Let's get to work. For the living
From November 21 to 24, events dedicated to the analysis of problems and the search for ways to develop Russian biotechnologies were held on the territory of the VVC and in the building of the Faculty of Biology of Moscow State University within the framework of the exhibition-fair "RosBioTech-2007".
The central event of RosBioTech-2007 was a two-day conference "Biotechnology of the XXI century: problems and prospects". Many forum participants noted the fact that at almost every stage of product creation – from the initial ideas to the release of finished industrial designs – there are many obstacles in the way of developers due to a variety of reasons.
There is almost no time to swingAccording to Pavel Rachmanin, President of the Russian Union of Manufacturers of Veterinary Medicinal Additives and Feed Media, the potential of the domestic biotechnology industry is currently significantly devalued due to the lack of continuity of research work.
In addition, biological science still exists in our country independently of practice; there is no coordinating body that would participate in the formation of state orders for high-tech products, and the mechanism of competition in conducting research is not developed. Isolation from world practice also affects: technological regulations do not meet international quality and safety requirements. Using the example of the agrobiological branch closest to him, Pavel Rakhmanin confirmed the validity of the thesis about saving drowning people by their own hands. In particular, to coordinate design work, R&D, and attract investment in this area, JSC "Institute of Biotechnology of Veterinary Medicine" was established in 2003. It is expected that the activities of this non-governmental organization will contribute to the production of competitive agricultural products.
The current position of Russia in the market of high–tech products, as Natalia Yanul, Development Director of the International Fund for Technology and Investment (IFTI), noted in her speech, is unenviable - only the penultimate place out of the 24 most developed countries. Nevertheless, according to the forecasts of business experts, including foreign ones, Russia, with a competent organization, is able to rise quite high in this list – that's just there is almost no time to swing. The representative of IFTI spoke about the fund's implementation of an innovative program to support the biotechnology industry in Russia. According to Natalia Yanul, the innovative economy depends primarily on two factors: the scientific and technical potential of the industry (what to invest money in?) and financing mechanisms (how to invest?). Today, world science is moving from grant support for research to a reimbursable investment of funds, and within the framework of such a scheme, lending is carried out on preferential terms. There is a paradox in Russia: with the existence of a sufficiently high scientific and technical potential, there is an acute shortage of so-called startup companies. Therefore, it is necessary to support small enterprises in the early stages of their development as soon as possible by creating private-public seed financing funds. The experience of IFTI in this sense is very indicative: in recent years, almost two thousand biotechnological projects have been studied, 24 of them have been supported, 18 small enterprises have been created.
However, the imperfection of laws regarding technology transfer and the underdevelopment of business angel institutions stand in the way of investors. According to Andrey Ivashchenko, project manager of the HimRar High Technology Center, there is no target program in Russia that allows scientists to help commercialize the results of their work. Next year, about a billion rubles will be allocated in Russia to support high–tech projects - this is ten times more than what can be mastered at present. Therefore, it is necessary to competently organize the search for scientific products suitable for such financing. It is hoped that the state will stimulate or even oblige a number of venture organizations to support the development of domestic biotechnologists in some form. But it is unclear which state structures will be able to coordinate the solution of such a problem: unfortunately, Russian technologies with the prefix "bio–", unlike the sphere of "nano-", do not have their own "flag bearer".
However, not everything is so bad. There are examples demonstrating positive trends in the development of Russian biotechnologies. Andrey Moshkin, General Director of JSC Biohimmash, cited the activities of his organization as an example of a really functioning company. Its main task is the development of biotechnologies as a business and the creation of a chain "from a test tube to a factory". In particular, an industrial site for the production of antitumor drug "Paclitaxel" has been created at the enterprise, bioplastics decomposed in the environment by natural microflora are being developed.
As for new medicines, it is very difficult to develop them "from scratch" – it is a long, expensive process, accompanied by high risks and lack of cooperation between developers. According to Konstantin Balakin, head of the Department of Computer-Medical Chemistry at the Research Institute of Chemical Diversity LLC, one of the most attractive ways to overcome these obstacles is to create integrated network structures that include state academic structures and private organizations that coordinate the creation of medicines. The networks include all stages of the manufacture of pharmaceuticals – from the initial design, modeling of the future drug to its release. But the main idea of such a scheme is to go as quickly as possible from the results obtained as a result of studying the genomes of living organisms to active medicinal compounds. By the way, it is thanks to this approach that a new branch has appeared at the junction of biology and medicine – chemogenomics.
