The development of Russian pharmaceuticals: a bad dancer...

SCIENTISTS AND PEOPLE
Elena Ukusova, STRF.ruAccording to Dmitry Morozov, CEO of the Biocad pharmaceutical company, the development of domestic pharma is hindered by the "stagnant" mentality of scientists and the vulnerability of domestic companies to Western pharmaceutical giants that have occupied the Russian market.

There are ideas. With motivation – problems…How can you characterize the interaction of Russian scientists with pharmaceutical manufacturers?

– The main problem is that scientists are not interested in the product as such.

They are interested in the process. An example is the creation of a vaccine against hepatitis B. It is now going into circulation: the Indians and Chinese make it for 15 cents per dose. In addition, the relevance of the release of such a vaccine is decreasing, because it is thanks to vaccination that the incidence of hepatitis is reduced. And still our country buys this vaccine in large quantities. Why? Yes, because there are no people who would come and say: "I can deliver 20 million doses at a competitive price!". Alas, at the moment there are no people with such knowledge. But where could all this knowledge have been born? Only in academic institutions. It is considered that knowledge cannot move from the walls of institutes to the market. Andrey Ivashchenko, the project manager of the HimRar Central Research Center, likes to draw a pit that separates them as an example. In my opinion, we are still far from the pit – there is simply nothing to cross it. Yes, you can fill it with money, but there will still be nothing to forward. And if a person can earn a little money, no one will give it away. Do you think academics don't know the rules of business in Russia?

But, you must agree, there are still adequate, progressive scientists in the country who are ready to build interaction with business.– There are very few of them as a percentage: they are very expensive for us, for the country.

It turns out that 80% of the money will go to dust, and for 20% we will support a person who is ready to work. This is a question of the role of the individual. Yes, there are laboratories with strong personalities who most likely say the right words. Question: how will they behave when you tell them "You have the money – give me the result!".

How can you change this attitude to your work, how to motivate scientists?– I'll tell you about my story.

When in 2002 I bought a part of the bankrupt Glavmicrobioprom Institute – the Institute of Engineering Immunology, thirty percent of its employees immediately went to work for me. But all of them were completely not set up for a specific target work.

The fundamental thing for changing the situation was that I, as the owner, could determine the rules of the game. At the same time, people clearly understand who is the boss, who gives money, what tasks the manager solves, and why. They solve practical problems, the results of which they see directly, receive money (we pay for patents to our authors). In addition, they see how it all sells. Our employees communicate with doctors, and when doctors tell scientists that the drug is good, that it works, when they walk around the wards and see children who have passed away after harsh chemotherapy thanks to our drugs, it has a very strong effect on scientists. They see that they are creating a product with their own hands that brings relief to people. These are fundamentally important motives that greatly distinguish my employees from many academic scientists. They feel completely different, they are actively working, although they are practically not published, because they have no time to write articles.

That's how we gradually managed to bring the team to its senses. Now it is one of the best teams in the country in the field of genetically engineered proteins.

Scientists are interested in exploring something, but I immediately say: "Stop, this is later. Now we have no chance to do this, we don't have the time and opportunity to start a bunch of parallel studies." Give me the result on time, scale it up, and when I already start selling, be kind, for example, to provide 30 grams of interferon-beta monthly to the whole country, and not just in a test tube. The most interesting thing is that when you set tasks this way, the employees' approach to technology completely changes. When people are focused on results, they are a terrible force. And only management can "sharpen" the result. And if you tell me that scientists themselves will earn knowledge, I will never believe it. They can create knowledge, and the understanding of how to make money from this knowledge is completely in other heads. And if you take an ordinary institute, then you need to work with them for a couple of years as a team in order to rally scientists, orient everyone to a single goal. I don't have separate teams, I can't afford to have five different teams at my institute working on different tasks, as in academic institutes. In fact, laboratories do what they want in them, complete fragmentation, no synergy. But one team of diverse specialists should work, only then will the product turn out. And your task is to drag a certain product through this whole chain in such conditions for 5 years, when everyone is already tired, and everyone is already tired, and it doesn't work out… But you've been dragging it for five years, starting from the gene to the moment when you can pour the drug into vials. This is a difficult big job, and without management there is nothing to talk about it at all.

In the USA, scientists are focused on business, they have a product in their head, its capitalization, market entry. If you are in business and earn money, you cannot afford to endlessly finance the process of scientific research. I had another level of argument: the result. I ask a question to scientists: "Show me who bought your product after you made it."

