The participants discussed the critical issues of changes that are taking place in the coronavirus reality: challenges for manufacturers in the development of innovative products and relevant government support measures for them, the impact of the pandemic on attitudes to innovation on the part of business and regulators, as well as how the interaction of fundamental science and production is going to develop.

The meeting was moderated by Vadim Tarasov (I.M.Sechenov First Moscow State Medical University). Among the participants in the session were: Dmitry Galkin (Deputy Director of the Development Department of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia), Dmitry Akhaev (Deputy Dean of the Faculty of Biology for Innovation at M.V.Lomonosov Moscow State University), Mikhail Nekrasov (NANOLEK’s General Director), Dmitry Kudlai (General Director of Generium, JSC), Andrey Ivashchenko (Chairman of the Board of Directors of NP TsVT KhimRar) and others.

The pandemic has highlighted some weaknesses in health systems worldwide. Due to this fact, we are continually analysing and making conclusions to take practical steps to improve communication among key stakeholders in the health industry. Simultaneously, the ongoing changes have sharpened and revealed one of the most important pharmaceutical and medical sectors’ objectives - creating innovative products.

Vadim Tarasov, Director of the Institute of Pharmacy and Translational Medicine of the Sechenov First MSMU: “The pandemic has shown that Russia, like other leading countries of the world, can generate its innovative products thanks to its research school. In the shortest possible time, our companies, the industry leaders, have brilliantly made a whole range of Russian medicines that allow our state and citizens to feel protected and receive adequate high-quality preventive treatment. This applies to the developments that have been made, among other things, by the participants in our discussion today. This also applies to vaccines in the field of which our country is at the forefront.

Now we are faced with the central question of creating a unified system in the Russian Federation that would make it possible to build truly innovative products. Moreover, there are already practical steps in this direction. Several large-scale projects for the development of science are being launched in the country, and a strategic academic leadership program is being launched. It is based on the cooperation of research institutions, scientific centres of Russian universities, which, in close connection with industrial, pharmaceutical enterprises, must build a chain for developing and implementing innovative products in the pharmaceutical and medical industries.”

Currently, we are all going through a severe ordeal. We are witnessing how the world’s leading countries could create reasonably quickly innovative medications that are needed for the treatment and prevention of Covid-19, including vaccines. Finding and producing vaccines is difficult and expensive, although essential for national security and export potential.

NANOLEK is one of the leaders in the production of paediatric vaccines. The participants were interested in hearing a comment on how the company sees development opportunities in terms of increasing its stability, what questions are there for the government and regulators about setting up the production of domestic vaccines, introducing the most promising developments, and what steps must be taken to perform the transition to innovation.

Mikhail Nekrasov, NANOLEK’s General Director: “NANOLEK is an innovative company in the first place. We initially decided that we are an enterprise that is engaged in production as well as scientific research. Our company’s development strategy is to combine scientific competencies and production resources for the implementation of joint projects to develop innovative immunobiological medicines; cooperation with leading scientific institutions. I mean collaborative work with the M.P.Chumakov Scientific Centre, and with Skolkovo. This approach helps develop science and ultimately not only creates but also produces original medicines.

Finding vaccines is not an easy job, but we understand that a biotech enterprise has two parts: sterile filling and the finished form production. The second is the production of the antigens themselves.

Thanks to the Ministry of Industry and Trade - its Pharma 2020 program has given impetus to develop innovative products in the industry. Now we discuss with them and the Ministry of Health the need to create additional experimental-industrial capacities that will make it possible to bring scientific developments into industrial production.

In this case, we are following the path of agreements with leading institutions. From laboratory development to production - it is a big step. We started by making the first step - a pure form (vaccine production: Polimilex®, an inactivated poliomyelitis vaccine, and Pentaxim®, a vaccine against five infections). We have begun to form a recombinant site (production of the antigens themselves) to produce vaccines on a full cycle. We follow the path of agreements with leading scientific institutions as an industrial partner. The coronavirus infection has shown that our country could quickly mobilize and produce a vaccine. Still, it is almost impossible to make the required number of doses (about 150 million) in 2-3 months because there are no such facilities in Russia. I am firmly in favour of innovation, but at the same time, for the creation of the required number of capacities for the production of biotechnological products.”