The chemogenomics Development program has already been established in the USA, China, Germany and in some other countries. The most striking example of such a network is the so–called Roadmap program, implemented in the United States and bringing together more than two dozen leading universities in the country that are engaged in research in a new field. Russia, with its scientific potential, is quite capable of organizing an effective network structure of the described type on its territory.
Dangers of biotechnologies: first to justify, then to regulateSpeaking about the problems of commercialization of the results of the activities of biologists, we should not forget about the possible dangers accompanying one or another of their high-tech products, in particular, genetically modified organisms (GMOs).
The conference participants formulated the most discussed problems related to their creation as follows: do they pose a danger to the environment and humans? If so, what is the scenario of the emergence and development of the threat? What are the response strategies? How should risk monitoring be carried out? And how should the state regulate the appearance of GMOs in general? All the speakers agreed that the answers to these questions should be scientifically justified in any case.
The issue of state participation in this area was in the focus of attention of the participants of the section "Biosafety: advantages and risks of practical use of the latest achievements of biotechnology". Alexander Golikov, Executive Secretary of the Black Sea Biotechnology Association, stressed that monitoring possible risks accompanying new technologies, in particular those related to GMOs, and taking adequate response measures are entirely the tasks of the state. The fact that government structures can quite successfully perform these functions is demonstrated by the examples of the United States and a number of European Union countries. It is noteworthy that state decisions on the minimum permissible levels of possible risks of GMOs have national characteristics associated with economic, social and cultural factors. So, in the United States, verdicts on the admission of new biotechnological products to the market are based on the principle of "what is proven to be harmless is safe", and in Ethiopia – "even what is proven to be harmless is dangerous" (this, however, does not prevent this African state from importing genetically modified plant crops). It should be taken into account: such works are very expensive. An evidence-based safety assessment of one GM product requires 10-15 million dollars.
Another area of work on biological safety is the assessment of risks associated with the use of nanomaterials in the field of living systems. According to Sergey Khotimchenko, head of the Laboratory of Food Toxicology of the State Research Institute of Nutrition of the Russian Academy of Medical Sciences, Russia lags behind developed countries here too. But in 2007, Rospotrebnadzor finally adopted resolutions suggesting the creation of the concept of toxicological studies, risk assessment methodology, methods of identification and quantitative determination of nanomaterials and nanoparticles. There are a number of features of nanoobjects that need to be taken into account: a small size that allows them to be embedded even inside DNA molecules; a large specific surface area of nanoparticles, leading to an increase in their reactivity and, as a consequence, toxicity; the role of nanoparticles as "conductors" that facilitate the penetration of extraneous, not always harmless, substances into the body; the absence of metabolic activity (for example, a nanomaterial, being the basis of a drug, can accumulate in the body).
The conclusion follows from this: traditional methods of toxicity assessment are not applicable for nanomaterials. Therefore, it is necessary to develop fundamentally new regulations and methods for detecting these objects.
Elusive opportunitiesThe conversation about the fate of GMOs continued at the meeting of the section entitled "The main directions of biotechnology of the XXI century: analysis and forecasts".
Konstantin Scriabin, Director of the Bioengineering Center of the Russian Academy of Sciences, Academician of RAS, in his speech called the situation in this area dramatic. "This is an absolute repetition of what we have already gone through with genetics," the scientist complained.
According to Konstantin Scriabin, there are two main challenges for genetic engineering in the world today, to which Russia has not yet responded in any way. The first challenge is energy related to the prospects of using biofuels. "Has anyone heard about the directive of the European Community, according to which in 2015 8% of all diesel should be biofuels?" – the speaker addressed a question to the audience. Without waiting for an answer, he continued: "Russia could keep Europe not only on the hook of oil and gas, but also on the hook of biodiesel! But what needs to be done to prevent this from happening? Prohibit the production of genetically modified rapeseed. Meanwhile, Ukraine has increased rapeseed crops five times this year alone. They just understand that this is a very promising export product – in the last six months alone, the price of rapeseed oil (as well as sunflower oil) on the world market has tripled."
By the way, the situation with genetically engineered potatoes is quite curious. On the one hand, in Russia it is not prohibited for use in food, but it cannot be grown here. But it is possible in Ukraine, from where, in fact, it comes to us.
The second challenge, to which Academician Scriabin drew the attention of those present, was crop losses. According to the most modest data, at least 36% of cultivated crops are lost annually in Russia from the effects of diseases, insects and weeds. "There is no such thing anywhere in the world," the scientist laments. – We are that unique country that does nothing but grow crops and ruin, grow and ruin. And this has been going on for many years. And the solution to the problem is simpler than simple: it is enough to enter a single gene. Meanwhile, the acreage allocated for genetically engineered plants is increasing globally by at least 13% per year - this year the total area was about 120 million hectares."