Another problem: there is no culture of work based on quality systems in our scientific organizations. All over the world, until you have calculated the statistics of the results of your work, you are not moving on. For example, we have a codification in the work planning system, formalized in network schedules, where it is described in detail how and in what form the results should be obtained in five years. We discuss knowledge, we have it formalized and fixed, otherwise the work is worthless. And each step of a particular performer goes according to the code of a certain stage of work and is recorded in a laboratory journal. But, I repeat, it is possible to work like this only by changing the mentality. This is a key process, lengthy and unrelated to the amount of funding in any way.

Scientists should be managed by customers. We need to come to a small institute, call everyone, build them up and say that we will work like this, like this. However, to do this, you first need to buy this institute. If not, you can take control. Otherwise, the process of stagnation will begin, which will last without effective management. Here is an example. Have you ever peeled cabbage? When you start to peel cabbage, there, of course, there is a stalk inside, on which everything is held. Maybe this is a silly comparison, but interaction with any scientific institute boils down to the question: who exactly will do the work? Talk to the director, with his deputy, and it turns out that there is no one to do all the work with their hands inside the institute!

Do you think that any pharmaceutical company should have its own research centers?- Yes.

You should build work on your set of products as follows: first, defining short–term goals, ensuring current, including technological, processes, which allows people from the laboratory to better understand the needs of production. The second is long–term goals. Of course, the institute should work on a whole bunch of goals, as, for example, we have. We're working on a bunch of tasks! The research center, of course, builds horizontal links with industrial implementation. Another task, if we talk about medium–term goals - generics, is as follows: it is necessary not just to bring the substance from China and package it, but to do at least part of the technological process ourselves. The next task for this center is promising products that have not yet been released from the patent: reproduction analysis, understanding what it is. Without its own research center, this chain of tasks is difficult to solve.

The rules of the game are common to allHow many original drugs are you currently developing?

– Five are in development, two are on sale.

The question is how long we will register our drugs. With interferon-beta, we only waited six months for permission for clinical trials. A very long time! This is a demonstration of the inefficiency of the existing system. It is not "sharpened" for Russian drugs, especially innovative ones.

What do we need now? Not even money – we will do it at our own expense. It is necessary to change the current system so that at least foreigners do not slam us in our market – and it will be fine. Example: we were the first in the country to make a granulocyte colony stimulating factor, developed the product for a year and a half, registered it for three years. We conducted clinical trials, proved the high effectiveness of the drug in comparison with its imported counterpart and entered the market. And the leading European corporations have been earning in our market for ten years: Rosh with a turnover of $ 28 billion, Teva with 11 billion and others. Do you think they are waiting for a small Russian company? If you look at the competitive field, then any Russian hi-tech that just appears will get into its own market in such an environment. In the United States, for example, this is not possible. But a domestic company in the USA will never be allowed in its life! It is necessary to spend all 15-30 million dollars on the first and second stages of clinical trials, registration procedures, promotion…

Do we also have to protect our markets from other people's drugs? Is it reasonable to close the Russian market now? Is there a full range of drugs in our domestic pharma that objectively meet modern requirements today?– I believe that it is necessary to protect our market.

But this is a matter of political will, which is still not enough. Regarding the quality of domestic drugs, I will answer only for my own. Basically, what is a quality system? This is, first of all, the stability of the process. It guarantees that no matter what, you will get a standard result. That's all. So, this is not a very difficult task, by and large.

Then why does no one want to change their system to the GMP standard?– GMP is a separate story.

Here is the situation. Even if you don't have fashionable technological innovations, you can still provide a good product. The main thing is that your product is stable. This is a matter of people's work and building a quality system. Western factories have internal rules that allow them to maintain technological processes, they do everything according to GMP. I am sure that more of our plants operate in accordance with GOST R52249-2004 – this is a translation of the European GMP. Another thing is that Western companies are trying to raise the bar for entering the market. Often – where there is no need. It's just a competition! Defending itself from competitors, within the framework of any campaign, a European firm with a turnover of 28 billion rubles. The euro may well lobby for some rules in Europe that will raise standards. There is absolutely no objective need. And if you follow this path, you will never catch up with them, because it is an endless process. Initially, everything was designed taking into account modern requirements, and if the question arises to determine the class of cleanliness of the premises or to measure the quality of water, then there will be no questions. There should be the minimum conditions necessary for the desired level. Because by raising the bar, certain myths are created, which subsequently bring a lot of money. These myths have been steadily introduced into the minds of consumers and many officials for decades.

