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CEO Blog: February 7, 2020

Induced pluripotent stem cells or iPS cells were discovered in 2012 by the Nobel prize winner Shinya Yamanaka, who is a professor at Kyoto University. Despite the option of building wealth by keeping this world-changing invention private, Dr. Yamanaka has decided to open source iPS cell-related technology to encourage researchers and pharmaceutical companies to adopt iPS cells. He thought this was the best option for patients with illnesses that could not be cured with existing treatments.

Almost ten years have passed since, and a number of clinical trials using iPS cells and transplantation into actual patients have been performed. Japan has always been a frontrunner in this field, and thanks to Dr. Yamanaka, the Japanese government has decided to invest $1B in regenerative medicine research in 10 years. While other countries have focused on research on ES cells rather than iPS cells, it was difficult to perform clinical trials and transplantation on humans given the ethical challenge that ES cells can only be produced from human embryos.

Japan was indeed leading the regenerative medicine field. Until recently.

Now, there is a bio-startup that Dr. Yamanaka calls “a threat.” That is BlueRock Therapeutics in the United States. The company has begun a clinical trial to transplant nerve cells made from iPS cells into patients with Parkinson’s disease and is working on treating heart failure with cardiomyocytes made from iPS cells and severe intestinal disease with gut nerve cells. These are completely competing with the efforts of Kyoto University’s CiRA to which Dr. Yamanaka belongs.

BlueRock Therapeutics is a bio-startup that was originally funded by Bayer and other companies and became a wholly-owned subsidiary of Bayer in August 2019. The amount raised by the company at the time of its establishment was about $225M, far exceeding the sum of all the funds collected by CiRA in the past. In addition, Fate Therapeutics in the United States has started making immune cells that attack cancer using iPS cells and administering them to actual patients.

Japan wins in technology and loses in business. This composition, which has been often said in the industrial world, has just begun to appear in the field of regenerative medicine. Japan is beginning to lag behind the United States in funding and commercialization. Moreover, the Japanese government announced a $10M annual budget cutoff for the iPS stockpile business, which was withdrawn at a later date, but the fact that the Japanese government once capped iPS cells remains unchanged.

So what should we do in Japan? Moving to the United States and continuing research is one way to do that. Although one may argue about national interests from a short-term perspective, there are patients all over the world who want treatment using iPS cells. For such patients, it doesn’t matter in which country they were made. If human life is paramount, crossing national borders should be a valid option.

Another way is to enter from different industries. A prejudice, which iPS cells and regenerative medicine should be handled only by researchers and companies involved in biotechnology, should be eliminated first. There are many areas where Japan has strengths, such as robotics, FA, and IoT. By having the companies from these fields enter in biotechnology and having them invest in research, at least the funding problem can be solved.

Also, there is “integration” that Japanese people are good at. By combining things originally made for different purposes, Japanese people kept creating a completely new added value. This is the way Japan has come a long way in industry and fought the world. I think this analog tactic is what is needed in the field of biotechnology and regenerative medicine in Japan.