Corresponding Member of the Russian Academy of Sciences Dmitry Kudlay
Photo: Alexander SHPAKOVSKY. Go to Photobank KP
“Medical biotechnology is in a period of explosive growth and investment,” Russian immunologist and corresponding member of the Russian Academy of Sciences Dmitry Kudlay told Komsomolskaya Pravda in 2021. We asked our interlocutor if the situation has changed now.
“Over the past two years, these investments have become more significant,” Dmitry Kudlay replied. – Broad search categories have been structured into those of strategic importance or of a clear innovative and useful nature. It is clear that the infectious trend has been pushed aside. And now everyone is interested in how the “freed up” capacities of those who relied on the products of the past pandemic will be used. For example, Generium carried out the first industrial scale-up of the Sputnik V vaccine in the world and it took two and a half years to produce the substance and the finished pharmaceutical form. The general trend is that searches in the field of molecular medicine and the number of equipment that has appeared in both public and private institutions have allowed to significantly accelerate the pace of research and development in the field of drugs, vaccines and diagnostic tools for genetic and rare diseases.
– What biotechnologies are now, as they say, in fashion?
– I can say that diagnostic and therapeutic solutions in regenerative medicine are included in the indicators of federal projects (in the structure of national projects, – explains the editor) in the field of medicine. Another direction is personalized medicine, which, among other things, has preventive purposes against the main causes of mortality: heart attacks, strokes, oncology and injuries. Projects such as the assessment of biological age characteristics have been developed. If we are talking about a state strategy in terms of life expectancy, then this should be achieved through personalized approaches. Since the current idea that an advertised dietary supplement will help everyone except irritation does not cause anything… We are all different, one product cannot help everyone in the same way. Currently there are treatment standards, but this is something general in order to achieve positive results in the majority of the population, preventing elements of mortality in the short and long term. In addition, federal projects include cell therapy and bioprinting. According to the latest data, 10 projects should be launched by 2030.
– What projects have appeared in recent years?
– For example, a project related to cell therapy. The country has the first industrial license for this type of technology. It is autologous cartilage for the treatment of joint injuries. What can you do? If the cartilage tissue is worn out or due to an injury to the knee joint, the defect can be corrected with the patient’s own cells. During arthroscopy, several grams of cartilage are removed through a mini-access, it is cultivated and, in fact, “3D cartilage” is grown within 6 weeks. Chondrospheres are then formed, which are reintroduced into the joint through a mini-access, filling in the damaged areas. In this way, you can cover defects of up to 10 square meters. cm of the damaged joint surface.
– Is this technology already in use?
– Yes. This is our licensed project, which received the first registration certificate in the country as a biomedical cellular product. I would like to thank those professionals with whom we went through the clinical research process. This is a group from Sechenov University, the Institute of Rheumatology, the Smolensk Federal Center of Traumatology and Orthopedics, and Samara Medical University. This technology is currently available in these institutions.
-What other projects are important to talk about?
Another project on spinal muscular atrophy, which is enjoying great media popularity. In my 20 years of working with pharmaceuticals and immunobiotechnologies, I have never seen such a dynamic and promoted nosology. You ask what the answer is. The answer, according to Marx, is the high cost of safe technology. There are three drugs in the world that are the standard treatment for SMA. They are all from different groups and have their own characteristics. And these are quite difficult projects to implement. We assigned a high priority to the task and started working on a project that belongs to the class of antisense oligonucleotides. That is, we have not had a single project in the country before that belongs to this group. And this is not even the biotechnology we are talking about today, but a project related to chemical synthesis. Our project was completed a few months ago. The drug nusinersen (Lantesens) is registered and is already being received by the first patients in the clinical observation program.
– It is known that the three drugs currently available are very expensive. The whole country is familiar with these videos in which it is urgently necessary to raise some money for an injection for a child.
– The first courses cost about 2 million dollars per child diagnosed with SMA. At the same time, these drugs have a significant lobby in high-level circles of the countries where they are produced. However, no matter how the financial relations develop, doctors, parents and pharmaceutical companies cannot be managed with one ruble or one dollar.
– Is the drug developed in Russia cheaper than the drugs being promoted?
– There is a manufacturer’s pricing methodology. And using this method we record the price taking into account a 25% discount.
– Is it a lot or a little?
– If we talk about this nosology, the country will save, according to our calculations, about 4 billion rubles.
– Compared to buying foreign medicines?
– Yeah.
– Thanks for the interesting conversation!
