Biomedicine is our everything!

Russian biomedicine will be passed through the Skolkovo "sieve"In the coming years, Russia intends to actively develop biomedicine – one of the key areas of modern scientific research.

Roman Bolgarin, Director for Development and Business Processes of the cluster, told RIA Novosti about the tasks of the cluster "Biological and Medical Technologies" of the Skolkovo Innovation Center, the principles of selection and financing of projects as part of its work.

Strategy and tacticsThe strategic goal of the Skolkovo biomedical cluster is to create an infrastructure ecosystem for innovations in the field of biomedical technologies, the Bulgarian said.

The project activity of the cluster is only one of the components, and not the largest in terms of labor costs and budgets. From the point of view of the development strategy, it is much more important to create a self-replicating innovation ecosystem consisting of mutually complementary system elements. These elements include research laboratories (collective use centers), interdisciplinary educational programs, joint research centers with large companies, the Bulgarian noted.

According to him, since July 2010, as part of the creation and structuring of the biomedical cluster as part of the Skolkovo Foundation, the cluster development concept has been actively developed. The world's largest consultants in the field of medicine and biotechnology were involved in the creation of the final version of the concept. In early February 2011, it was presented in Moscow at the first international forum of the biomedical cluster, and then approved by the advisory Scientific Council of the Skolkovo Foundation.

According to the concept, four main areas of cluster work have been identified – biomedicine (genomic and postgenomic biomedical technologies, cellular technologies, complex diagnostic and treatment methods, medical equipment and materials), biopharmaceuticals (medicines), systemic bioinformatics and industrial biotechnologies (as an interdisciplinary direction).

"According to the existing forecasts of the development of biomedical and biotechnological markets, these four areas are the most dynamically and systematically developing, especially in Russia," the Bulgarian explained.

One of the key tasks of the cluster is the creation of research infrastructure sites in the main areas of biomedical technologies. Such sites include the so-called "link laboratories", linking existing and promising competencies in terms of technologies, equipment, personnel, the Bulgarian said.

"To date, all link laboratories created as part of the cluster's activities have been created on the basis of already selected projects," he said. Such a laboratory can be further transformed into a center for collective use if it is self–sufficient (in a clearly defined field of activity - for example, in the modeling of medicines), has the necessary equipment and personnel, if it has the potential for development.

With the participation of the cluster, three infrastructural link laboratories have already been created: synthetic biology (based on the Faculty of Biology of Moscow State University), systemic Biopharmaceutics (based on the Institute of Bioorganic Chemistry named after M.M. Shemyakin and Yu.A. Ovchinnikov of the Russian Academy of Sciences) and transgenomic and postgenomic technologies (based on the Institute of Gene Biology of the Russian Academy of Sciences).

The Bulgarian noted that the priority strategic goals of the cluster can also include building relationships with the largest market players – biomedical and pharmaceutical companies that can create their own research and development centers.

In addition, educational programs on biomedicine will be organized on the basis of infrastructure sites, which will become the "forerunner" of the future Skolkovo Technological University.

How projects are selected...All projects coming to the Skolkovo Foundation undergo mandatory external expertise.

"In our cluster, the expert community includes about 100 external experts, among whom there is an approximately equal ratio between leading Russian and Western scientists, as well as representatives of a large biomedical business community," the Bulgarian said. The experts also include members of the Advisory Scientific Council of the Skolkovo Foundation.

Each project is sent out for evaluation to 10 experts. "To pass, it is necessary to receive a positive assessment of more than half of the quorum (quorum – at least five experts) of the expert panel on the project. It is important to note that most of the biomedical cluster projects that received financial support in the form of grants had a positive assessment from 6-7 experts," the Bulgarian said.

Funding in the form of a grant for research activities can only be received by a company that has received the status of a resident of the Skolkovo Foundation.

For successful examination and subsequent consideration by the fund's investment committee, projects must meet several key criteria, the Cluster Development Director stressed.

Thus, the project must be scientifically justified and practically feasible, the infrastructure site for its implementation must be clearly marked, having the necessary equipment and personnel. It can be either its own site (laboratories of existing research centers and departments of universities, sites of companies), or leased for the purpose of implementing the project, if we are talking about the stages of preclinical or clinical trials, the Bulgarian explained.

The project must also have a professional team of specialists with sufficient technological and scientific competencies.

In addition, intellectual property rights to the project technology should be clearly formalized and a strategy for formalizing intellectual property rights to the project results should be defined. "There should be at least patent applications, and best of all, the patents themselves," the Bulgarian said.

Another requirement is the mandatory presence of foreign co–executors. "One can argue with this requirement, but, on the other hand, it is a confirmation of the quality and potential relevance of the project results from the international scientific community," the expert said.

Finally, the Skolkovo Foundation gives preference to those projects in which the applicant company invests its own money or attracts a co-investor.

"It is important to note that for the first projects of the biomedical cluster, the presence of a co-investor was a prerequisite. In our projects that have received grants from the foundation, on average up to 40% of the declared cost of implementation costs is borne by the applicant – and with "live" money. Thus, we can say that the co–investors voted with their money for all the projects we supported," the Bulgarian noted.

