29 April 2009

The role of the pharmaceutical industry in innovative development

Pharma will push Russian innovations
Sergey Tsyb, Director of the Department of Chemical and Technological Complex and Bioengineering Technologies of the Ministry of Industry and Trade of Russia, talks about the role of the pharmaceutical industry in the innovative development of the country.Recorded by Konstantin Kiselyov, STRF.ru
– Sergey Anatolyevich, the Ministry of Industry and Trade of the Russian Federation has sent an updated draft Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2020 for consideration and approval to the Government of the Russian Federation.

Why do you think Russia needs its own pharmaceutical industry?– In addition to the unconditional social significance of this industry, I would like to highlight the following aspect.

The pharmaceutical industry today is one of the most innovatively capacious industries, partly due to the latest achievements of world science in the field of studying the human genome. Here is the intersection of many sciences. These are chemistry, biology, medicine, mathematics. And it is in this industry that it is most difficult to establish an innovation process, since any new product is tested directly on a person, and this is not only an additional cost of time and money, but also huge risks. Please note that only highly developed countries can afford their own innovative pharmaceutical industry. And if they managed to establish an innovation process in this segment of the economy, then in other segments it is usually also possible.

– What does the Russian pharmaceutical industry look like to you in 5 years?– In five years, we hope that the majority of high-tech generics and bio-generics will already be produced on the territory of the Russian Federation in accordance with European quality standards.

At the same time, we assume that many local pharmaceutical manufacturers will invest significant funds in the development of new products. I think that in the future, when we take statistics on ongoing clinical trials in the Russian Federation, we will see not only three phases of multicenter studies initiated by the international Big Pharma, but also many first and second phases of clinical trials of innovative drugs. This will ensure that in another 5 years, the latest drugs will dominate the portfolios of local manufacturers.

All the main parameters of the pharmaceutical industry development are specified in the draft Strategy "Pharma 2020", they were calculated and obtained not only based on expert evaluation methods, but also using a fairly serious mathematical modeling apparatus. The main "strategeme" of this document has been repeatedly stated: the domestic pharmaceutical industry will be able to survive in the conditions of globalization only if it develops according to an innovative scenario. In other words, the pharmaceutical industry will have enough innovative products to refinance the development of new ones.

– Is the pharmaceutical industry development strategy an industry strategy or a significant element of the state industrial policy?– As you know, the state socio-economic policy of the Russian Federation consists in the transition from an energy and raw materials economy to an innovative one.

In this sense, industrial policy, as an element of general policy, is also focused on an innovative development model. As I have already said, if we manage to create a model of an innovation system in the pharmaceutical industry, then it will most likely work in other industries. In this sense, the Pharma2020 Strategy seems to be an extremely significant element of the state industrial policy as a whole.

– How do you see the interaction with the relevant departments: the Ministry of Health and Social Development and the Ministry of Education and Science? What kind of interaction has already been established? Are there any difficulties?– A very correct question.

Due to the interdisciplinarity and social significance of this industry, the interaction between the listed departments, as well as the Russian Academy of Sciences, the Russian Academy of Medical Sciences and other state institutions and authorities is extremely important. It is for this reason that Prime Minister Vladimir Putin at last year's meeting in Kursk proposed to create a Council under the Deputy Prime Minister of the Russian Federation to coordinate such interaction. And we hope that this Advice will work in the coming months.

As for cooperation at the departmental and academic levels, it is already being established. In particular, in April 2009, within the framework of the Ministry of Industry and Trade of Russia, a scientific and technical council was established to implement measures in the field of development of the chemical, medical and pharmaceutical industries, as well as the biotechnological complex of Russia. We hope that this council, among other things, will contribute to the establishment of interaction between science and business, which is the key to the successful innovative development of any industry.

– How do you assess the scientific and scientific-technical potential of Russian science in the relevant field?– Our scientific schools have centuries-old traditions and have huge potential, especially in the field of fundamental research.

However, applied science has significantly lost its potential in recent decades. And this is primarily due to the fact that the change of the "planned" economy to the "market" hit it the most. It is no longer possible to support all applied science at the expense of the state budget, and business does not yet have sufficient resources and motivation to co-finance those developments that emerge from the depths of our science. This is partly because it is easier to invest in advertising and branding, and partly because many developments made in the bosom of academic science are simply not needed on the market today. It requires a balanced policy of the state to stimulate both innovative proposals (academic science) and innovative demand (industrial science).

– How do you assess the personnel potential in this area?– Unfortunately, this is one of the main limitations for the implementation of an innovation strategy, especially in the field of applied industrial science and technology.

Since there was no demand for such specialists, our universities did not prepare them. Therefore, our current graduates have to be retrained for a long time, and often retrained. The draft Strategy "Pharma 2020" pays great attention to this issue and suggests specific measures, including those related to the return of our specialists who have gained experience in the Western industry.

Portal "Eternal youth" www.vechnayamolodost.ru29.04.2009

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