The Skolkovo Foundation's Biomedical Technologies Cluster, in conjunction with the companies OST Rus and GCT, held the first ever educational seminar, 'The release of medicines onto the market: from pre-clinical trials to registration. Practical aspects' in the Hypercube.
The seminar was dedicated to all the stages of the release of medicines on the Russian market - from pre-clinical trials to registration of medicines. As Kamila Zarubina, a Doctor of Philosophy (PhD) in Biological Sciences) and an analyst at the Biomedical Technologies Cluster, explained to the website sk.ru, it is crucial that biomedical start-ups understand the modern principles and characteristics of the process of developing medicines and releasing them on the market, in order to plan research activity successfully. "During this seminar, issues related to clinical research, data processing, budgeting principles, audits and registration procedures were examined in great depth for the first time, and this was welcomed by our resident companies. In the future we plan to organize further such subject-based events for those of our start-ups that have been working on innovative medicines," Zarubina announced.
Taking part in the seminar were leading experts in the field of clinical studies and the release of medicines on the market, who were seeking answers to the following questions together: how can plans for clinical studies be drawn up, and designs and protocols compiled; what should the budget for these studies be, how many patients should be involved and during which phase; how should the data obtained in the studies be processed and how can the regulator's audit be passed; and how can a registration dossier be put together and how much time is required in order for it to be approved?
Professor Elena Telnova, the leading scientist on the staff of the Scientific Research Institute for Public Health, Russian Academy of Sciences, opened the seminar with a report on the registration of medicines in Russia. She spoke about the regulations which govern the procedure for registering medicines, the registration dossier and the time required for registration, and the current international practices (FDA, EMEA) for approving innovative approaches to medicines. "The first step in the process of releasing a medicine on the Russian market is to register it. The registration procedure contains 4 stages: compiling a registration dossier, receiving permission for clinical trials and conducting them, a quality analysis and decision from the Ministry of Health on registering the company and adding it to the State register. It is important that small companies engaged in producing innovative medicines understand all the stages of releasing medicines on the market. A lot of work is currently taking place to bring the regulations into line with modern international standards, but this is extremely labor-intensive and time-consuming, so changes will only be made on a gradual basis," said Elena Telnova.
Staff at OST examined the principles of developing a plan for pre-clinical trials based on specific practical examples, designing a clinical programme, and processing the data obtained in clinical trials and the findings of audits. The processing of data obtained during clinical trials includes all aspects of the processing of clinical data using a wide range of computer systems and apps, inventions and database support systems, data clean-up systems, encryption etc. The testing processes used depend on which phase of the clinical tests is taking place. Elena Startseva, the Director of Business Development at OST Rus, said: "The seminar was an excellent event which was the result of collaboration with the Skolkovo Foundation. We were able to shine some light on both theoretical and practical issues that are relevant to our sector at the moment, and we enjoyed hearing some positive feedback from the people who attended the seminar."
Staff from the contract research company GCT shared their vision of approaches to budgeting on clinical studies projects. The project is considered efficient due to, among other things, the reduced time-frame and/or a cost saving whilst adhering at all times to quality requirements and staying under budget.
The event was attended by experts from major pharmaceutical companies from the clinic trials and registration departments. Anna Gotskaya, the Director of the project ANO 'National Institute of Innovations', a resident company at the Foundation, shared her thoughts on the event: "Our participation in the educational seminar 'Releasing medicines on the market: from pre-clinical trials to registration. Practical aspects' enabled us to find out more about various aspects of releasing medicines on the market. The format of the seminar enabled us not only to find out new information but also to exchange our experiences with our colleagues. I would particularly like to highlight the professional way in which the event was organized, including the preliminary work carried out by the organizers with those who attended the seminar."