Ensuring Drug Security Forum

Russia has completed the first year of its Pharma-2030 strategy for the development of the pharmaceutical industry. According to the DSM Group, the size of the Russian pharmaceutical market increased to RUB 2.578 trillion in 2023. The Strategy Implementation Plan approved by the Russian government includes a wide range of measures to support the pharmaceutical industry with thorough planning for the next three years. However, the Long and Active Life national project that has been announced extends the planning horizon until 2030 due to the continued implementation and funding of federal projects to combat diabetes as well as cardiovascular, oncological, and infectious diseases. The government and business need to analyse the initial results and come up with proposals to modernize the Strategy, improve the drug regulation system, and update tools to support domestic pharmaceuticals, including innovative developments and the production of active pharmaceutical substances and ingredients for their creation. Russia must find ways to introduce innovative solutions, achieve technological sovereignty, and increase the share of domestic medicines. What results have the first year of the Strategy produced? What different approaches are needed due to the expanded planning horizon? What qualitative changes are crucial for the successful implementation of the country’s federal projects? Which unified coordinate system should be selected to predict the healthcare system’s demand for drugs? What are the most effective measures to support the pharmaceutical industry

Moderator
Aleksey Kedrin, Chairman of the Board, Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (EAEU)

Aleksey Kedrin

Chairman of the Board, Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (EAEU)

Alexey Leonidovich Kedrin was born on September 28, 1966 in Onega, Arkhangelsk region. After graduating from the Faculty of Journalism of Leningrad State University, Alexey worked in the field of public relations in Saint-Petersburg City Administration. After that, Alexey held senior positions in Russian Presidential Academy of National Economy and Public Administration under the President of the Russian Federation and in FMCG market companies.
Today Alexey is the Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union. Since 2022 - holds the position of Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU.

Panellists
Elena Astapenko, Director, Department of Pharmaceutical Provision and Regulation of the Circulation of Medical Devices, Ministry of Health of the Russian Federation
Vilena Galkina, Director for Relations with Government Authorities, Geropharm LLC
Dmitry Zaitsev, General Director, Pharmstandard
Andrey Ivaschenko, Chairman of the Board of Directors, ChemRar Group of Companies
Dmitry Kudlay, Vice President for the Introduction of New Medical Technologies, Generium
Timofey Nizhegorodtsev, Deputy Head, Federal Antimonopoly Service of the Russian Federation
Yevgeni Nifantiev, Deputy Chairman of the State Duma Committee of the Federal Assembly of the Russian Federation of the Health Protection Committee
Ekaterina Priezzheva, Deputy Minister of Industry and Trade of the Russian Federation
Aleksandr Semenov, President, Active Component
Evgeniya Shapiro, Director General, PSK Pharma
Lyudmila Scherbakova, President, Velfarm Group of Companies

Elena Astapenko

Director, Department of Pharmaceutical Provision and Regulation of the Circulation of Medical Devices, Ministry of Health of the Russian Federation

Vilena Galkina

Director for Relations with Government Authorities, Geropharm LLC

Dmitry Zaitsev

General Director, Pharmstandard

Andrey Ivaschenko

Chairman of the Board of Directors, ChemRar Group of Companies

Dmitry Kudlay

Vice President for the Introduction of New Medical Technologies, Generium

Corresponding Member of the Russian Academy of Sciences, Doctor of Medical Sciences, Deputy General Director of JSC GENERIUM, Deputy Dean for Innovation and Translational Work of the Faculty of Fundamental Medicine, Lomonosov Moscow State University, Professor of the Department of Pharmacology, Institute of Pharmacy, Sechenov Moscow State Medical University under the Ministry of Health of Russia, leading researcher at the State Scientific Center Institute of Immunology, FMBA of Russia.
Honorary Chemist of the Russian Federation, Laureate of the Russian Government Prize in the field of science and technology. Awarded the Medals of the Order of Merit for the Fatherland, I and II degrees.
A native of the city of Novokuznetsk, Kemerovo region.
Education:
- Novosibirsk State Medical University, Medicine faculty.
- Moscow Pedagogical State University, Foreign languages.
Currently holds a senior position in the biotechnology company GENERIUM, which develops and produces innovative and reproduced medicines used in various areas of healthcare.
He is a leading specialist in the field of fundamental and practical medical biotechnology, immunobiology, molecular diagnostics and cell therapy.
The practical area of his activity is development, scaling up of production and implementation of therapeutic proteins and advanced therapy medical products for diagnosis and treatment of severe socially significant diseases.
Author of 489 scientific papers, including 18 monographs and practical guides, as well as 9 patents for inventions. Hirsch index according to RSCI equals to 38. Member of the editorial board of 8 scientific journals.
He is a member of:
- National Association of Rare Disease Experts,
- National Association of Experts in the Field of Primary Immunodeficiencies,
- National Association of Specialists in Thrombosis, Clinical Hemostasiology and Hemorheology,
- FABA (Federation of Asian Biotechnology Associations),
- EBTNA (European Biotechnology Thematic Network Association),
- ERS (European Respiratory Society).
Actively implements scientific achievements, being:
- Deputy Chairman of the Council for the priority direction “20c” of scientific and technological development of the Russian Federation “Transition to personalized medicine, high-tech healthcare and health-saving technologies, including through the rational use of medicines” under the President of the Russian Federation,
- Expert of the Council for the Development of the Pharmaceutical Industry of the Ministry of Industry and Trade of Russia regarding innovative products,
- Co-author of the state programs of the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation “Pharma 2020” and “Pharma 2030”,
- Member of the Board of Trustees of the Russian Science Foundation (RSF),
- Member of the Council of the Presidium of the Russian Academy of Sciences on personalized medicine,
- Member of the interdepartmental council of the Russian Academy of Sciences on scientific substantiation and support of the pharmaceutical policy of the Russian Federation,
- Member of the Expert Council of the Sirius University of Science and Technology and the Sirius Educational Center.