Currently, seven companies that have received resident status have been formalized in the biomedical cluster, five of them have received financial support in the form of foundation grants. There are about 140 projects in the cluster's portfolio at various stages of expertise and structuring, the expert said.

...And how are they fundedAny project funded by the Skolkovo Foundation is divided into stages – key points.

Currently, the fund has transferred tranches only for the first stages of the supported projects. Further funding will be provided only after the completion of the previous stages and upon the fulfillment of pre-determined key performance indicators of a particular stage, accurately measured by parameters and regulated by time, the Bulgarian explained.

"It is important to note that the projects are structured in such a way that many intermediate products at different stages of the project, in turn, can also be objects of commercialization (for example, in the form of obtaining a patent for an innovative technique developed and used at one of the stages of the project)," the expert stressed.

Five biomedical projects of Skolkovo were allocated 540 million rubles in 2010, the Bulgarian said. Upon reaching the key points of the first stage of project implementation and targeted spending of funds by the end of 2011, they will receive another tranche of 420 million rubles, the Bulgarian noted.

"At the same time, in 2011 it is planned (in these five projects – ed.) to attract funds from co–investors (including project companies - ed.) in the amount of about 370 million rubles. In addition, this year the Biological and Medical Technologies cluster plans to allocate grants for another 20 new projects (in addition to those for which funding has already been allocated in 2010 – ed.)," he said.

The total amount of funding planned in 2010-2013 for cluster projects that received the first tranche of grants last year is 3.15 billion rubles. Of these funds, the share of financing by the Skolkovo Foundation is about 2 billion rubles (about 60%), the share of co–investors is 1.15 billion rubles (about 40%), the Bulgarian noted.

"It is noteworthy that up to 40% of the project funding goes to the purchase of equipment and bringing laboratory facilities, special communications to the required standards. Up to 30% of the funding goes to preclinical and clinical trials. From 20% to 30% goes directly to the remuneration of scientific specialists, including foreign scientists, postgraduates and interns involved in projects," the Bulgarian said.

Benefits for residents"It is important to note that not all applicant companies applying for resident status ask for financial support in the form of grants," the Bulgarian stressed.

The status of a resident of the Skolkovo Foundation gives companies engaged in innovative activities significant tax benefits that allow them to effectively optimize the costs of research and development, he explained.

"For biomedical projects, the item of expenditure on equipment, which is largely imported, is very expensive. For residents of Skolkovo, customs payments, as well as VAT paid by persons involved in the implementation of the project, are reimbursed when importing equipment if the equipment is intended for research activities in the innovation center," the Bulgarian noted.

In addition, residents of the fund are entitled to VAT exemption for 10 years from the date of obtaining the status if the annual revenue of the company amounted to more than 1 billion rubles, and the total profit did not exceed 300 million rubles, the expert said.

A resident of the fund may also be exempt from paying income tax if the annual volume of its revenue does not exceed 1 billion rubles.

Taking into account the preferential grid of reduced insurance contributions to the pension fund and the compulsory medical insurance fund, the total cost savings of the Skolkovo resident company may exceed 20%. "For developing innovative companies, such savings are a significant financial lever for planning and optimizing their investment strategy," the Bulgarian noted.

"Sieve" for the best projects"In biomedicine, an investor, as a rule, if it is not the own development of a large pharmaceutical corporation, enters the project at the completion phase of preclinical trials and (or) the first two phases of clinical trials, when there is a certain probability that the result of the project will enter the market.

The first stages of creating a drug or cellular technology, in particular, the search for "targets", library screening, preclinical trials are the most expensive and high–risk. It is this research part itself that is the object of support in the form of grants from Skolkovo," the Bulgarian stressed.

For such expensive projects, a clearly defined plan for the commercialization of products is very important (including at intermediate stages – for example, in the form of patenting), the Bulgarian noted. "Accordingly, we finance such projects in the form of grants, in which there is a clear and clear plan for commercialization," he explained.

But the results of such Skolkovo projects should be sufficient and adequate for further promotion to the market in order to be "picked up" by other structures from among development institutions, venture funds and strategic industry investors, the expert stressed.

"The Fund is currently working together with our institutional partners, such as Rusnano, the Russian Venture Company, Vnesheconombank, trying to select and structure projects in such a way that there is a full–fledged chain from the idea to industrial production," the Bulgarian said. "We are also negotiating with potential consumers of the results of these projects – strategic industry investors," he added.

Venture business statistics show that, at best, only every tenth project is successful – and this is considered the norm. The effectiveness of Skolkovo projects may be higher, the Bulgarian believes.

"Each of the projects already selected for financing must succeed. For them, we estimate the probability of such success at 80%. The function of the cluster and the expert community as a kind of "sieve" for the selection of really effective and best projects is also to increase this probability," the Bulgarian said.

Portal "Eternal youth" http://vechnayamolodost.ru11.03.2011