interview 01
Science/Technology Advisor,
Quality Assurance
Yuji Makino
In a word, “serious?” was my first thought. As I had not directly been involved in business of long-listed products and had no idea on their potential, I thought, “Can we really do business with long-listed products alone?” based on the prevailing notion back then.
As drug prices kept dropping, I did not imagine that the business would continue this long. Initially, I thought, “Does this mean we do ‘the end-of-life planning’ for medicines?” My friends also had a negative prospect on long-listed products.
Yet, I brought several people on board for the business because the potential of long-life medicines might be more than we could expect, and if so, I thought it would be “magical”.
Not knowing exactly the extent of this potentiality, I intuitively thought there must be some values in long-listed products since they survive for a long time, and it might be fun to reverse something everyone was in denial of. This kind of twisted mentality pushed me to accept an offer to become a founding member of the company.
I was initially asked to help recruitment for the company, but because the position of Chief Pharmaceutical Officer was vacant, I served as Chief Pharmaceutical Officer for a year and a half until a successor is found.
It would be understandable to create a new company, if we have a parent company. But I was so surprised to find out that we had to do it from nothing. There were no personnel, no office, or not anything.
It was a start from zero, even no standard documents for the pharmaceutical business required by the health authority. Furthermore, we had to negotiate over product acquisition while creating a company in a short time.
Initially, we rented a small space in the office owned by a person concerned until our office is set up. Chief Pharmaceutical Officer, Safety Manager and Quality Control Manager used to sit together, surrounding desks there, and accepted an onsite inspection from Tokyo Metropolitan Government to obtain the marketing licenses for pharmaceuticals.
By the time of inspection, we had to prepare all documents including GQP and GVP from scratch. That was the most tough work for us. There were seven or eight people working for the company when we started the business. By the time the office was set up, they increased to more than ten.
For the first two years, we had our hands full with just executing the tasks necessary to reliably distribute the acquired products to medical institutes.
As initially recruited members were able to carry out such duties without fail, we were able to take off as scheduled without serious setbacks.
Since the initial phase has been settled, now it is time to determine our future direction and how we further grow this company.
Now we know the business of long-listed products is feasible depending on our approach. I think that it is time for us to consider an additional area to enter for the company growth with a different scope from the one at the start, while sustaining the business of long-listed products as our core business.
I happened to watch a TV program, featuring Dr. Takeshi Yoro, anatomist, explaining insect anatomy. He said that insects alive now were the survivors in selection over 6 billion years. I found that the survivors were so admirable.
The survival of long-life medicines in selection also means that their values are not lost. On the other hand, we have to resolve issues such as production cost and facilities in order to have the long-life medicines survive also in the future.
When we are approached by an overseas company who is interested in our product, or when a product is subject to drug repositioning, we find difficulty for filing an application to new regulatory registration since its dossier is quite old. It would be an interesting opportunity, however, if we take on such challenges.
Otherwise, it is going to be a real end-of-life planning.
At the time of initial recruitment, I refrained from approaching young people and targeted only seniors since I could not guarantee anything for them, even for myself.
Because the number of personnel initially planned was limited, we had to select those seniors who were professional players.
Some were very skilled since they got training for a long time in their previous companies. But as they climb up a promotion ladder there, one day they become distant from practices.
A person who successfully climbed the promotion ladder is not necessarily suitable to this company. To operate business with the limited number of people, we must be a gathering of independent players who can work as a team.
Current senior members in the company are such personnel, and I hope that that kind of people will join us.
With regard to young people, it would be possible to train them on a job by teaching the way seniors do, if a corporate organization is big enough. But we cannot afford to do that in the current situation. It is our issue how to develop them.
As they are entrusted duties, they may feel a sense of satisfaction to some extent. We must consider how to provide them with development opportunities, going forward.
Back to seniors, their workstyles are different; some want to work full-time, some, 3 days a week, and some, on a contract basis. They all opt for various workstyles.
Our company offers such diverse workstyle. Seniors may find it extremely comfortable working for the company. This allows a good work-life balance also in terms of time spent with family.
For some of those who joined us from pharmaceutical companies mainly developing new drugs, they face challenging issues in this company that are unexpected for them. Nonetheless, everyone enjoys tackling such issues, because they experienced the bitter and the sweet of life in business.
Seeing the aspects previously unnoticed in the pharmaceutical industry is exciting. Those who joined us from leading pharmaceutical companies may feel sorrow because of a small company. But if this business model of long-life medicines is successful, we will be highly regarded. It is indeed exciting to see the company for which I once thought “serious?” is functioning well.
A mixture of persons coming from various companies means a mixture of various corporate cultures. Such diversity is an attractiveness of the company.
The pandemic of coronavirus infection makes it difficult to have daily discussion with colleagues other than meetings and to have time to exchange opinions despite such diversity. When we can do that, the company becomes more interesting company.
