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clinical trials have been suspended in russia, what does this mean for the drug market for doctors and patients today absolutely? so, first of all, we have taken, no matter how i want to call it response measures, but measures that, if need will make it possible to obtain virtually any drug that is circulating somewhere on the world market in the future. some patients who are clearly in the study, and the drug helped and for them, e access to a clinical study, early access to a new innovative

drug. on the general scale of the country. probably , well, it’s not so, and that is, no one will notice such developments are increasing russian pharma companies in august, we received permission to conduct a clinical study in spinal muscular therapy, where children up to 8 months will participate , a program is also actively implemented for neuroplastomy, also in younger patients. what original own innovative research is being carried out right now, this is a new target on the market today, but there are no drugs for this target, so the molecule is unique, and we are planning this development, and not only in russia but also in the world. at the world's largest symposium on tumors of the gastrointestinal tract this summer, san francisco, the attention of many scientists was

chained to a tiny vial in a vial alphabet, the world's first targeted drug that works specifically against specific parts of cells in stomach tumors drugs that hit precisely such targets were developed by two leading oncologists from russia, professor sergeyan and oncologist ilya timofeev , scientists have been selecting molecules for 6 years while they received this exclusively russian development. a historical inhibitor of fibroblast growth receptors. behind these scientific words, the essence of the discovery is to hit right on target, when the patient is already nothing helps in such drugs the world has not yet been. we found that this target is expressed on stomach cancer cells and on cancer and ovarian cells, which are very common in russia, so the task was to come up with a drug that blocks this target. the innovativeness of this development lies in the fact that the drug binds to certain centers. in this receptor and changes it, a change in this receptor

leads to the fact that the tumor cell of the stomach of gastric cancer is not activated and the tumor and metastases their startup is dying, with the support of the fund from the bell, it conducted preclinical studies and the first phase is already on alofani people. introduced 21 patients from russia in all gastric cancer with multiple metastases, non-standard drugs. they didn’t help anymore, then some patient was in serious condition. if we achieved control in 8% of cases, their tumor stopped developing over the disease . one more a patient. six lines of therapy received the body, stuffed after already 2 months of the appointment of the alphabet. itself did not begin to shrink enough. here, in particular, by 24%, one large by 7%. and most importantly, this patient e from may 2021 to the present

has shown himself to be not very taxic ahead, the second phase of the study is already 150%. alafanip has been shown to work in patients who have already exhausted standard therapy. that is, essentially. these patients are candidates for hospice. the first results allowed e, initiate a phase ii study where the alphabet will already be studied in previously untreated patients who have not received. e. medicinal treatment is also gastric cancer, the second indication is ovarian cancer, for which there are also very few drugs and little revolution of data for this tumor. we decided to try to use the alphabet and learn it in patients too, who can no longer receive standard care. the russian company pharm - this is its production and laboratory in the moscow technopark acquired license for alafanib. and already, together with the

developers of the drug, it will conduct the second phase of studying research in oncology - this is mainly the study of foreign drugs, and this year, for obvious reasons, there are fewer and fewer of them, and in this regard, we, as a domestic company, are trying to maintain the level . ah and ah, we are taking more and more innovative developments into our portfolio. this is an innovative molecule, and one of the first in the class, and we have very high hopes for its development and release. including in in some foreign countries, the results of the first phase, they were also greatly inspired, by the way the alphabet purposefully twists the receptor for tumor cells, the absence of strong side effects and the main thing, how it helps to prolong life and from the centers in the city of omsk, and the patient received, and received i think 14 rounds of chemo, a to a. the appointment of lafonibo and e, the duration of therapy with this particular drug was 18 months. this is a colossal period, that is, during this period

, the patient showed a positive trend. in in the second phase, italian specialists will study the mechanisms of this drug. in the second phase , we already choose more specific doses based on the data of the first and e, carry out a preliminary assessment of the effectiveness. second phase. yes, this is probably the most, but the key moment when we can understand that the drug really works. we are in the clinical research department of the logical science center. there are about 30 clinical trials of various drugs every year, which are studied in patients with different types of endocrinopathy. this is the holy of holies of our department , the premises for the storage of biological samples, which we receive as part of a study today at the leading federal endocrinological center in russia, about 200 volunteers, those who agreed to test new drugs on themselves, when everyone

is under drips, these are usually very early phases of research and most of the time it's healthy volunteers and when it comes to patients, it's real patients who participate in research. this is, of course, an individual approach, there have always been russian and more often international studies from 20 to 40 programs per year, all studies that were started, where patients were included and their treatment continues, but, probably, since march or april almost all new international studies have established kit. at first it was logistical problems, and then it was just decided to stop the recruitment in the center , they always tested innovative medicines and bio analogues of russian production, including new types of insulin, this sugar, 82, how good it is now. how much time has passed after eating. an hour and a half hour and a half, this is a very good first insulin injection in the world was made exactly 100 years ago in russia today about five million people with confirmed diabetes.

