Round-table discussion “Transfer of modern pharmaceutical technologies and increasing the availability of quality medicines”
Participants of the 1st All-Russian Pharmaceutical Run were greeted by the moderator of the event, Alexey Martynov, President of the Association of Biomedical Cell Products Manufacturers.
Cluster system helps to effectively localize production, creating the necessary conditions for this. Therefore, Anatoly Sotnikov, the general director of the Agency for Innovative Development - the center of cluster development of the Kaluga Region, was invited to be the first to discuss. 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 strength of lobbying the interests of its members, of course, is much higher than that of individual companies. Secondly, the more pharmaceutical companies there are, the tougher the competition will be for personnel. The cluster helps to create civilized working conditions with specialists. Also regions create training centers. Third, it is important to develop a joint strategy, an understanding of each other’s development. And finally, the cluster helps to solve a number of questions of its participants. Synergistic projects appear.”
Igor Pozharnov, Chairman of the Kaluga Pharmaceutical Cluster Association, Head of the Government Relations Service of AstraZeneca Industries LLC, spoke about the development of the cluster in the region, investment attractiveness and personnel training: radiopharmaceuticals, preclinical and clinical studies, production of substances, finished dosage forms and training.
“I will note that for the government, the expansion of existing industries, attracting new companies is a priority. To this end, we guarantee maximum support of projects at all stages: from the placement to the solution of current issues both before the start-up of the enterprise, and after. Also a significant role is played by the presence of a cluster. This is a professional community that is perceived at the highest level,” Ilya Veselov, Minister of Economic Development of the Kaluga Region, continued the cluster topic, who also raised the issue of personnel training in his report.
Alexander Toporkov, GR-director of LLC NEARMEDIC PLUS, 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 production of substances and finished dosage forms. We dispose pharmaceutical and medical waste. Inside the Kaluga pharmaceutical cluster, there is a deep integration of its members, we deeply help each other.”
Igor Yefimov, executive director of the Kaluga Pharmaceutical Cluster Association, shared his experience in industrial cooperation, joint research and development, and also spoke about the training, retraining and advanced training programs of National Research Nuclear University Moscow Engineering Physics Institute: “The task of the cluster is to develop its pharmaceutical enterprises and the region in whole. The most important mechanism and driver of development is intracluster cooperation. ”
During the localization, 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 for Russian citizens, is a priority for Bosnalek. Technology transfer, as part of the localization process, is very important for this task. But it should be borne in mind that the issue of availability of drugs is more ambitious and involves the participation of all parts of the industry, including the supply chain. ”
Experts in the field of technology transfer told the participants of the Pharmaceutical Race what needs to be done to accurately transfer technology. Dmitry Polstyanov, General Director of X-TECH, systematized the concept of transfer: “The purpose of technology transfer activities is the transfer of knowledge about the product and the process between development and production within a single production site or between production sites to achieve the goal of a commercial product release. This knowledge forms the basis for the production process, the control strategy, the process validation approach and continuous improvement.” The expert recommended sources on technology transfer: ISPE Good Practice Guide: Technology Transfer, 2014 (International Society of Pharmaceutical Engineering, Guide to Good Practice, Technology Transfer, 2nd edition, 2014), as well as the WHO Recommendations on Technology Transfer 2011.
Alexander Willemson, Head of the Strategic Partnership Department, told about the successful experience of Petrovax Pharm technologies transfer. The speaker talked about localization at the level of the full production cycle of Pfizer partners with 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 some kind of 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 technology transfer is the research of pharmaceutical preparations. Achievements and opportunities of Medical Radiological Research Center named after Tsyba in the field of developing reference drugs and performing preclinical tests was demonstrated by the head of the laboratory of radiation pharmacology of the scientific center Marina Filimonova. The expert talked about modern laboratory developments, such as a vasopressor agent, a highly effective and safe radioprotector, a remedy for the prevention of complications of radiation therapy, as well as a combined agent for targeted therapy of malignant tumors. Marina Filimonova emphasized the importance of the interaction of scientists with the business, so that these developments could enter the market.
The overall results of the work of the health care system in the field of access to pharmaceutical preparations in Kaluga and the region were demonstrated by Alla Vasina, the head of the department for organizing pharmaceutical preparations supply at the Ministry of Health of the Kaluga region: “64 medical organizations, 1580 doctors, 75 medical assistants are involved in the ussuing of preferential prescriptions in the Kaluga region. 58 pharmacy organizations are involved in the supply of drugs to privileged categories of citizens. According to the results of 2018, in Kaluga region in the regional register of persons eligible for preferential drug provision, there were 78572 people. To provide citizens with drugs and medical products, in 2018 more than 1 billion rubles was allocated from the budget to provide the welfare beneficiaries living in the region.”
After the round table, the participants of the race took part in a tour of the Volkswagen engine plant, the automotive partner of the 1st All-Russian Pharmaceutical Race.
The general information partner of the I All-Russian Pharmaceutical Race is a newspaper, an Internet portal and television "Pharmaceutical Bulletin".
More information about the project can be obtained on the official website of Pharmaceutical Race by the link: www.pharmprobeg.ru
