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Life Sciences in 2030: A New Era for Biotechnology
26 May 2018
10:00—11:15
KEY CONCLUSIONS
Stable and loyal regulatory environment is the basis for investment in the development and production of new medicines and materials

Gene and cell therapy, new recombinant drugs and the new materials needed to make up for lost functions are among the main trends today. <...> We are working intensively on the regulatory basis for medication approval and registration of medical devices. We already can state that our regulatory framework is one of the most loyal to both developers and producers — Sergei Kraevoi, Deputy Minister of Healthcare of the Russian Federation.

We need certain state-set game rules that will be fixed at least in the medium term. The research takes a rather long period and the state should consistently and purposefully support the companies that will invest in investments — Dmitry Khalilov, Partner, Head of the Group for the Provision of Services to Enterprises of the Consumer Goods Sector, CIS, EY.

The future of medicine - prevention, predictability and personalization

There is a definite trend not to cure on-going illnesses, but rather to predict the propensity, predisposition of a particular person to a particular disease. Whether it's gene editing or selecting individual treatment and customized drugs — Igor Drozdov, Chairman of the Board, Skolkovo Foundation.

ISSUES
The number of clinical trials in Russia is decreasing due to problems with finances and intellectual property protection

Russia has a great starting position: capacity and infrastructure. Clinical trials take up 60–70% of the world's total R&D, which amounts to about USD 100 billion. However, over the past 7 years the number of clinical trials in Russia has declined, not increased. What are the reasons for this lag? First of all, these are complex price and reward conditions. Gaps in the regulation of intellectual property rights. To a certain extent, this is a localization problem — Meir Pugatch, Professor, University of Haifa.

Research programmes take a long time. Innovative technology takes 10 to 15 years or even more to develop and get to the market. Long research periods and colossal resources typically in excess of USD 1 billion that go into these studies, make the protection of intellectual property extremely important — Joerg Moeller, Corporate Executive Vice President, Member of the Executive Committee of Bayer AG's Pharmaceutical Division, Head of Global Development, Bayer AG.

In Russia, many projects are conducted in a format of collective development at the junction of commercial players and academic science in the universities. Here we face the lack of a culture of protecting intellectual property rights of scientific groups. Often times, research teams do not have enough resources and they simply ignore timely protection. A negative factor is a KPI development by the regulator, when the scientific teams are evaluated by citation indexes and publications. They chase it and go out into the public field before it's necessary, and lose the opportunity to patent their designs — Vasiliy Ignatiev, CEO, R-Farm.

Russian legislation does not keep up with the development of the biotechnology market

In order to create medical technology, you need to have data. And data collection is a sensitive story. The attitude towards collecting biomaterial is ambiguous. We, on one hand, can not do without digitizing this data, but on the other hand we have an issue of information security and legislation — Igor Drozdov, Chairman of the Board, Skolkovo Foundation.

There is no stable regulatory environment in Russia. Still, frequently changing legislation does not keep pace with the development of the market. For example, legislation on biocell technology was adopted only in 2017–18 — Dmitry Khalilov, Partner, Head of the Group for the Provision of Services to Enterprises of the Consumer Goods Sector, CIS, EY.

SOLUTIONS
Creating effective tools for state support

Since we started implementing Pharma 2020 strategy, we new players appeared in the market, those who can produce bioanalogic drugs. For its part, the Ministry of Industry and Trade creates support tools, both regulatory and financial. In biotechnology, we supported more than 50 projects worth more than 3 billion roubles. Now we support organizations that are ready to invest their own funds and then compensate their costs by providing subsidies for clinical research and production — Aleksey Alekhin, Deputy Director of the Department of pharmaceutical and medical device industry development - ‎Ministry of industry and trade of the Russian Federation.

Optimization of industry regulation

Together with HealthNet, we are working on the issue of identifying special innovative medicines and medical products. We are working to legalize the use of laboratories for advanced development. We want to identify when it is allowed to use diagnostic and treatment methods that have not yet been registered, yet the developer still submits them with the expert community approval. This is the methodology of directed innovative development — Sergei Kraevoi, Deputy Minister of Healthcare of the Russian Federation.

The material was prepared by the Russian news agency TASS