while there is improvement in favor. here are the technical means of managing diabetes, which facilitate this management. at the same time, it allows to achieve such a level of glucose so close to normal that life expectancy is today is not limited, and complications do not develop at all. alexander lagutin was diagnosed with type 1 diabetes a few years ago , he participated in all possible clinical trials in the center of endocrinology and russian and imported drugs. when, for example, these daily studies were. i campaigned online. well, people with safe diabetes of the first type, well, guys naturally, because there only men could participate and a rather large percentage of people who came read informed consent and understood that they do not want, that they fear health. oh well, because it's not a resort,

actually lie down. uh, a day or even more under droppers, when every 5 minutes they take blood from a vienna for myself, i decided to participate. this is an opportunity to get insulin someday, which you need to inject several times a day, and for example, once a week, and someday in the future. perhaps one of the first to even be cured. the hope remains that some absolute cure will be found, an absolute cure for this. disease, despite the fact that when in principle, i would say that i live life to the fullest. i don’t limit myself to anything, of course, i still remember my life when i didn’t have to count carb granules. uh, in food and think about what is high or low or my sugar, at the moment, perhaps the departure of many western studies from russia countrywide nobody. and not deadly diseases, but such care is calling from the market to be reflected primarily in patients suffering from some rare disease or

patients with oncological diseases, who today have a very large choice of therapy, and for doctors whether this experience is again an early access to new drugs. this is participation in international cooperation. so i don’t think that the lack of following cuts us off for years from those drugs that companies want to register in russia like that, well, this complicates the situation, we continue to send samples to the western laboratory, and we continue to have clinical trials that were at four until february. and there are russian studies that will be processed in russia. in the first six months of 2022, the ministry of health issued 425 permits for clinical trials , which is almost 30% more than in the same period of 2021, noticeably less in the list of international projects. but much more local trend. e on the redistribution of the research market, the total number of e studies for the first half

of this year, and even more than for e for the first half of last year, or the average according to statistics for 17 and 21 years. we are now talking about statistics published by associations of clinical trial organizers, but in the second quarter the number of international clinical trials decreases, the number of local trials increases, the number of russian equivalence trials increases. uh, that is, more. hmm, the relative share of russian. the share did not increase relative to international ones; it decreased in russia, foreign pharmaceutical companies. often, the last phases of research are carried out. there are already evaluating effective dosages side effects and almost always these are drugs for the most dangerous diseases. what does clinical research mean for the patient? we understand that these are often breakthrough innovative drugs in such super, for example, as oncology and for patients. e recruitment into clinical trials

means, sometimes it means saving a life, the association of patients in russia has already turned to western pharmaceutical companies. please return the study to the country. that is, you know this in some way for camouflage, but the refusal in the future to supply life-saving drugs to our country, so we consider the interests and rights of patients here very cool. e are violated, of course, the russian pharmaceutical industry is moving forward and there is, uh, a whole play, yes, companies that operate at the highest international level, but we must understand uh, everything, uh, all niches are not just physically, especially in a short time, they cannot be closed foreign companies will be able to stop recruiting russian. centov, explaining the suspension of the logistics problem in order for the study to be validly recognized and its results not certain conditions were questioned. here are biomaterials according to these conditions. in the event of any validation, the audits must be

delivered within there in various ways from 24 to 48 hours to the central laboratory. unfortunately , there was no central laboratory on the territory of the russian federation before these events. the more we talk to the companies, the more they say they would love to come back here. uh, either it will be open. e, central laboratory on the territory of the russian federation where we, respectively, will be able to withstand these guarantees, or the borders will be opened to russian standards, if at least one medical center did not participate in the research in russia, the device cannot receive state registration and be legally sold exception made for medicines for arfan, that is, extremely rare diseases, the university spoke out i do not agree with the fact that we will lose 300 promising drugs there in the near future, which could come to us. well, apparently colleagues do not know our regulator very well, it will be able to get, but this is not within the framework

of multicenter studies, but if any company wants to register this drug in the russian federation, then it comes here and conducts only in the russian federation without including foreign countries, and pre-registration studies that the russians will not be there participate. uh, in research. well, it's in the research phase. they get this drug, they get it for free, but this is a fairly small number, as a rule, from the total number of cases , this does not mean absolutely that the drug is not here will come or vice versa, if the study. it was carried out here, then 100% that the drug will come here. shogrin's syndrome appeared dryness in the organs of the eye, nose in the mouth, the skin was very dry and i had a problem with my eyes with vision, but no matter how

focused my vision was, i worked at the right institute, and i suddenly stopped. to work as before i was diagnosed. in general, it's enough. soon almost immediately. well, as far as i'm concerned, this disease is a fairly rare autoimmune rheumatological disease. and so the medicines that directly treat exactly uh. this disease is not his, viz. eh, the ones that soften. uh, symptoms at this center that specializes in clinical research on innovative drugs. she got into the program testing a new russian cure for her illness. uh. hmm uh, i actually had a mitigation of the symptoms of the disease. and now it’s treating

precisely it’s painful, i’ve been noticing my syndromes lately, that it’s become easier for me to go out loud and other symptoms, so i see which is beneficial. that's it. this is a treatment with a frequency of 2 weeks. uh, i come to the clinic , uh, a mandatory examination is carried out, the study is necessary at this time and an injection is given, and the next 2 weeks. i have already come to such a point that now i will leave these injections for myself at home, all the drugs are given to me in my hands. she has been in the program for 2 years. this is an opportunity not only to help scientists, but also to get quick access to treatment herself and undergo free examinations. i hope to receive this medicine for a long time while the process is going on.

