Vol.20, March 2021
Center for Innovation Policy Research, Kanagawa University of Human Services, Japan
How society views regenerative medicine and stem cell research
Background and goals of research
Originally, my background was so-called stem cell research. Based on this, my current research is focused on how stem cell research is viewed by society. Currently, I am doing research on how society views regenerative medicine and stem cell research. Also, regenerative medicine and cell therapy is needed to be put into practical use and accelerate its practical use.
From this point of view, I am also conducting research on the cost of regenerative medicine and cell therapy by trying to understand its economic aspects. I am currently conducting research at the newly established Kanagawa University of Human Services in the Tonomachi district of Kanagawa.
Since Tonomachi has a large concentration of regenerative medicine and cell therapy companies, this is a good opportunity to let people in the Tonomachi area and others outside this town know the existence and name of the University.
So with this goal in mind, I give a special class on "regenerative medicine and cell therapy." I have asked professors with whom I have been in contact to give lectures on regenerative medicine and cell therapy to cover various topics, including basic research to clinical applications.
Society has very high expectations for regenerative medicine and cell therapy. Our awareness survey showed that about 70% of the general public agrees with society's expectations for regenerative medicine and cell therapy and the promotion of research.
On the other hand, do researchers and the general public really agree with what they think? How much difference is there between what researchers want to convey and what society wants to know? As expected, my surveys show differences between these two views. Scientists know the level of their research. But they think it is not yet important to convey issues related to practical use, financial costs, safety issues, or concrete examples of what to do when something happens.
On the other hand, the general public considers it important to be a beneficiary, so "how much does it cost?"; "how can you deal with something when something happens?"; "who will take responsibility?" are priority issues. So my research is to find ways of closing this gap. Of course, there is also a research aspect in the area of so-called science communication.
Regarding "how much money does it cost?" It has been generally said that mass production would enable economies of scale. It is often said that economies of scale are justified in many industries' history, but is regenerative medicine and cell therapy really an industrial form that offers such economies of scale? Shouldn't we know that as well? From this point of view, I am currently doing many kinds of research.
Recent results and advances
When considering regenerative medicine and cell therapy as I said, there is an aspect strongly discussed as economies of scale, but it is not the only aspect. In other words, it is not just about the production process. Regenerative medicine and cell therapy is used for pharmaceuticals, and medical treatment, so extremely high safety is required.
On the other hand, the product is not a substance or antibody-drug made through conventional chemical synthesis. Antibody drugs are certainly of biological origin, but they can be obtained as substances called "antibodies." But cells are living things. Unlike antibodies, their molecular weight is not fixed.
Therefore, regarding the confirmation of safety, etc., it should be different from that related to chemical products or antibody drugs to-date, but the safety has been confirmed in the form of being included in biological examples so far.
Therefore, one important point is that regenerative medicine and cell therapy products become expensive due to the costs to comply with regulations. Simply put, the cost of regenerative medicine and cell therapy products cannot be reduced simply by corporate efforts. Both producers and regulators must consider the total costs.
What is a benefit for society? From this point of view, we will consider not only industry, academia, and government but also the private sector. We see that we must build an ecosystem for new regenerative medicine and cell therapy.
What made you interested in iPS cells?
Initially, I was doing basic research on regenerative medicine and cell therapy. I am still working on blood regeneration. When I entered University, it was the time when ES cell research and human ES cells were established.
Also, when I was in high school, the problem of organ transplantation was a huge problem. In other words, it was an era when the problem of brain death and organ transplantation were greatly highlighted.
I was very interested in regenerative medicine and cell therapy itself and wanted to do such research in the future. I went on to the pharmacy department of a private university with many people working on chemistry and chemical synthesis.
I was able to expand my horizons when I started graduate school. As I said, ES cells were seen scandalously worldwide, and the ethical and moral pros and cons of breaking fertilized eggs were being questioned by society.
To what extent are the general public and those who are studying ethics talking after understanding the scientific facts in the judging criteria? Even when I read newspapers, bioethics treatises, etc., I really feel that their study of life and biosciences or stem cells is the difference from people who actually work on these topics.
Under such circumstances, I think it would be good if a person could create a channel to interact with society or think about policy matters while maintaining a sense of the field. This was the starting point for my research.
Of course, research on vaccines is not unheard of in Japan. People are doing research on RNA vaccines in Osaka as well as some companies. However, it was not the same speed as America and Europe. One thing I can say is that producing a vaccine does not mean that you can handle a pandemic.
As you know, there is an influenza vaccine for influenza, but there are also anti-influenza drugs. The point is that if you want to stop a pandemic, you must have therapeutic drugs and vaccines as a set. It is necessary to establish collective immunity to some extent using vaccines and connect lifelines with symptomatic treatments. You need both "wheels" or approaches.
In Japan, iPS is often thought of as a regenerative medicine and cell therapy, but what I originally have been researching is hematopoietic stem cells called hematopoietic stem cells of the blood. There are also various stem cells. In fact, various researchers around the world are working on cell-based COVID-19 therapy, and mesenchymal stem cell-based therapy is leading the way because it seems to have the most promise.
It is a situation that seems to be effective as a symptomatic treatment that suppresses inflammation and cytokine storm. In the sense of "turning both wheels," I think that regenerative medicine and cell therapy is now becoming more powerful.
However, in terms of money, there is no doubt that it is not cheap. Of course, it costs a huge amount of money. From the perspective of a sustainable society, I think it is a problem that is not limited to pandemics. Nowadays, it is premised that medical expenses are extremely high for regenerative medicine and cell therapy and the antibody-drug mentioned above.
However, due to the creation of new medicines, people who have been unable to participate in or return to communities such as companies and communities due to high medical costs will be able to live and return to society and support its future growth.
When you think about it, a proper calculation has not been made yet, and it is one of the things that I think I should do, but from the viewpoint of the social cost burden, it costs a lot of money when considered alone, and it may actually be a necessary cost burden from the perspective of maintaining our society.
I think we should also consider that there may be more benefits than money. To some extent, developed countries are still striving to reduce costs while establishing their effectiveness. Or, in the form to somehow shift the cost burden globally, scientific results should be returned to developing countries. I think the current pandemic situation is very strongly linked to the future.
Expectations for King Skyfront
King Skyfront has the Central Institute for Experimental Animals, one of the most important bases for developing and maintaining laboratory animals in Japan.The National Institute of Health Sciences which is an important hub for creating science for new regulations. Actually, I would like to see a hospital in the future.
But this also has the National Institute for Experimental Animals, which is an important element of the ecosystem for implementing so-called the proof of concept discussed earlier. As I said before, for the largest component of the cost, there's the National Institute of Health Science which studies the science that forms the basis of regulations.
From that perspective, King SkyFront can be an important base of the ecosystem. Considering that a bridge will be built from Haneda Airport in the future, making it easier to access from all over the country and around the world. If King SkyFront evolves to become a hub for clinical research, I think it would become a major base for regenerative medicine and cell therapy not only in Japan but also globally.
I think that King SkyFront will become a hub for translational research, taking ideas from the lab to society. I hope it will become a major hub as a starting point for the industrialization of ideas.