Monday, October 26, 2015

Update on Japan's New Cell Therapy Regulations

By: Leah Kinthaert

At the Cell Therapy BioProcessing Pre-Conference Symposia for the BioProcess International Conference and Exposition, VP of Business Development for RepliCel and cell therapy industry thought leader Lee Buckler updated the audience on Japan's new cell therapy regulations. Buckler was a great person to give insight into these new regulations, because RepliCel is partnered with a Japanese company.

The regulatory environment for cell therapies changed greatly in 2012 when Shinzo Abe was elected prime minister. Last year Abe (who has since then been re-elected) set a plan in action to change the existing regulations and provide $1 billion in stem cell research funding over the next 10 years. This political and economic driven regulatory innovation has created a market push into Japan; Buckler described how his company re-prioritized Japan into their strategy due to this seachange.

Japanese companies are actually getting overt recommendations from their government to go into cell therapies; the government has incentivized companies to locate in Kobe, where the Kobe Biomedical Research Center is located. Buckler stated: "One can't underestimate the power of government to influence corporate decisions. CEOs feel the need to respond to government presence."

Buckler went on to give details about his company RepliCel's research in Japan. RepliCel has partnered with one of the world's top hair care and cosmetics companies, Shiseido. Shiseido has built their own manufacturing facility in Japan, making RepliCel one of just two companies with a cell manufacturing footprint in Japan.

Buckler ended his lecture by asking the audience to ponder this question: "Over the long term, will it (changes in Japanese regulations) have real lasting commercial implications?"

The agenda for the PreConference Symposia on Cell Therapy Bioprocessing on Monday, October 26 can be found here.

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