The power of Russia will grow as a biopharm
How to grow a Russian big farmEvgenia Dorogova, STRF.ru
In the production of medicines, Russia lags behind the West by 15-20 years.
Nevertheless, experts assure that our pharma has great potential: due to the development of its biopharmaceutical industry. The options for stimulating it and possible constraints were discussed by leading scientists and entrepreneurs at a recent round table organized by the Park-Media publishing house at the MSU biofactory.
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The main systemic problems of the pharmaceutical industry in Russia, according to the Pharma 2020 strategy project:
• Inability to provide the population of the Russian Federation with the main nomenclature of modern medicines, the entire production cycle of which would be located on the territory of the country.
• Low level of innovations and technologies used in the development and production of medicines.
• The low level of ensuring the drug safety of Russia, including the Armed Forces, according to the nomenclature of medicines used in wartime.
The round table "Biopharma: creating conditions for effective growth" was held within the framework of the III Scientific and Practical Conference "Prospects for the development of innovations in biology". Famous scientists and representatives of the pharmaceutical business gathered in the cool and bright Large Biological Auditorium of the MSU Biofactory. Each participant was presented with fresh publications issued by the Park-Media Publishing House: the brochure "Pharma 2020: problems and prospects" (download the brochure – pdf, 2M – here) and the last two issues of the journal Acta Naturae; they acted as program materials of the round table and served as a visual support for some comments.
Opening the event, its moderator, Alexander Gordeev, General Director of the Park–Media Publishing House, immediately outlined the goal: "to confirm that the Russian pharmaceutical industry is not closed in terms of competitive advantages and possible prospects in the future," and called on experts to discuss which areas of biopharmaceuticals have the highest priority for Russia, and how science, government and business can interact in this area.
To throw off the "iron curtain" of bureaucracyThe tone of the event was set by a very emotional speech by Corresponding member of the Russian Academy of Sciences Alexander Gabibov, Head of the Biocatalysis Laboratory of the Institute of Bioorganic Chemistry.
academicians M.M. Shemyakin and Yu.A. Ovchinnikov. In his opinion, "a country that wants to develop the pharmaceutical industry should not be in a state where any international parcel cannot legally pass through customs." While the world has been conducting preclinical trials of new drugs on knockout animals for a long time (one or another gene has been "turned off" artificially), it is almost impossible to bring them legally from abroad to our country. A similar legislative "plug" is with the transportation of substances that have some toxicity. "All countries are fighting terrorism. Ours is fighting in the "most effective" way for officials – prohibitive," Mr. Gabibov said. Comparing this situation with the "Iron Curtain", the scientist said: "You can not continue to cook in your own juice and be behind the barrier in the face of our customs authorities. This is the practical moment that the scientific community must fight in the most decisive way."
Someone from the audience suggested a way that many active citizens have recently resorted to: write a letter to the president and to the modernization commission in the State Duma. The speaker doubted that the letter would fall into the right hands. Alexey Konov, Vice-president of the Bioprocess Group of companies, tried to dispel these doubts by reminding about the existence of professional legal bureaus that can prepare not just a letter, but an application reasoned from a legislative point of view. In this form, in his opinion, there is a chance that the first persons of the state will get acquainted with it.
From the customs bureaucracy, which greatly slows down the work of scientists, the participants of the round table moved on to obstacles formed as if from within the scientific community itself. How to find really promising research groups, to distinguish them from the huge mass of performers of various grants, Mr. Gabibov raised the question, because there are many failed projects, moreover, there are real crooks from science.
It would seem how easy it is to conduct painstaking monitoring of research teams. But even such a process risks becoming overgrown with paperwork. "Scientists spend time on research, then on writing a report for those who oversee their work, and then on related discussions. All stages of this process go with a decrease in efficiency, and the output is just a stack of papers. It shouldn't be like this! I am against overorganization!" – said Alexander Gabibov.
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According to Article 36 of the Federal Law of the Russian Federation "On Medicines", preclinical trials of medicines are conducted by developers in order to obtain scientific methods of assessments and evidence of the effectiveness and safety of medicines. Their conduct is regulated by the rules of laboratory practice approved by the federal agency for quality control of medicines, and is carried out according to an approved plan with the maintenance of a protocol and the preparation of a report. Preclinical animal tests are conducted in accordance with international regulations.
Then the corresponding member of the Russian Academy of Sciences Sergey Lukyanov, another representative of the Institute of Bioorganic Chemistry, head of the Laboratory of Molecular Technologies for Biology and Medicine, took the floor. In his report, several suggestions were made on how to implement the results of the painstaking work of scientists.
