"The real game is about to come." Nobuya Yamanaka talks about IPS15

IPS cells are made of mice for 15 years this year.Movement for practical use accelerates, but what are the tasks?What is the future direction?We asked Professor Shinya Yamanaka, director of IPS Cell Research Institute, Kyoto University.

――Corable trials on products derived from IPS cells are becoming more active.How do you see it?

Corporate trials and clinical research and clinical research by Academia researchers are progressing.In a long R & D, I feel that I have passed back and entered the second half.Here is a critical moment.I want to run while cooperating with each other.

――Is the assumed goal approved or sold?

First of all, it may be a conditional approval (which will require a survey of therapeutic effects after approval), but we will eventually receive formal approval and deliver it to patients as a general treatment.

I've always been thinking not only to deliver, but also to deliver at a conscientious price.It's hard from now on, but I want to do my best.

――The government provides approximately 110 billion yen in 10 years from 2013 to FY2013 to regenerative medicine centered on iPS cells.On the other hand, no support after FY2011 has not been decided.The plan for practical use is delayed from the initial goals, but what policies do you get over?

I think that most of each company's plan is planned for "Best Scenario".It is expected that it is a little late due to various problems and obstacles.

Every company or any researcher is working hard without interruption.Everyone was able to turn back without even one dropout.In medical research, it is even difficult.He pays tribute to the efforts of many companies and researchers so far.

However, it is a real game from now on.Especially in the case of medical research and regenerative medicine, the closer you get to the goal, the more expensive.

At the phase of the clinical trial, it costs 1 billion or 2 billion for cell manufacturing.In many cases, the venture is responsible, but can we get over here?It is approaching the so -called "valley of death".

Looking back on the history of Japanese medical research so far, I think there were several cases where they could not pass through the valley of death and had them do it overseas, such as the United States.

It has become a product overseas, reimported it, and has been "ultra -expensive medical care", which is tens of millions of millions, and in some cases, when returning to Japan.I have seen such reality.

Regarding IPS, I would like to cross the valley of death in Japan.To do so, it is important for each company to share information and eliminate waste instead of doing it.

For this reason, the Kyoto University IPS Cell Research Foundation (IPS Foundation) was launched in April last year, which is responsible for the business of stockpiling iPS cells and providing it to companies and research institutions.I would like to work together with the company to share information and cross the valley of death together.I think that even if it is a valley that can not be reached by a company alone, it is often possible to cross if we cooperate.

Many companies are considering cell information, domestic and overseas regulations, and the entry into Europe and the United States, so we share as much as possible negotiations with the US Food and Pharmaceutical Bureau (FDA) and omit waste.

――What are cost measures to overcome the valley of death?

The IPS Foundation has accumulated cell manufacturing facilities, organizations, and know -how.

In collaboration with companies aiming for clinical trials, we use our staff in our facilities, and in some cases, we have people come from companies to manufacture cells together.It will reduce the cost.

Sometimes the same iPS cells are used by multiple companies.Share where you can share.I want to save people, time and funds.

――Do you have a delay in IPS research due to Corona evil?

Due to the influence of the new colon virus ...