On May 30, in the Kaluga Region, within the framework of I All-Russian Pharmaceutical Run, a round table discussion took place entitled “Transfer of modern pharmaceutical technologies and increasing the availability of quality medicines”. Experts discussed pressing issues in this area: localization of production, the advantages of cluster systems in the development of enterprises, the regulatory aspect and technical features of the process .
The moderator of the event Aleksey Martynov , president of the Association of Biomedical Cellular Products Manufacturers “AP BMKP” greeted the participants of the First All-Russian Pharmaceutical Run.
The cluster system helps to effectively localize production, creating the necessary conditions for this. Therefore, the first to be invited to the discussion was Anatoly Sotnikov , general director of the Agency for Innovative Development – Center for Cluster Development of the Kaluga Region. The expert presented four factors that allowed the Kaluga pharmaceutical cluster to achieve high results: “First, any cluster is a community of enterprises, the power and lobbying power of the interests of its participants, of course, is much higher than that of individual companies. Secondly, the more pharmaceutical enterprises, the tougher the competition for personnel. The cluster helps create civilized working conditions with specialists. Also, regions create training centers. Thirdly, the development of a joint strategy, understanding of each other’s development is important. And finally, the cluster helps to solve a number of questions of its participants. Synergetic projects are emerging. ”
Igor Pozharnov , spoke about cluster development in the region, investment attractiveness and training Chairman of the Board of the Kaluga Pharmaceutical Cluster Association, Head of Government Relations with AstraZeneca Industries LLC: “The main directions of cluster development are research and development of new molecules, including radiopharmaceuticals, preclinical and clinical studies, production of substances, finished dosage forms and preparation frames. “
“I note that for the government it is a priority to expand existing industries, attract new companies. To do this, we guarantee maximum support for projects at all stages: from placement to solving current issues, both before the start of the enterprise and after. The presence of a cluster also plays a significant role. This is a professional community that is perceived at the highest level, ”continued the cluster theme of the Minister of Economic Development of the Kaluga Region Ilya Veselov , who also raised the issue of training in his report.
Alexander Toporkov , Director of Government Relations with NIARMEDIC PLUS LLC, spoke about the impact of the Kaluga pharmaceutical cluster on the socio-economic development of the region and its features: “We have 10 full-cycle plants, there are both the production of substances and finished medicines. We recycle pharmaceutical and medical waste. Inside the Kaluga pharmaceutical cluster, the deepest integration of its members is taking place, we deeply help each other. ”
Igor Efimov , executive director of the Kaluga Pharmaceutical Cluster Association, shared his experience in industrial cooperation, joint research and development, and spoke about training, retraining and advanced training programs at NRNU MEPhI: “The cluster’s task is to develop incoming in it pharmaceutical companies and the region as a whole. The most important mechanism and driver of development is intracluster cooperation. ”
When localizing, it is important to maintain production technology. Valentina Buchneva , head of the Eurasia business unit of Bosnalek JSC, presented the side of pharmaceutical manufacturers: “Providing consumers with access to new pharmaceutical technologies and drugs, thereby improving the quality of life of Russians, is a priority for Bosnalek. Technology transfer, as part of the localization process, is very important for solving this problem. But it should be borne in mind that the issue of drug accessibility is broader and involves the participation of all parts of the industry, including the distribution chain. ”
Transfer experts told Farm Run participants what needs to be done to accurately transfer technology. Dmitry Polstyanov , CEO of IKS-TECH, systematized the concept of transfer: “The purpose of the technology transfer is to transfer knowledge about the product and the process between development and production within the same production site or between production sites for achieving the goal of commercial product release. This knowledge forms the basis for the production process, control strategy, approach to process validation and continuous improvement. ” The expert recommended technology transfer sources: ISPE Good Practice Guide: Technology Transfer, 2014 (International Society for Pharmaceutical Engineering, Good Practice Guide, Technology Transfer, 2nd Edition, 2014), as well as the 2011 WHO Technology Transfer Recommendations.
Petrovax Pharm, Head of the Strategic Partnership Department Alexander Willemson , spoke about the successful experience in technology transfer of NGOs Petrovax Pharm. The speaker spoke about the localization at the level of the full production cycle of Pfizer partners with the Prevenar® 13 vaccine, Boehringer Ingelhelm with modern thrombolytics Aktilize® and Metalize®, as well as the company’s internal projects. The expert also paid attention to the main aspect of his work: “Strategic partnership is a certain environment, these are your partners with whom you constantly interact. You can call them at any time, ask for advice. Petrovax has many partners in Russia. ”
An important component of the transfer are drug studies. Achievements and capabilities of the MRRC them. A.F. Marina Filimonova, the head of the laboratory of radiation pharmacology at the Research Center for Radiation Pharmaceuticals and preclinical trials, demonstrated the test. The expert spoke about modern laboratory developments, such as a vasopressor agent, a highly effective and safe radioprotector, a tool for the prevention of complications of radiation therapy, as well as a combination of targeted therapy for malignant tumors. Marina Filimonova emphasized the importance of the interaction of scientists with business so that these developments could enter the market.
Alla Vasina , the head of the drug supply organization department of the Ministry of Health of the Kaluga Region, demonstrated the overall results of the work of the healthcare system in the field of access to medicines in Kaluga and the region: “64 medical organizations, 1,580 doctors, 75 paramedics. 58 drugstore organizations are involved in the dispensing of medicines to privileged categories of citizens. According to the results of 2018, in the Kaluga region in the regional register of persons entitled to preferential drug provision, there were 78,572 people. In order to provide citizens with medicines and medical devices in 2018, more than 1 billion rubles were allocated from the budget to provide a preferential category of citizens living in the region ”
After the round table, the rally participants took part in an excursion of the Volkswagen engine plant, an automobile partner of the First All-Russian Pharmaceutical Run.