Timofey Nizhegorodtsev

Deputy Head, Federal Antimonopoly Service of the Russian Federation

In 1997, Timofey Nizhegorodtsev graduated from the Biology Department of Irkutsk State University. In 2009, he received a Master of Jurisprudence degree from the Russian Academy of State Service under the President of the Russian Federation.
At the Federal Antimonopoly Service of Russia, he is engaged in the development of competition in the social sphere and trade. With his direct involvement, a system of public and expert advisory councils under the FAS Russia was created. A number of action plans and packages of amendments to the regulatory legal acts for the development of competition in such spheres as health care and trade, tourism and education, as well as in the sphere of ritual services have been prepared. These include the Law on Trade (2009) and amendments to it (2016), the Law on Education (2012), the Law on Compulsory Health Insurance (2010), as well as amendments to the Law on Tourist Activities, the Law on Public Health Protection (2010) and the Law on Circulation of Medicines.
Timofey Nizhegorodtsev contributed greatly to the tariff regulation in the field of circulation of medicines. In particular, in 2018, new rules for state registration and re-registration of maximum selling prices for drugs included in the list of VEDs were developed and approved by Government Decree No. 1207, as well as a methodology for calculating such prices. In addition, with his participation legislation on the interchangeability of medicines was prepared (2014, 2019).
He was also actively involved in the development of "antimonopoly packages".
In 2007, Timofey Nizhegorodtsev headed the Department of the social sphere and trade of the Federal Antimonopoly Service of Russia.
In 2018, the work of the Department of Control of the Social Sphere and Trade in the field of competition advocacy was highly appreciated at the international level. The regulatory act developed by the Department, which brought transparency to the specifics of the description of medicines for medical use that are procured by the state, won in the category "Creating Markets for Private Sector Development" and thus for the first time brought FAS Russia 1st place in the World Bank-ICC international competition on competition advocacy.
In 2013, he was awarded the Medal of the Order "For Merit to the Fatherland" II degree, in 2017 - the Medal of the Order "For Merit to the Fatherland" I degree.
In 2011, he was awarded the title "Honorary Worker of the Antimonopoly Agencies of Russia".
In 2015, he was awarded the Badge of Honor of the Federal Antimonopoly Service "For Merits in the Development of Competition in Russia".
In 2019, he was awarded the Medal of the Federal Antimonopoly Service "For Distinction in Service" III degree.
In 2019, he was awarded the medal "For Contribution to the Development of the Eurasian Economic Union".
As Deputy Head of the Federal Antimonopoly Service of Russia, Timofey Nizhegorodtsev supervises health care, social sphere, trade and non-productive services.

Yevgeni Nifantiev

Deputy Chairman of the State Duma Committee of the Federal Assembly of the Russian Federation of the Health Protection Committee

Ekaterina Priezzheva

Deputy Minister of Industry and Trade of the Russian Federation

Aleksandr Semenov

President, Active Component

Alexander Semenov has been working for the benefit of the pharmaceutical industry for more than 25 years, under his professional leadership, in October 2020, Active Component JSC concluded a special investment contract (SPIC) with St. Petersburg and the Ministry of Industry and Trade of the Russian Federation, and in December 2020, with the participation of officials of the Government of the Russian Federation, launched the 1st stage of the second production site of chemical pharmaceutical substances, most of which were not previously produced in Russia. Currently, the Company's portfolio includes over 60 INN substances for the most popular and socially significant medicines. Thanks to personal participation, strategic thinking and deep involvement of Alexander Semenov in management processes, Active Component is constantly increasing its production portfolio, the number of its own unique developments, the volume of products and creates new jobs. Through its activities, the Company contributes to the prosperity of the region, strengthening the national security of the country and reducing dependence on imported drugs, which served as its inclusion in the federal register of system-forming enterprises. Alexander was awarded the Gratitude of the Governor of St. Petersburg and is the winner of the "TOP CEO of 2021" competition according to Kommersant, is happily married and has four children.

Evgeniya Shapiro

Director General, PSK Pharma

Lyudmila Scherbakova

President, Velfarm Group of Companies

Front row participant
Victoria Galkovskaya, Deputy Head, The Federal Service for Intellectual Property (Rospatent)

Victoria Galkovskaya

Deputy Head, The Federal Service for Intellectual Property (Rospatent)