The session was moderated by Igor Korobko, Director of the Science, Innovative Development and Management of Medical and Biological Health Risks Department of the Ministry of Health of the Russian Federation.
In the opening speech, Mr. Korobko emphasized that the BMCP are a qualitative step in medicine and improvement of patients’ quality of life. At the same time, he noted that currently in Russia there are the almost ready development results in the portfolios of the biotechnological companies. Regulatory framework under the Federal Law “On biomedical cell products” has created conditions for application of the innovative solutions in this field. Therewith it ensures the quality and effectiveness of use of the biomedical cell products in medical care, including solving the problems of regulatory barriers removing in the moment when the new advanced technologies go beyond the frames of existing regulations.
Deputy Director of the Federal Service for Surveillance in Healthcare, Valentina Kosenko made a report about the specifics of the biomedical cell products production, licensing requirements for the production sites, current situation on the licensing of the biomedical cell products manufacturing sites in the Russian Federation. Alexey Alekhin, Director of Pharmaceutical and Medical Industries Development Department of the Ministry of Industry and Trade of the Russian Federation, told the participants about international experience in acceleration of the BMCP industry development, the possibility to receive the state support and promotion of commercialization in this field in the Russian Federation. Mr. Alekhin also pointed out that the BMCP take a significant place in the “Pharma 2030” Strategy.
Director of the Koltzov Intitute of Developmental Biology of Russian Academy of Sciences Andrey Vasiliev focused on the place of the BMCP in the treatment of socially significant diseases and issues of increasing importance of the BMCP quality control, that are already used in the world practice. Vadim Merkulov, Deputy General Director of FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation on the pharmacological products expertize told about the perspectives of issuing of the state registration for foreign analogs of the BMCP in the Russian Federation. Mr. Merkulov also gave an exposure on the specifics of biomedical expert evaluation in accordance with the legislation of the Russian Federation, the main differences between international and national requirements for pre-clinical and clinical trials of the biomedical cell product and the existing programs of accelerated withdrawal of such products into the market in the world.
Director of Medical Department of R-Pharm Company, Deputy Head of Healthnet field working group of National technological Initiative Mikhail Samsonov focused on the BMCP investment attractiveness, features of the market, risks and withdrawal timings, as well as the necessary ecosystem for its realization. Alexey Lyundup, Head of Advanced Cell Technologies Department of the Regenerative Medicine Institute of I.M. Sechenov First Moscow State Medical University shared the results of the analysis of the modern international market on regenerative medicine and its structure, described the upcoming role of the scientific products in the field of cell technologies, about the ongoing clinical research in this area around the world.
President of the Association of Biomedical Cell Products (BMCP) Manufacturers, Alexey Martynov gave his assessment of the current situation in the BMCP industry development in the Russian Federation, as well as modern factors hindering the development of this field. Mr. Martynov also expressed his confidence in the development of this innovative and perspective industry in the Russian Federation.