uh, if research. and then, if it passes, this is a survey with positive results, it goes on sale, then i will also be able to receive it on this. i hope my experience helps and my results. residents will help in that it will enter the market this drug. i will take it the clinic was created under the alzheimer's prevention and disease project. volunteers received drugs and were followed up for 5 years. today, there are a lot of research in various areas of neurology . neuro degenerative diseases. uh, we were participating in clinical trials, and in this cardiology we had a number of protocols for the prevention of dyslipidemia and cardiovascular complications. and we work in psychiatry,

including in child psychiatry, recruiting new western studies. they stopped here, but at the same time, the tests already begun are continuing and, as the companies promise, they will be brought to an end when hmm began to stop. and new research in russia and then current research, well, at least in our the center they all continued part of the analyses. we are now sending to russian laboratories. these are invitro and helix uh, since we have to evaluate rather quickly, yes, safety for patients, therefore, well, pharmaceutical companies, including global ones, and a number of them have made a decision, yes, and we are now working with russian laboratories. at the same time, those samples that require a evaluation in the central laboratory. they continue to arrive at the central laboratory, despite any difficulties. petersburg biocad is known

with its innovative developments, today there are more and more studies of russian and breakthrough drugs and the number of ongoing clinical trials. we have increased if last year there were 23 active programs already in the twenty- second of them 37 and we plan to increase the number of clinical trials conducted simultaneously the company received permission to study original drugs developed in russia , including for the treatment of melanoma and other diseases in august we received permission to conducting a clinical study in spinal muscular therapy, where children up to 8 months will participate, is also actively implemented, a program for neuroblastoma is also in younger patients, and the study is interesting from our original and is not like any other drugs for the treatment of diseases in jareva. this is called spondyloarthritis in another way

and now the enrollment in the second phase of the clinical trial is already being completed. at first it was ordinary back pain, then blockade injections are no longer victor was helped by his opener, as most often happens cases of ankylosing sponditis. she was diagnosed with ankylosing spondylitis at a young age due to the mobility of drugs. the only thing that is being improved and more usefully lends itself to full radiation is only stopped. now he is in remission and undergoes regular examinations. in lymphology in novosibirsk , it is here that they have been dealing with the problems of rheumatology for more than 20 years. ankylosing spondylitis causing fusion of the vertebrae has been successfully treated with genetic engineering preparations all these years, but they expensive and require special storage, the average course of treatment of a patient with engineered pectyrogen disease with biological preparations today in russia is from 400 to 800,000 rubles. in year. this is

a serious burden on the budget. so here they thought about an alternative drug for the disease. ankylosing spondylitis, an extremely widespread rheumatic disease, it is considered that approximately 0.2.06% of the world's population suffers from this disease. this is a colossal number. here is an average patient falls ill approximately in 20 years. approximately 10 years, the disease is manifested by the fact that his back hurts in the morning. he does not pay attention to this, he believes that everyone will consider him some kind of malingerer for the agrants, but only when he can no longer get out of bed. he is starting to think about himself now going to clinical trials the drug will be based on optomers of small molecules that bind to target molecules and hit the target the authors are synthesized artificial chemical synthesized short fragments of nucleic acids that are able to specifically bind strictly defined by molecules. in our case,

such a molecule is interleukin, 17, which , uh, triggers inflammation in spondyloarthritis. our task is to bind this molecule with the help of an optomer and place it to give a signal for inflammation . the synthesized molecule showed that it is not toxic to the laboratory. animals and have shown that in mice in which we specifically induced spondyloarthritis after the introduction of autoworld, while signs are mitigated illness. that is, they increase mobility. they walk better innovative drug. after all you research. it may be ready by 2030, patients will have to inject into the substance, like diabetics insulin all their lives, so for him at the institute they are developing a gadget for injection and it would be as convenient as possible to create

a special device, and in which there would be a reservoir with a medicine, using the example of insulin pump or insulin pen that can be with the patient for a long time together. and at the same time, drugs do not deteriorate, do not lose their effectiveness, retain their usual activity. and, uh, optomeric technologies allow us to assume that such a device can be created while research is still at the start, but the institute staff has already managed to test the drug for safety. the path from a molecule to a pharmaceutical market for innovative drugs around the world takes years, even decades, but only in this way. step by step, scientists are working to make their drugs available in the future. more patients.

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