Merkulov Vadim Anatol'evich

Bolatbekova M.S., Kudlay D.A., Melnikova E.V., Merkulov V.A., Taube A.A. 1243

The successful development of the economy of a modern state is directly related to the entry into the market of new advanced therapy medicinal products. For Russia, the process of developing and implementing biomedical cell products will become the basis for the successful transformation of the pharmaceutical market into a knowledge-intensive market economy. Biomedical cell products can act as one of the main tools of such a promising and capital-intensive direction as regenerative medicine. The field of biomedical cell products therapy is developing rapidly, but there are still questions about the safe use of biomedical cell products therapy. The growing need for effective recommendations for the participants of the biomedical cell products market has determined the relevance of this study. Multivariate analysis of the prospects and barriers to the development of the biomedical cell products market to justify and develop recommendations for investors, pharmaceutical manufacturers and distributors for the production and sale of biomedical cell products in Russia. Materials and methods. The materials were regulatory legal documents of regulatory bodies: the USA, the EU, the Russian Federation, the EAEU, as well as analytical materials of open access. Results. A comparative analysis of the production features and the formation of the cost of autologous and allogeneic biomedical cell products revealed the ways of development of the biomedical cell products market. Further, the key directions of the prospective development of the biomedical cell products market were identified and characterized, risk factors, drivers and barriers were identified. Conclusion. In the direction of regulatory support: – create a general register for monitoring the results of research and the use of biomedical cell products. – to develop an information environment for comparing large sets of biomedical cell products life cycle data obtained from different sources; – to develop regulatory approaches to the circulation of biomedical cell products in the market. In the direction of technological support: – plan the implementation of automation of all stages of the production process; – to provide for the development of technology transfer methods; – to maintain the pharmaceutical quality system in an up-to-date functioning state; – implement a platform for training qualified personnel for this field. In the direction of marketing support: – to create logistics chain systems, with the help of integration technologies, capable of ensuring uninterrupted supply of biomedical cell products with minimal risks to the quality of the supply chain reliability; – supply planning should take into account the stability and storage conditions of the biomedical cell products; – scaling up production leads to a reduction in cost, and an increase in the use of biomedical cell products in routine medical practice leads to an increase in the present value; – conduct training of production employees, distributors and medical personnel. – develop a commercialization strategy for each biomedical cell products separately.

Bolatbekova M.S., Kudlay D.A., Melnikova E.V., Merkulov V.A., Taube A.A. 1243

The successful development of the economy of a modern state is directly related to the entry into the market of new advanced therapy medicinal products. For Russia, the process of developing and implementing biomedical cell products will become the basis for the successful transformation of the pharmaceutical market into a knowledge-intensive market economy. Biomedical cell products can act as one of the main tools of such a promising and capital-intensive direction as regenerative medicine. The field of biomedical cell products therapy is developing rapidly, but there are still questions about the safe use of biomedical cell products therapy. The growing need for effective recommendations for the participants of the biomedical cell products market has determined the relevance of this study. Multivariate analysis of the prospects and barriers to the development of the biomedical cell products market to justify and develop recommendations for investors, pharmaceutical manufacturers and distributors for the production and sale of biomedical cell products in Russia. Materials and methods. The materials were regulatory legal documents of regulatory bodies: the USA, the EU, the Russian Federation, the EAEU, as well as analytical materials of open access. Results. A comparative analysis of the production features and the formation of the cost of autologous and allogeneic biomedical cell products revealed the ways of development of the biomedical cell products market. Further, the key directions of the prospective development of the biomedical cell products market were identified and characterized, risk factors, drivers and barriers were identified. Conclusion. In the direction of regulatory support: – create a general register for monitoring the results of research and the use of biomedical cell products. – to develop an information environment for comparing large sets of biomedical cell products life cycle data obtained from different sources; – to develop regulatory approaches to the circulation of biomedical cell products in the market. In the direction of technological support: – plan the implementation of automation of all stages of the production process; – to provide for the development of technology transfer methods; – to maintain the pharmaceutical quality system in an up-to-date functioning state; – implement a platform for training qualified personnel for this field. In the direction of marketing support: – to create logistics chain systems, with the help of integration technologies, capable of ensuring uninterrupted supply of biomedical cell products with minimal risks to the quality of the supply chain reliability; – supply planning should take into account the stability and storage conditions of the biomedical cell products; – scaling up production leads to a reduction in cost, and an increase in the use of biomedical cell products in routine medical practice leads to an increase in the present value; – conduct training of production employees, distributors and medical personnel. – develop a commercialization strategy for each biomedical cell products separately.