The lively interest of those present at the section was aroused by the report of the Adviser of the Russian Academy of Sciences, Academician Evgeny Sverdlov, dedicated to gene-therapeutic approaches in the treatment of oncological diseases. The statistics are appalling: 10 million people are diagnosed with cancer every year in the world, and despite some success in therapy, the problem is very far from being solved. Moreover, the dynamics are disappointing: by 2015, about nine million people are expected to die, by 2030 the number of deaths will increase to 11.5 million.
In this regard, Evgeny Sverdlov noted the importance of gene therapy as one of the most promising approaches in oncology. According to the academician, intensive work has been carried out in recent years on clinical trials of anticancer drugs of this class. In China, in particular, two drugs are already allowed – gendicin and H101, which are used in the treatment of advanced head and neck cancer. The academician believes that in the near future there will be an exponential increase in the number of drugs approved for the treatment of various types of cancer.
"Gene therapy destroys the causes of the disease by artificially introducing new genetic information into the cell. For example, the essence of the Suicide Gene Therapy technique (from the English "therapy with the help of killer genes") is the introduction of a so-called killer gene into the cell, which turns a non-toxic pro–agent into a toxic one," the academician said. At the same time, he drew the audience's attention to the fact that out of 1,340 gene therapy protocols undergoing testing, only one belongs to Russia, which is 0.1% (the US accounts for 66% of trials, the UK - 11.5%). Nevertheless, by 2009, Russia is expected to launch GMP-certified production of drugs of this group.
Real quality sells itself"True quality sells itself – real quality sells itself" – this American proverb, perhaps, is quite suitable as the motto of the last exhibition-fair of biotechnological products – after all, all potential investors are interested in being offered a really good product.
Visitors of the fair were able to get acquainted with examples of the use of biotechnologies in various fields: in pharmacology and medicine, food industry and agriculture, ecology and energy. The exhibitors were leading Russian companies that presented their technologies and products.
The visitors were particularly interested in the educational and laboratory complex "Biotechnology", created by employees of Tomsk Polytechnic University and LLC "Scientific and Production Enterprise "Polytech"" under the "START" program of the Fund for the Promotion of Small Forms of Enterprises in the Scientific and Technical Sphere. Biotechnological production is a set of delicate processes that are susceptible to the slightest fluctuations in the parameters of industrial installations. Biotechnological engineers working in factories are truly piece goods. These specialists are able to feel changes in the operation of the units literally "with their fingertips", which, without exaggeration, elevates their work to the rank of art. In fact, the training of such specialists takes place directly at the workplace. But the high rates of development of modern biotechnologies do not allow us to wait until a person who has come to production will master specific skills – hence the need to organize an appropriate educational process for biotechnological engineers directly within the walls of universities. And now, for the first time in our country, a unique laboratory complex has been created, which can become a universal training base for future biotechnologists. In this complex, a variety of works can be carried out, in particular: the cultivation of microorganisms, the production of lipids, polysaccharides and organic solvents, amino acids, vitamins, antibiotics and enzyme preparations. The processes are controlled by a personal computer, while no special interface cards are required. The software allows flexible management of the complex and processing of the received information. In addition, specially for the educational and laboratory complex "Biotechnology", its creators have developed a professional development program for laboratory assistants, process engineers and other specialists.
It should be noted that the complex created by Siberian developers has another attractive side. It consists in the ability to "cover" the process of biotechnological production as a whole, taking into account many factors affecting the production of the final product. Whereas in industrial conditions, each specialist serves only one unit from the entire factory complex.
And on November 23, a scientific and practical conference "Prospects for the development of innovations in biology" was held at the Faculty of Biology of Moscow State University, as well as a stage of the competition of youth scientific innovation projects "UMNIK", which involved the work of young scientists from various research organizations. When evaluating them, the jury (which included representatives of not only the scientific community, but also the business community) focused on the main criterion - the potential for commercialization of the developments of young innovators. The authors of the five best projects, in the opinion of the evaluation commission, received certificates of 400 thousand rubles each as prizes. Young researchers should spend this amount within two years to bring their developments to prototypes suitable for entering the market of high-tech products.
Vladimir Sychev, Nino Gvazava, STRF.ruPortal "Eternal youth" www.vechnayamolodost.ru