportunity for growth and development by implementing regulatory changes and stimulating investment.
Dr. Fusako Nishigaki outlined how Japan’s new regulatory framework will speed up the clinical development process. In November 2014, the government implemented changes to the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act). The most important aspects of these changes are: 1) they establish a new and separate category for RM products, and 2) they outline an expedited approval system for RM products.
Under the new rules, a product can obtain conditional approval to go to market after Phase I testing has shown that it is safe and has a likely benefit. While the product is on the market, it undergoes further evaluation to determine efficacy. In the past, RM products required an average of 5-8 years for approval. It is estimated that using the new system the time to approval could be cut to approximately 3.5 years. Some recent examples prove that the new system works. Last year JCR Pharmaceuticals received approval for an allogeneic mesenchymal stem cell therapy for graft versus host disease, and Therumo was granted approval for autologous skeletal muscle grafts to treat heart disease.
One of the take home messages from this seminar was that the development of the RM market will require international partnerships. The Japanese government is involved in a number of initiatives aimed at encouraging foreign investment and collaboration. In June 2011, the Forum for Innovative Regenerative Medicine (FIRM) was established to foster international collaborations between companies. The government also has plans to build the Life Innovation Center (LIC), a facility in the Tokyo region dedicated to promoting the industrialization of RM technologies.
The push for collaboration has resulted in some notable international partnerships. Lonza, one of the leading cell manufacturing companies in the world, has recently partnered with Nikon to help them build a cell therapy business. RepliCel is a Canadian company that has partnered with cosmetics maker Shiseido to become one of the few foreign companies with plans to carry out clinical trials in Japan.
The translation and commercialization of RM products is largely uncharted territory. While great strides are being made, no one government or organization has a successful blueprint for this process.
Japan’s leadership in this area is challenging assumptions and encouraging a different approach. For instance, Japan’s new regulatory changes have shown that it does not take the better part of a decade to bring an RM product to market. Ultimately, this forward thinking will benefit patients who will have faster access to new treatment options.
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