"The creation of a modern medicine is a rather expensive unique process every time, and not all laboratories are ready for it," the scientist said. – Research institutes work, get fundamental knowledge about nature, but they are not adapted to carry out any further manipulations with the acquired knowledge." Commercialization of the results is hindered, according to Sergey Lukyanov, primarily by weak marketing, lack of knowledge and support in matters of "what to patent", as well as the inability of employees of scientific organizations to negotiate with pharmaceutical companies. According to the scientist, small innovative enterprises will help to cope with these difficulties. They can either buy out developments from research groups, or participate in their work, helping at all stages of bringing an idea to market. Scientists get a solid benefit from this: innovative organizations take on all the risks and problems associated with investing funds, negotiations and legal support of transactions. And firms get a part of the profits. As Sergey Lukyanov stated, "if there are a dozen and a half or two small innovative firms at each institute, then this will be a significant step forward."
The speaker was approached with two questions: what means to create such companies, and how to divide the income between them and researchers? According to Sergey Lukyanov, grants will help in solving the first issue, and regarding the "division of the acquired", in case of a successful patent, he proposed a "simple" solution: "to negotiate for the future."
Define goals, distribute tasksAlexey Konov from the Bioprocess group of companies devoted his speech to the schemes of implementation of developments in the field of medicines.
These schemes, according to him, should be effective, fast and clear, since the current state of our biopharma is more than deplorable. The speaker "diagnosed" its lag behind the advanced states by 15-20 years, which exceeds any psychological limit. In the absence of large GMP manufacturers, the release of medicines in the Russian Federation is carried out by several weak and disparate generic productions. It is not surprising that foreign medicines are mainly on pharmacy shelves. It is expensive for an ordinary citizen and not cheap for the country as a whole. According to Mr. Konov, the annual losses of the state from the import of vital and essential medicines are no less than seven billion rubles.
Slides with which the speaker illustrated the presentation helped to feel the dynamics of the backlog of the domestic pharmaceutical industry with all the acuteness. It was interesting to compare the achievements of two countries that are now developing – Russia and India. The starting point was chosen in 1975, when Russia was leading in a number of areas of microbiological and pharmaceutical production, and the Indian pharmaceutical industry was absent as a phenomenon. In 2005, more than two hundred GMP plants were already actively working in India. And in Russia, according to Konov, now no pharmaceutical company, including Bioprocess, can be classified as large. They are either small or medium. Having realized this harsh truth, the speaker concluded, it is necessary to start the struggle for leadership again, in which it is important to define short-term and strategic objectives. Among the first, according to him, is the solution of the problem of import substitution and technical re–equipment. Creating innovative products and technologies is a much more serious process.
"We have always tried to do everything at once, without setting clear goals for ourselves," Alexey Konov was annoyed. So, according to him, under the guise of strategic tasks, Russia often continues to solve practical ones (for example, to support generic companies), although the public-private partnership scheme would allow in a short time to compensate for the country's 15-year lag in development and technology. According to the businessman, the Ministry of Industry, the Ministry of Health and other government departments should deal with short-term issues. At the same time, the financial component falls on the shoulders of the market participants themselves and the Development Bank. In such conditions, Mr. Konov believes, it is possible to successfully solve strategic issues. And such structures as the Bortnik Foundation, Rosnauka (through federal targeted programs) and the Russian Venture Company should invest in innovations, that is, support long-term projects.
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CJSC Binnopharm manages pharmaceutical and biotechnological assets of AFK Sistema. It has been in existence since 2006. At the end of 2009, Binnopharma has four innovative medicines in its portfolio. The predecessor of Binnopharma, MTX Holding, in 2005, for the first time in Russia, released a full–cycle hepatitis B vaccine – from the active substance to the finished form.
Alexey Konov does not see a breakthrough in the development of the domestic pharmaceutical industry without several aspects. In particular, he noted: the need to concentrate efforts on the main socially significant and particularly costly groups of diseases, the import of high-tech developments, effective procurement practices (for example, multi-year tenders and "tax holidays"), foreign partnerships and the introduction of a drug insurance system. A new training program with a race in the "needs of tomorrow" is also important, and here it is necessary to decide "where exactly we are running".
Mr. Konov drew an algorithm for creating a large innovative pharmaceutical company. To begin with, it is necessary to gain a solid portfolio of products being developed, which will minimize risks. Secondly, to achieve sales of Russian medicines on the world market. Thirdly, innovation should be based on the most promising intellectual property found both in the expanses of the homeland and abroad.
How to implement the plan? The answer may be to use the most effective pharmaceutical business model today – a disintegrated pharmaceutical company, which is designed to carry out the selection and management of projects, as well as marketing of developments. The development and production themselves need to be localized in special laboratories and enterprises under contract.
