The Russian Association of Experts in Cell Technologies and Therapy will be Created with PRMU Participating
The first meeting of the founders of the Russian Association of Experts in Cell Technologies and Therapy was held in Saint Petersburg
The first meeting of the founders of the Russian Association of Experts in Cell Technologies and Therapy was held in Saint Petersburg. The meeting was attended by leading experts in the field of cell technologies, representatives of biotechnological centers of cell technologies, clinicians and heads of relevant organizations. It was decided to create a non-profit organization – the Russian Association of Experts in Cell Technologies and Therapy. The founders of the Association were Yegor Prikhodko, Director General of Stem Cell Bank Pokrovski Ltd, and Marfa Yegorikhina, Senior Research Scientist, Head of the Biotechnology Laboratory of PRMU. As of today, the documentation required for the state registration of the Association is being prepared.
Thus far, Russia has many open issues in the field of clinical use of cell products. Bringing together experts working in this field and ensuring the interaction between the professional community and regulatory bodies of executive and legislative power will be one of its key goals.
- Promising developments of drugs based on somatic cells – cell products, in simpler terms, – are already available at a number of entities. Many of them have successfully undergone not only laboratory but also animal testing. However, the registration process should be completed for these products to reach the clinic. So numerous issues arise at this point. I would like to note that there is not a single registered cell product in Russia for now! In many cases, the laws are short on specifics, and each drafter tries to get advice from the regulatory body. Meanwhile, there is no unified information field for professionals to communicate in, and the drafters address the regulator with one and the same question. It delays the process, – Marfa Yegorikhina said.
Moreover, legislative changes have been scheduled for this year with a focus on regulating the production and circulation of cell products, which will also trigger many questions. These products are currently not included in the standards of specialized medical care approved by the Ministry of Health. It means that there is no clear explanation to the doctor as to the legal environment for the use of such products to treat a particular disease, and it is unclear to the clinic who should pay for the treatment of a patient using this product. Thus, the cell products that have entered the market will not be much sought after – even those with proven high efficacy. The Association should become a link in the chain that will interconnect experts to develop recommendations for the use of these products, and it will apply to the Ministry of Health officially on behalf of the professional association to include the given recommendations in the standards of care. We also deem it necessary to set consolidated quality standards, to elaborate the legal aspects of working with cell products, and inform all the experts about consistent approaches employed by the Ministry of Health to introduce such products.
- We hope that the Association will become the institution and the information space to allow all the interested parties – from drafters and manufacturers to the final link, doctors, – to cooperate, exchange information, make suggestions and interact efficiently with the state authorities regulating this industry, – Marfa Yegorikhina continued.
- The forming of an Association is required to build up a safe, constructive and profitable cell therapy market in Russia for all the stakeholders. Today there are separate ‘islands’ in this country – entities involved in working with somatic cells. Large-scale fragmentation when regulating the production of biomedical cell products, a lack of clear algorithms for routine work, licensing or clinical trials hampers the development of various types of cell therapy dramatically. In our field, in most cases, everything rests on the enthusiasm of individual experts and managerial support. When forming the Association, we adhere to the idea of bringing together all the experts working in this area to create a single information ecosystem for the market of cell therapy and cell products, and also to disseminate information about the entities and experts involved. Besides, one of the goals of the Russian Association of Experts in Cell Technologies and Therapy is to form an overall opinion of experts, practitioners and communicate it to the state regulatory bodies – and, in some cases, perhaps, co-elaborate the regulatory documentation for this area of biomedicine to develop faster in this country, so that we can give doctors the tools to save patients without delay, – as Yegor Prikhodko commented.
Thus far, Russia has many open issues in the field of clinical use of cell products. Bringing together experts working in this field and ensuring the interaction between the professional community and regulatory bodies of executive and legislative power will be one of its key goals.
- Promising developments of drugs based on somatic cells – cell products, in simpler terms, – are already available at a number of entities. Many of them have successfully undergone not only laboratory but also animal testing. However, the registration process should be completed for these products to reach the clinic. So numerous issues arise at this point. I would like to note that there is not a single registered cell product in Russia for now! In many cases, the laws are short on specifics, and each drafter tries to get advice from the regulatory body. Meanwhile, there is no unified information field for professionals to communicate in, and the drafters address the regulator with one and the same question. It delays the process, – Marfa Yegorikhina said.
Moreover, legislative changes have been scheduled for this year with a focus on regulating the production and circulation of cell products, which will also trigger many questions. These products are currently not included in the standards of specialized medical care approved by the Ministry of Health. It means that there is no clear explanation to the doctor as to the legal environment for the use of such products to treat a particular disease, and it is unclear to the clinic who should pay for the treatment of a patient using this product. Thus, the cell products that have entered the market will not be much sought after – even those with proven high efficacy. The Association should become a link in the chain that will interconnect experts to develop recommendations for the use of these products, and it will apply to the Ministry of Health officially on behalf of the professional association to include the given recommendations in the standards of care. We also deem it necessary to set consolidated quality standards, to elaborate the legal aspects of working with cell products, and inform all the experts about consistent approaches employed by the Ministry of Health to introduce such products.
- We hope that the Association will become the institution and the information space to allow all the interested parties – from drafters and manufacturers to the final link, doctors, – to cooperate, exchange information, make suggestions and interact efficiently with the state authorities regulating this industry, – Marfa Yegorikhina continued.
- The forming of an Association is required to build up a safe, constructive and profitable cell therapy market in Russia for all the stakeholders. Today there are separate ‘islands’ in this country – entities involved in working with somatic cells. Large-scale fragmentation when regulating the production of biomedical cell products, a lack of clear algorithms for routine work, licensing or clinical trials hampers the development of various types of cell therapy dramatically. In our field, in most cases, everything rests on the enthusiasm of individual experts and managerial support. When forming the Association, we adhere to the idea of bringing together all the experts working in this area to create a single information ecosystem for the market of cell therapy and cell products, and also to disseminate information about the entities and experts involved. Besides, one of the goals of the Russian Association of Experts in Cell Technologies and Therapy is to form an overall opinion of experts, practitioners and communicate it to the state regulatory bodies – and, in some cases, perhaps, co-elaborate the regulatory documentation for this area of biomedicine to develop faster in this country, so that we can give doctors the tools to save patients without delay, – as Yegor Prikhodko commented.
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