Should imported drugs sold in Russia undergo clinical trials with us?– I'm for equal conditions.

We pass, and why don't they? What we have now is unprofitable for domestic producers. No one controls Western manufacturers. If you look at the letters of Roszdravnadzor describing the reasons why some series of imported drugs were rejected, you will read about such things as mechanical inclusions in tablets, which simply means dirt got in. We are talking about GMP, but no one knows where the drugs are brought to us from. Who goes to foreign factories? What do we consume? This is where the magic power of the brand comes into play.

Priorities should be set by the stateHow high is the confidence that after clinical trials the drug is successfully put on the market?

Let's assume that two hundred new drugs announced in the Pharma 2020 strategy have been received. And then what? Won't it turn out that the market won't need them?– Many factors will influence.

Many manufacturers do not understand at all what they will face after registration, it seems to them that they need to mix, register and everything will blossom. I repeat: even if you have reached the bottles, no one is waiting for you on the market.

If there are no alternatives on the market and there is less competition, then yes, all 200 will pass. Then everything depends on the market demand for these products. Therefore, the task of tomorrow is to understand what challenges from the point of view of killer diseases we will face in 5-15 years. These forecasts are obvious, and it is already clear to everyone that some diseases will go away, and others will come to the fore. Hence, it is clear which therapeutic groups are needed to combat this or that disease, it is clear which innovative products are needed. From here it is also clear that it will be necessary to order what to finance. Take the money and look for those who are physically able to make new drugs. You ask what developers need – for example, money and a production site. You give everything you need, and people work. A simple scheme.

But everyone here is trying to make money on the "construction site", on the process. A large company understands that it is impossible to exploit, say, insulin for a long time. Therefore, she is looking for new ways, looking for how to at least modernize the old product, give it slightly more useful properties. Accordingly, they are bringing out new products, differentiating from the product that will soon be released in the generic. And we are still like a chicken on eggs. When we were building our factory in 2000, closer to the end of construction, I was looking for products that could be produced at the new enterprise. I have visited almost all the institutes. And it became clear that, firstly, there are very few products, and secondly, even if someone has something, they keep everything to themselves. No one gives anything to anyone, no one wants anything. If they have some product that sells a little, they earn their four or five kopecks. Such money is enough to support three or four people for several years. And then foreigners come and calmly take this market, displace these products. This system has worked like this before, and it still works like this. People who came out of the institute environment into business, the logic is: "I don't want to go into partnership with anyone, I'll do something quietly myself, I'll sell a little, I'll have enough."

How do I see the solution to such a problem? There had to be some kind of alliance with major pharmaceutical manufacturers. Either to license them, or to put them into a share in your company on some shares. This way it will be possible to attract substantial resources, create large-scale production. Due to the "scale effect", it would be possible to get a low cost of the product and continue to play quietly in the market. Whether it will be possible to win or not, no one will say in advance, but you can try. And then the question would be solved, how many doses should be produced, how much of them is required by the country. In the meantime, everything is being done in small quantities, on the territory of the institute, at its own factory – as much as we could, so much was done. And the cost of production is high.

What should be the role of the state in the development of the pharmaceutical industry?– The main thing that is needed from the state is clear and equal rules of the game in this market for all its participants, because now foreign pharmaceutical companies are in better conditions compared to Russian companies.

This includes not only equal admission of companies to participate in public procurement, but also equal conditions in terms of licensing and registration of medicines and substances.

Secondly, we need a clear state policy in the field of medical care and drug provision of the population. It is necessary for the state to determine which diseases are the most dangerous for the population, the level of morbidity for which types of diseases the state wants to significantly reduce. In this case, we will develop new medicines based on the need for them.

If we talk about the direct participation of the state, for example, the financing of individual companies and organizations – the benefit of the presence of the state in the form of a direct founder or through the authorized capital in this market is significant – then you need to approach it very carefully.

If we do not discuss the question of how this can negatively affect the market from the point of view of competition, but only talk about the effectiveness of investments, then they should be directed to companies that are focused on the final result in their work. To those organizations that profit from the sale of medicines. Otherwise, the state will continue to finance the process - whether it is support for the scientific activities of collectives or just "construction". No result will be achieved in this case.

Portal "Eternal youth" www.vechnayamolodost.ru12.05.2009