According to Alexey Konov, following this scheme, there is a chance in seven to nine years to grow something that can be called a Russian big farm. Moreover, some tools are already available: development institutions, seed funds, the Pharma 2020 strategy, the federal law on the transfer of intellectual property of research institutes to small enterprises, and more. Add to this the hope and desire for change, and, perhaps, we will soon have more medicines in packages with the proud inscription "Made in Russia".
However, in general, the very convincing business building schemes that Alexey Konov shared with the participants of the round table rest on the fact that new medicines should be produced on the basis of substances that have passed the stage of preclinical testing. New difficulties arise here.
Create platforms for conducting experimentsAlexander Sobolev, Head of the Laboratory of Molecular Genetics of Intracellular Transport at the Institute of Gene Biology of the Russian Academy of Sciences, spoke about the problems of organizing preclinical tests.
"A lot of interesting developments are being created in domestic laboratories," the scientist began the report. – But the researchers have nothing to interest the investor and the manufacturer. We have an almost complete absence of institutions for preclinical tests." For example, there are only two sufficiently strong places in Moscow where pre-clinical trials of future medicines can be carried out: the vivarium in the Pushchinsky branch of the IBH and the N.N. Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences. In their laboratories, it is possible to test developments on immunodeficient mice. "However, when testing, for example, a cancer remedy, we cannot limit ourselves to mice," Mr. Sobolev noted and repeated the idea from Alexander Gabibov's report about the need to conduct a preclinic on knockout animals.
According to Alexander Sobolev, Russia needs much more institutions with at least a minimal set of lines of immunodeficient and transgenic animals, as well as special animal models (so-called orthotopic) to study the effect of drugs on malignant tumors during preclinical studies. "I would like to see a vivarium where there are the last three positions!" admitted Mr. Sobolev. Also, in his opinion, a procedure for uncomplicated purchases of animals abroad should be provided for these institutions (which again rests on the problem of customs clearance raised by colleague Gabibov). The scientist suggested contacting the Ministry of Education and Science with a request to introduce lots in the Federal Target Program for the creation of institutions for conducting preclinical tests, whose services could be used by several institutes at once. He emphasized the fact that the preclinical stage of drug development is funded by the state all over the world.
Mr. Sobolev told how a foreign university became interested in the research of his laboratory (the development of transporters of anticancer drugs) and even allocated a five-year grant for preclinical trials. The scientist considers this success to be more luck, since, as a rule, no one is in a hurry to purposefully pay for preclinical tests of new substances. "No one has any recipes for good luck," Mr. Sobolev summed up the report.
Not to catch up with Western developments, but to get ahead of themThe round table ended with a speech by Yuri Sukhanov, Head of the Research and Development complex of Binnopharm.
The speaker briefly presented to the audience the main directions of the company's activities and the successes that it managed to achieve despite the short period of existence. In particular, "in October 2009 AFK Sistema, represented by Binnopharm, opened one of the most modern GMP production facilities in Russia with the participation of Vladimir Putin," Yuri Sukhanov noted with pride. There are only 12-15 such experts in our country.
But despite some "green shoots" on the Russian pharmaceutical field, which are already being taken care of at the highest level, "we do not have a pharmaceutical market, in fact," the representative of the holding stated. "There is something that is regulated; and regulated, in general, inefficiently."
According to him, the creation of biopharmaceutical clusters in Russia, following the example of successfully operating abroad, will increase the efficiency of the entire industry. (Bioclusters as a support for the development of the pharmaceutical industry and as stimulators of innovation are also at stake in the draft strategy "Pharma 2020".) But if in the West these complexes of geographically adjacent interconnected organizations that are engaged in similar activities in the biotechnological field are formed mainly on the basis of research centers, most often educational; then in Russia, Mr. Sukhanov believes, the basis of a biocluster should be a production enterprise - private or public.
According to Yuri Sukhanov, you can get a "well-functioning apparatus for innovation", for example, in Moscow, if you combine the same "Binnopharm" as a ready–made production site, a scientific and educational institution, say, Moscow State University ("You can't find a better arbiter and technology expert than Moscow State University," he is convinced-N. Sukhanov), and institutions of the Russian Academy of Sciences, as well as to supplement the "kit with a platform for scientific communication and trade mechanisms".
"Maybe these are Napoleonic plans," Yuri Sukhanov said, "nevertheless, this could be the most successful way to obtain new innovative drugs. We should strive not for import substitution, but for something more than import substitution. We must stay ahead of Western developments without catching up with them. The main thing is to cooperate, communicate and jointly look for ways to solve problems." This main task was fully fulfilled by the participants of the round table at the MSU biofactory.
Portal "Eternal youth" http://vechnayamolodost.ru04.12.2009